BioCentury This Week

The 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.”

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On the latest BioCentury This Week podcast, BioCentury’s editors assess the implications of the FTC’s challenge to the $7.1 billion acquisition of cancer screening company Grail by next-generation sequencing company Illumina. They also discuss what’s at stake as the U.S. Supreme Court weighs arguments in the patent dispute over anti-PCSK9 mAbs between Sanofi and Amgen, and how CEOs of gene therapy companies are thinking about the competitive landscape at a time when products with preliminary evidence of safety and efficacy are dropping out of clinical development across multiple indications. This week’s podcast is sponsored by Jeito Capital.

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On the latest BioCentury This Week podcast, BioCentury’s editors assess responses to their VC survey regarding the collapse of Silicon Valley Bank in light of First Citizens’ acquisition of SVB. BioCentury’s editors also discuss how FDA’s advisory committee meeting for tofersen from Biogen and Ionis bolsters the case for neurofilament as a surrogate endpoint in amyotrophic lateral sclerosis, and why last week’s FDA draft guidance on accelerated approval could make cancer drug development harder for small biotechs. This week’s podcast is sponsored by Jeito Capital.

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 On the latest BioCentury This Week podcast, BioCentury’s editors assess how companies are upending pipeline and business strategies due to the Inflation Reduction Act, along with other takeaways from a survey on the IRA’s implications, conducted by BioCentury with the support of BIO. They also discuss CMS’s memo outlining how it intends to implement the IRA’s price-setting provisions, the T cell therapy landscape and insights from BioCentury’s Distillery. This week’s podcast is sponsored by Jeito Capital. 

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On a special edition of the BioCentury This Week podcast, Editor in Chief Simone Fishburn and Director of Biopharma Intelligence Stephen Hansen assess the priorities for VCs and their portfolio companies in the immediate aftermath of the collapse of Silicon Valley Bank. They also discuss the gap left in the biotech ecosystem given SVB’s unique relationship with VCs and small companies, and what the knock-on effects may be on the sector as it continues to grapple with the bear market.

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On 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.

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On the latest episode of the BioCentury This Week podcast, BioCentury’s editors assess the challenges and opportunities facing Christopher Viehbacher as he begins to implement his vision for Biogen. The team also analyzes the state of play among NK cell therapy companies and discusses highlights from BioCentury’s Emerging Company Profile of Paratus Sciences Corp., a well-funded biotech being built around the idea that insights derived from the study of bat biology can be applied directly to human health and health security. This week’s podcast is sponsored by Jeito Capital.

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Leaked drafts of legislation overhauling Europe’s pharmaceutical laws are causing consternation at biopharma companies. BioCentury’s editors discuss how the revised framework could cut IP protections and why any benefits from the legislation are not sufficient to attract investment to Europe. They also discuss the potential implications of an imminent ruling in a Texas lawsuit challenging FDA’s approval of abortion drug mifepristone, and comment on the departure of FDA’s Billy Dunn.

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On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the latest payment models from CMS could mean for cell and gene therapies, and how a new model could incentivize the completion of confirmatory trials for drugs with accelerated approval. BioCentury's editors also discuss the outlook for China's public markets and details around the genetic medicine delivery technology of recently launched Aera Therapeutics.

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Last week’s Oncologic Drugs Advisory Committee meeting to discuss PD-1 inhibitor Jemperli offered insights into new endpoints, single-arm studies and the future of FDA advisory committee panels. On the latest BioCentury This Week podcast, BioCentury’s editors assess how GSK's standout dataset in a rare form of rectal cancer could qualify the program for exceptions to FDA’s standard practices and what it could mean for patients. BioCentury’s editors also discuss signs of greater regulatory flexibility on the important but controversial overall survival endpoint, highlights from BioCentury’s Distillery and what NASDAQ debuts by Mineralys and Structure say about the state of the market for biotech IPOs. 

