Shows
BioCentury This WeekEp. 304 - Syncona Reshapes Fund; Lilly's $1B Verve Bet; FDA's 2-Track FuturePublicly traded U.K. investment firm and company builder Syncona is restructuring its fund amid ongoing market challenges in the biopharma industry. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the firm will steer its portfolio toward returns for shareholders, while aiming to build a new fund away from public markets. The analysts then assess Eli Lilly's takeout of cardiovascular base editing company Verve, and what Washington Editor Steve Usdin calls FDA’s new “two-track” future for evaluating new therapies for approval — those with clear-cut benefits and those with ambiguous efficacy safety and efficacy profiles — in light of...2025-06-2435 min
BioCentury This WeekEp. 300 - Biotech’s $13B Deal Day, ASCO's Hot Targets, Drug Pricing ThreatDealmaking by a pair of pharmas has given the biotech industry its best day of transactions in months, tallying nearly $13 billion in guaranteed payments across two deals. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the takeout of Blueprint Medicines for $9.1 billion up front gives Sanofi a drug for a rare immunological disorder and bolsters the French pharma’s already strong presence in immunology. The analysts also assess the $3.5 billion partnership between BioNTech and Bristol Myers Squibb for an asset targeting cancer’s hottest target, PD-(L)1 x VEGF, and underwhelming data from the leadin...2025-06-0338 min
BioCentury This WeekEp. 294 - AACR Spotlight on SMARCA2 degraders. Plus: David Baker, Drug PricingAmong the formerly undruggable targets gaining translational momentum, SMARCA2 has intrigued researchers for its potential to treat challenging solid tumors. On the latest BioCentury This Week podcast, BioCentury's editors zero in on preclinical research supporting different degraders of SMARCA2 at this year’s American Association for Cancer Research (AACR) annual meeting.They also discuss takeaways from Editor in Chief Simone Fishburn’s conversation with David Baker, the Nobel-prizewinning pioneer in protein design, and Steve Usdin reports that pharmaceutical industry executives are in a state of alarm over President Trump’s push to include a “most favored nation” policy for Medica...2025-05-0630 min
BioCentury This WeekEp. 293 - Tau Time for Alzheimer's. Plus: FDA Delays, Merck's $4B Deal, HK IPOsBelief in tau — both as a target and surrogate endpoint — for Alzheimer’s is building among leaders in the field. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses how tau could be reaching a tipping point. Also on this week’s episode, Washington Editor Steve Usdin details how political moves have begun to intrude into the Trump administration’s regulation of vaccines, a topic that’s also taken up by Phil Krause and Luciana Borio in a BioCentury Guest Commentary published Monday. BioCentury’s editors then discuss delays for drug regulation at FDA, Merck KGaA's $3.9 billion deal t...2025-04-2931 min
Vital Health PodcastSteve Usdin: Tariffs, Price Controls, & Inflation Reduction Act (IRA)In this episode, host Duane Schulthess sits down with Steve Usdin, Senior Washington Editor at BioCentury Publications since 1993 and one of the most cited experts on FDA regulation, Medicare policy and the political forces driving biopharma innovation, to explore the major forces reshaping U.S. life sciences: looming Section 232 tariff probes, the unintended “small-molecule penalty” baked into the Inflation Reduction Act, deep NIH/FDA budget cuts, post-COVID science skepticism, and China’s surge in clinical filings, and what these policy shifts mean for innovation, patient access and America’s competitive edge. Recorded April 8th, 2025 Key Topics:2025-04-2356 min
The BioCentury ShowEp. 82 – Act Now or Fall Behind: Michelle Rozo on Biotech’s National Security StakesThe U.S. will cede its preeminence in biotechnology to China within three years unless the government acts urgently, an independent commission chartered by Congress warns. “Our window to act is closing,” the National Security Commission on Emerging Biotechnology said in a newly released report. “We need a two-track strategy: make America innovate faster, and slow China down.” BioCentury Washington Editor Steve Usdin discusses the report's recommendations and warnings with the commission’s vice chair, Michelle Rozo, on The BioCentury Show.View full story: https://www.biocentury.com/article/655654#biotech #biopharma #pharma #lifescience #politics #policy #law 2025-04-1731 min
BioCentury This WeekEp. 288 - FDA and Tariffs Turmoil, and AACR PreviewLoss of leadership, cuts to staffing and a proposed reorganization at FDA have heightened biotech risk amid an already turbulent macroeconomic climate, according to BioCentury’s Washington editor Steve Usdin. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the turmoil at FDA could affect a sector already grappling with the uncertainty brought by the Trump administration’s trade war.The editors also explore the growing pipeline of VEGF-targeted bispecifics in a preview of upcoming presentations at annual meeting for the American Association for Cancer Research (AACR). And they discuss how companies may once again need t...2025-04-0826 min
BioCentury This WeekEp. 286 - Sofinnova’s Pan-European Accelerator, China Biotechs, Trump TariffsEuropean venture firm Sofinnova Partners is expanding the reach of its Biovelocita accelerator beyond Italy to stretch across the greater continent. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how Biovelocita became the largest life sciences accelerator in Europe. The editors also discuss Novo Nordisk's latest addition to its obesity pipeline via a deal in China, and how the partnership reflects the state of cross-border dealmaking more broadly. And Washington Editor Steve Usdin assesses President Trump’s threat to impose 25% tariffs on pharmaceutical imports and provides an update on how FDA’s staff is navigating the polici...2025-03-2524 min
BioCentury This WeekEp. 285 - BIO's Trump 2.0 Plan. Plus: Autoimmune CAR Ts & Telix's Radiopharma PlayBIO is engaging with President Donald Trump to protect and improve FDA. It’s also hoping biopharmas can dodge tariffs and find paths to modify the Inflation Reduction Act and reinstate pediatric priority review vouchers. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin delivers takeaways from his conversation with John Crowley, CEO of the industry trade group.BioCentury’s editors also discuss how autoimmune CAR T companies are competing for resources and the end-to-end radiopharma ambitions of Telix Pharmaceuticals. A 2023 landscape on the radiopharma space can be found here.View full story: https://www...2025-03-1828 min
