BioCentury This Week

Stellar 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 the one big difference between the PDUFA user fee bills making their way through the House and Senate. Senior Editor and Head of Discovery & Preclinical Development Karen Tkach Tuzman also reviews the latest highlights from BioCentury’s Distillery

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 Stellar ASCO data for Enhertu show how there’s “massive ground” that can still be covered and improved upon by applying new modalities against older targets, said Editor in Chief Simone Fishburn on the latest edition of BioCentury This Week. Fishburn and the BioCentury podcast team dig into the data for antibody-drug conjugate Enhertu from AstraZeneca and partner Daiichi Sankyo for previously treated HR-positive, HER2-negative breast cancer patients. They also assess how new modalities are breathing fresh life into HER3 and explore the themes raised by Fishburn in her conversation with Richard Pazdur, and some of his FDA colleagues at the American Society of Clinical Oncology conference in Chicago. The team also discusses the latest cut of data for tofersen from Biogen in SOD1-mutant amyotrophic lateral sclerosis. 

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The latest data cut for KRAS G12C inhibitor adagrasib from Mirati Therapeutics underwhelmed investors. On the latest BioCentury This Week podcast, BioCentury’s editors discussed the readout, which came in an abstract ahead of this week’s American Society of Clinical Oncology meeting, and previewed some of ASCO’s most anticipated data, which will emerge in “late-breaker” presentations. The podcast team also explored the legal battle over IP related to CRISPR editing in bacterial cells, the latest on an investigation by CStone Pharmaceuticals into a derivative investment that broke company policy, the launch of the Advanced Research Project Agency for Health and the status of user fee negotiations in Congress. This week’s podcast is sponsored by MSD, whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre.  For more information visit, msd.com/licensing. 

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On the latest BioCentury This Week podcast, BioCentury’s editors explore how biotechs are turning to tumor targeting, IL-15 expression and alternate cell sourcing to enhance the potency and longevity of NK cell therapies. The podcast team also discusses Janet Woodcock’s new remit at FDA, Bristol Myers Squibb's pullout from Russia and the bipartisan effort moving medical product user fee reauthorization legislation forward in both houses of Congress. This week’s podcast is sponsored by MSD, whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre.  For more information visit, msd.com/licensing. 

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Ensuring that a biotech reaches its key inflection points as effectively as possible during the ongoing capital crunch affects a company across the board, including its people, pipeline and financing toolkit, Shorla’s Sharon Cunningham said on a special Bio€quity Europe edition of the BioCentury This Week podcast. Cunningham and BII’s Bobby Soni joined the BioCentury podcast team to discuss navigating the downturn as a CEO of a private biotech, the untapped talent pools able to run start-ups and the ecosystem in Bio€quity Europe’s next site, Ireland. This week’s podcast is sponsored by MSD (Merck & Co. Inc. in the U.S.).  For more information visit, msd.com/licensing. 

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Even as industry is facing a global talent crunch, Europe’s biotechs have it better than ever, Medicxi’s Francesco De Rubertis said on a special edition of the BioCentury This Week podcast recapping the first two days of the Bio€quity Europe conference in Milan. He and MSD’s Khatereh Ahmadi joined the BioCentury podcast team to discuss the battle for top talent and the state of deal-making amid the ongoing downturn. This week’s podcast is sponsored by MSD (Merck & Co. Inc. in the U.S.), whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre.   For more information visit, msd.com/licensing. 

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The sale of a minority stake in Sofinnova Partners to PE firm Apollo will allow the European VC to grow while retaining its independence. Fresh off a conversation with Sofinnova’s Antoine Papiernik, Associate Editor Stephen Hansen explains the 50-year-old firm’s proactive approach to finding a partner among private equity firms and what’s next for the firm now that it has more financial firepower. The podcast team also discusses the latest translational tidbits from BioCentury’s Distillery, the first look at clinical data from the CRISPR-based gene editing platform of Caribou and how biopharmas are weighing their commitment to Russian patients against calls to disengage from the country.  This week’s podcast is sponsored by MSD (Merck & Co. Inc. in the U.S.), whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre.   For more information visit, msd.com/licensing. 

