BioCentury This Week
372 episodes - English - Latest episode: 5 days ago - ★★★★★ - 11 ratingsBioCentury's streaming commentary on biotech industry trends, plus interviews with leading KOLs. For three decades, BioCentury has given biopharma executives, investors and institutions the power to make business-critical decisions through independent, deep-dive analysis; high-quality data; industry-leading business intelligence; and global conferences.
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Episodes
Ep. 227 - Defending Accelerated Approval. Plus: Endpoint Innovation & AIM Amiss
April 22, 2024 23:00 - 22 minutes - 15.6 MBA “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, whic...
Ep. 226 - Vertex’s Alpine Buy, Goldman’s Venture & IRA Tea Leaves
April 16, 2024 00:00 - 22 minutes - 15.8 MBVertex Pharmaceuticals' acquisition of Alpine Immune Sciences will bolster a growing kidney disease franchise that could help diversify Vertex’s business beyond its blockbuster cystic fibrosis franchise. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what attracted Vertex to Alpine and why it believes its newly acquired therapy can outshine others for IgA nephropathy. The editors discuss how Goldman Sachs aims to scale private biotechs via its venture strategy and t...
Ep. 225 - 2Q Markets Preview & AACR Takeaways
April 08, 2024 23:00 - 21 minutes - 14.9 MBM&A has been driving a recovery for biotech, with $62 billion in takeouts in the past six months restocking specialist investors’ coffers for their next wave of investments. On the latest BioCentury This Week podcast, BioCentury’s editors assess the state of the public markets heading into the second quarter, including the outsize role PIPEs have had in financing industry’s comeback. They also discuss their takeaways from analyzing nearly 7,000 abstracts from the American Association for Can...
Ep. 224 - Biotech IPOs, Avalon & FDA at SCOTUS
April 02, 2024 00:00 - 21 minutes - 14.6 MBUpcoming catalysts could drive value creation at NASDAQ’s newest biotech, Boundless Bio, after it stumbled in its trading debut last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss Boundless’ IPO in the context of the current market for fresh paper and profile the “sweat equity” model of Avalon, the VC firm led by Jay Lichter. Turning to Washington, BioCentury’s editors assess possible outcomes for the Supreme Court case on abortion drug mifepristone, and why t...
Ep. 223 - Biosecure, Bruce Booth & Ultrarare Drugs
March 26, 2024 00:00 - 28 minutes - 19.4 MBBills seeking to rein in Chinese CDMOs and genomics companies will deal a massive blow to biotech companies, if passed in their current form, according to results from an industry survey conducted by BioCentury. On The latest BioCentury This Week podcast, BioCentury’s editors discuss results from the survey, including responses that underscore executives’ concerns that the legislation would cause delays in drug development and a majority’s displeasure with BIO’s about-face to support the mea...
Ep. 222 - Crowley’s Vision for BIO, Plus: MASH & CAR Ts
March 18, 2024 23:00 - 20 minutes - 14.3 MBPutting 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 suppor...
Ep. 221 - China Biocontroversy, Plus: Diversity Matters
March 12, 2024 00:00 - 31 minutes - 21.9 MBA 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 sh...
Ep. 220 - Biotech’s Financing Flurry & Distillery Spotlight
March 05, 2024 02:00 - 24 minutes - 16.8 MBThe $3 billion raised by biotechs in a series of follow-ons and PIPEs last week marked another strong showing for a sector seeking to outrun the bear market. On the latest BioCentury This Week podcast, BioCentury’s editors assess the state of fundraising for biotechs and their performance in the after-market. They also preview a forthcoming analysis of preclinical papers published in the Distillery, BioCentury’s coverage of translational science, describe the latest on anti-China bills in Co...
Ep. 219 - East-West Summit Preview
February 28, 2024 01:00 - 25 minutes - 17.5 MBAsia’s emerging “Arc of Innovation” spans from China, Japan and South Korea through the turf-neutral gateway of Singapore and west to India, with the ecosystems of these countries contributing to the arsenal of therapeutics and diagnostics that benefit patients globally. On a special edition of the BioCentury This Week podcast, Aslan’s Carl Firth, McKinsey’s Franck Le Deu and Wendy Pan of BayHelix and Goodwin join BioCentury on the eve of next week’s BioCentury-BayHelix Biopharma Summit in S...
Ep. 218 - Bob Nelsen Insights, TL1A, Rare Diseases
February 27, 2024 01:00 - 24 minutes - 17.1 MBArch Venture Partners’ Bob Nelsen is excited about AI’s potential in biotech and convinced the U.S. healthcare system could do a far better job delivering on the promise of the biopharma industry’s innovations. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from Nelsen’s appearance on The BioCentury Show, including how the longtime investor in China’s life sciences sector has adopted a more cautious stance on the country given increasing geopolitical tens...
