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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.
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.
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.
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.
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.
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.
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.
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.
Dig deeper into BioCentury’s analysis of these issues and more at BioCentury.
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.
Dig deeper into BioCentury's analysis of these issues and more at BioCentury.
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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