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Rep. Jake Auchincloss of Massachusetts said the Commissioner’s National Priority Voucher program did not receive congressional backing. The FDA has also not yet made disclosures for eight senior reviewers, according to Auchincloss.
FEATURED STORIES
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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Read our takes on the biggest stories happening in the industry.
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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Anavex Life Sciences’ stock dropped by more than a third in value on Tuesday after results for a Phase II/III Rett syndrome study failed to impress investors.
Agios Pharmaceuticals met the primary endpoint in a late-stage trial investigating its drug mitapivat in treating adults with non-transfusion-dependent alpha- or beta-thalassemia.
After reporting positive mid-stage results for its LSD-based therapy for generalized anxiety disorder, MindMed’s chief medical officer sat down with BioSpace to discuss the path forward.
Greg Slabodkin, Heather McKenzie and Tyler Patchen discuss BioSpace’s tenth annual NextGen list of the hottest new life sciences companies.
In a collaboration agreement announced Wednesday, Boehringer Ingelheim will gain access to Ribo’s platform to target hepatocytes with investigational siRNA therapies for nonalcoholic or metabolic dysfunction-associated steatohepatitis.
Over the past year, obesity treatments have become the focus of intense media attention and discussion in healthcare — with increased focus on Wegovy and Zepbound. This attention has highlighted the need to address the global obesity epidemic.
The regulator greenlit 55 new drugs last year, seven of which belonged to Pfizer, including an ulcerative colitis treatment and a migraine nasal spray—both acquired in multibillion-dollar buys.
Patients treated with Longboard Pharmaceuticals’ bexicaserin saw a 32.5% drop in the frequency of countable motor seizures relative to placebo in a Phase 1b/IIa study. The company’s shares soared 316% Tuesday on the news.
The antibody-drug conjugate market remains hot so far in 2024 with Tuesday’s collaboration and license agreement between Roche and MediLink Therapeutics to develop a next-generation ADC in oncology.
The Swiss pharma is looking to leverage Voyager Therapeutics’ capsid technology for gene therapies aimed at treating Huntington’s disease and spinal muscular atrophy.