Ep. 217 - Safer CAR Ts & World’s First TIL Therapy
February 21, 2024 02:00 - 24 minutes - 17.2 MBOff switches and non-viral delivery technologies may be the solution to CAR T therapies’ most recent safety problem. On the latest BioCentury This Week podcast, BioCentury’s editors discuss alternative CAR T technologies already in development that avoid or reduce the risk of secondary malignancy. The editors also discuss the world-first approval of Iovance's tumor-infiltrating lymphocyte (TIL) therapy, highlights from BioCentury’s most recent survey of the translational literature in the Di...
Ep. 216 - Anti-China Biotech Policy: Biosecure & Beyond
February 16, 2024 01:00 - 26 minutes - 18.3 MBAnti-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.
Ep. 215 - ADCs, Psychedelics & IPOs
February 13, 2024 01:00 - 24 minutes - 17.2 MBInnate immunity is getting another shot at cancer through antibody-drug conjugates, with immunostimulatory antibody-drug conjugates moving from concept to clinical product. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the therapies work and what sets them apart from conventional ADCs. The editors also survey the companies developing psychedelic therapies that aim to overcome the difficulties of the business model, and assess Gilead's $4.3 billion takeout of li...
Ep. 214 - BMS’s Patent Cliff, Congress Targets China Biotech
February 06, 2024 01:00 - 29 minutes - 20.5 MBAs it approaches a steep patent cliff, Bristol Myers is charting its course to bridge a transition period and return to growth. On the latest BioCentury This Week podcast, BioCentury’s editors assess the pharma’s pipeline and recent M&A, outlining the clinical and commercial successes the company needs to navigate the next few years. The editors also discuss what’s behind bills in Washington that target four Chinese companies identified by Congress as “biotechnology companies of concern," th...
Ep. 213 - Biotech IPOs & IL-18 Momentum
January 30, 2024 02:00 - 28 minutes - 19.3 MBNASDAQ’s first biotech public listings of 2024 provided hopeful signs for a rebound in the biotech IPO market. On the latest BioCentury This Week podcast, BioCentury’s editors assess the performance of IPOs by CG Oncology and ArriVent and what’s next for the IPO market. They also discuss the growing IL-18 field, look ahead to the schizophrenia milestones coming this year, and size up the Singapore biotech ecosystem and what the country needs to do to cement a position on the global biotech m...
Ep. 212 - 2024 Buyside View & Arnold Ventures' Impact
January 23, 2024 01:00 - 30 minutes - 20.7 MBBiotech investors are looking to catalysts that can create, or dramatically expand, commercial markets as they look ahead to a long-awaited recovery for industry. On the latest BioCentury This Week podcast, BioCentury’s editors assess the milestones on buysiders’ radar for 2024, including in areas such as obesity, pain and metabolic-associated steatohepatitis (MASH). They also discuss the influence of biopharma critic Arnold Ventures, a philanthropy that has reshaped the drug pricing public ...
Ep. 211 - 2024 Markets Preview, Woodcock's Legacy
January 17, 2024 00:00 - 22 minutes - 15.3 MBInvestors and bankers are as upbeat about biotech’s prospects heading into 2024 as they have been since 2020, but maintaining the momentum that began building in 4Q23 is contingent on the Fed meeting expectations that it will ease interest rates. On the latest BioCentury This Week podcast, BioCentury’s editors assess the environment for financings and M&A in the year ahead. They also discuss Janet Woodcock’s legacy at FDA as she readies to step down at the end of the month and the latest dev...
Ep. 210 - J.P. Morgan Healthcare Conference Wrap
January 13, 2024 02:00 - 27 minutes - 18.9 MBCautious optimism was the theme during a J.P. Morgan Healthcare Conference week that featured patchy skies, large-but-not-mega deals and a surfeit of sideline summits around San Francisco’s Union Square. BioCentury’s editorial team discusses the week’s M&A deals, including J&J's $2 billion takeout of ADC company Ambrx, and Merck & Co. acquiring T cell engager biotech Harpoon for nearly $700 million; takeaways from the Sachs Neuroscience Innovation Forum and other adjacent forums; and investo...
