Shows
BioSpaceSecond Half Milestones, KalVista’s Surprise Approval, Another RFK Jr. Lawsuit, MoreWhile most of the U.S. was celebrating the 4th of July holiday, President Donald Trump was busy signing the One Big, Beautiful Bill into law. This wide-ranging tax law has a few implications for the biopharma industry, including expanded IRA exemptions for orphan drugs. Looking ahead to the second half of 2025, BioSpace reviews some of the upcoming catalysts highlighted by Jefferies’ “Halftime Show” report,including a highly anticipated Phase III readout for Eli Lilly’s oral obesity candidate orforglipron and an eye on rare disease decisions under the “new” FDA. Speaking of FDA decisions, this week kicked...2025-07-0923 min
BioSpaceUnderstanding the FDA's AI Guidance in PharmacovigilanceIn this episode of Denatured, Archana Hegde from IQVIA discusses the practical challenges faced by pharmacovigilance (PV) professionals as they navigate the FDA's first draft guidance for AI in drug development, published in January 2025. Hegde explains that the vagueness of the current framework is like “a recipe with no pictures and mystery ingredients." During the discussion, she highlights areas of existing confusion.This episode is presented in partnership with IQVIA.HostLori Ellis, Head of Insights, BioSpaceGuestArchana Hegde, Senior Director, PV Systems...2025-07-0124 min
BioSpaceNavigating Funding Freezes and AI FrontiersLori Ellis, head of insights at BioSpace, discusses some of the recent events and topics that are buzzing around BIO and DIA in 2025 with Rich Daly, CEO of Catalyst Pharmaceuticals, Peter Ronco, CEO of Emmes Corporation, and Phil Vanek, founder of Redline Bio Advisors. They address funding, the partnering market, AI, and also the recent FDA and CGT roundtable discussion.HostLori Ellis, Head of Insights, BioSpaceGuestsPeter Ronco, CEO, EmmesPhil Vanek, Founder, Redline Bio Advisors; Chief Commercial Officer, ISCT...2025-06-1927 min
BioSpaceAnother Gene Therapy Death; Biopharma M&A Picks Up; a Vaccine Board of Vaccine SkepticsThis week, BioSpace is at 50% power as Heather McKenzie and Jef Akst are off attending this year’s BIO Conference in Boston. The half-team discusses this week’s biggest news: the death of another patient who took Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys. The patient was a non-ambulatory teenager who experienced acute liver failure after receiving the gene therapy, which is the same cause of death for an Elevidys patient reported in March. Sarepta announced that it was halting treatments to non-ambulatory patients and on a media call discussed new steps in its therapeutic protocol for pre...2025-06-1820 min
BioSpaceRFK Axes CDC Vaccine Advisors ; Metsera’s Weight Loss Win; FDA Supports CGTThis week the BioSpace team was sent into an after-hours scramble by the news that Health and Human Services Secretary Robert F. Kennedy Jr. had fired the remaining members of the CDC’s Advisory Committee on Immunization Practices. The secretary argued in an op-ed that accompanied the announcement that the “clean sweep” was necessary to “reestablish public confidence in vaccine science.” The move came amid heightening rhetoric from Kennedy about the safety of vaccines and sparked concerns that the Secretary will replace the committee with people who sympathize with his anti-vaccine positions. On the drug developmen...2025-06-1120 min
BioSpaceAI's Role in Decoding the FDA's New Regulatory CommunicationsIn a dynamic regulatory environment, IQVIA’s Michelle Gyzen suggests that AI may be the best and only way to keep with changes that are happening daily–and sometimes hourly.In this discussion Lori and Michelle touch on the governance frameworks for cybersecurity, risk, and how AI transformation and integration is evolving to help regulatory professionals navigate the speed and complexity of global requirements.HostLori Ellis, Head of Insights, BioSpaceGuestMichelle Gyzen, Sr. Director, Strategic Regulatory Solutions; Head of Regulatory Services Innovation & Technology,2025-06-0515 min
BioSpaceM&A Ticks Up, ASCO Excites and Vaccines Cause More DramaThe words of the week so far in biopharma are “deals” and “cancer”—or, more specifically, money being invested in cancer and other key therapeutic areas. With the American Society of Clinical Oncology’s annual conference underway in Chicago, Bristol Myers Squibb got in the PD-1/PD-L1xVEGF game, paying potentially more than $11 billion to co-develop BioNTech’s solid tumor bispecific BNT327. Elsewhere, Sanofi nabbed the year’s second-biggest buyout, picking up Blueprint for $9.5 billion, expanding its rare disease portfolio. And Regeneron plunked down up to $2 billion to license a dual GLP-1/GIP receptor agonist from Chinese biopharma Hansoh...2025-06-0420 min
BioSpaceHow Target Product Profiles Guide the Industry Through Uncertain TimesLori Ellis, head of insights and Ian Fisher, head of development of analytics at IQVIA, discusses the critical importance of Target Product Profiles (TPPs) for life sciences companies, especially during uncertain times with funding challenges. Fisher emphasizes that TPPs serve as strategic guiding light which help companies articulate their development goals and demonstrate value to potential investors and partners.This episode is presented in partnership with IQVIA.HostLori Ellis, Head of Insights, BioSpaceGuestIan Fisher, Head of Development Analytics, IQVIA2025-05-2229 min
BioSpacePfizer’s $6B China Deal, Drug Pricing and FDA’s New COVID Vaccine PlanPfizer stole the headlines this week with a pact worth up to $6 billion with Chinese biotech 3SBio for a PD-1/VEGF candidate just three months after inking a clinical trials collab for a similar drug with Summit Therapeutics. It’s the largest Chinese licensing deal in recent memory, as pharmas continue to turn to the country to fill their pipelines. Also on Tuesday, the Department of Health and Human Services offered a smidge more detail on President Donald Trump’s Most Favored Nation executive order. A press release explained that drug prices will be tied to the...2025-05-2122 min
BioSpaceEroding Immunity: Vaccine Hesitancy and CynicismPaul Offit, MD, Director of the Vaccine Education Center at the Children's Hospital of Philadelphia and the Maurice R. Hilleman Professor of Vaccinology, Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania, identifies himself as a "vaccine skeptic"–someone who demands data and evidence–which he believes is the appropriate stance for medical professionals and regulators.After the Cutter incident in 1955, which resulted in 250 cases of polio caused by batches of polio vaccine containing live polio virus given to the public, the FDA took up this mantle in evaluating vacc...2025-05-0828 min
BioSpaceTariffs Continue to Dominate Q1 Earnings, AACR Excites Cancer Space, CEO Pay Gaps, MorePolicy issues—particularly tariffs—loom large as Q1 2025 earnings season rolls on, with Pfizer , Novartis, AstraZeneca and many more all reporting this week. On Pfizer’s call, CEO Albert Bourla called the Trump administration’s national security concerns “legitimate,” but objected to the proposed tariffs in general. Meanwhile, Novartis CEO Vas Narasimhan brushed off the tariff risk but expressed concern over President Donald Trump’s desire to bring back the ‘Most Favored Nations’ rule. Meanwhile, cancer conference season is in full swing, with the American Association for Cancer Research’s annual event continuing in Chicago. Merck, GSK, Boehringer Ingelheim...2025-04-3024 min
BioSpaceEconomic Challenges, Strategic Investments: Reshaping the Women's Health LandscapeThis discussion features BioSpace's head of insights Lori Ellis, Kearney partner Martin Hadosi, and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine emphasizing the need for collaboration to improve women's health.This discussion features Lori Ellis, Martin Hadosi, and Melissa Laitner, who emphasize the need for collaborative effort across multiple sectors including industry, healthcare organizations, researchers, and patient advocacy groups. Regarding investment challenges, they acknowledge the current difficult economic environment affects all biomedical research, not just women's health specifically.This episode is presented in partnership...2025-04-2410 min
