Califf's confirmation as FDA chief gives biopharma industry a 'steady hand' at the agency: analyst Biotech pipeline is outpaced by antibacterial resistance, new BIO report says The top 10 M&A targets in biotech for 2022 Provider groups scramble to convince lawmakers, CMMI to continue Direct Contracting model Digital stethoscope maker Tyto Care nabs European approval for its lung sound-identifying AI ASCO GU: J&J plays up precision therapy approach for Zejula's prostate cancer bid after mixed results Cytokinetics drug fails late-stage trial testing exercise capacity, as FDA considers nod in heart failure HHS awards community health centers $55M to expand telehealth access for underserved groups Veracyte’s prostate cancer genomic test can guide patients to best treatment, study finds A new SPAC decides to enter murky waters to hunt for biotechs in downsized $75M IPO Thermo Fisher dishes up $40M for Pennsylvania facility expansion, creating more than 100 jobs The average nonprofit hospital CEO takes home 8 times more than their hourly workers, Lown Institute finds Quantum-Si taps founder Rothberg, prolific medtech entrepreneur, as interim CEO Editor's Corner: Fierce Biotech gets a fierce makeover Featured Story | By Kevin Dunleavy By a narrow vote of 50-46, Robert Califf has been confirmed by the Senate to run the FDA. Analysts at RBC Capital Markets applauded the confirmation, saying Califf can bring regulatory stability to the biopharmaceutical industry by providing more consistent messaging. read more |
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Top Stories By Max Bayer Biotechs do not have the arsenal of antibiotic hopefuls in their pipelines to match the growing threat of antimicrobial resistance, according to a new BIO report published Monday. read more By Annalee Armstrong All the biopharma world is talking about right now is M&A. Who’s going to buy? How much are they willing to spend? Who’s going to get bought? Here are our predictions. read more By Robert King Providers are making an all-out lobbying effort to convince progressive lawmakers and regulators to keep the Direct Contracting payment model, which some lawmakers say is an effort to privatize traditional Medicare. read more By Conor Hale The CE mark covers the web-based software module as a separate medical device. read more By Angus Liu The cancer drug Zejula carries a broad FDA label for ovarian cancer patients. But in metastatic, castration-resistant prostate cancer, the PARP inhibitor appears to work only for a niche population—and that’s bad news for the drug in its ongoing fight for market supremacy against AstraZeneca and Merck & Co.’s rival Lynparza. read more By Kyle LaHucik Cytokinetics' heart failure drug omecamtiv mecarbil failed to improve exercise capacity in patients with a certain kind of heart failure in a phase 3 study. The trial is not part of the package that the biotech sent to the FDA for a Nov. 30 decision on the drug. read more By Dave Muoio The new American Rescue Plan funds build on a 6,000% uptick in virtual care services being provided by HRSA-funded community health centers from 2019 to 2020. read more By Andrea Park While many companies developing blood tests and genomic analyses for cancer are aiming to improve early diagnosis, most of Veracyte’s tests focus instead on what comes after. read more By Kyle LaHucik Genesis Unicorn Capital has landed on the Nasdaq, a whole 12 months after incorporating, with a $75 million Wall Street debut to find a biotech or pharma company. read more By Fraiser Kansteiner Thermo Fisher, plowing ahead on a $650 million bioprocessing expansion, has unveiled a $40 million upgrade at its single-use technologies facility in Millersburg, Pennsylvania. The site is expected to employ more than 1,000 people once fully renovated in the middle of 2023. read more By Dave Muoio Hospital size, type and location all play a role in the pay discrepancies between nonprofit hospital workers and their top executives, according to a Lown Institute analysis that found CEOs receiving up to 60 times more than staff. read more By Andrea Park Jonathan Rothberg, Ph.D., credited as an inventor of high-speed, next-generation DNA sequencing, has described himself as a “parallel” rather than serial entrepreneur by founding and overseeing multiple biotech and medtech startups at once. read more By Annalee Armstrong Fierce Biotech is rolling out some big changes to help you get the news, analysis and insights you need in an easier-to-read format on our webpages. read more |