Biotech HangoutEpisode 131 - February 14, 2025On this week’s episode, Chris Garabedian, Yaron Werber and Sam Fazeli discuss the challenges facing the biotech sector, including high interest rates and the overabundance of public biotech companies. The hosts take a look at recent IPOs, noting that Metsra and Sionna have performed well, while others like Septerna and Upstream struggled. Reasons for the market’s reaction to IPOs was also discussed, including concerns about valuation, competition and future funding needs. The hosts also discuss the potential acquisition of SpringWorks by Merck. BioCentury’s Steve Usdin also joins the show to discuss the policy and regulatory environment. He out...2025-02-231h 01
The BioCentury ShowEp. 77 - AI’s Next Leap: Foresite Labs’ Vik Bajaj on Predictive BiologyClinical trials will be launched in the next year or two to test predictions about causal biology made by artificial intelligence models, Vik Bajaj, co-founder and CEO of Foresite Labs and managing director of Foresite Capital Management, believes. Foresite teamed up with Arch Venture Partners last year on a $1 billion venture round to fund Xaira Therapeutics, which aims to reinvent the R&D process via AI-driven protein design and biological discovery technologies.Bajaj, who serves as interim president of Xaira, discussed the potential for artificial intelligence to accelerate biomedical progress in an interview with Washington Editor Steve Usdin...2025-02-0735 min
The BioCentury ShowEp. 76 - FDA Inflection Point: Steve Usdin on Biopharma during Trump 2.0All presidential transitions with a change of party come with disruption and threats as well as opportunities. But this one, in particular with regard to the implications for FDA, is different from all those Steve Usdin has been covering in his 30-year tenure as Washington editor at BioCentury.In particular, this is an inflection point for the agency that currently serves as the global gold standard for drug regulation, said Usdin on a special edition of The BioCentury Show covering the ramifications for the biopharma industry of the second Trump administration. Usdin has recently outlined the threats and...2025-01-2434 min
The BioCentury ShowEp. 75 - PBMs, IRA, RFK Jr: A Conversation With Rep. Jake AuchinclossRep. Jake Auchincloss (D-Mass.), an influential voice in Congress on life sciences issues, gained stature last week when he was appointed to serve on the Energy & Commerce Committee, giving him a seat at the table for debates over legislation affecting FDA, CMS and NIH and a host of issues of critical importance to the biopharma industry.In an interview with Washington Editor Steve Usdin on The BioCentury Show, Auchincloss outlined his priorities for the 119th Congress, from pushing “muscular” PBM reform over the congressional finish line to finding bipartisan support for refining the IRA's orphan drug exemption and adva...2025-01-1336 min
BioCentury This WeekEp. 271 - Biotech in the New Year. Plus: Beyond BiosecureCan biotech break free of the macro factors that have buffeted the industry of late? On the first BioCentury This Week podcast of 2025, BioCentury’s editors offer their predictions for the New Year and — exploring the themes from Simone Fishburn’s latest Letter from the Editor — ask whether biotech can overcome the financing environment, policy concerns and geopolitical tension that have been hammering the industry to deliver on the meaningful strides companies have been taking to deliver innovations to patients.Plus, Washington Editor Steve Usdin discusses what U.S. policymakers need to do now in the wake of a year’s...2025-01-0734 min
BioCentury This WeekEp. 270 - Temple’s FDA Legacy. Plus: Chinese Innovation & Novo Obesity DataPreview: In his five decades at FDA, Robert “Bob” Temple helped revolutionize the ways medical products are developed and regulated. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin reflects on the legacy of Temple. Temple, who is retiring, crafted the modern clinical trial paradigm, created the accelerated approval pathway, and set precedents for incorporating patient perspectives in regulatory decisions. Usdin also discusses the opportunities and threats for the agency under Trump 2.0.BioCentury's editors also discuss China’s academic innovation, arguing that a wave of new target biology is now coming from Chinese university labs and the underw...2024-12-3134 min
BioCentury This WeekEp. 268 - Biosecure Setback & Novartis' $1B PTC DealA pair of lawmakers have dealt the Biosecure Act a setback that could derail the legislation, even as Congress continues its push to reduce reliance on China in the life sciences. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains why Sen. Rand Paul (R-Ky.) and Rep. Jamie Raskin (D-Md.) refused to sign off on inclusion of the anti-China biotech bill in the must-pass National Defense Authorization Act, what provisions the defense bill has that seek to enhance U.S. biotech supply chain resilience and whether Biosecure can be resurrected. And in the latest in neurology...2024-12-1021 min
BioCentury This WeekEp. 267 - Trump's NIH Pick & Multi-targeted CAR TsOn the latest BioCentury This Week podcast, Washington Editor Steve Usdin and colleagues discuss how President-elect Donald Trump’s pick to lead NIH, Jay Bhattacharya, would lead NIH and how that could affect the biopharma industry.The BioCentury team then discusses its analysis of abstracts released ahead of the American Society of Hematology (ASH) and Society for Immunotherapy of Cancer (SITC) annual conferences, highlighting methods for applying dual or bispecific CAR T cell designs to solid tumors. And they also analyze FDA approvals of products by biotech companies, noting that current trends show biotechs shedding their reliance on ph...2024-12-0327 min
BioCentury This WeekEp. 266 - Jefferies Recap, FDA Commissioner & Biosecure UpdatePositive vibes about biotech emanating from the Jefferies Healthcare Conference were overshadowed by the uncertainty that is ahead because of the result of the U.S. elections. On the latest BioCentury This Week, BioCentury’s editors discuss how the unconventional cabinet nominations of the incoming Trump administration have cast a pall over what had been growing enthusiasm for the prospects of the biotech sector. Washington Editor Steve Usdin also discusses what the nomination of Marty Makary as the next FDA Commissioner could mean for the sector, and recaps the latest update on the Biosecure Act. The BioCentury editors also di...2024-11-2626 min
Beneath The Helmet Show - Firefighter Wellness & Mental Health (mind-body-spirit)Reuniting: The Epic Season 1 Reunion Of Voices From Beneath The Helmet.The Epic Season 1 Reunion Of Voices From Beneath The Helmet. In this special reunion episode of 'Beneath the Helmet,' host Arjuna George celebrates the podcast's second season finale and his third anniversary of retiring from the fire service. Each guest shares updates on their personal and professional journeys, from writing books and launching coaching businesses to profound advice for new and retiring firefighters. The episode also delves into wellness strategies, mindset shifts, and recommended resources aimed at helping first responders navigate their careers more effectively.