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Via new guidance and its Project Optimus, FDA is pushing companies to do dose-optimization studies instead of maximum-tolerated dose studies, BioCentury Executive Director Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues discuss the burdens and benefits of the shift, in particular for biotechs. BioCentury’s editors also assess new challenges and opportunities for FDA and regulated industry now that the agency is starting to implement PDUFA VII and mandates from the spending bill passed by Congress late last year, including clinical trials diversity, and analyze a move in the House of Representatives to ban the use by federal or state governments of quality-adjusted life years (QALYs) to make health coverage or pricing decisions.

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BIO’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.

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New manufacturing systems for CAR Ts aren’t just about speed, Executive Director for Biopharma Intelligence Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues discuss the safety, efficacy and access benefits from rapid manufacturing platforms, and how these systems are set to change the way CAR T cells are delivered to patients. BioCentury’s editors also analyze the state of incentives for orphan drug development as the Orphan Drug Act turns 40, how the FTC’s non-compete proposal could have unanticipated effects for biotech, and what solutions former FDA commissioners are proposing to battle misinformation about science.

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Investors broadly agree that biotech indexes won’t revisit the lows seen last year, but they’ll need their portfolio companies to survive until the industry begins its comeback, said Director of Biopharma Intelligence Stephen Hansen on the latest BioCentury This Week podcast. Discussing key takeaways from BioCentury’s 2023 Financial Markets Preview, Hansen detailed reasons to be positive in the year ahead, but cautioned that the financing windows will continue to be narrow and companies without a material catalyst this year need to deploy all the tools at their disposal to stay alive. Hansen and colleagues also discussed the milestones buysiders expect to drive excitement this year, and the outlook for M&A and partnerships, including the impact of the Inflation Reduction Act on dealmaking.

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A trio of billion dollar deals for late-stage and commercial assets featuring contingent value rights were among the highlights of the first day of the J.P. Morgan Healthcare Conference in San Francisco on Monday. BioCentury's editors discuss AstraZeneca's takeout of CinCor, Ipsen's buy of Albireo and Chiesi's acquisition of Amryt as well as other takeaways from JPM, the CERSI summit and the Neuroscience Innovation Forum. The team also discusses the latest in Alzheimer's.

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The 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 priced Alzheimer’s drug Aduhelm, trends in FDA’s 2022 approvals and what the editorial team is looking for in the year ahead.

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Phase III results for resmetirom from Madrigal Pharmaceuticals are more than enough for a regulatory submission in non-alcoholic steatohepatitis, said BioCentury Director of Biopharma Intelligence Paul Bonanos. Bonanos and colleagues discuss what Madrigal got right in running its trial for the challenging NASH indication, and what’s next in the pipeline. BioCentury’s editors also assess highly anticipated, heavily scrutinized data from Moderna among other 4Q22 readouts from neoantigen programs, as well as translational highlights from BioCentury’s Distillery.

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A 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.

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The $28.7 billion takeout of Horizon Therapeutics by Amgen marks a continuation of the large cap biopharma’s return to the inflammatory and autoimmune space where it’s been most commercially successful, Associate Editor Stephen Hansen said on the latest BioCentury This Week podcast. Hansen and his BioCentury colleagues discuss the deal’s synergies as well as new targets and IL-18 data at the American Society of Hematology (ASH) conference, and the evolving landscape for selective estrogen receptor degraders.

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CTAD data for lecanemab showed more definitively than any past readout that targeting β-amyloid can lead to clinical benefit for Alzheimer’s patients, but the field is still wrestling with its use as a surrogate endpoint, BioCentury Executive Editor Selina Koch said on the latest BioCentury This Week podcast. Koch and the BioCentury podcast team break down the implications of data from Eisai and Roche at last week’s Clinical Trials on Alzheimer’s Disease meeting and look ahead to what’s next for the field. BioCentury’s editors also discussed how proposed changes to the U.K.’s R&D tax credit scheme could hurt British biotechs and what regulatory heads of global biopharmas who are members of the Charles Forum are envisioning for the post-COVID regulatory environment.

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A model term sheet created by a consortium of academic institutions, VCs and law firms could reduce the negotiation time around life sciences start-ups for universities and VCs by 80%, Associate Editor Stephen Hansen said on the latest BioCentury This Week podcast. Hansen detailed how the consortium came together and what it hopes to accomplish. The BioCentury editors also discussed implications of CSL's decision to price the first hemophilia B gene therapy approved by FDA at $3.5 million, as well as an FDA-NCI study that could serve as prototype for streamlined pragmatic trials.