Ep. 209 - Biotech M&A, Innovation, Public Policy in 2024
January 05, 2024 02:00 - 37 minutes - 25.9 MBA flurry of large acquisitions to close out 2023 is likely to carry into the New Year as pharmas continue to show appetite for late-stage assets. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the latest trends in biotech M&A, potential takeout targets for 2024 and the impact on dealmaking of a more aggressive FTC. They also assess sentiment heading into next week’s J.P. Morgan Healthcare Conference, analyze future drivers of innovation in biotech, and preview the y...
Ep. 208 - XBI Rally, ASH Highlights & '24 Picks
December 19, 2023 01:00 - 24 minutes - 16.5 MBSignals from the Fed that rate cuts are on the way rallied biotech indexes last week, but is the uptick more than a blip? On the latest BioCentury This Week podcast, BioCentury’s editors discuss how interest rate cuts could spur a risk-on rotation back into the sector by generalist investors, the possibility of biotech outperformance in 2024, and what it will take for the IPO window to open. They also assess progress demonstrated by companies’ with next-generation gene editors at this year’s...
Ep. 207 - Sickle Cell, AbbVie Deals, BIO CEO, March-in
December 12, 2023 00:00 - 30 minutes - 21 MBFDA’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 ...
Ep. 206 - Roche, AbbVie Deals; Plus: FDA & CAR T
December 05, 2023 00:00 - 19 minutes - 13.7 MBBiopharma’s latest pair of multibillion-dollar takeouts come in two of industry’s hottest areas: ADCs and obesity. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the move by Roche into obesity via its acquisition of Carmot Therapeutics and the winding journey of ADC company ImmunoGen to its $10.1 billion buyout by AbbVie. BioCentury’s editors discuss what FDA’s statement on the risk of T cell malignancy following BCMA- or CD19-directed CAR T cell therapy means for c...
Ep. 205 - Radiotherapy Deep Dive; Plus: Congress, BioNTech
November 28, 2023 00:00 - 25 minutes - 17.5 MBRadiopharmaceuticals have experienced a resurgence over the past decade, with a series of approvals, billion-dollar deals and growing sales. On the latest BioCentury This Week podcast, Director of Biopharma Intelligence Karen Tkach Tuzman previews her upcoming analysis of the space, discussing the multidimensional nature of the technology’s evolution, and the field’s next-wave targets behind PSMA and SSTR2. BioCentury’s editors also discuss the legacies of two U.S. lawmakers who won’t stand ...
Ep. 204 - First CRISPR Approval & IRA’s Lost Orphans
November 20, 2023 22:00 - 29 minutes - 20 MBThe world’s first approval of a CRISPR-based gene editing therapy, granted by the U.K.’s MHRA, was a milestone for the technology that was just discovered about 12 years ago. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the implications of the landmark and the challenges that still face partners Vertex Pharmaceuticals and CRISPR Therapeutics in launching and scaling the rollout of Casgevy exagamglogene autotemcel (exa-cel) in the U.K. and beyond. The editors also ...
Ep. 203 - POC for Verve? Plus: IRA & East-West Deals
November 14, 2023 00:00 - 21 minutes - 14.7 MBVerve achieved the first proof of concept for an in vivo base editing therapy, but investor concerns weighed on the company’s stock, clouding the readout’s reception. On the latest BioCentury This Week podcast, BioCentury’s editors dissect the data for VERVE-101 in heterozygous familial hypercholesterolemia and discuss how the choice of initial target and indication for a new modality or technology can have a major impact on how POC data are perceived by investors. The editors also assess th...
Ep. 202 - A DMD Decision & Endpoint Innovation
November 07, 2023 01:00 - 30 minutes - 20.9 MBThe controversy around Sarepta continues as the company’s executives were confident last week that the data from the Phase III EMBARK trial of Duchenne muscular dystrophy gene therapy Elevidys were enough to warrant full approval despite missing the study’s primary endpoint. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the pitfalls facing FDA as the agency considers whether to apply regulatory flexibility in its decision-making and the impact its decision could ha...
Ep. 201 - ESMO, NIH & IRA
October 30, 2023 22:00 - 17 minutes - 12.3 MBThe European Society for Medical Oncology (ESMO) had everything from practice changing Phase III data readouts to new solid tumor targets. On the latest BioCentury This Week podcast, BioCentury’s editors recap the biggest data presentations from last week’s annual ESMO meeting, including the impact of Phase III data for ADCs and bispecifics on the treatment landscape for tumors such as urothelial cancer and EGFR-mutant non-small cell lung cancer (NSCLC). The editors also discussed takeaways ...
