- As Pfizer's booster AdComm nears, FDA staffers say COVID vaccines are already working as intended
- Moderna, AbCellera join forces to tackle major mRNA opportunity
- Google, ProMedica team up with IncludeHealth to tap into growing virtual MSK market
- CEOs of AbbVie, BMS, Lilly, GSK and more raise concerns about Washington's intensifying drug-pricing push
- Amylyx can proceed with ALS submission to FDA afterall, marking a win for patients’ advocacy efforts
- Tia clinches $100M to build out clinics, virtual care as investors bank on women's health startups
- COVID-19 tracker: Pfizer responds to contamination reports; Breakthrough data support the case for boosters, Moderna says
- Allay Therapeutics rakes in $60M for 'tunable' non-opioid treatment for joint replacement pain
- ALS Ice Bucket Challenge advocacy group calls for speedy FDA approval of Amylyx now-pending drug
- Census Bureau: 28M Americans lacked health coverage in 2020
- Zimmer Biomet dubs spine, dental spinout ZimVie and names C-suite appointments
- Docs press CMS for permanent telehealth flexibility, relief from pay cuts in fee schedule comments
Featured Story | By Eric Sagonowsky Ahead of the FDA's advisory meeting to review Pfizer's COVID-19 booster application, agency staffers voiced skepticism about the need to quickly roll out follow-up shots. As it stands, authorized COVID vaccines are doing their job, the staffers said. read more |
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Top Stories By Nick Paul Taylor Moderna’s early vision, years before it became synonymous with COVID-19 vaccines, was to “enable the body to produce its own healing proteins.” Infectious disease and cancer vaccines later rose up the list of priorities at Moderna, but work on the original plan continued—and is now getting a boost through a pact with the industry’s go-to antibody shop AbCellera. read more By Heather Landi Google and ProMedica Health System are investing in a rapidly growing virtual care market to get a slice of the $213 billion spent annually on musculoskeletal care. The two companies are partnering with IncludeHealth to launch a musculoskeletal (MSK) operating system that any provider can use to offer integrated virtual physical care for patients. read more By Eric Sagonowsky As officials in Washington weigh contentious drug-pricing measures, there's even more evidence that pharma companies are worried about potential reform. read more By Annalee Armstrong The FDA has done a U-turn on Amylyx’s amyotrophic lateral sclerosis (ALS) drug AMX0035. After asking for a new phase 3 study in April, the agency will now accept the biotech’s submission based on phase 2 evidence. read more By Heather Landi Tia, a startup building what it calls a "modern medical home for women," secured a hefty $100 million funding round to scale its virtual and in-person care. read more By Noah Higgins-Dunn,Kevin Dunleavy,Fraiser Kansteiner Five unused vials of Pfizer's vaccine were found to have white floating matter in them, although the company maintains the substance was likely ingredients that hadn’t fully dissolved. Diagnostics maker Cepheid has scored an FDA emergency nod for a new version of its rapid COVID-19, flu and RSV molecular test. Plus more. read more By Andrea Park Backed by a treatment-tuning technology platform, Allay Therapeutics is giving pain relief a major upgrade. read more By Beth Snyder Bulik The ALS Association, known for its Ice Bucket Challenge fundraising, is pushing for a speedy FDA approval of Amylyx's now pending ALS candidate submission—but is history repeating itself? In the wake of Biogen’s Aduhelm surprise approval this summer, some are questioning what role that approval is playing in the FDA's renewed willingness to evaluate Amylyx’s drug. read more By Paige Minemyer An estimated 28 million Americans lacked health insurance in 2020, according to new data from the Census Bureau. read more By Conor Hale From the French word “vie,” meaning life, and “zim,” meaning, well, Zimmer, the new company will focus on robotic spine surgery systems, cervical disc replacements, dental implants and more. read more By Robert King Doctor groups are pressing CMS to permanently expand telehealth flexibilities that the agency is proposing to run through 2023. read more |
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