00:00 Introduction03:09 Guest Introductions and Highlights
22:41 Advice for New Firefighters
26:34 When to Hang Up...2024-11-201h 16
BioCentury This WeekEp. 265 - RFK Jr. & HHS, Blenrep's Comeback, China DealsGiving RFK Jr. control of HHS would be disastrous, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Expanding on his Editor’s Commentary, Usdin explains why Kennedy would be an unmitigated disaster for FDA, NIH and CMS, for biopharmas and for patients. He calls on biopharma leaders to speak out and affirm basic truths, even if it puts them in harm’s way.BioCentury’s editors also discuss why new data for GSK's Blenrep — an oncology therapy withdrawn two years ago — help make the case for introducing new therapies earlier in the course of treatment...2024-11-1929 min
BioCentury This WeekEp. 264 - Prepping for Trump & Alzheimer's EthicsTrump 2.0 presents opportunities and challenges for leaders of the biopharma industry, which needs effective public policy to thrive. On the latest BioCentury This Week, BioCentury Washington Editor Steve Usdin explains what those opportunities are and lays out the potential impact on the public policy environment, which could have repercussions on FDA and beyond.BioCentury’s editors then analyze how companies, academics and advocates are pushing back on claims that they should have disclosed the results of APOE4 genotype testing to Alzheimer’s trial participants and investigations by Chinese authorities into AstraZeneca China President Leon Wang and fellow AZ empl...2024-11-1229 min
BioCentury This WeekEp. 262 - EGFR Case Study, FDA & PoliticsTwenty years of innovation in therapies targeting EGFR provides a case study in how generation of differentiated products against the target can drive market growth. On the latest BioCentury This Week podcast, BioCentury’s editors discuss EGFR as a prime example of the value in best-in-class development strategies, with meaningful improvements across multiple modalities delivering substantial therapeutic benefits to patients. Analogous best-in-class opportunities aren’t limited to cancer, but are also playing out in other settings such as immunology.The editors then discuss a recent event that hosted FDA commissioner Rob Califf and four former commissioners, all of whom...2024-10-2923 min
BioCentury This WeekEp. 258 - Breaking the Bear: 4Q Public Markets PreviewBiopharma buysiders and bankers at long last believe the conditions are ripe for biotech growth and outperformance, BioCentury’s Stephen Hansen says on the latest BioCentury This Week podcast. Hansen and colleagues take stock of the sector’s growth potential after three long years of the bear market as they discuss BioCentury’s 4Q24 Public Markets Preview.Also on this week’s show, Washington Editor Steve Usdin discusses his Editor’s Commentary, in which he argues that FDA leaders planned reforms for its advisory committee process fall far short of what they need to do. Usdin then delivers t...2024-10-0839 min
The BioCentury ShowEp. 69 - Lee Fleisher: An Insider’s Account of CMS’s Alzheimer’s Coverage DecisionsCMS’s controversial decision to restrict access to Alzheimer’s mAb treatments, including Aduhelm, approved under FDA’s accelerated pathway was a unique case that is unlikely to set a precedent, former CMS CMO Lee Fleisher told BioCentury. “I do not think this will be repeated,” he said. In an interview with The BioCentury Show's Steve Usdin, Fleisher gives a behind-the-scenes account of the decision-making process, including the role of accelerated approval. He also discusses the opportunities and risks for healthcare posed by AI, and the scientific and legislative steps that will be needed to make real the promise of blood-b...2024-10-0434 min
BioCentury This WeekEp. 255 - Pediatric PRVs, Biosecure & Novo's Obesity MissRep. Frank Pallone’s misunderstanding of how the pediatric priority review voucher program works has been one factor undermining support for an incentive that brings new drugs to kids, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin explains how the voucher process works and why it’s valuable to the country’s youngest patients, as well as to small biotechs and larger biopharma alike.Usdin also discusses the latest twists and turns for the Biosecure Act, and BioCentury’s Stephen Hansen assesses the obesity data from Novo Nordisk that destroyed more than $30 billion in value...2024-09-2421 min
The BioCentury ShowEp 67 - AAM's Craig Burton on Opportunities, Challenges of U.S. Biosimilars MarketThere is good news in this year’s Association for Accessible Medicines report on savings from biosimilars, including a 30% increase over the last year in savings attributed to biosimilars. The report also explores the economic, policy and regulatory headwinds that are preventing the industry from generating savings at a level that would have a dramatic effect on the U.S. healthcare system.In an interview with Washington Editor Steve Usdin on The BioCentury Show, Craig Burton, executive director of AAM’s Biosimilars Council, calls out business practices and government policies that are holding the industry back and discusses the...2024-09-0528 min
BioCentury This WeekEp. 249 - Biotech IPO Buzz, Pharma Deal Trends, Washington UpdateShaking up an underwhelming year for fresh biotech paper, a trio of biotechs filed to go public on NASDAQ last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the IPO filings by MBX and Massachusetts companies Zenas and Bicara. Washington Editor Steve Usdin returns to the podcast to provide updates on the Inflation Reduction and Biosecure acts, as well as the life sciences policies of presidential candidates Donald Trump and Kamala Harris. And Director of Biopharma Intelligence Karen Tkach Tuzman zeroes in on the latest trends among pharma’s deals with biotechs over the past 12 mont...2024-08-2729 min
BioCentury This WeekEp. 244 - Leqembi's Thumbs-Down in Europe. Plus: Perioperative Cancer, Pediatric Review VouchersEurope’s CHMP has again ruled in contrast to FDA for a neurology product, this time on Biogen and Eisai’s Leqembi for Alzheimer’s disease. On the latest BioCentury This Week podcast, BioCentury editors discuss the similarities and differences between Leqembi lecenamab and Aduhelm aducanumab, the first anti-amyloid mAb from Biogen and Eisai and what it means for the next in line from that class, Kisunia donanemab from Eli Lilly. The editors also break down last week’s ODAC meeting, which discussed trials in perioperative cancer for checkpoint inhibitors, and talk about the looming delay in reauthorization of the rare...2024-07-3029 min