BioSpaceBonus: Q1 2025 Job Market UpdateIn this bonus episode, BioSpace’s vice president of marketing Chantal Dresner and careers editor Angela Gabriel take a look at job market performance in the first quarter of 2025. They discuss job posting trends, application rates and layoffs. Also discussed are recent decisions of the Trump administration and how they are impacting the workforces of the private sector, HHS and academia.Want to receive our latest quarterly job market reports? Subscribe to Career Insider for our job market updates, job trends, career advice and more.2025-04-1509 min
BioSpaceBreaking Down Barriers: The Nuanced Approach to Women's Representation in Medical ResearchThis discussion features BioSpace's head of insights Lori Ellis, Kearney partner Martin Hadosi, and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine examining the underrepresentation of women in clinical trials. They stress that rather than waiting for regulatory guidance, the industry should proactively improve trial accessibility and inclusivity, as there's mutual benefit in faster enrollment and more diverse participation.This episode is presented in partnership with DIA, in support of their 2025 Global Annual Meeting taking place June 15-19 in Washington DC.HostLori Ellis, Head of Insights, BioSpace2025-04-1010 min
BioSpaceBalancing Protection and Inclusion: The Evolution of Women in Clinical TrialsMartin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives, National Academy of Medicine, join Lori Ellis, head of insights, to discuss the evolution of women's inclusion in clinical trials. They note that while overall representation has improved, significant challenges remain. They highlight how industry mindset has evolved from being protectionist to inclusion.This episode is presented in partnership with DIA, in support of their 2025 Global Annual Meeting taking place June 15-19 in Washington DC.HostLori Ellis, Head of Insights, BioSpaceGuestsM...2025-03-2709 min
BioSpaceTrump’s Pharma Tariffs, Monarez for CDC, Novo’s New Obesity Play, MorePresident Donald Trump doubled down on tariff threats targeting pharma, saying additional levies on pharmaceuticals will come “at some point,” per CNBC. Meanwhile, Johnson & Johnson became the latest big pharma to respond to Trump’s warning of potential tariffs if companies don’t reshore their manufacturing, announcing a massive $55 billion U.S. manufacturing and R&D investment. Not all companies are on board, however: AstraZeneca is looking eastward, pumping $2.5 billion into a new research facility in Beijing. Also on the policy front, Trump nominated acting CDC director Susan Monarez for the top job after pulling his first no...2025-03-2619 min
BioSpaceSarepta’s Elevidys Death, FDA’s Vaccine Move, Weldon Whiplash, PDUFAs in CardioA patient with Duchenne muscular dystrophy taking Sarepta’s gene therapy Elevidys has died of acute liver failure, possibly related to a recent viral infection. Sarepta, which said it will update Elevidys’ label to reflect the new safety signal, saw its shares drop 22% on the news but analysts still seem positive on the drug, as treatment options for Duchenne remain limited.Meanwhile, both AstraZeneca and Taiho Pharmaceuticals announced acquisitions worth up to $1 billion or more in two sizzling therapeutic spaces, cell therapy and antibody-drug conjugates, respectively.Despite canceling a vaccine advisory committee late last month, the...2025-03-1919 min
BioSpaceA Conversation With Mark McKenna, CEO of MiradorOn the sidelines of this year’s J.P. Morgan Healthcare Conference in San Francisco, BioSpace Senior Editor Annalee Armstrong sat down with Mark McKenna, CEO of Mirador Therapeutics, a member of BioSpace’s NextGen Class of 2025. Their discussion here focused on the company’s two-pronged approach to developing therapies for inflammatory and fibrotic diseases, as well as the importance of operating under stealth at this time for the biotech.This is the second episode in a special series of The Weekly focused on how NextGen companies are navigating the current business environment.2025-03-1812 min
BioSpace“Perfect Patient” Industry Burdens; Exits and Investment in Women’s HealthMiruna Sasu, CEO of COTA, has been labeled as a disrupter in the industry. In this episode, she discusses the challenges of stringent inclusion and exclusion criteria of clinical trials. She also dives into her main takeaways from this year's JP Morgan Healthcare Conference and Scope Summit around exits and investment in women's health.HostLori Ellis, Head of Insights, BioSpaceGuestsMiruna Sasu, President and CEO, COTADisclaimer: The views expressed in this discussion by guests are their own and do not repre...2025-03-1316 min
BioSpaceCOVID Reflections, Novo’s Next-Gen Weight Loss Struggles, Another Depression Miss, MoreAs we mark five years since the World Health Organization officially declared the COVID-19 pandemic, the BioSpace editorial team reflects on the health crisis of a generation and how it changed us—and the biopharma industry. While companies like Pfizer, BioNTech and Moderna raked in billions from their vaccines, J&J and Novavax struggled to capture a significant piece of the market. Five years later, much has changed. A substantial number of us now work from the comfort of our homes—though that may be changing for some in the life sciences—and biopharma has a new obsession...2025-03-1218 min
BioSpaceTariff Threat Continues, More Meetings Cancelled, AbbVie Makes Obesity Play, MoreDonald Trump’s tariffs have headlined myriad news stories this week—including at BioSpace, where we reported Pfizer CEO Albert Bourla’s claim that his company is prepared to reshore manufacturing if the president makes good on threats made last month. Eli Lilly also appears to be preparing, commiting $27 billion to boost its U.S. manufacturing capacity. Meanwhile, another regulatory meeting has been canceled under new HHS Secretary Robert F. Kennedy Jr. Reuters revealed last week that an upcoming meeting of the FDA’s external advisers for vaccine policy on March 13 has been canceled—just a week after the CDC...2025-03-0515 min
BioSpaceA Conversation With Kevin Marks, CEO of DelphiaOn the sidelines of this year’s J.P. Morgan Healthcare Conference in San Francisco, BioSpace Senior Editor Annalee Armstrong sat down with Kevin Marks, CEO of Delphia Therapeutics, a member of BioSpace’s NextGen Class of 2025. Their discussion here focused on the company’s novel science of activation lethality, which involves forcing cancer cells to overactivate and thereby overload cell stress pathways, as well as Delphia's relatively smooth path to a $67 million series A raise thanks to contributions from Google Ventures (GV), where Marks was previously employed.This is the second episode in a special series of The Weekly f...2025-03-0418 min
BioSpaceMoney Meets Medicine: A Disruptor's Guide to Life Sciences InvestmentMiruna Sasu, CEO of COTA, has been labeled as a disrupter in the industry. In this discussion, she highlights the challenges of investing in the life sciences industry. She also suggests how the investor mindset needs to change as well as offer solutions that benefit both investors and developers seeking investment.HostLori Ellis, Head of Insights, BioSpaceGuestsMiruna Sasu, President and CEO, COTADisclaimer: The views expressed in this discussion by guests are their own and do not represen...2025-02-2713 min