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There are clear indicators of the maturation of China’s biotech sector, although east and west biopharma leaders have diverging views on how easy cross-border investment will be going forward, BioCentury’s Editor-in-Chief Simone Fishburn said on the latest BioCentury This Week podcast. Fishburn detailed her takeaways from the summit held last week, while Executive Editor Selina Koch reviewed her panel on the optimism R&D leaders have for the future role multi-omics can play in drug development. BioCentury editors also discussed the recent appointments of Chris Viehbacher as CEO of Biogen and David Epstein of Seagen and the challenges each face at their respective embattled biotechs.

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As China’s biopharma companies experience their first “biotech winter,” they should be engaged in active portfolio management, stopping projects that will not meet their investors’ expectations, Agio Capital General Manager Henk Joos said on BioCentury This Week. On a special East-West Summit edition of the podcast, Joos and Immune-Onc Therapeutics founder and CEO Charlene Liao discussed pipeline prioritization and other company survival tactics during today’s difficult financing environment.

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Cash conversation and sticking to priorities are essential for China’s biotech’s as they navigate today’s gloomy funding environment, Zhaoke Ophthalmology’s Lisa Feng said on a special East-West Summit edition of the BioCentury This Week podcast. Feng, who is CBO and CFO of Zhaoke, Jones Day’s Tony Chen and Paul Hastings’ Phoebe Yan discuss challenges of compliance risk in a digital world, China’s value-based procurement and IP landscape and the environment for IPOs and licensing deals for China’s biotechs.

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The 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 translational papers highlighting new targets and technologies with disease-modifying effects.

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 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 BioCentury Show with Andy Plump, who is president of R&D at Takeda 

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Biopharmas and investors have been warning of the Inflation Reduction Act’s potential to hurt patients — concerns that had been theoretical until last week, when Alnylam became the first company to announce that it may abandon plans to add an indication to an orphan drug’s label. On the latest BioCentury This Week podcast, BioCentury’s editors discuss why a provision in the IRA prompted the biotech to pause plans to start a Phase III trial of vutrisiran for Stargardt disease, what other therapies might be affected and the impact on patients. The BioCentury podcast team also discusses how Argenx is applying lessons of past orphan drugs to the launch of myasthenia gravis drug Vyvgart, as well as non-profit Accumulus Synergy Inc.’s plans to bring interactions between drug sponsors and regulators, and among regulators, into the 21st century.

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McKinsey’s Franck Le Deu and BayHelix’s Guo-Liang Yu join the BioCentury This Week podcast to discuss globalization and cross-border innovation in the biopharma and preview the upcoming BioCentury-BayHelix East-West Summit. BioCentury’s co-founders — CEO Dave Flores, Chairman Karen Bernstein — and Editor in Chief Simone Fishburn and BioCentury head of BD Josh Berlin also join the podcast to discuss the importance of globalization for biopharma and patients, the current environment for cross-border dealmaking and expected highlights of the East-West Summit, which will take place in Redwood City, Calif., Nov. 14-16.

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A pair of neurology companies are in the spotlight on the latest edition of the BioCentury This Week podcast. BioCentury’s editors assess how Lundbeck has evolved in the past five years, with a fresh emphasis on first in class in its revamped pipeline, and how Biogen could acquire its way into being a near-term growth company. BioCentury’s editors also discuss the Biden administration’s initiative that seeks to compensate for decades of underinvestment in the nation’s biomanufacturing capacity and takeaways from Nora Volkow, director of NIH’s National Institute on Drug Abuse, during her appearance last week on The BioCentury Show.

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On 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 for the country’s burgeoning life sciences sector. 

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On 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.