The BioCentury ShowEp. 64 - NPC CEO John O’Brien: Why America Needs an Honest Conversation About Drug PricingIgnorance about the path from scientific discovery to approved drugs, high out-of-pocket costs, and a byzantine healthcare system that obscures net prices while inflating list prices have fueled policies that threaten biomedical progress, John O’Brien, CEO of think tank National Pharmaceutical Council, told BioCentury.In an interview with The BioCentury Show's Steve Usdin, O’Brien, who led efforts to reduce drug prices as an HHS official during the Trump administration, said that whoever wins the White House in November will step into a political atmosphere that is hostile to biopharma companies. While it is difficult to predict what...2024-07-1133 min
BioCentury This WeekEp. 241 - U.K. Biopharma on the Move. Plus: IRA, BiosecureThe U.K.’s life sciences ecosystem boasts “palpable energy at the very innovation end of the spectrum in biotech, with a lot of really quality science,” BioCentury Editor in Chief Simone Fishburn says on the latest BioCentury This Week podcast. Fishburn assesses the maturation of the country’s biotech industry, including the need for an influx of capital to catalyze the sector’s growth. Washington Editor Steve Usdin discusses the latest developments for the Inflation Reduction and the Biosecure acts as well as the benefits of the breakthrough therapy pathway. Also on BioCentury.com, listeners may want to check out...2024-07-0918 min
The BioCentury ShowEp. 62 - Rick Bright: Navigating the Avian Flu ThreatThe U.S. is experiencing events that are either the first stages of a widespread avian influenza outbreak or a fire drill that will show how well the nation is prepared for an outbreak. The U.S. has not stepped up to meet the challenge, Rick Bright, the former director of BARDA, told BioCentury.In an interview with The BioCentury Show's Steve Usdin, Bright said there are opportunities for biotech companies to help fill voids in surveillance, point-of-care diagnostics, vaccines and therapeutics. The federal government must provide leadership and funding to unleash industry, but it has acted slowly...2024-06-1340 min
BioCentury This WeekBonus Content - Derek Lowe Unplugged: AI; Biosecure; FDA, Abortion & SCOTUS; and more“I’m a short-term pessimist and a long-term optimist” about the potential for AI to transform drug development, Derek Lowe, author of the In the Pipeline blog, told BioCentury Washington Editor Steve Usdin on the latest BioCentury Show. Lowe's skepticism about claims that AI will rapidly transform the field is driven by a belief that the “problems that we have in the drug industry that we want to solve are almost inversely proportional to the ability of AI to solve them." Lowe also discussed the Biosecure Act and U.S. reliance on Chinese contract manufacturing and development organizations; talked about wh...2024-05-1632 min
The BioCentury ShowEp. 59 - Derek Lowe Unplugged: AI; Biosecure; FDA, Abortion & SCOTUS; and more“I’m a short-term pessimist and a long-term optimist” about the potential for AI to transform drug development, Derek Lowe, author of the In the Pipeline blog, told BioCentury Washington Editor Steve Usdin on the latest BioCentury Show. Lowe's skepticism about claims that AI will rapidly transform the field is driven by a belief that the “problems that we have in the drug industry that we want to solve are almost inversely proportional to the ability of AI to solve them." Lowe also discussed the Biosecure Act and U.S. reliance on Chinese contract manufacturing and development organizations; talked about wh...2024-05-1632 min
BioCentury This WeekEp. 231 - Biosecure Revised. Plus: Venture Rounds, Deals of NoteLawmakers’ changes to the Biosecure Act create breathing room for U.S. biopharma companies to move on from Chinese CDMOs, Washington Editor Steve Usdin said. On the latest BioCentury This Week podcast, Usdin and his BioCentury colleagues discuss what the revisions mean for biotechs and what’s next for the legislation, plus how WuXi AppTec is defending itself against the bill’s allegations. Director of Biopharma Intelligence Paul Bonanos discusses last week’s surge in venture activity, including the largest biotech round, a $200 million series C by Lonnie Moulder’s Zenas BioPharma, as well as recent deals of note, including...2024-05-1425 min
BioCentury This WeekEp. 227 - Defending Accelerated Approval. Plus: Endpoint Innovation & AIM AmissA “drive-by analysis of accelerated approval is intellectual malpractice,” argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues explain why a paper on the expedited regulatory pathway written by researchers at the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital misleads the public about the value of drugs granted accelerated approval. The paper also fails to grasp the pathway’s purpose, which is “to allow risk-taking when there’s evidence that a therapy is reasonably likely to benefit patients who are suffering from a serious condition,” Usdin writes i...2024-04-2322 min
The BioCentury ShowEp. 56 - BIO’s John Crowley on the Biosecure ActThis is a previously recorded episode of The BioCentury Show. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.BIO CEO John Crowley believes that biotech is part of a “great global rivalry” between the U.S. and China. The role of biotech in determining the outcome of this rivalry, and a belief in the need for reducing U.S. reliance on Chinese biotech companies, led BIO to reverse its opposition to the Biosecure Act. Crowley acknowledges concerns that the enactment of the bill in its curr...2024-04-1736 min
BioCentury This WeekEp. 222 - Crowley’s Vision for BIO, Plus: MASH & CAR TsPutting patients at center stage is at the core of John Crowley’s vision for BIO as he begins his tenure leading the biotech trade group. On the latest BioCentury This Week podcast. Washington Editor Steve Usdin details Crowley’s plans to revitalize BIO at a time when effective representation in Washington is more important than ever.BioCentury’s editors also discuss FDA’s landmark approval of Madrigal's liver disease drug and a decision by FDA’s Oncologic Drugs Advisory Committee to support a pair of BCMA-directed CAR T cell therapies in earlier lines to treat multiple myeloma, and what’s...2024-03-1920 min