BioSpaceExamining Gene Therapies, Bispecific Antibodies and Other Novel ModalitiesAt the 2025 National Biotechnology Conference, gene therapies, bispecific antibodies and other novel modalities—relative newcomers to medicine—will be much discussed. In this curtain raiser, BioSpace speaks with conference chair Prathap Nagaraja Shastri of J&J about these highly anticipated topics. HostJef Akst, Managing Editor, BioSpaceGuestPrathap Nagaraja Shastri, Scientific Director and Group Leader, Clinical Pharmacology and Pharmacometrics, Johnson and JohnsonBioSpace is a media partner of the National Biotechnology Conference. 2025-02-2525 min
BioSpaceTrump’s Hammer Hits FDA, Moderna Falls Further and Patent Cliffs LoomPresident Trump has been on a staff cutting rampage since taking office, and this weekend, the hammer came down on an undisclosed number of FDA employees. The firings—which reportedly affected staffers within the FDA’s centers for food, medical devices and tobacco products—came days after Robert F. Kennedy Jr. was confirmed as HHS secretary.One space that could have an ally in RFK Jr. is psychedelic therapies, which the new HHS boss has accused the FDA of “suppressing,” along with stem cell therapies. On the flip side, Kennedy is a well-known vaccine critic, though his confirmati...2025-02-1914 min
BioSpaceA Conversation With Dannielle Appelhans, CEO of COUROn the sidelines of this year’s J.P. Morgan Healthcare Conference in San Francisco, BioSpace Senior Editor Annalee Armstrong sat down with Dannielle Appelhans, CEO of COUR, a member of BioSpace’s NextGen Class of 2025. Their discussion here, focused on the company’s long history leading up to its $105 million in series A funding at the start of 2024 and the possibility of an initial public offering in the future, among other things, represents the first of a special series of The Weekly focused on how NextGen companies are navigating the current business environment. Host2025-02-1809 min
BioSpaceNavigating Patient Journeys with Tom WhiteheadBioSpace’s Head of Insights Lori Ellis and Tom Whitehead, co-founder of the Emily Whitehead Foundation discuss the challenges navigated by cancer patients, weaving in their personal experiences with treatment and how they would encourage those undergoing treatment to speak up and advocate for themselves.This episode is presented by the Genscript Biotech Global Forum 2025.HostLori Ellis, Head of Insights, BioSpaceGuestsTom Whitehead, Author, Keynote speaker; Co-Founder, Emily Whitehead FoundationDisclaimer: The views expressed in this discussion by guests are th...2025-02-1317 min
BioSpaceNew M&A Action, BMS’ Ongoing Cost Cuts and the Insatiable Demand for Weight Loss DrugsWe saw more action on the M&A front this week as Novartisbought back its blood thinner abelacimab and the rest of Anthos Therapeutics for up to $3.1 billion and still ahead, a potential buyout of SpringWorks Therapeutics by Merck KGaA, which confirmed it’s in “advanced discussions” with the biotech. Meanwhile, Eli Lilly signed aglobal licensing deal for a MASH asset with South Korea’s OliX Pharmaceuticals.As Q4 and full-year 2024 earnings continue to roll in, BMS, Eli Lilly,Novo Nordisk, AstraZeneca, Eisai, Vertex and Gilead all reported their results in the past week. Notably, BMS continues to reorg...2025-02-1211 min
BioSpaceThe Patient's Perspective with Tom WhiteheadBioSpace's Head of Insights Lori Ellis and Tom Whitehead sit down and discuss cell and gene therapies from the perspectives of patients. What do caregivers and patients consider to be risks when lives are on the line?
This episode is presented by the Genscript Biotech Global Forum 2025.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Tom Whitehead, Author, Keynote speaker; Co-Founder, Emily Whitehead Foundation
Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their...2025-01-3012 min
BioSpaceTrump Takes Over, Wegovy Still Trails Zepbound and BioSpace Recaps JPMDonald Trump was sworn in as the 47th president of the United States on Monday, bringing with him a host of healthcare nominees and potential changes to the FDA, M&A and drug pricing. The new administration was a key focus point at the 2025 J.P. Morgan Healthcare Conference last week, where Annalee Armstrong spoke to executives from several companies about what they’re expecting from a second Trump term.
Also at JPM, Mirador Therapeutics CEO Mark McKenna boldly predicted that 2025 would see the return of the megamerger. Speaking of M&A, Annalee spoke with leaders from Bi...2025-01-2220 minBioSpaceBonus: Q4 2024 Job Market UpdateIn this bonus episode, BioSpace's vice president of marketing Chantal Dresner and careers editor Angela Gabriel take a look at Q4 job market performance and what we expect to see ahead. We dive into year-on-year data and recent job trends.
Want to receive our latest quarterly job market reports? Subscribe to Career Insider for our job market updates, job trends, career advice and more.
2025-01-2110 min
BioSpaceA Conversation with Peter Marks: Insights into GenScript Biotech Forum 2025In this episode of Denatured, Dr. Peter Marks M.D., PhD. gives his thoughts on the future of cell and gene therapies. He speaks candidly about opportunities and realities, manufacturing and its role in efficacy and the CGT runway.
Dr. Marks was keynote speaker at the GenScript Biotech Forum in San Francisco this week.
Host
Lori Ellis, Head of Insights, BioSpace
Guest
Peter Marks M.D., PhD., Director, Center for Biologics Evaluation and Research (CBER)2025-01-1618 min
BioSpaceA Conversation with Peter Marks and Tom Whitehead: Insights into GenScript Biotech Forum 2025 (Teaser)TEASER: This episode is little sneak peak into upcoming podcasts as well as topics that will be discussed at the 2025 GenScript Biotech Global Forum on January 15 in San Francisco. Listen in as Peter Marks and Tom Whitehead share their thoughts on the CGT space for 2025.
Register for the event here.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Peter Marks M.D., PhD., Director, Center for Biologics Evaluation and Research (CBER)
Tom Whitehead, Author, Keynote...2025-01-1006 min
BioSpaceNextGen Class of 2025, M&A Uptick Predicted Heading Into JPM, FDA Decisions to WatchHappy New Year! BioSpace released our NextGen: Class of 2025 this week, highlighting 25 biopharma startups to watch this year. The companies on this list are not afraid of a challenge, wading into some of biopharma’s most competitive therapeutic spaces. As analysts predict an uptick in M&A in ’25, could some of them be potential targets? One NextGen 2025 company that could already be fielding calls is Metsera, which reported promising Phase II data for its investigational subcutaneous GLP-1 therapy on Tuesday.
The GLP-1 space continues to garner significant attention, with both Eli Lilly and Novo Nordisk seeking to prot...2025-01-0814 min
BioSpaceTrials and Capital: Women’s Health and APAC's Healthcare RevolutionThis conversation focused on a few remaining topics discussed at length at Jefferies late last year, with the same topics anticipated to make an appearance at JPM. In this episode, our guests the industry’s need to catch up with women’s health issues and the innovative lead the APAC region has taken in clinical trials.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Miguel Forte, President, International Society for Cell & Gene Therapy; Board Member, ARM; CEO and Board Member, Kiji Therapeutics
Ali Pashazadeh, Founder, Tree2025-01-0216 min
BioSpaceAnalysis vs Beliefs, CEO Challenges, GLP-1 Investments2025 is set to change the industry. The new administration is poised to challenge many existing processes. The question is whether they will be based on data-driven analysis or ideologies and beliefs.
Our guests address this concern along with the existing challenges CEOs face, particularly manufacturing processes.
Additionally, they discuss weight loss drugs, focusing on GLP-1s, with medical precision.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Miguel Forte, President, International Society for Cell & Gene Therapy; Board Member, ARM; CEO and Board Me...2024-12-1924 min
BioSpaceBiopharma’s Manufacturing Push and Other 2024 TrendsNote: BioSpace is taking a break for the holidays. The next episode of The Weekly will air Jan. 8, 2025. Happy New Year!
