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Acting Center for Drug Evaluation and Research Director Tracy Beth Høeg reportedly disagreed with staff who wanted to approve Sanofi’s type 1 diabetes drug. It’s far from the first time a political appointee has allegedly meddled in a recent FDA decision.
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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.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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Altimmune’s obesity candidate pemvidutide strongly preserved lean muscle mass, with fat accounting for more than 78% of weight lost by participants in a Phase II study.
Novo Nordisk’s Wegovy elicited greater weight loss in women than in men with heart failure, according to data presented Sunday at the American Diabetes Association’s 2024 Scientific Sessions.
The combined company began trading Friday under the Nasdaq symbol TECX. A $130 million private placement was also completed, with a cash runway into mid-2027.
Jazz Pharmaceuticals’ calcium channel modulator suvecaltamide in a mid-stage trial was unable to significantly lower tremor burden in patients with essential tremor, the company reported Thursday.
Vertex Pharmaceuticals’ three cystic fibrosis drugs—Kaftrio/Trikafta, Symkevi and Orkambi—will now be available through England’s National Health Service, following the signing of a long-term reimbursement agreement.
Vanda Pharmaceuticals has rejected two unsolicited takeover offers, saying that they are “opportunistic attempts” to acquire the biotech at a heavily discounted price.
While Thursday’s label expansion and traditional approval for the gene therapy is an important milestone, many challenges still face the Duchenne muscular dystrophy community.
Zealand Pharma’s petrelintide cut body weight by more than 8% on average, with a good overall safety and tolerability profile.
On the heels of a Phase III flop for Pfizer’s Duchenne muscular dystrophy gene therapy candidate, the FDA has green lighted the expanded use of Sarepta Therapeutics’ Elevidys.
The pharma industry is staring down the barrel of a widespread loss of exclusivity, with more than 190 products going off-patent between 2022 and 2030. Here are some strategies company are employing to manage the drop in revenue.