‘In the long-term interests:’ FDA oncology chief defends rejection of Lilly, Innovent cancer drug 'Stay alive': Wave of layoffs crashes into biotech startup inferno Pfizer and BioNTech go to Hollywood with splashy Oscars sponsorship How CVS Kidney Care is thinking about personalized care for patients Bayer CEO Baumann faces revolt from investor Temasek Holdings: report Amylyx to answer for single-study ALS application at FDA advisory panel Amid warnings of potential Russian cyberattacks, new Senate bill directs CISA, HHS to shore up digital defenses Biobeat widens lead over Apple, Fitbit with FDA nod to add more vital sign monitoring to smartwatch FDA halts use of GlaxoSmithKline and Vir's COVID-19 drug Xevudy in 8 northeast states Another Biogen-Ionis collab hits the dust after phase 1 ALS flop NeuraLace taps new CEO to oversee rollout of nerve stimulation device for pain relief Lilly, after making $1B bet, posts 'compelling' late-phase data on Dupixent rival Podimetrics snags $45M to prevent diabetic foot amputations with temperature-detecting mat Biden seeks $2.1B funding boost for FDA, part of pan-agency pandemic preparedness plan Verily's clinical research and healthcare businesses are growing, execs say, as company eyes post-pandemic opportunities Featured Story | By Angus Liu In an interview with Fierce Pharma, Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence, defended the rejection of Eli Lilly and Innovent Biologics' China-developed PD-1 inhibitor despite a pricing promise from the partners. read more |
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| | Webinar: Comparing the FDA, EMA & PMDA In Vitro DDI Guidance Thursday, April 14, 2022 | 11am ET / 8am PT In January 2020, the FDA published its final guidance for industry on in vitro drug-drug interaction (DDI) studies. Dr. Taylor will offer his expert perspectives on major changes, challenges and impacts to development strategies that resulted, compare it with the current EMA and PMDA in vitro guidance documents and discuss how to harmonize your drug development strategies to meet the expectations of all three. Register Now. |
Top Stories By Kyle LaHucik,Max Bayer,Annalee Armstrong At least 30 biopharmas have announced layoffs since September 2021, and the wave is likely to continue as thousands of startups struggle to stay above the competition. read more By Ben Adams Oscar-winning actor Will Smith slapping comedian Chris Rock made the biggest headlines out of the Oscars Sunday night. but the sponsorship from Pfizer and COVID shot partner BioNTech was for the pharma marketing world a bigger moment. read more By Paige Minemyer It takes a home-first approach to its care model, and is currently co-developing a hemodialysis device that is built specifically with home care in mind. read more By Kevin Dunleavy With a shareholder meeting set for April 29, two major investors in Bayer, Temasek Holdings of Singapore and Alatus Capital, have informed board chairman Norbert Winkeljohann that they want CEO Werner Baumann to be removed. read more By Annalee Armstrong The single clinical trial Amylyx Pharmaceuticals presented to support approval of its ALS drug is “not exceptionally persuasive,” according to the briefing document the FDA released ahead of this week's planned advisory panel, which will review the treatment. read more By Dave Muoio The legislation was brought to the Senate just days after the Biden administration warned of potential cyberattacks from Russia. read more By Andrea Park Though major tech developers like Apple and Google-owned Fitbit have taken center stage in the race to infuse wearable technology with as many health-tracking capabilities as possible, a small startup out of Israel has quietly lapped them all. read more By Kevin Dunleavy The U.S. has paused the distribution of GlaxoSmithKline and Vir Biotechnology’s antibody drug Xevudy in the northeast, where the new omicron subvariant, BA.2, accounts for more than half of new infections. The states included in the directive are Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island and Vermont. read more By Max Bayer Biogen and Ionis Pharmaceuticals are packing up and moving on after another antisense ALS candidate flopped in the clinic, less than six months after toferson failed. read more By Andrea Park Less than a year after sewing up FDA clearance for its first nerve stimulation device, NeuraLace has brought on a new CEO to guide the clinical rollout of the Axon Therapy system. read more By Nick Paul Taylor Eli Lilly has turned over the cards on its $1.1 billion bid to challenge Sanofi and Regeneron’s Dupixent for the atopic dermatitis market. Analysts at Jefferies called the data compelling, although a hoped-for point of differentiation over the blockbuster incumbent has weakened. read more By Rebecca Torrence Podimetrics landed $45 million in series C funding to expand the reach of its SmartMat, which detects signs of inflammation in the feet to prevent diabetic foot ulcers and resulting amputations. read more By Annalee Armstrong The Biden administration has proposed a $2.1 billion boost in funding for the FDA in 2023 to support the Cancer Moonshot program and pandemic preparedness. In total, the FDA could be up for $8.39 billion, a 34% increase over the $6.25 billion enacted for 2022. read more By Heather Landi At a high-level view, the puzzle pieces of Verily's work across healthcare and clinical research are starting to fit together, according to Amy Abernethy, M.D., president of Verily’s clinical research business. Fierce Healthcare caught up with Abernethy and Verily's Jessica Mega at recent healthcare conferences to talk about the company's efforts to support precision health. read more |