Novo dominated headlines over the last week, with a kidney disease label expansion for Novo Nordisk’s Ozempic in Europe but a newly flagged safety risk for the drug, with a Danish regulator requesting that the EMA review reports of a rare eye disease in patients who took the GLP-1. Meanwhile, over the weekend Novo Nordisk’s parent company, Novo Holdings, and CDMO Catalent announced that they had received all regulatory clearances to close the proposed $16.5 bill...2024-12-1813 min
BioSpacePrevious Investment Patterns Set to Repeat in 2025“Cautious optimism” is circling once again as the industry approaches 2025. However, many companies are treading water, barely holding on as the market continues at a slow pace. Ali Pashazadeh and Miguel Forte have an open discussion about the state of the market.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Miguel Forte, President, International Society for Cell & Gene Therapy; Board Member, ARM; CEO and Board Member, Kiji Therapeutics
Ali Pashazadeh, Founder, Treehill Partners
2024-12-0523 min
BioSpace51%: The Untapped MarketWomen represent 51% of the population; not investing is a poor investment strategy. Incorporating women into leadership positions, into board rooms, is the only way to tap this market.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Konstantina Katcheves, Senior Vice President, Innovative Medicines Global Business Development and Acquisitions, Teva Pharmaceuticals
Sanskriti Thakur, Chairwoman, TOWER Capital Group2024-11-2113 min
BioSpaceAbbVie’s Surprise Schizophrenia Flop, AstraZeneca’s China Drama, Hope in Huntington’s, MorePossibly the biggest news this week comes from the schizophrenia space, where AbbVie’s emraclidine failed two mid-stage trials. Acquired by AbbVie in its $8.7 billion Cerevel Therapeutics buy, this result is in stark contrast to that of Bristol Myers Squibb’s $14 billion acquisition of Karuna Therapeutics, which yielded Cobenfy—the first novel schizophrenia drug approved in 35 years.
Also having a tough month is AstraZeneca, which despite reporting strong Q3 sales Tuesday has been dealing with drama at its China headquarters as a top executive there is being investigated for alleged medical insurance fraud.
Meanwhile, Bayer had le...2024-11-1315 min
BioSpaceInvesting in AI: Benefits, Regulatory ChallengesNo discussion regarding the future is complete unless AI is incorporated.
In this episode, Konstantina Katcheves of Teva Pharmaceuticals and Sanskriti Thakur of TOWER Capital Group provide their insights on the impact of not only the benefits of the technology but the regulatory challenges and uncertainty surrounding AI.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Konstantina Katcheves, Senior Vice President, Innovative Medicines Global Business Development and Acquisitions, Teva Pharmaceuticals
Sanskriti Thakur, Chairwoman, TOWER Capital2024-11-0713 min
BioSpaceLilly’s Q3 Miss, Novo’s MASH Win, CAR T’s Autoimmune Pivot, MoreLast week, Eli Lilly suffered a rare third-quarter earnings miss as diabetes and obesity drugs Mounjaro and Zepbound fell short of Wall Street expectations, in
part due to wholesalers’ stocking decisions. On the flip side of the GLP-1 race, Novo Nordisk’s Wegovy aced part 1 of a pivotal Phase III trial in metabolic dysfunction–associated steatohepatitis (MASH), with results comparable to Madrigal’s Rezdiffra, according to analysts.
In ClinicaSpace this week, BioSpace explores the shift in the CAR T cell therapy space from cancer to autoimmune disease as early data spark excitement and companies recruit autoimmune experts to fill i...2024-11-0616 min
BioSpacePfizer’s Q3 Earnings Win, Deals Galore, Countdown to Election, MoreEarnings heat up as Pfizer got a much-needed Q3 beat amidst criticism from activist investor Starboard Value. Novartis and Sanofi are among others that have outpaced Wall Street expectations this quarter, as Eli Lilly, Merck, AbbVie, Amgen, Biogen, GSK, Bristol Myers Squibb and Takeda are all reporting today and tomorrow.
The past week has also seen a pack of deals, with AbbVie’s $1.4 billion buy of Aliada Therapeutics, Roche’s potential $1 billion deal with Dyno Therapeutics
and Novartis’ up to $2.1 billion commitment to Monte Rosa’s molecular glue degraders.
With less than a week until Election...2024-10-3017 min
BioSpaceSteady But Slow: Future Outlook for InvestmentIn this episode, we’re talking money.
The guests in this discussion recognize that the economic climate has been different (and more chaotic) in last three to four months, but expect a steady but slow improvement as we move into the new year.
This episode reviews 2024’s investment landscape and the policies influencing investment going into 2025.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Konstantina Katcheves, Senior Vice President, Innovative Medicines Global Business Development and Acquisitions, Teva Pharmaceuticals
Sanskriti Thakur, Chairwoman, TOWER Capital2024-10-2416 min
BioSpaceTrodelvy’s Bladder Cancer Withdrawal, Sage Therapeutics Layoffs, Sanofi’s Radiopharma Investment, MoreLast week, Gilead withdrew Trodelvy in bladder cancer after the antibody-drug conjugate failed to meet the primary endpoint in a confirmatory study. This follows Pfizer’s recent withdrawal of another therapy that had earned FDA accelerated approval, Oxbryta for sickle cell disease. With few other options available to patients, BioSpace took a look at 5 sickle-cell candidates currently in clinical trials.
Following a disappointing Alzheimer’s readout, the company’s third neuro stumble in six months, Sage Therapeutics will lay off over 165 employees—about
33% of its workforce. The company is reporting Q3 earnings on Oct. 29.
On a more pos...2024-10-2318 min
BioSpaceQ3 Earnings Kick Off With J&J, Bluebird in Tough Spot, Novo-Catalent Deal Under Fire, MoreIt’s that time again: earnings season. Q3 calls started out with a bit of a snore from J&J, which did beat analyst expectations but announced no big shakeups or surprises. As expected, the company saw shrinking revenue for its blockbuster Stelara, which just lost to Lilly’s Omvoh in a
head-to-head clinical trial in Crohn’s disease.
Last week, a concerning study was published regarding seven children who developed blood cancers after being treated with bluebird bio’s gene therapy Skysona. This publication comes at a time when the company is struggling to regain its share pr...2024-10-1615 min
BioSpaceHow AI Could Ease Tension in Clinical TrialsDesignating something "safe" in this industry means acceptable risk. AI can help us improve acceptable risks if it is used appropriately. However, industry experts must be thoughtful and responsible in their use of AI within clinical trials.
In the third episode of our mini series on artificial intelligence, our guests explore the challenges and benefits of integrating technology into the lives of patients.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Mike King, Senior Director of Product and Strategy, IQVIA
Moritz von Stosch Chief Innovation Officer, DataHow
Nindhana Parantham...2024-10-1012 min
BioSpaceBioSpace at Meeting on the Mesa, WuXi Considers Selling U.S. Facilities, Big Pharma Layoffs, MoreThe cell and gene therapy sector may be on the road to recovery after being met with investment headwinds following the highs seen during the pandemic, according
to data presented Monday at the 2024 Cell & Gene Meeting on the Mesa hosted by the Alliance for Regenerative Medicine. BioSpace News Editor Greg Slabodkin reports from Phoenix.
Last week, news broke that WuXi AppTec and WuXi Biologics, two companies named in the BIOSECURE Act, are looking to unload facilities in the U.S. and abroad as uncertainty looms over their U.S. business prospects.
