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Johnson & Johnson trots out two-dose COVID vaccine data as it builds case for boosters European antitrust regulator delivers ultimatum to Illumina over $8B Grail deal Kaiser Permanente union authorizes strike vote amid stalled contract negotiations Verrica's lead drug VP-102 rejected by FDA thanks to issues at contract manufacturer Aerie CEO exits days after downplaying midphase eye disease flop Ascension latest nonprofit to rebound with $5.7B net income for 2021 Merck women's health spinoff Organon debuts first awareness campaign, taking on unplanned pregnancy Bristol Myers, Genentech and Celgene bought their old biotechs. Stafford and co. are ready for their next $60M act NextGen Healthcare taps former Teladoc exec Sides as new CEO amid boardroom spat Boston Scientific offers up $336M to devour Devoro Medical and its blood clot removal tech COVID-19 tracker: U.S. vaccine donation effort running into logistical hurdles Featured Story | By Kevin Dunleavy Johnson & Johnson showed that a second shot of its COVID-19 vaccine given two months after the first provides 94% protection against symptomatic COVID-19 and 100% protection against severe disease. Additionally, the two doses given two months apart yield a four- to six-fold increase in antibody levels. read more |
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| | Webinar: Building a robust FIH biologics regulatory CMC package Thursday, October 7, 2021 | 2pm ET / 11am PT Join us to learn how to develop a robust first-in-human (FIH) regulatory CMC package for recombinant biological molecules by integrating the following activities into your project plan: progressively developing knowledge of the molecule’s critical quality attributes to justify the manufacturing and control strategy, planning for continuing development, and identifying opportunities to enhance with scientific advice. Register Now. |
Top Stories By Conor Hale The European Commission described its actions as an unprecedented step in response to the companies’ defiant move last month, which finalized an $8 billion transaction in the face of pending antitrust probes on both sides of the Atlantic. read more By Dave Muoio The union of 24,000 nurses and other healthcare professionals say that the California provider's weak pay increase proposal will lead to staffing shortages. A Kaiser representative responded by highlighting the high cost of care and union members' existing above-average compensation. read more By Joseph Keenan Verrica Pharmaceuticals, which is seeking approval for a medication to treat skin diseases, said the FDA issued a complete response letter that outlines problems at a CMO facility being used to manufacture the treatment. read more By Nick Paul Taylor Maybe primary endpoints matter after all. Days after dismissing the importance of a midphase flop, Aerie Pharmaceuticals CEO Vicente Anido has left the company, leaving an interim leader to pursue what he claimed was “a clear path toward approval.” read more By Dave Muoio The faith-based nonprofit logged greater revenue and operating income for the year, but noted that volumes were consistently disrupted. It credited government funds and investment successes for its ability to sustain services. read more By Natalie Missakian When Merck's women’s health spinoff Organon launched in June, it promised to listen to—and amplify—women’s voices on overlooked health concerns. Now, the company is getting specific, with its first public awareness video tackling unplanned pregnancy. read more By Emmy Lucas Jeffrey Stafford and his team of industry veterans have seen their biotechs go on to be acquired by the likes of Genentech, Bristol Myers Squibb and Celgene. Now, the collective is ready for its next venture: launching RNA biotech 858 Therapeutics with a $60 million series A fundraising. read more By Heather Landi Ambulatory technology company NextGen Healthcare tapped former Teladoc executive David Sides as its new chief executive officer. Sides takes the reins as the health IT company is embroiled in a very public boardroom spat. Company founder Sheldon Razin launched a proxy campaign for an alternative slate of director candidates for board seats. read more By Andrea Park The deal will see Boston Scientific put down about $269 million up front to acquire Devoro, in which it has been a strategic investor since 2019. Down the line, it’ll pay out up to another $67 million as its new subsidiary hits certain unspecified clinical and regulatory milestones. read more By Noah Higgins-Dunn,Kevin Dunleavy,Fraiser Kansteiner,Emmy Lucas As the United States works to get doses to developing countries, those health systems are running into logistical problems. Officials are warning about false positive tests from Abbott Laboratories. Plus more. read more |