BioCentury This WeekEp. 221 - China Biocontroversy, Plus: Diversity MattersA congressional committee meeting last week on biotech and national security provided a glimmer of hope that lawmakers could be persuaded to consider taking steps to bolster the U.S. bioeconomy, BioCentury Washington Editor Steve Usdin explains why the at times cartoonish spectacle of lawmakers pushing anti-China biotech bills highlights the need for scientists and entrepreneurs to build relationships in Washington.Plus: Editor in Chief Simone Fishburn argues that the future of diversity should not be bound up in the fate of DEI. And BioCentury's editors discuss the pivotal trial setback for Amylyx in ALS and what may...2024-03-1231 min
BioCentury This WeekEp. 216 - Anti-China Biotech Policy: Biosecure & BeyondAnti-China biotech bills are raising alarms at U.S. biotechs, with CEOs worried they could lose access to CDMOs WuXi AppTec and WuXi Biologics, and that legislation could imperil collaboration with Chinese companies more broadly. BIO has warned Congress the bills “would immediately and negatively” affect the U.S. biotech ecosystem. On this special edition of the BioCentury This Week podcast BioCentury Washington Editor Steve Usdin and colleagues discuss the pending legislation.Reach us by sending a text2024-02-1626 min
BioCentury This WeekEp. 207 - Sickle Cell, AbbVie Deals, BIO CEO, March-inFDA’s decision to approve two gene therapies for sickle cell diseases could be transformative for patients, but both multimillion-dollar drugs will face access issues. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what’s next for the companies, and for patients, following the approvals. The editors also analyze how AbbVie is restocking its pipeline via M&A, including its second multibillion deal in a week, a takeout of Cerevel, and why the acquisition is important beyond the pharma’s own portfolio. And Washington Editor Steve Usdin assesses BIO’s decision to name John Crowley as its new CE...2023-12-1230 min
BioCentury This WeekEp. 187 - Alnylam-Roche; Plus: Insights on the IRA, FTCA hypertension deal with Roche will help Alnylam execute on its growth strategy of moving into more prevalent diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal does for both companies and why plans for a cardiovascular outcomes trial (CVOT) before the launch of zilebesiran are critical for maximizing the program’s commercial opportunity.BioCentury’s editors also preview this week’s episode of The BioCentury Show, in which Washington Editor Steve Usdin speaks with Alkermes about the politics and policy environment around drug pricing and the Inflation Reduction Act and assess the latest d...2023-07-2424 min
BioCentury This WeekEp. 185 - Leqembi's Launch, Biotech IPOs, Sarepta ApprovalFull approval of Leqembi lecanemab-irmb will unlock reimbursement and energize Alzheimer’s R&D, but the launch will be slow, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues break down the takeaways from BioCentury’s interview with Chris Viehbacher, CEO of Biogen, and discuss the challenges of launching a product for a disease that has until now been untreatable.BioCentury’s editors also discussed the prospects for the IPO window in the second half now that the market for follow-on financings is showing signs of life, and the controversy surrounding Elevid...2023-07-1125 min
BioCentury This WeekEp. 184 - Califf's FDA reforms & Polaris' SchulmanFDA Commissioner Rob Califf’s biggest legacy could be his reform of FDA’s advisory committee process. But what is uncertain is whether his review can bring together enough consensus among agency leaders to drive a meaningful change, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues discuss the areas of the U.S. regulator’s advisory committee process where there is — and isn’t — agreement on needed changes, and what could make this time different from a lengthy history of calls for change. BioCentury’s editors also preview an upcoming discussion with Polaris Partne...2023-06-2727 min
BioCentury This WeekEp. 183 - EMA's Cooke, What's Next for IPSCs, & Leerink is BackEmer Cooke may have already cemented her legacy as executive director of EMA through her leadership of the European regulator during the COVID-19 crisis. But she still faces a big task in navigating the agency through Europe’s new pharma legislation, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues discuss a wide-ranging fireside chat held last week in Amsterdam with Cooke, including how the agency adapted post-Brexit and the differences that need to be appreciated between the European and U.S. regulators.BioCentury’s editors also discuss the future of induc...2023-06-1930 min
BioCentury This WeekEp. 182 - Merck’s IRA suit, Leqembi and MCEDs at ASCOA lawsuit over the Inflation Reduction Act by Merck & Co. suit signals to Republicans that the pharma has no compunctions about attacking Democrats, the Biden administration and the president himself, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleague discussed the significance of the move by Merck, its likelihood of success and why the pharma chose its combative tone for the first lawsuit challenging the Medicare drug price-setting provisions of the IRA.BioCentury’s editors also assessed remarks at the BIO convention by FDA Commissioner Rob Califf related to the accelerated ap...2023-06-1330 min
BioCentury This WeekEp. 181 - Highlights from ASCOASCO’s kickoff included blunt comments from two CEOs who said the IRA is causing their companies to delay launches of cancer drugs for smaller indications, BioCentury Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues discussed remarks at the American Society of Clinical Oncology conference by Novartis' Vasant Narasimhan and Genentech's Alexander Hardy regarding how the Inflation Reduction Act is forcing the companies to make difficult decisions regarding their pipelines and patients’ access to their therapies.The podcast team also assessed highlights from ASCO’s data presentations, including antibody-drug conjug...2023-06-0625 min