As Eli Lilly resolves sh...2024-10-0916 min
BioSpaceBMS’ Schizophrenia Approval, Pfizer’s Sudden Sickle Cell Withdrawal and Roche’s Pharma Day
Bristol Myers Squibb notched one of this year’s biggest approvals as the FDA greenlit Cobenfy, formerly KarXT, as the first novel treatment for schizophrenia in 35 years. Cobenfy’s origins go nearly as far back, beginning as an Alzheimer’s hopeful developed by current obesity rivals Eli Lilly and Novo Nordisk. On a lower note, Pfizer withdrew sickle cell medicine Oxbryta from the market, sending patients and advocates scrambling for more information.
In other news, Roche hosted a Pharma Day event where it touted the $850 million acquisition of a portfolio of CDK inhibi...2024-10-0217 min
BioSpaceAI Return on Investment: Just Because We Can, Should We?Globalization, return on investment, diverse data sets undiscovered: this episode continues the exploration of AI. As we see the industry level out AI adoption, the future is still exciting and yet uncertain. With quantum around the corner, there are still challenges with AI at every turn.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Mike King, Senior Director of Product and Strategy, IQVIA
Moritz von Stosch Chief Innovation Officer, DataHow
Nindhana Paranthaman, Executive Medical Director, Clinical Development, Summit Therapeutics
Paul Agapow, Head of Data Science, BioNTech2024-09-2618 min
BioSpaceSickle Cell Gene Therapies Reach Patients, Moderna Cuts, Obesity Pill Race and ESMO 2024After their groundbreaking approval last year, infusions of Vertex and CRISPR Therapeutics’ and bluebird bio’s sickle cell gene therapies have begun, bringing hope to patients and the companies closer to realizing revenue. Meanwhile, bispecifics and anti-TIGIT therapies were all the rage at ESMO 2024 as BioNTech, GSK and iTeos, BMS and more reported positive results across multiple cancers.
Last week, Moderna announced it would slash its R&D budget by $4 billion as it targets 10 new approvals through 2027. Possibly boding well for this target, the biotech features prominently on our list of 5 late-stage mRNA vaccines to watch. Meanwhile, the...2024-09-1817 min
BioSpaceAI Promises: Funding Data Literacy and Reality FirstAs 2024 closes, it is only right to discuss where we are when it comes to AI and where we will be in the future.
As technology continues to evolve and blend into science in 2025 and beyond, a practical approach to what it can and cannot do must be explored.
Additionally, how overpromising while underdelivering has affected investors' and the industry’s confidence in AI.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Mike King, Senior Director of Product and Strategy, IQVIA
Moritz von Stosch Chief Innovation Officer, DataHow
Nindhana Paranthaman, Executive Medical Direct...2024-09-1219 min
BioSpaceFuture-Proofing: Inclusive and Protective Patient StrategiesAs the legal landscape continues to evolve, the uncertainty surrounding diversity, equity and inclusion (DEI) initiatives increases though the life sciences industry continues to move forward with DEI initiatives to include all patients in clinical trials.
In this episode, our guests discuss framing strategies designed to protect DEI initiatives from legal challenges. Additionally, the guests acknowledge the importance of clinical trial sites in gaining patient trust. We also address the increased burden technology is putting on the sites as well as patients, suggesting potential ways to reduce these burdens.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Otis...2024-08-2925 min
BioSpaceEyes Wide Open: Gaining Patient Trust in the Face of Evolving Women’s Health Policies in State LegislationsIn the second part of the discussion, our guests address clinical trial design which if done without careful consideration of the patient population can exclude patients from clinical trials instead of being inclusive.
Using specific examples, our guests highlight the progress the industry has made to design inclusive clinical trials but stress the continuing need for improvement.
In parallel, our guests discuss the continual judicial actives at the federal and state level surrounding women's health issues. As states begin to challenge other states for access to women's data, the future participation of women patients in...2024-08-1523 min
BioSpaceLykos Rejection, Pfizer’s RSV Win, Lilly Vs. Novo and MoreIn one of the year’s most highly anticipated decisions, the FDA rejected Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder (PTSD). Reaction from Lykos was swift, with the company stating its intention to “ask for reconsideration of the decision.”
Meanwhile, against the backdrop of the CDC’s recent RSV guidelines, Pfizer scored a big Phase III win for its shot in immunocompromised adults. Separately, Merck halted a Phase III trial of its Keytruda, anti-TIGIT, chemo combo in small cell lung cancer but made a splash with the potential $1.3 billion acquisition of Curon’s B cell depletion therapy. And...2024-08-1421 min
BioSpaceThe Political Shape of the Future Clinical Trial SpaceThe 2023 New Benchmarks on Demographic Disparities in Pivotal Trials study indicates that as Black representation increases, clinical trial enrollment time decreases.
This is contradictory to what has been reported in the past. However, the highest disparity in clinical trial enrollment remains to be Black or African descent patients, with only a third being enrolled in clinical trials.
Understanding not just the benefits on patient lives, but also the cost-effectiveness of adequate representation, pharma companies are continuing to lean into DEI practices for their clinical trials.
In parallel, the legal environment for DEI initiatives...2024-08-0122 min
BioSpace2 Earnings Bonanza, M&A Accelerates and Alzheimer’s DataSecond-quarter earnings season continues with Big Pharma beating Wall Street expectations, the author of an encrypted email sent to BioSpace has a proposal for Moderna and Merck, Roche and Viking seek quicker entry to the obesity market, and AAIC is in full swing.
As July comes to a close, biopharma second-quarter earnings continue to roll in with Pfizer, Merck, AbbVie, AstraZeneca and many more reporting. So far, everything is coming up roses with most major companies beating Wall Street expectations. But every rose has its thorn and for biopharma executives this has long been drug price negotiations...2024-07-3118 min
BioSpaceLayoffs Persist, GLP-1s Launch for Weight Loss in ChinaWhile the biopharma industry has seen glimmers of economic optimism, there were still more than 14,000 employees laid off in the first half of 2024. And BioSpace’s readers are among them. In this week’s Job Market Trends, H2 Update, 43% of respondents indicated they are currently unemployed, the highest-ever rate since BioSpace started conducting surveys.
One large company that intends to eliminate around 680
jobs in its project development sector over the next few years is Novartis. Despite this, the Swiss pharma announced positive Q2 results last week, exceeding revenue expectations thanks to the continued revenue generated by its bloc...2024-07-2415 min
BioSpaceWho Is Driving The Bus - Drug Developers & Healthcare Providers or AI?This is the third episode of Denatured's discussion on diversity, equity and inclusion (DE&I).
AI represents unlimited opportunities to increase efficiency, but as our guests note, it can also do incredible harm to patients and society. It largely comes down to training of the professionals using AI, as well as understanding how the AI model was grounded or trained. The data quality must be accurate and clean, but as they noted, DE&I is an issue the industry has been struggling with for decades.
The solution lies in humans identifying problems, such as the...2024-07-1819 min
BioSpacePfizer’s Oral GLP-1 Push, Lilly Vs. Novo and PBMs Under PressurePfizer stole the show late last week with the announcement that it will move forward with its oral GLP-1 analog danuglipron. While Pfizer may hope to advance in the already crowded race to bring an oral GLP-1 to market, some analysts reacted to the news with caution, mainly due to lack of data.
Meanwhile, in the injectable GLP-1 space, it’s primarily a two-horse race between Novo and Lilly. While Novo had a two-year head start, Lilly has been picking up ground since the November 2023 approval of Zepbound (tirzepatide). A recent observational study saw tirzepatide outperform Novo’s se...2024-07-1713 min
BioSpaceDE&I: Understanding That We Don’t Understand at Molecular LevelThis is the second episode of Denatured's discussion on diversity, equity and inclusion (DE&I).