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The neurodegeneration field had two big wins with even bigger implications for the future of Alzheimer’s disease and ALSs, Executive Editor Selina Koch says on the latest episode of BioCentury This Week. Koch lays out the importance of the positive Phase III data for lecanemab in Alzheimer’s and the coming debate over access to the therapy, while also noting the potential for read-through to other neurodegenerative diseases from FDA’s approval of Amylyx's ALS drug Relyvrio. BioCentury’s editorial team also discusses mounting pressure on the Biden administration to curb outbound investments from the U.S. into China and the work of biopharma non-profit Life Science Cares.

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Everything’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 and Phase III data for Alzheimer’s therapy lecanemab that’s due from partner Eisai.

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A year after it reported its first clinical data showing CRISPR-based gene editing may live up to its promise, Intellia has provided evidence for the second time that its platform can knock down a clinically relevant target in the liver, and revealed the first data showing it can deliver clinical benefit. On the latest BioCentury This Week podcast, BioCentury's editors discuss the hereditary angioedema data for NTLA-2002. They also explain why the Inflation Reduction Act could have an outsized effect on the development of orphan drugs and how an Executive Order related to the Committee on Foreign Investment in the United States (CFIUS) signed by President Joe Biden singles out biotech and biomanufacturing for intensified foreign investment scrutiny.

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Biopharma executives and investors are bracing for the impact of the newly passed Inflation Reduction Act. On the latest BioCentury This Week podcast, BioCentury's editors discuss pharma CEOs’ warnings that the law will reduce incentives for small molecule drug development, how biotech VCs may adjust deployment of their funds and how the government could implement the law.Turning to readouts from the European Society of Medical Oncology Congress, the BioCentury podcast team explains why the latest data for Amgen's Lumakras could shake up the KRAS inhibitor race and how Chinese investigator-initiated trials are accelerating CAR T innovation.

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Digital fluency, the imperative to have an impact on society and an eagerness to make change now, not in future decades, mark the future leaders of the industry, says BioCentury Editor in Chief Simone Fishburn. On the fifth and concluding BioCentury This Week podcast accompanying Back to School 2022, Fishburn and BioCentury’s editorial team discuss the defining traits of industry’s incoming generation of leaders and the evolving skills required for the future of biotech. Access all of BioCentury's Back to School content here.

https://www.biocentury.com/topics/back-to-school-auth 

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The 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 here.

https://www.biocentury.com/topics/back-to-school-auth 

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Solving the biopharma industry’s management crunch will require today’s leaders to open their networks, and provide more leadership opportunities and mentoring to rising leaders, says BioCentury Editor in Chief Simone Fishburn. On the third of five BioCentury This Week podcasts accompanying Back to School 2022, Fishburn and BioCentury’s editorial team discuss the group of employees who see the C-suite as their next step, why they want to get there and the impediments they must overcome. BioCentury’s editors also assess how VCs are building boards to guide first-time CEOs, and discuss concerns that the increase in compensation across the biopharma sector has gotten out of hand. Access all of BioCentury's Back to School content here.

https://www.biocentury.com/topics/back-to-school-auth

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The past two years have forced a reckoning for CEOs throughout the biopharma industry that will shape the next generation of success stories. On the second of five BioCentury This Week podcasts accompanying Back to School 2022, BioCentury’s podcast team discusses what makes a good CEO and how leaders are building teams to manage successful biotechs. BioCentury’s editors also draw on the results from BioCentury’s Talent Survey to discuss the flourishing cohort of women CEOs leading today’s biopharmas and how industry is thinking about diversity, equity and inclusion.

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BioCentury’s 30th annual Back to School edition focuses on talent: where to find talent and how to nurture it. It’s a special Back to School package because the issue involves every person in the life sciences ecosystem at a critical time in the biopharma industry’s evolution, says Editor in Chief Simone Fishburn on the latest BioCentury This Week podcast. Fishburn and the BioCentury podcast team set the stage for the five-day Back to School series, which draws on analysis of BioCentury’s Talent Survey and interviews with more than 85 people at all career stages. The series includes dives into C-suites, the flourishing cohort of women CEOs, industry’s rising leaders and heavy lifters, VCs, regulators and more.