BioCentury This WeekEp. 179 - DMD Gene Therapies, CBER & NIHIf FDA approves Sarepta's gene therapy for Duchenne muscular dystrophy, patients will soon face the difficult choice between taking this treatment or waiting for a better option among the “unprecedented” amount of innovation ahead in DMD, as taking both may not be an option, BioCentury Executive Director Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues assess the landscape for DMD gene therapies ahead of the May 29 PDUFA date for delandistrogene moxeparvovec.Also on the show, BioCentury Washington Editor Steve Usdin discusses takeaways from his conversation with FDA's Peter Marks; three tasks for Monica Bert...2023-05-2327 min
BioCentury This WeekEp. 174 - EC Pharma Law, ALS Biomarker, Astellas' Iveric DealBiopharma companies believe a draft law that seeks to overhaul European pharmaceutical policy for the first time in years is out of sync with innovation, Washington Editor Steve Usdin said on the latest BioCentury This Week. Usdin and colleagues assessed the EC’s proposals in the legislation, as well as what’s changed since a version of the draft was leaked earlier this year. BioCentury’s editors also discussed the implications of FDA’s acceptance of NfL as a surrogate endpoint for amyotrophic lateral sclerosis for companies with clinical neurodegeneration programs, plus the $5.9 billion takeout of geographic atrophy company Iveric b...2023-05-0224 min
BioCentury This WeekEp. 170 - Abortion Ruling & FDA; New VC Funds; IRAThe ruling on abortion drug mifepristone issued Friday by Texas District Judge Matthew Kacsmaryk could destabilize drug regulation, opening up every FDA approval to second guessing by any court in the U.S., Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin assesses the implications of the decision and sheds light on the thinking of former senior FDA attorneys regarding the case. BioCentury’s editors also discuss the latest from venture firms Canaan, SR One, and newly launched Cure Ventures, and deliver takeaways from BioCentury’s recent webinar on the Inflation Reduction Act, “Navigating the IRA.”2023-04-1119 min
BioCentury This WeekEp. 165 - SVB Fallout, Plus: Pfizer-SeagenOn the latest BioCentury This Week podcast, BioCentury’s editors assess the fallout from the collapse of SVB and the sale of SVB UK to HSBC. BioCentury’s editors also discuss the proposed $43 billion acquisition of Seagen by Pfizer, takeaways from CDER Director Patrizia Cavazzoni’s conversation with Washington Editor Steve Usdin on The BioCentury Show and Editor in Chief Simone Fishburn’s call for pharma to put more women in the C-suite. This week’s podcast is sponsored by Jeito Capital.Reach us by sending a text2023-03-1424 min
BioCentury This WeekEp. 159 - BIO's Priorities, ESG & Venture TrendsBIO’s push for FDA to be more flexible on accelerated approval requirements is unlikely to resonate at the agency, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin explains why BIO is concerned about the “erosion” of accelerated approval as FDA considers whether requiring confirmatory trials to be under way at the time of approval should be the default policy. He then details the trade group’s other top priorities. Also on the podcast: how imminent climate disclosure rules from the SEC could affect biotechs and recent trends in venture financing.Reach us by se...2023-01-3123 min
BioCentury This WeekEp. 155 - U.K. Biotech, Aduhelm, 2022 Approval TrendsThe U.K. government is signaling that life sciences companies will be shielded from changes to an R&D tax relief policy that would otherwise leave small biotechs losing millions of pounds, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues discuss the behind-the-scenes initiative by the U.K. BioIndustry Association to protect companies from being affected by serious unintended consequences of the policy changes as they continue to weather the bear market.BioCentury’s editors also assess documents released by Congress that shed light on Biogen's rationale for how it...2023-01-0435 min
BioCentury This WeekEp. 153 - The Inflation Reduction ActA strategy for navigating the Inflation Reduction Act is essential for every biopharma company, regardless of size or location, Washington Editor Steve Usdin said on a special edition of the BioCentury This Week podcast. Usdin and his BioCentury colleagues discuss why creating an IRA strategy is so complex, when and how CMS is going to set prices for drugs selected for scrutiny and what the chances are that the act can be repealed or modified.Reach us by sending a text2022-12-1919 min
BioCentury This WeekEp. 146 - What's Next in Washington, Plus: SITC & the DistilleryThe lack of a “red wave” in the U.S. midterm elections sets up a “last gasp of old-fashioned, horse-trading politics” by lawmakers that could affect multiple pieces of life sciences legislation, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin details what’s at stake for biopharma in Washington during the remaining weeks of 2022, and what’s in store for life sciences in the next session of Congress. BioCentury’s editors also discuss trends at this year’s Society for Immunotherapy of Cancer (SITC) conference and the latest from the Distillery, BioCentury’s summaries of top translation...2022-11-1518 min
BioCentury This WeekEp. 145 - What's Next for BIO, Plus: Pfizer, GSK BIO needs to pick a leadership team rather than a leader to give the trade group all the skills it needs moving forward, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and Editor in Chief Simone Fishburn discuss how BIO needs to address the challenges it now faces, as well as the results of BioCentury’s industry-wide survey on the state of the trade group.BioCentury’s podcast team also assess the latest developments in RSV product development, the infectious disease pipelines of Pfizer and GlaxoSmithKline, and top takeaways from Fishburn’s conversation on The...2022-11-0820 min
BioCentury This WeekEp. 141 - Neoantigen Vaccines, Drug Pricing, U.S.-China & U.K. TurmoilOn the latest BioCentury This Week podcast, Senior Editor Karen Tkach Tuzman surveys the landscape of neoantigen cancer vaccines, touching on what’s changed in the past five years, 2022’s key readouts and what’s next for the field. Washington Editor Steve Usdin discusses the White House’s plans to use executive powers to reduce drug prices and, recapping his latest Editor’s Commentary, explains why he believes the U.S. and China should not allow rivalry in life sciences to turn into enmity that hurts patients. Finally, Editor in Chief Simone Fishburn assesses what turmoil in the U.K. means f...2022-10-1825 min