Ep. 200 - Merck-Daiichi, Roche-Roivant, Base Editors
October 24, 2023 00:00 - 27 minutes - 18.9 MBDaiichi Sankyo has drawn more value from its antibody-drug conjugate pipeline via a $4 billion deal with Merck & Co. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the deal in the context of the burgeoning ADC space and size up the assets that Merck is in-licensing as well as how the deal fits with Daiichi’s pipeline strategy. The editors break down Monday’s $7.1 billion deal by Roche for the Telavant subsidiary of Roivant Sciences, the latest in the evolving TL1A s...
Ep. 199 - China Summit Preview
October 20, 2023 20:00 - 23 minutes - 16.4 MBBayHelix’s Guo-Liang Yu and McKinsey’s Josie Zhou join the BioCentury This Week podcast to discuss cross-border innovation and deal flow in the biopharma sector during a preview of the BioCentury-BayHelix China Healthcare Summit. The summit kicks off at a time of record cross-border deals and validating comments from the leaders of MNCs such as Pfizer, Novartis and Sanofi that innovation by China biopharmas is world class. The 10th annual BioCentury-BayHelix China Healthcare Summit is Nov. 2...
Ep. 198 - Novartis Finds Focus & EU Pharma Law
October 16, 2023 23:00 - 27 minutes - 19.2 MBNow that Vas Narasimhan has finished the major dismantling of Novartis, he’s turning his attention to fixing R&D. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what’s next for the Swiss pharma now that Narasimhan has focused it down to what he calls a pure play innovative medicines company. The editors also analyze the European Parliament’s proposed changes to the first major overhaul of European pharmaceutical law in 20 years, including suggested adjustments relat...
Ep. 197 - Mirati Takeout & 4Q23 Financial Markets Preview
October 09, 2023 22:00 - 28 minutes - 19.6 MBBMS’s acquisition of Mirati for up to $5.8 billion not only gives the big pharma a potential best-in-class KRAS inhibitor in a field that appears to be opening up, but also a clinical program against one of the hottest targets in precision cancer, PRMT5. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what Bristol Myers Squibb stands to gain from its acquisition of Mirati Therapeutics, which had rumors swirling about its potential takeout last week. BioCentury’s edi...
Ep. 196 - CAR T's Next Act & Hudson's Vision for Sanofi
October 03, 2023 00:00 - 29 minutes - 20.2 MBBiopharma companies are moving quickly to figure out how to optimize CAR T cell therapies for autoimmune diseases now that it’s becoming clear the modality has clinical activity and possibly even curative potential in the disease area. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the trigger for this surge of interest, the indications, targets and companies in play and whether the technology can meet the higher safety bar in autoimmune indications. BioCentury’s ed...
Ep. 195 - East-West Summit Preview
September 25, 2023 22:00 - 19 minutes - 13.7 MBBayHelix’s Guo-Liang Yu and McKinsey’s Olivier Leclerc join the BioCentury This Week podcast to discuss cross-border innovation and deal flow in the biopharma sector and preview the upcoming BioCentury-BayHelix East-West Summit. Yu discusses the importance of the event for BayHelix, and Leclerc previews McKinsey’s second East-West Summit report, which will focus on the impact of AI on the sector. BioCentury co-founder, President and CEO Dave Flores, Editor in Chief Simone Fishburn, and head ...
Ep. 194 - IPO Outlook & IRA Lawsuits
September 19, 2023 00:00 - 24 minutes - 16.7 MBThat a broad swath of new money flowed into last week’s IPOs by RayzeBio and Neumora is a good sign for biotech and a departure from deals done last year, BioCentury's Stephen Hansen said on the latest BioCentury This Week podcast. Hansen and colleagues assess the offerings and the companies’ aftermarket performance alongside NASDAQ’s six other top biotech IPOs of the year for signs of what’s next for companies looking to go public. BioCentury’s editors also discuss what new regulatory requi...
Ep. 193 - East-West CAR T Deals, Plus: Amgen-FTC
September 12, 2023 00:00 - 22 minutes - 15.6 MBConstructing deal terms to take advantage of both the translational research benefits in China and the market opportunity in the U.S. is slowly emerging as a strategy to advance CAR T cell innovation. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how deals for the technology have evolved since the 2017 partnership between Legend and Janssen for Carvykti and the opportunity for East-West collaborations to drive CAR T cell development. BioCentury’s editors also asses...
Ep. 192 - Tier-jumpers: a Back to School Overview
September 05, 2023 22:00 - 32 minutes - 22.5 MBWhat are the criteria that enable companies to achieve the kind of success that leads to a jump in market cap tier? On the latest BioCentury This Week podcast, BioCentury’s editors discuss Back to School 2023, which examines the ingredients for building long-term, sustainable, high-value biotech companies.
