SKYLARK sings: Sage, Biogen hatch positive phase 3 data in postpartum depression Who needs Humira? AbbVie projected to be the top pharma company by sales in 2028: analysts Moody's: Outlook stable for insurers even as Medicaid, ACA enrollment declines loom BD to patch cybersecurity risks found in drug dispensing, lab management tech BioMarin's hemophilia A gene therapy further delayed amid new FDA questions Startup Homeward inks partnership with Rite Aid to provide primary care in rural communities After flagging death risks, FDA rescinds accelerated approval for TG Therapeutics' Ukoniq SEC reaches $628K settlement with SCWorx over 'false and misleading' COVID test scheme Kaufman Hall: Hospitals face 4th straight month of declining operating margins Amgen's heart drug reduces cardiovascular disease risk factor in phase 2 trial FDA puts Sanofi's Cialis prescription-to-OTC trial on hold, citing problems with study's design Featured Story By Nick Paul Taylor Sage Therapeutics and Biogen have delivered a clear win for zuranolone in the phase 3 SKYLARK trial of women with postpartum depression (PPD), although questions about the commercial opportunity led to a muted response to the data. read more |
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| | Biotech got the world back on track. Now, we’re getting back together, and what happens next is Limitless. #BIO2022 | Top Stories By Kevin Dunleavy Analysts surveyed by Evaluate Pharma predict AbbVie will generate more prescription drug sales than any company in 2028. They see AbbVie's $66 billion in expected 2028 sales closely followed by Roche at $65 billion. Johnson & Johnson, Merck and Pfizer round out the top 5 in their projections. read more By Paige Minemyer Insurers can expect a stable credit outlook and low double-digit earnings growth this year after a strong first quarter, according to a forecast from Moody's Investors Service. read more By Andrea Park BD said it would issue software updates for two of its products after discovering separate privacy concerns and potential hacking risks in each. read more By Max Bayer BioMarin’s commercial aspirations for its hemophilia gene therapy remain on ice after the FDA lobbed additional questions for the company to address, pushing back an expected approval submission to September. read more By Heather Landi Two months after launching her new rural healthcare startup Homeward, former Livongo executive Jennifer Schneider, M.D., has landed a big partnership with retail pharmacy Rite Aid. read more By Kevin Dunleavy The FDA has rescinded its accelerated approval of TG Therapeutics' lymphoma drug Ukoniq because of concerns that its use might increase the risk of death. The risk became apparent during a phase 3 trial of the drug in chronic lymphocytic lymphoma (CLL) and small lymphocytic lymphoma (SLL) patients. read more By Andrea Park SCWorx agreed to a settlement with the SEC that will see it pay a $125,000 penalty and a disgorgement of $471,000, plus prejudgment interest of just over $32,700. read more By Robert King Hospitals and health systems in April saw their median operating margins decline by nearly 40% compared to March as lower volumes and higher expenses take a toll. read more By Annalee Armstrong Back in 2020, Amgen cast aside a cardiovascular disease hopeful from Cytokinetics and pointed the spotlight at a small interfering RNA treatment it thought could make up for the lost partnership. Now, in some limited phase 2 data, the pharma is making its case. read more By Zoey Becker Sanofi is aiming to switch erectile dysfunction pill Cialis from prescription to over-the-counter availability, but the FDA isn't allowing the trial to continue for now. read more |