BioCentury This WeekEp. 140 - Turbulence at BIO, Plus 4Q Preview & the DistilleryOn the latest BioCentury This Week podcast, Washington Editor Steve Usdin details the circumstances leading up to Michelle McMurry-Heath’s resignation as CEO of BIO on Monday. The podcast team also discuss BioCentury’s 4Q22 Financial Markets Preview, with Associate Editor Stephen Hansen assessing biotech’s attempt to emerge from the ongoing bear market recovery as inflation and rising interest rates foster a risk-off environment. Senior Editor Karen Tkach Tuzman discusses the latest translational tidbits from BioCentury’s Distillery and the impact Nobel Prize laureate Carolyn Bertozzi has had on the biotech industry.Reach us by sending a text2022-10-1129 min
BioCentury This WeekEp. 138 - FDA User Fee Endgame, East-West Summit & BiogenEverything’s at stake for FDA as user fee legislation approaches a critical deadline this week, Washington Editor Steve Usdin says on the latest episode of BioCentury This Week. Usdin details the next steps in the process, which FDA reforms are being dropped from the “clean” user fee bill and the future of healthcare legislation. BioCentury’s editorial team also recaps the top takeaways from Global Blood Therapeutics CEO Ted Love’s appearance on The BioCentury Show, previews the upcoming BioCentury-BayHelix East-West Biopharma Summit and assesses two upcoming milestones for Biogen: an FDA decision on tofersen for amyotrophic lateral sclerosis...2022-09-2727 min
BioCentury This WeekEp 135 Pt. 4 - Filling Biopharma's Talent PipelineThe need to recruit and train regulators is acute in developed as well as low- and middle-income countries, BioCentury Washington Editor Steve Usdin says. On the fourth of five BioCentury This Week podcasts accompanying Back to School 2022, Usdin and BioCentury’s editorial team discuss how drawing top talent means agencies must persuade candidates that careers are infused with purpose and support a vital mission. BioCentury Senior Editor Karen Tkach Tuzman says biopharma companies, facing their own talent crunch, will benefit from making themselves more visible, accessible and instructive to new entrants. Access all of BioCentury's Back to School content he...2022-09-0216 min
BioCentury This WeekEp. 130 - Steady as a Roche. Plus: Washington TurbulenceAs Severin Schwan’s steady hand on the tiller of Roche passes to another insider, BioCentury’s podcast team examines how initiatives during the outgoing CEO’s tenure, including those related to digital and data science, handed a solid deck of cards to diagnostics head Thomas Schinecker as he takes on the top job at the Swiss pharma. Plus: Washington Editor Steve Usdin assesses Sen. Richard Burr’s attempt to deliver a “clean” user fee bill, pharma and biotech executives’ chances to revise the drug price regulation provisions of the Democrats’ budget reconciliation bill, and why it might be too late for Pre...2022-07-2519 min
BioCentury This WeekEp. 129 - Burr Bill, Novartis Makeover, ALS UpdateSen. Richard Burr’s new approach to a critical medical products user fee bill funding FDA must be taken seriously because the clock is ticking, and it’s ticking loudly, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin explains why Burr has introduced the bare-bones legislation and what’s at stake for industry in the weeks ahead. BioCentury's editors also discuss FDA’s neurodegeneration blueprint, clinical updates in ALS from Clene and base editing from Verve, and plans to reshape Novartis.Reach us by sending a text2022-07-1921 min
BioCentury This WeekEp. 125 - Next Steps for ARPA-HOn the latest BioCentury This Week podcast, Washington Editor Steve Usdin details how the Advanced Research Projects Agency for Health is taking shape as the new U.S. agency seeks to deliver transformative science and the latest moves by Rep. Anna Eshoo to change its structure via legislation. The podcast team also explores the U.K. NHS’s deal with Pfizer Inc. and Shionogi & Co. Ltd. on a subscription-based payment pilot for antibiotics, which could serve as an example for other payers considering similar initiatives; why an IP agreement by the WTO will do little to move the needle on...2022-06-2124 min
BioCentury This WeekEp. 124 - CRISPR's High Bar, Private Equity Inroads and the DistilleryStellar data for Vertex Pharmaceuticals and CRISPR Therapeutics could set a high bar for the next generation of gene editing players to beat in β thalassemia and sickle cell disease, indications that had previously been considered as the best disease to show proof-of-concept for the modality, said Executive Director of Biopharma Intelligence Lauren Martz on the latest edition of BioCentury This Week. The BioCentury podcast team also reviews Associate Editor Stephen Hansen’s analysis of how the trend of private equity firms acquiring or partnering life sciences VCs will impact the financing environment, and Washington Editor Steve Usdin’s take on th...2022-06-1427 min
BioCentury This WeekEp. 104 - Biotech Shows Support for Ukraine, Plus Latest Intellia DataIndustry leaders have vowed to disengage with Russia until it stops its invasion of Ukraine and respects its neighbor’s sovereignty. What's the likely impact of their pledge and what are the implications of the crisis in Ukraine for biopharma companies around the globe? Plus: Assessing the latest cut of data for Intellia's pioneering in vivo CRISPR-Cas9 therapy and key takeaways from Washington Editor Steve Usdin’s conversation with ICER’s Steve Pearson on The BioCentury Show. This week’s podcast is sponsored by life sciences investment firm Jeito Capital.Reach us by sending a text2022-03-0122 min
