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Seven Novo Nordisk board members have resigned. The new board headed by former Novo Nordisk CEO Lars Rebien Sørensen will align behind the new CEO’s massive restructuring plan.
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The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies across the finish line, but industry leaders say there are more concrete steps the regulator could take to help patients.
With AbbVie’s $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ lead depression drug, the psychedelic therapeutics space has soundly rebounded from Lykos’ rejection last year. There are now seven programs in Phase III trials across the sector, with multiple companies vying for that first approval.
A decade-long journey has come to an end for Stealth BioTherapeutics and the Barth syndrome community with the first-ever treatment for this uncommon mitochondrial disease. CEO Reenie McCarthy called it a “pivotal victory” that “offers hope for expedited regulatory attention to other ultra-rare diseases.”
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Athira Pharma will cut about 49 positions, including two people in the C-suite. The announcement follows the company’s disappointing results for its investigational Alzheimer’s therapy.
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Novo Nordisk, under new CEO Maziar Mike Doustdar, has a new attitude. It’s making Pfizer livid.
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To drive true innovation in drug development, executives must not let excitement about the latest shiny object obscure ultimate outcomes.
Heading into the final quarter of a year that has seen dramatic upheaval at the FDA—from the exodus of numerous senior leaders to unclear policy changes and a safety saga that engulfed the gene therapy space—drug approvals appear roughly on par with recent years.
Therapies from industry leaders BioMarin and Ascendis Pharma supply a key hormone that promotes bone growth. In order to move the field forward, challengers are looking to address the underlying cause of the rare, genetic disease.
The British pharmaceutical giant has joined the direct-to-consumer push, following Pfizer and Amgen’s announcements in response to the president’s calls to lower U.S. drug prices.
A new version of the controversial bill removes the specific company names that were included in a previous iteration but still requires the industry to ditch Chinese biotech contractors in order to receive federal dollars.
Investor reaction to the deal was muted, with BMO Capital Markets analysts saying they “continue to look for more” from Bristol Myers Squibb before they can “get excited about the near term turnaround story.”
AviadoBio will have the option to exclusively license UGX-202, a vision-restoring gene therapy for the rare eye condition retinitis pigmentosa.
GoodRx, an online platform that offers drug discount coupons to patients, is in talks with the government to participate in the forthcoming TrumpRx program.
The British proposal to increase support for pharma is “clearly positive,” according to analysts at Leerink, who noted that the NHS’ move will improve patient access to treatments.
Novo will add Akero’s efruxifermin to its MASH portfolio, which includes Wegovy after the GLP-1 gained an FDA nod in the indication earlier this year.