Data is the essential piece for both science and technology. The lack of DE&I data is becoming even more imperative as we move towards personalized medicines. Without understanding why there are differences in outcomes, the industry will continue to see worsening outcomes. However, DE&I is still not at the forefront of the mind during clinical trial designs, which influences not only the training but the application of AI models. Additionally, what this means not only for life sciences but also...2024-07-0223 min
BioSpaceBioSpace at #DIA2024: Workforce Trends, Trial Design, Peter Marks & RecapBioSpace's Lori Ellis and Chantal Dresner are bringing live updates from #DIA2024 in San Diego this week where we've been attending sessions on trial design, digital twins, cell and gene therapy regulation, clinical research workforce trends, professional development and many more. We discuss some of our key takeaways and event highlights, including Lori's exclusive interview with CBER director Dr. Peter Marks.
Hosts
Lori Ellis, Head of Insights, BioSpace
Chantal Dresner, VP of Marketing, BioSpace2024-06-2009 min
BioSpaceChallenging Research Models to Improve Health EquityDiversity, equity and inclusion (DEI) continues to be a challenge for drug and medical device developers. While there has been some improvement in clinical trials, our guests note that unless there is a commercial or regulatory need, DEI is still an afterthought for many developers when designing clinical trials.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Ali Pashazadeh, CEO,Treehill Partners
Charlotte Jones-Burton, Board Member, bluebird bio; Founder & President, Women of Color in Pharma
Chia Chia Sun, Chief Commercial Officer, Fab Biopharma; CEO, Damiva
Phyllis Greenberger, Senior V...2024-06-2023 min
BioSpaceBIOSECURE’s Surprise Absence, the $100+ Billion Future Weight-Loss Market, DIA and MoreWe’re off to a rocky start this week on the clinical side, with some safety issues. BioNTech and MediLink’s ADC was placed on partial hold after multiple patient deaths, and some safety concerns were also revealed for Gilead’s blood cancer therapy magrolimab.
But on a more upbeat note, DIA in San Diego is filled with hope of collaboration and a focus on the patient experience. Head of Insights Lori Ellis joins BioSpace’s editorial team to discuss what’s she’s observed so far at the meeting and what she’s looking forward to in the coming d...2024-06-1914 min
BioSpaceBioSpace at #DIA2024: Convergence and CollaborationBioSpace's Lori Ellis and Chantal Dresner are bringing live updates from #DIA2024 in San Diego this week where the first day kicked off with an inspiring story from Tom and Emily Whitehead of the Emily Whitehead Foundation, setting the tone for patient-centric discussions.
The following panel featuring Emer Cooke, Chair, ICMRA an Executive Director, European Medicines Agency; Peter Marks, Director, CBER, FDA; Carsten Linnerman, CEO, Neogene Therapeutics, AstraZeneca Group; Dean Kamen, Founder, DEKA; and Stacy Hurt, Chief Patient Officer, Parexel emphasized the imperative of collaboration to improve outcomes, between regulatory bodies as well as with patients.
2024-06-1705 min
BioSpaceDonanemab’s Promise, BIO Wrap and Mass LayoffsThe big news of this week so far was Monday’s FDA advisory committee for Eli Lilly’s Alzheimer’s drug donanemab, where the vote was unanimous in support of the anti-amyloid antibody. If approved, donanemab would be a direct competitor of Biogen and Eisai’s Leqembi, but analysts believe there’s plenty of room in the market for
both, and even predict that donanemab’s potential approval could be beneficial for Leqembi in the long run by increasing investments in advocacy and infrastructure.
The mood was decidedly different from last week’s FDA
adcomm, which voted overwhelmingly...2024-06-1216 min
BioSpaceBioSpace x DIA: Robust Integrated Regulatory StrategiesHow do we ensure strategic vision and thoughtful implementation when pursuing new opportunities in science and technology?
Our guests discuss challenges around reimbursement, intellectual property, change management and the critical nature of early engagement.
Additionally, we are joined by Tamei Elliott of DIA who shares insights on key discussions and themes of the upcoming meeting in San Diego.
This is the third and final episode in our preparation for the roundtable discussion: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products taking place at the DIA 2024 Global Annual Meeting.
2024-06-0621 min
BioSpaceThe ABCs of Biopharma This Week: ASCO, BIO and CancerConference season kicked into high gear this week with the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and the BIO International Convention in San Diego. Check out BioSpace’s ASCO24 Tracker with all the biggest data and other news from the cancer meeting, which wrapped up on Tuesday.
Among the trial results highlighted at ASCO24 were BMS’ Phase III study results in liver cancer. There was also a lot of news on non-small cell lung cancer (NSCLC): Pfizer presented results from a Phase III trial evaluating its ALK inhibitor Lorbrena, BMS provided three updates on i...2024-06-0512 min
BioSpaceBioSpace x DIA: Advanced Therapy Product Regulatory ConfusionRegulators suggest developers engage in discussions early, however those conversations cannot take place unless developers are sure of the asset's category.
Existing confusion surrounding advanced therapy products may become more challenging as both science and technology evolve.
With both developers and regulators, two risk adverse entities, addressing this evolution and continually updated regulations, advanced therapy product development continues to be a collaborative process.
This is the second episode in our preparation for the roundtable discussion: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products taking place at the DIA 20...2024-05-3018 min
BioSpaceAstraZeneca’s Ambitious Target, Pharma Layoffs Continue and ASCOAt its Investor Day 2024 event last week, AstraZeneca announced plans to reach $80 billion in total revenue by 2030—up from $45.8 billion in 2023—and to launch 20 new medicines by the end of the decade. Does AstraZeneca have the assets and developmental pipeline to hit this lofty target?
Meanwhile, Bayer, BMS and Pfizer are looking to conserve cash through cost-savings plans that include layoffs. It’s a trend we’ll be keeping a close eye on as companies face potential implications from upcoming patent expirations, the Inflation Reduction Act’s Drug Price Negotiation Program and investor expectations.
On the R&D fr...2024-05-2813 min
BioSpaceBioSpace x DIA: Navigating the Emergence of CGT Combination ProductsWith every new advancement in either science or technology there is increased excitement as we see the potential. Cell and gene therapies (CGT) as combination products are emerging as the stage in the evolution of technology and science merging together. While the potential benefits for patients are great, there are risks and challenges that must be carefully considered.
This discussion is part of one of a precursor of the roundtable discussion: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products taking place at the DIA 2024 Global Annual Meeting.
James Wabby...2024-05-2320 min
BioSpaceWomen's Health: Where Politics and Science Meet12 billion dollars: one of the boldest women’s health research moves an administration has made for women’s health research. On a global scale, this has caused countries and sovereign states to start investing in women’s health.
But in the United States, the funding is not guaranteed. It depends on congressional approval, which is complicated during an election year. As the United States continues to grapple with politics and science meeting, the global healthcare sector is already beginning to reframe the language and invest in women’s health research.
Host
...2024-05-0921 min
BioSpaceBioSpace Heads to #ASGCT, Along with Thousands in Cell and Gene TherapyIn this special edition of The Weekly, we discuss the much-anticipated annual meeting of the American Society of Gene & Cell Therapy in Baltimore. It starts Tuesday and will hit on wide-ranging issues facing the cell and gene therapy (CGT) space, from new therapeutic advances to safety concerns and regulatory considerations to manufacturing and commercialization.