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Despite public market investors shying away from preclinical companies amid biotech’s bear market, large biopharmas have ramped up their deal making for early-stage assets and technologies and are willing to pay for access to new modalities, says BioCentury’s Stephen Hansen on the latest BioCentury This Week podcast. Hansen and colleagues also discuss the implications of FDA’s approval of gene therapy Zynteglo from bluebird bio Inc., and the latest advances and leaders in the field of epigenome editing.

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A flurry of follow-on financings last week suggests a receptive market for companies with recent catalysts, BioCentury’s Paul Bonanos says on the latest BioCentury This Week podcast. Bonanos and colleagues discuss what last week’s offerings, led by schizophrenia company Karuna Therapeutics, say about which companies might be able to tap the public markets and under what circumstances. The podcast team also examines how computational protein design is shifting its center of gravity from mechanistic calculations based on physical forces to more powerful machine learning approaches trained on reams of data, and why a deal between the SEC and its Chinese counterpart on cross-border audits could be nearly in hand.

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The proposed $5.4 billion takeout of sickle cell company Global Blood Therapeutics by Pfizer is the latest sign of life in biotech M&A, BioCentury Associate Editor Paul Bonanos says on the BioCentury This Week podcast. Bonanos and colleagues explain how Pfizer plans to use its global reach to get Oxbryta to parts of the globe most affected by sickle cell disease, which disproportionately affects people of African, Middle Eastern and South Asian descent. Plus: how schizophrenia data from Karuna makes the biotech ripe for a takeout; amyloidosis data from Alnylam; and why Amgen’s latest data for Lumakras suggest the future of one of the most promising KRAS inhibitor combinations is now in doubt.

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Acquisition target Seagen has carved out such a differentiated portfolio of antibody-drug candidates that the company may not see much direct competition from other ADCs in the near term, BioCentury’s Lauren Martz says on the latest edition of the BioCentury This Week podcast. Martz and the BioCentury podcast team analyze how Seagen has built a pipeline around almost entirely first-in-class targets and assess how the latest cut of data for the company’s Padcev enfortumab vedotin-ejfv could broaden the ADC’s reach among cancer patients.

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As 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 President Joe Biden to get a nominee for NIH director through Congress.

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Sen. 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.

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Even with signs that the biotech winter may be starting to thaw, buysiders continue to expect more near-term pain for the sector as consolidation continues for smaller companies with limited cash and few options for raising more, Associate Editor Stephen Hansen says on the latest edition of the BioCentury This Week podcast. Hansen sums up the takeaway messages from BioCentury's 3Q22 Financial Markets Preview, detailing the impact of the barren financing landscape, investors’ priorities, and whether the sector has finally hit bottom. The podcast team also discuss an initiative by gene therapy companies to resolve and pre-empt immune-related toxicities seen in some Duchenne muscular dystrophy trials and the latest push by Congressional Democrats and the Biden administration to regulate the prices of some drugs.

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AstraZeneca’s takeout of single-asset spinout TeneoTwo for $100 million up front is but the latest payout to shareholders in TeneoBio, who could stand to see even more upside in the years ahead, says Associate Editor Paul Bonanos on the latest edition of the BioCentury This Week podcast. Bonanos and the BioCentury editors also discuss how TeneoTwo investor Lightspeed Venture Partners has deepened its commitment to life sciences investing; Arch Venture Partners’ plans to deploy its new $3 billion venture fund; and the latest translational highlights from BioCentury’s Distillery and Translational in Brief sections. Plus: A preview of BioCentury's fall conference.

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On the latest BioCentury This Week podcast, a pair of deals demonstrates how Galapagos CEO Paul Stoffels is shifting the Belgian biotech’s strategic focus from small molecules toward a diversified portfolio. Plus: why Friday’s Supreme Court decision to overturn Roe v. Wade sets the stage for legal and legislative battles that could have broad implications for biopharma and how a new crop of Indian biotechs are seeking to offer dramatically cheaper CAR T therapies. This week’s podcast is sponsored by the BioCentury-BayHelix East-West Summit 2022.

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On 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 COVID countermeasures; and top takeaways from Zai Lab CEO Samantha Du on The BioCentury Show. In addition, they call for members of the biopharma community to participate in a BioCentury survey on the talent crunch facing industry. All responses will remain confidential.

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