Biotech
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CDC panel to discuss COVID, hepatitis B shots in meeting next month
A federal register notice confirmed dates for the anticipated advisory meeting, which will follow an FDA decision to narrow COVID…
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Lilly to submit obesity pill after hitting goal in third late-stage trial
In people with diabetes and obesity, orforglipron led to weight loss near what people without diabetes experienced in prior testing.
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FDA cancels adcomm on Biohaven drug; Catalent lays off staff
Analysts found the agency's decision to cancel the meeting encouraging. Elsewhere, the Novo Holdings-owned CDMO cut about 350 staff in…
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FDA approves Ionis’ hereditary angioedema drug
Dawnzera is the third medicine cleared by U.S. regulators this year for the rare genetic condition. Ionis set its list…
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Xoma, a drug royalty specialist, buys another ‘zombie’ biotech
A deal to acquire Alkermes spinout Mural Oncology is Xoma’s fourth since June and the latest evidence of interest in…
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Stealth resubmits rare disease drug to FDA
The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the…
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HHS revives defunct task force on childhood vaccine safety
The panel’s reinstatement is one of a series of controversial moves made by Robert F. Kennedy Jr. to put vaccines…
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Lilly says it will raise drug prices in Europe, responding to Trump threats
As the Trump administration works to implement a “most-favored nation” policy, Lilly said it’s “rebalancing” drug prices to “align” costs…
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Insmed gains US approval of lung disease drug forecast to be blockbuster
Brinsupri, which Insmed acquired from AstraZeneca nearly a decade ago, is the first treatment for bronchiectasis that’s not caused by cystic…
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Regulatory uncertainty and access challenges changing go-to-market models, DTC, and DTP
DTC isn’t converting to Rxs at the pharmacy. Learn how access may be key to your brand’s success.
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