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FDA Commissioner Marty Makary intends to resign on Tuesday, according to several sources. This report follows a tumultuous 13-month tenure in which Makary oversaw the controversial rejections of several rare disease drugs and âpredictable volatilityâ within the agency.
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New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish Americaâs number one killer: heart disease.
The FDAâs decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisionsâthe CDC and the FDAâs two primary review units.
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Robert F. Kennedy Jr.âs health department has consistently touted radical transparency as being key to its mission. Recent instancesâthe FDAâs decision not to disclose the recipients of three Commissionerâs National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papersâcall this intent into question.
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Altimmuneâs 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 Nordiskâs Wegovy elicited greater weight loss in women than in men with heart failure, according to data presented Sunday at the American Diabetes Associationâs 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 Pharmaceuticalsâ 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 Pharmaceuticalsâ three cystic fibrosis drugsâKaftrio/Trikafta, Symkevi and Orkambiâwill now be available through Englandâs National Health Service, following the signing of a long-term reimbursement agreement.
Vanda Pharmaceuticals has rejected two unsolicited takeover offers, saying that they are âopportunistic attemptsâ to acquire the biotech at a heavily discounted price.
While Thursdayâs label expansion and traditional approval for the gene therapy is an important milestone, many challenges still face the Duchenne muscular dystrophy community.
Zealand Pharmaâs 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 Pfizerâs Duchenne muscular dystrophy gene therapy candidate, the FDA has green lighted the expanded use of Sarepta Therapeuticsâ 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.