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Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavneos
Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.
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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Eli Lilly joins hands with Engage Bio, acquiring the DNA delivery platform developer in hopes of bolstering its genetic medicines portfolio.
While the manufacturer is on the list of authorized GLP-1 importers, FDA inspectors found the company relabeled APIs from another site in a potential attempt to “circumvent safeguards.”
FDA veteran Richard Pazdur outlined his priorities for the next FDA commissioner but stopped short of putting himself forward as a candidate to lead the agency at an RBC Capital Markets event on Tuesday.
While both Beam Therapeutics and Wave Life Sciences touted notable biomarker benefits for their respective alpha-1 antitrypsin deficiency assets, analysts said that Beam might have the efficacy advantage as Wave’s drug hits an efficacy “ceiling.”
Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.
UCB’s Bimzelx elicited significantly stronger joint relief at 16 weeks than AbbVie’s Skyrizi in a Phase 3 head-to-head study of psoriatic arthritis.
Fallout from the resignation of FDA Commissioner Marty Makary continues as several other senior regulators are removed from their posts; pharma’s top paid CEOs make up to 358 times more than their employees; Revolution Medicine’s pancreatic cancer results highlight movement in the deadly disease space; more.
Analysts are extremely encouraged by Phase 2 trial results for Relay Therapeutics’ PI3KA inhibitor in treating vascular malformations (VM), prompting the biotech to eye a potential path to accelerated approval.
BioMarin’s investigational therapy failed to elicit clinical improvements in patients with ENPP1 deficiency, while also missing key secondary endpoints of rickets severity and growth.
Despite having no definitive data, Sen. Ron Johnson (R-WI) in a letter to health secretary Robert F. Kennedy, Jr. suggested there was a conscious effort by the Biden administration’s FDA to cover up the safety risks of COVID-19 vaccines.