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Industry’s dueling headwinds of capital and talent are the focus of this year’s Bio€quity Europe meeting, and in a special episode of BioCentury This Week, two veterans of the burgeoning Italian life sciences ecosystem, Sofinnova Partners' Graziano Seghezzi & Ambrosetti's Corrado Panzeri, say the country’s biotech sector now has the capital and networks to weather the storm.

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The House Energy & Commerce Committee has a bipartisan deal on reauthorizing FDA user fees that sets the parameters for FDA reforms, including enhancing accelerated approval and improving clinical trial diversity — but how much will the legislation change in the coming months and how? On the latest BioCentury This Week podcast, BioCentury’s editors discuss the requirements for FDA, HHS, sponsors and other stakeholders that would come into effect under the House’s proposed user fee legislation and what’s next for the bill. The podcast team also discusses Howard University’s mission to address racial health disparities, and how the university brings a human focus to research that might have otherwise stuck to laboratory models.

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Chinese biotechs face regulatory delays for their therapies due to pandemic-related barriers to inspections by Western regulators and FDA’s reluctance to accept China-only data. On the latest BioCentury This Week podcast, BioCentury’s editors discuss why a setback for surufatinib from Hutchmed could be a sign of things to come for its China peers. The podcast team also analyzes a flurry of FDA activity and assesses what the IPO by vaccine play HilleVax says about the market for fresh paper.  This week’s podcast is sponsored by Kendall Square Orchestra. 

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The first clinical data from Nkarta’s CAR natural killer cell platform add to the growing evidence that a CAR may provide the efficacy boost NK cell therapies have needed. BioCentury's editors analyze the significance of the data, which drove a 141% gain in the biotech's stock. They also discuss the biopharma legacy of the late Sen. Orrin Hatch, how biopharma companies are coping with the extended lockdown in Shanghai, and takeaways from J.P. Morgan’s Mike Gaito appearance on The BioCentury Show. This week’s podcast is sponsored by Kendall Square Orchestra.

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Long-awaited proof of concept for AstraZeneca’s PARP-1-selective therapy opens the door to combination strategies previously limited by hematopoietic toxicity, Senior Editor Karen Tkach Tuzman says on the latest edition of BioCentury This Week. Tkach Tuzman surveys data from the growing DNA damage repair (DDR) field from this year’s American Association for Cancer Research meeting, and the team also discusses the legacy of outgoing NCI Director Ned Sharpless, concerns over McKinsey's work for FDA and life sciences clients and the latest crop of BioCentury Emerging Company Profiles. This week’s podcast is sponsored by Bio€quity Europe.

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Positive fund flows and modestly better performance by biotech indexes offer hints that the beginnings of a recovery could be possible in the near term, even as the financing drought grinds on. On a BioCentury This Week Special Report, BioCentury’s editors discuss the conditions, including clinical catalysts and M&A, that could spark a recovery for the biopharma sector. This week’s podcast is sponsored by Bio€quity Europe.

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BioCentury's editors break down CMS’s final coverage decision on amyloid mAbs for Alzheimer’s disease, focusing on what the lessons are from Aduhelm’s journey through FDA and CMS, and what sponsors of the next crop of Alzheimer's therapies should expect when seeking approval of their programs. Plus: highlights from the latest translational coverage in BioCentury’s Distillery, a call from FDA’s Patrizia Cavazzoni for increased funding to support regulatory innovation, and takeaways from Editor in Chief Simone Fishburn’s conversation on The BioCentury Show with EQRx Inc.’s Jami Rubin.

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Novartis is prioritizing “high-value,” multibillion-dollar assets as it reorganizes. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the Swiss pharma’s plans to reunite its oncology unit with the rest of its pharma business and carve out a new C-suite post to oversee strategy and growth. Plus: how Merck KGaA is changing the way it is building its pipeline following late-stage clinical disappointments and what to look for at the upcoming Association for Cancer Research (AACR) meeting. 

