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After review, Amgen is certain that Tavneos is effective and has a favorable benefit-risk profile. The company informed the FDA on January 28 that they would not pull the drug.
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Analysts parsed the limited data available for Pfizer’s obesity candidate on the pharma’s fourth-quarter earnings call Tuesday, looking for any nugget of additional context.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
After suffering in the wake of expired tax incentives for pharmas, the island is trying to take advantage of geopolitics to grow its drug manufacturing sector.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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Analysts do not believe the Phase III stumble for aticaprant will derail J&J’s broader neuroscience strategy, particularly given its recent $14.6 billion acquisition of Intra-Cellular Therapeutics and the success of Spravato for treatment-resistant depression.
A new Pitchbook report found $4.3 billion in funding to women-fronted biotech companies across 121 deals. The increase comes as sociopolitical headwinds slam into initiatives to support women and minorities.
Novo Nordisk is intervening in the lawsuit filed by a drug compounders trade group against the FDA over the agency’s decision to declare the Wegovy shortage over. Eli Lilly did the same in a parallel case over Zepbound’s removal from the FDA shortage list and this week a judge denied the compounders’ injunction.
Neffy 1 mg is the “first significant innovation” for epinephrine delivery in small children aged 4 years and up in over 35 years, according to ARS Pharmaceuticals.
The Senate hearing for FDA Commissioner nominee Marty Makary comes after President Trump’s NIH pick, Jay Bhattacharya, was grilled by the legislative body on Wednesday.
While hiring activity has not yet picked up, it should do so soon, according to BioSpace Recruitment Manager Greg Clouse. Meanwhile, another year-over-year decrease in layoffs means less competition for jobs.
The new formulation of Keytruda, currently under FDA review, is sparking conflict with Halozyme, which makes enzymes that convert intravenous drugs into injectable versions.
Novo Nordisk’s NovoCare will now provide uninsured or underinsured patients access to Wegovy for just $499 per month—less than half of its list price.
At the heart of the deal is the drug candidate dordaviprone, which is months away from a regulatory verdict for its use in H3 K27M-mutated diffuse glioma.
The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC advisory committee meetings.