Big hitters in the CGT space will be there. Sarepta, whose gene therapy for Duchenne muscular dystrophy Elevidys received accelerated approval in June 2023, will be presenting, as will CRISPR Therapeutics, which in the last few months brought to market Casgevy, its Vertex-partnered CRISPR-based...2024-05-0312 min
BioSpaceWhere Do We Go From Here? The Future of Women's HealthThe potential impacts on clinical trial outcomes warrant a discussion surrounding the current definition of women’s health.
In the second episode on our series on women's health, we discuss what may happen to future generations if women, the custodians of generational health, are not comfortable sharing complete medical histories. Additionally, we discuss how broadening the definition will open funding to address women’s health.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Sans Thakur, Founder and Chairwoman of Tower Capital
Chia Chia Sun, Chief Commercial Officer at Fab Biopharma2024-04-2522 min
BioSpaceAmylyx and ALS, Continued ADC Excitement, Dire Drug ShortagesThe past two weeks have seen Amylyx lose its only marketed product but receive numerous accolades for its decision to voluntarily withdraw Relyvrio after a failed Phase III trial in amyotrophic lateral sclerosis. Analysts and insiders spoke with BioSpace this week about the company's future and a possible regulatory precedent for other drugs approved based on a single trial.
Elsewhere, antibody-drug conjugates continue to steal the show in oncology. At the American Association for Cancer Research’s annual meeting, Merck and Kelun Biotech presented Phase I/II data showing that their TROP2-directed ADC elicited promising disease con...2024-04-1720 min
BioSpaceIt's a Design Problem: Women and Clinical TrialsLast month, President Biden signed an Executive Order on Advancing Women’s Health Research and Innovation, signalling the significance of women's health to the government and consequently investors.
While women’s clinical trial participation has increased, clinical trials still largely are not designed for women. In this episode, our guests discuss the many areas where trials can be improved, such as human and historical diagnosis and screening biases, accessibility, data capturing, and more. They further discuss the importance of women’s health for the future.
Host
Lori Ellis, Head of Insights, BioSpace
Gues...2024-04-1119 min
BioSpaceWill the IRA’s Focus on the Pharmaceutical Industry Hurt the World’s Healthcare System Instead of Helping Patients?The pharmaceutical industry is facing critical attention, particularly around drug pricing and development costs. Drug development cost is about 10% of the total healthcare spend in the United State. Broader issues such as local monopolies, utilization, unit, and costs and local monopolies, politics and a fragmented payer system contribute to the increasingly high costs to patient.
Challenging as these issues are, they must be addressed to lower patient costs. In this episode, our guests discuss more efficient drug development practices but also some of the broader issues within the United States healthcare system and the IRA’s impacts on...2024-03-2822 min
BioSpaceMoney talk: Salary trends and raisesThis week, we're talking money! Following the release of BioSpace's 2024 Salary Report, we discuss salary trends and how they are impacting the biopharma workforce. Considering growth rates, we also discuss asking for raises vs looking for a new job and what salary trends may spell out for the rest of the year.
Guest
Chantal Dresner, VP of Marketing, BioSpace
Angela Gabriel, Content Manager - Careers, BioSpace
Host
Lori Ellis, Head of Insights, BioSpace 2024-03-2115 min
BioSpaceHistoric approval for MASH, CAR-Ts in the spotlightPhew, what a week!
One of the most anticipated FDA decisions of the year dropped last week when the regulator approved Madrigal’s Rezdiffra as the first therapy for MASH (formerly known as NASH).
Then on Friday, BioSpace kept a close eye on an advisory committee discussing J&J’s Carvykti and BMS’s Abecma, two CAR-T therapies seeking label expansions as earlier lines of treatment in multiple myeloma despite the risk of early death.
Also discussed: BIO’s decision from last week to cut ties with the China-based biotech WuXi AppTec. 2024-03-2017 min
BioSpaceThe unintended consequences of small moleculesContinuing on from our previous episode "The gap is where the pain is", this episode focuses on a healthy discussion regarding the IRA, particularly the unintended consequences to small molecule development within the industry and for patients.
Topics explored in this discussion are potential reasons behind the small molecule negotiation timeline decision, the antibody drug conjugates (ADC) boom, the investment environment, and positive steps the government is making through legislation to equalize the negotiation timeline.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Ali Pashazadeh, CEO,Treehill Partner...2024-03-1424 min
BioSpaceThe gap is where the pain is: Drug pricing and patient costsWhen it comes to drug pricing, there have been (and are) bad actors in the industry, but the conversation usually ends there. Five KOLs from different parts of the industry come together to discuss the complexities surrounding drug spend and pricing, innovation, funding, and the overall healthcare system. This episode explores the drug pricing gap between consumer experience and industry norms. Join Lori and our KOLs as we explore the drivers of healthcare costs, the CBO, rebates, and overall spend in this new series.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Ali...2024-02-2920 min
BioSpaceKeep calm and CAR-T on?Almost 30,000 patients have now been treated with CAR-T cell therapies since it was the first approval in 2017. In November 2023, the FDA launched a probe into malignancies caused by CAR T therapies, and just last week the agency called for a class-wide box warning on all commercial CAR-T therapies with ongoing investigations into cases of secondary malignancies. How do we approach this balancing act of treatment and side effects?
Also this week: IPOs march on with ArriVent, CG Oncology, Alto Neuroscience, Fractyl Health; and what's happening re: Congressional Budget Office, Centers for Medicare & Medicaid Services and drug pricing.2024-01-3117 min
BioSpaceWhat can biopharma expect from the job market?Following a challenging year of layoffs and limited funding, Chantal Dresner, VP of Marketing at BioSpace, discusses the findings of our most recent Employment Outlook Report including unemployment, anticipated job search activity, hiring trends and current workforce sentiment. 2024-01-2518 min
BioSpaceOn the ground at #JPM2024 - Day 1 highlightsHello from San Francisco! BioSpace is reporting from #JPM2024 bringing you key takeaways and highlights from day one.
Join Lori, Greg and Tyler as they discuss what's moving and shaking.
You can follow our coverage as our team adds updates throughout the day.
Get Greg's take on what this year might hold in store and how the Biden administration's policies may play a role in discussions.
Join us tomorrow for Day 2 highlights!
2024-01-0810 min
BioSpaceAlternative funding strategies to discuss at JPM with Halia Therapeutics, the ADDF and Triumvira ImmunologicsThe last year has demonstrated that a sound financing strategy and compelling company narrative are essential to securing funding – it’s become more important than ever that investors are excited before taking the plunge. Given the current economic environment that is causing challenges in biopharma, how should companies be approaching funding in 2024?
Listen to this discussion on different kinds of funding options available, how companies can optimize their chances to secure funding and how they should be assessing VCs in addition to alternative partners – particularly if your company will be seeking funding at JPM next week. Our host a...2024-01-0448 min
BioSpaceThe top life sciences startups to watch this yearWelcome to 2024! This week we're discussing BioSpace's tenth annual list of the hottest new life sciences companies in the U.S. NextGen Class of 2024 includes organizations that launched between September 2022 and September 2023 with a Series A funding.
BioSpace's Greg Slabodkin, Heather McKenzie and Tyler Patchen discuss. 2024-01-0314 min
BioSpaceWhat VCs look for when investing with MPM Capital, Endeavor Venture Fund and Two Bear CapitalHow can startup leaders support long-term sustainable growth and investment?