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AACR is just around the corner, and new data being presented at the conference details how stakeholders are improving the specificity of CAR T therapies in solid tumors and improving their ability to penetrate the tumor microenvironment. Plus, BioCentury’s editors discuss the upcoming FDA advisory committee for ALS therapy AMX0035 from Amylyx, including FDA’s stance on the efficacy data and the challenges around weighing the safety of a therapy for a patient community in desperate search of new treatments vs. maintaining an efficacy standard for approvals.

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The importance of FDA’s approval of Bristol Myers' LAG3 inhibitor Opdualag nivolumab/relatlimab for melanoma, the pharma’s disruptive marketing strategy and what’s next among checkpoints in the clinic headline the latest BioCentury This Week podcast. BioCentury's editors also discuss why there’s still a lot of excitement regarding the IL-2 cancer pipeline despite last week’s setback for Nektar Therapeutics and the paths less traveled to raising money as the downturn grinds on. This week’s podcast is sponsored by life sciences investment firm Jeito Capital. 

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Chinese immuno-oncology companies are changing how they interact with FDA as they seek approval of PD-1 programs. On this episode of BioCentury This Week, BioCentury’s editors discuss takeaways from a survey of CEOs and R&D heads developing PD-1 or PD-L1 inhibitors about what’s next for their programs. The team also previews translational data expected at next month’s meeting of the American Association for Cancer Research (AACR) and legislation making its way through Congress as the House Energy and Commerce Committee’s health subcommittee prepares to gather. This week’s podcast is sponsored by life sciences investment firm Jeito Capital. 

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War Pulls Biotech to Ukraine, Out of Russia: BioCentury's editors look at how the worsening crisis in Ukraine is affecting the global life sciences community, and discuss the challenges and tactics for removing Russian capital from biotech VC funds and the takeaways form a Guest Commentary by 4BIO Capital’s Dima Kuzmin that calls for a thoughtful approach to economic disengagement from Russia. Plus: what highly anticipated TROPiCS-02 data means for Gilead's Trodelvy sacituzumab govitecan-hziy and Senior Editor Karen Tkach Tuzman returns for another monthly installment of What’s on Tap in the Distillery. This week’s podcast is sponsored by life sciences investment firm Jeito Capital. 

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Industry 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.

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Newly confirmed FDA commissioner Rob Califf will be prioritizing a proactive communications strategy, including combating misinformation about science, whilst guiding FDA through the pandemic and trying to keep the agency above Washington’s political fray. Plus, BioCentury’s editors discuss how late-stage investors are adapting to biotech’s bull market and Amgen’s application of its rapid development strategy to its pipeline. Sponsored by Jeito Capital, a global leading investment company with a patient benefit driven approach that finances and accelerates the development and growth of ground-breaking innovation. Learn more at Jeito Capital.

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FDA and its advisory panel of oncology experts have repudiated the use of China-only data for regulatory submissions in the U.S. How will China's cancer companies adjust to this new regulatory environment? Plus, BioCentury's editors discuss the upcoming vote on Rob Califf, President Biden's nominee to become the next FDA commissioner, and the latest translational trends in cancer, infectious and neurology as identified BioCentury's Distillery. Sponsored by ICON, the clinical research organization offering flexible partnership model for biotech companies. Learn more at ICON.

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Weathering the bear market. Oncology chief’s change in thinking on PD-1 therapies. Plus BioCentury’s 2021 innovative start-ups. This week’s podcast is sponsored by ICON.

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This week’s podcast is sponsored by ICON.

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BioCentury’s new in-depth conversational series launches with Scott Gottlieb as debut guest. This week’s podcast is sponsored by ICON.

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Part two of BioCentury’s 2022 Financial Markets Preview, access to Alzheimer’s mAbs, and translational highlights from the Distillery. This week’s podcast is sponsored by ICON.

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