What To WatchOur Emmy predictions! The Morning Show is back for season 2On this weekend's What to Watch: EW TV critic and The Awardist podcast co-host Kristen Baldwin joins Gerrad Hall to give her final predictions for some of the biggest categories at this year's Emmy Awards; Jennifer Aniston and Reese Witherspoon are back for season 2 of The Morning Show, and Hasan Minhaj tells us about his audition for a big song-and-dance scene; Sex Education returns for its third season on Netflix; the movie Everybody's Talking About Jamie makes its debut on Amazon Prime Video; and filmmaker Steve McQueen debuts a new series of documentaries expanding on the themes and history...2021-09-1730 minWhat To WatchBrooklyn Nine-Nine comes to an end...againOn today's What to Watch: Looking back on the legacy of Brooklyn Nine-Nine with EW Sr. Writer Dan Snierson, as we prepare for it's series finale — again; Robert Langdon is back, this time on the small screen in Dan Brown's The Lost Symbol; and Netflix debuts the new animated series He-Man and the Masters of the Universe. Steve Lemme and Kevin Heffernan, the stars of Tacoma F.D. — which is back for its third season — tell us what they're watching. Plus, entertainment headlines — including Jeff Probst on the new titling system for Survivor, and Generation co-creator Zelda Barnz on that show...2021-09-1616 minWhat To WatchSelena Gomez, Steve Martin, Martin Short lead crime dramedyOn today's What to Watch: Selena Gomez, Steve Martin, and Martin Short are partners in true-crime in the Hulu dramedy Only Murders in the Building; after helping viewers tidy up, now Marie Kondo is Sparking Joy on her new Netflix series; and unsuspecting homeowners have a chance to win $25,000 on Jason Biggs' Cash at Your Door. DC's Stargirl star Anjelika Washington tells us what shows she's loving. Plus, entertainment headlines — including the cast of Survivor 41 and Emily VanCamp leaving The Resident — and trivia.More at ew.com, ew.com/wtw, and @EW.Host: Gerrad Hall (@gerr...2021-08-3115 minWhat To WatchAddison Rae in He's All That, Jason Momoa on See season 2On this weekend's What to Watch: TikTok star Addison Rae and Cobra Kai's Tanner Buchanan lead the gender-flipped He's All That; Lil Rel Howery, Yvonne Orji, John Cena, and Meredith Hagner star in the raunchy comedy Vacation Friends; Jason Momoa talks season 2 of his Apple TV+ drama See; Pen15 gets animated for a special episode; and Netflix's latest sports docuseries Titletown High touches down. Stars of RuPaul's Drag Race try their hand — and wigs — at Emmys trivia. The Real Housewives of Beverly Hills' Erika Girardi is tired of Sutton Stracke — her choice words for her are our Sound Bite of the W...2021-08-2717 minWhat To WatchDaniel Radcliffe explores the Oregon Trail on Miracle WorkersOn today's What to Watch: Daniel Radcliffe and Steve Buscemi are back for another season of Miracle Workers, this time navigating the Oregon Trail; the new children's animated series Ridley Jones debuts on Netflix; and The Flash celebrates its 150th episode. EW's Marcus Jones takes us on a trip to Rutherford Falls and tells us what he loves about that series starring Ed Helms. Plus, entertainment headlines — including the Emmys announcing Cedric the Entertainer as 2021 host, and Paris Hilton's new cooking show — and trivia.More at ew.com, ew.com/wtw, and @EW.Host: Gerrad Hall...2021-07-1316 minWhat To WatchThe 5 shows we're most excited for this summerOn this episode of What to Watch, we picked the 5 shows we're most excited for this summer. We're previewing season 2 of Ted Lasso, starring Jason Sudekis; Tom Hiddleston's return as Loki for the Disney+ series; and the dark comedy Only Murders in the Building, starring Selena Gomez, Steve Martin, and Martin Short. Plus, EW's Derek Lawrence fills us in on the third series in the Power Universe, Raising Kanan; and EW's Marcus Jones breaks down all the drama — including crimes and threesomes — on Netflix's Elite. And we're throwing it back to her first acting role for trivia about Selena Gomez...2021-05-3122 minWhat To WatchBlack History Month kicks off: Small Axe, Da 5 Bloods, moreOn today's What to Watch: We're kicking off Black History Month celebrating black performers and artistry by taking a look at some recent movies and TV programs from Black voices that are available to stream: John Boyega reveals why he could relate to his police officer character in Steve McQueen's Small Axe; hear from Ma Rainey's Black Bottom director George C. Wolfe about the late, great Chadwick Boseman; and Spike Lee explains why he wanted Delroy Lindo's character to be a Trump supporter in Da 5 Bloods. EW's Chancellor Agard tells us why he is re-watching Donald Glover's TV series...2021-02-0116 min
The Earnings Podcast from AlphaStreetZions Bancorporation (ZION) Q3 2020 Earnings CallZions Bancorporation (NASDAQ: ZION) Q3 2020 earnings call dated Oct. 19, 2020.
Zions Bancorporation’s Third Quarter 2020 Earnings Results Webcast. Transcript link:
CEO: "we are generally pleased with the overall results for the quarter. Earnings per share are back to a level experienced throughout much of 2019. Although, revenue has declined somewhat from what experienced then. Our non-interest expenses declined moderately, resulting in adjusted pre-provision net revenue, excluding the charitable contribution we made during the quarter of pre-provision net revenue of $297 million, which is actually somewhat stronger than the quarterly average in 2019. Additionally with the diluted shar...2020-10-201h 04
BioCentury This WeekSpecial Report: Getting Real about COVID-19 Data Part 2: A conversation with Mark McClellanMark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University describes in podcast interview with BioCentury’s Washington Editor Steve Usdin how the pandemic has accelerated progress on integrating real-world data and evidence into research and practice.2020-05-0816 min
BioCentury This WeekSpecial Report: Getting Real about COVID-19 Data Part 1: A conversation with Amy AbernethyAmy Abernethy, FDA’s principal deputy commissioner and acting CIO describe in podcast interview with BioCentury’s Washington Editor Steve Usdin how the pandemic has accelerated progress on integrating real-world data and evidence into research and practice.2020-05-0821 min
Rabbitt Stew ComicsEpisode 105November solicitations, Dark Tower movie review, Manhunter Special, Nightwing: New Order 1, Seeley on Hellblazer, Generations: Thor, Doctor Aphra Annual, Secret Empire 9, Hard Place 1, Hi-Fi Fight Club 1, Archie 23, Catalyst Prime: Incidentals 1, War Mother 1, Calla Cthulhu, Clueless: Senior Year, AD After Death Director, Injustice 2 DLC Hellboy, Joker movies, Collectors Corps unboxing. Details: Manhunter Special by Dan DiDio, Keith Giffen, Mark Buckingham, Sam Humphries, Steve Rude, Jack Kirby; Nightwing: New Order 1 by Kyle Higgins, Trevor McCarthy; Generations: Unworthy Thor and Mighty Thor by Jason Aaron, Mahmud Asrar, Jordie Bellaire; Doctor Aphra Annual by Kieron Gillen, Marc Laming, Will Sliney, Jordan B...2017-08-302h 06