Ep. 191 - Circular RNA, Psychedelics, & Upcoming BioCentury Summits
August 22, 2023 00:00 - 22 minutes - 15.7 MBCircular RNA’s durability could convey efficacy and manufacturing advantages over therapies based on linear mRNA. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the rising therapeutic modality, with a look at the technology, companies and investors in the space. They also assess the pipeline of psychedelic therapies as the product candidates move toward proof of concept, homing in on psilocybin-based product candidates, which are the most abundant and some of the mo...
Ep. 190 - Obesity Mechanisms, Noubar Takeaways, Scleroderma Platform Trial
August 14, 2023 23:00 - 18 minutes - 12.6 MBThere’s a tectonic shift happening in obesity research and drug development, BioCentury Editor in Chief Simone Fishburn said on the latest BioCentury This Week podcast. Fishburn and colleagues discuss how the success of obesity therapies from Novo Nordisk and Eli Lilly targeting the incretin axis has galvanized a wave of drug development with different molecular targets as well as last week’s threshold-setting cardiovascular outcomes trial data from Novo and recent obesity deals by the two c...
Ep. 189 - Biogen-Sage Setback, Biotech IPOs, Sanofi Digital
August 07, 2023 23:00 - 22 minutes - 15.7 MBA complete response letter from FDA in major depressive disorder could severely dent the commercial prospects for Zurzuvae zuranolone even as the drug gained approval for postpartum depression. On the latest BioCentury This Week podcast, BioCentury’s editors assess what the agency’s decision, which included a request for at least one additional study, means for Biogen and its partner Sage Therapeutics. BioCentury’s editors also discuss the thawing market for biotech IPOs, zeroing in on the d...
Ep. 188 – Pharma deals; Plus: Genentech, Leerink Conversations
July 31, 2023 21:00 - 25 minutes - 17.6 MBAn analysis of pharma deal trends over the past year shows a focus on first-in-class assets with autoimmune diseases being a major focus of interest. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal trends mean for prospective pharma partners and whether the expected focus on late-stage products, and a material increase in valuation for late-stage programs, is supported by the data. BioCentury’s editors also talk about a recent conversation with Genentec...
Ep. 187 - Alnylam-Roche; Plus: Insights on the IRA, FTC
July 24, 2023 20:00 - 24 minutes - 17.1 MBA 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...
Ep. 186 - 3Q Markets Preview, Donanemab & Lilly-Versanis
July 17, 2023 23:00 - 19 minutes - 13.3 MBWith investors seeing the worst days fading into the rearview mirror, the sector has begun to chart a path out of the biotech bear market. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the indicators to watch for a recovery as described in the 3Q23 Financial Markets Preview. They also analyze the latest data from Alzheimer’s therapy donanemab from Eli Lilly, noting it sheds light on which patients stand to benefit from the therapy, and they discuss the pharma’s ta...
Ep. 185 - Leqembi's Launch, Biotech IPOs, Sarepta Approval
July 11, 2023 00:00 - 25 minutes - 17.8 MBFull 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...
Ep. 184 - Califf's FDA reforms & Polaris' Shulman
June 26, 2023 23:00 - 27 minutes - 18.7 MBFDA 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 differ...
Ep. 184 - Califf's FDA reforms & Polaris' Schulman
June 26, 2023 23:00 - 27 minutes - 18.7 MBFDA 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 differ...
EMA's Cooke, What's Next for IPSCs, & Leerink is Back
June 19, 2023 20:00 - 30 minutes - 20.7 MBEmer 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 th...
Ep. 183 - EMA's Cooke, What's Next for IPSCs, & Leerink is Back
June 19, 2023 20:00 - 30 minutes - 20.7 MBEmer 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 th...
Ep. 182 - Merck’s IRA suit, Leqembi and MCEDs at ASCO
June 13, 2023 01:00 - 30 minutes - 21 MBA 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 ...
Ep. 181 - Highlights from ASCO
June 05, 2023 23:00 - 25 minutes - 17.8 MBASCO’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 di...
Ep. 180 - ASCO, Neuropsych & the IRA
May 30, 2023 23:00 - 19 minutes - 13.6 MBTwo Phase I checkpoint inhibitor readouts due at ASCO 2023 are bringing excitement back to immuno-oncology, said BioCentury’s Lauren Martz on the latest BioCentury This Week podcast. Martz and her editorial team colleagues discuss what stands out about the data for LAG3 inhibitor fianlimab from Regeneron and anti-TIGIT mAb tiragolumab from Genentech. The editors also break down takeaways from BioCentury's conversation on precision neuropsychiatry with Husseini Manji, co-chair of the U.K. Men...