BioSpace’s Lori Ellis speaks with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen for their advice and recommendations on how biopharma startups should approach funding.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Ansbert Gadicke, Managing Director, MPM Capital
Martin Gershon, Managing Partner & CIO, Endeavor Venture Fund
Mike Goguen, Founder and Managing Partner, Two Bear Capital 2023-12-2144 min
BioSpaceEvery move you make: Biopharma industry under heavy scrutinyBiden administration flexes regulatory muscles, putting pressure on the biopharma industry over ‘price gouging’ and invoking march-in rights; meanwhile Sanofi throws in towel over threat of injunction
Renewed interest in psychedelics after MindMed’s Phase IIb trial of its LSD-based candidate meets primary endpoint in patients with generalized anxiety disorder.
Bluebird bio changes its tune, signing an ‘outcomes- based’ agreement with commercial payer, and Pfizer struggles continue.
BioSpace's Lori Ellis, Greg Slabdodkin and Tyler Patchen discuss.
And that's a wrap on 2023! We'll see you in the New Year.
2023-12-2016 min
BioSpaceWhat VCs really think of the market right now with MPM Capital, Endeavor Venture Fund and Two Bear CapitalWhat needs to happen for funding in biopharma to bounce back? BioSpace’s Lori Ellis discusses the macroeconomic environment and biopharma funding outlook with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen.
Host
Lori Ellis, Head of Insights, BioSpace
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Ansbert Gadicke, Managing Director, MPM Capital
Martin Gershon, Managing Partner & CIO, Endeavor Venture Fund
Mike Goguen, Founder and Managing Partner, Two Bear Capital 2023-12-1422 min
BioSpaceMajor FDA approvals for Vertex/CRISPR; bluebird gets black box warning and price scrutinyThat was Week with a capital W. Two major FDA approvals for sickle cell came through on Friday - Casgevy, the first-ever CRISPR-based gene editing therapy from Vertex and CRISPR Therapeutics, and bluebird bio’s Lyfgenia, which comes with a hefty price tag and a black box warning.
Axcella announced its closure; what does the future of long-covid treatments look like, especially as attention shifts to different markets like ADCs and neurological treatments?
Also discussed - Vanda drops $100m on rights to MS drug Ponvory, AI regulatory developments in Europe.
BioSpace's Lori Ellis, Greg...2023-12-1316 min
BioSpaceFast and furious evolution: How to ensure AI is catalyst for positive societal change with Microsoft and IQVIAThis is the second part of our discussion on the evolution of artificial intelligence and its impact on life sciences with guests from Microsoft and IQVIA.
We dive into regulation, real-time management, and AI's various applications and how it can streamline different processes.
We also discuss the cost and affordability of AI; the tremendous investment required and when holding off on new tech is valuable.
Hear how AI is highlighting society's flaws and may become the catalyst for societal change.
Host
Lori Ellis, Head of Insights, BioSpace
2023-12-1231 min
BioSpaceIntegrating AI in life sciences to change employee behavior with Microsoft and IQVIAOver the last year, the reaction to generative AI has changed - and so have behaviors. People are integrating AI to become more productive and it is happening now in healthcare and life sciences. Hear from senior leaders at Microsoft and IQVIA to get their take on how generative AI is impacting productivity, employee engagement and how to mitigate risks.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Matt O’Donnell, Industry Executive Health & Life Sciences, Microsoft
Mike King, Senior Director of Product and Strategy, IQVIA 2023-12-0720 min
BioSpaceGLP-1 and ADC rollercoasters pick up speedThe weight loss market sees more ups and downs - Altimmune joins the fray and sees a stock jump while Pfizer experiences setbacks; and European Medicines Agency seeks additional information as part of its ongoing review of the potential risk of suicide and self-harm thoughts associated with the class. Meanwhile, AbbVie buys ImmunoGen for a cool $10B and scores a win with Teliso-V as ADC momentum continues to build.
Plus, the FDA investigates malignacies linked to CAR-T.
BioSpace's Lori Ellis, Greg Slabodkin and Tyler Patchen discuss. 2023-12-0613 min
BioSpaceArtificial Intelligence, Part 3: Improving Communication to Impact Patient BehaviorPatient behavior has always had an influence on clinical trials - so how do we contend with missing and/or irregular data now that it is feeding AI models? And how do providers continue to work with patients to optimize and grow data pools?
This is the third and final part of a discussion focused upon data bias, accuracy, access and the future of AI in drug development.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Paul Agapow, Director of Innovation, Data Science and Strategy, GlaxoS...2023-12-0517 min
BioSpaceArtificial Intelligence, Part 2: Human Interaction, Liability, and Patient SafetyThe breadth of AI in healthcare applications is broad. How much human oversight is necessary or preferred when leveraging AI in the interest of patient safety?
Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction.
This is part two of a discussion focused upon data bias, accuracy, access and the future of AI in drug development.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Paul Agapow, D...2023-11-3016 min
BioSpaceDeals, Dupixent and GLP-1 drug shortagesThis week we talk struggles with GLP-1 drug shortages and what that might mean for Novo/Lilly competitors; Regeneron and Sanofi positive results for Dupixent in COPD.
Plus, Merck buys Caraway, Beigene's deal with Ensem, ups and downs for Flagship.
Join BioSpace's Lori Ellis, Greg Slabodkin and Tyler Patchen as they discuss the most important biopharma news this week. 2023-11-2917 min
BioSpaceFirst ever CRISPR gene therapy approval: What happens next?Last Thursday, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved CRISPR/Cas9 gene-edited therapy exagamglogene autotemcel (exa-cel). Will the FDA follow suit? What can patients expect the price tag to be?
Plus, a good handful of approvals for AstraZeneca, Pfizer and Astellas' Xtandi, and Keytruda.
Join BioSpace's Lori Ellis, Greg Slabodkin and Heather McKenzie as they discuss the news this week. 2023-11-2113 min
BioSpaceArtificial Intelligence, Part 1: Bias, Access, ROI, Potential Success and FailureThis is part one of a discussion focused upon data bias, accuracy, access and the future of AI in drug development. Topics explored are ROI, human bias, data challenges, data management plans, and human expertise.
Host Lori Ellis, Head of Insights, BioSpace Guests Paul Agapow, Director of Innovation, Data Science and Strategy, GlaxoSmithKlineMike King, Senior Director of Product and Strategy, IQVIA Nindhana Paranthaman, Executive Medical Director, Exelixis Moritz von Stosch, Chief Information Officer, DataHow 2023-11-1618 min
BioSpaceZepbound vs Wegovy: A two horse raceLast week, the FDA approved Eli Lilly's obesity drug Zepbound, creating an anticipated intense competition between it and Novo Nordisk's Wegovy. BioSpace's Greg Slabodkin, Tyler Patchen and Lori Ellis discuss the weight loss race and the future of this drug class.
Plus, a quick recap on Valneva, the FDA's first Chikungunya vaccine approval.2023-11-1514 min
BioSpaceQ3 earnings recap: Winners, losers & surprisesThis week (our inaugural episode!) BioSpace's Greg Slabodkin, Tyler Patchen and Lori Ellis discuss the good, the bad and the ugly of biopharma's reported Q3 earnings. They also tackle what's going on at Pfizer, ADCs, deals and more.
Want to dive deeper on BioSpace? Read more on Pfizer's recent cuts as part of their cost-savings program and more insight on Q3 earnings for Gilead, Novo Nordisk, Moderna, Vertex, BMS, Lilly, GSK.
Meanwhile, industry-wide layoffs march on and in case you missed it - bankruptcies reached a record high.2023-11-0817 min