Obesity
With 10 active or planned Phase 3 trials underway for Metsera’s berobenatide, Pfizer has signed a deal with Blackstone Life Sciences to finance the program to approval.
Novartis confirms that nine patients treated with its spinal muscular atrophy gene therapy Zolgensma have developed tumors; the FDA orders GLP-1 drugmakers to add a warning to their labels about the risk of a rare eye condition that can lead to vision loss; and the agency is set to decide on no fewer than 11 therapies this month, including closely watched applications from Summit Therapeutics, Vertex and Capricor Therapeutics.
Twelve marketed drugs, including Eli Lilly’s and Novo’s weight loss mega-blockbusters, will require a label change under the new FDA update.
The Phase 3 results help clarify the safety profile of Zealand and Boehringer Ingelheim’s survodutide, but analysts do not think the drug will find utility beyond patients with liver-related risk factors.
AstraZeneca has apparently made a $10 billion bid to acquire Rhythm Pharmaceuticals, an offer William Blair suspects will not be the last for the hot ticket metabolic biotech.
With the first Phase 3 data expected for Amgen’s MariTide next year, analysts are looking for evidence that the GLP-1 candidate is tolerable. Meanwhile, the company has begun testing an autoinjector formulation.
Novo CEO Mike Maziar Doustdar insists that his company is ahead of fierce rival Eli Lilly as oral Wegovy rises to 8 million total prescriptions since its January launch.
The majority of the large pharmas have now reported third quarter earnings—spoiler alert: Eli Lilly made more money than anyone expected. Plus, the FDA dropped another initiative aimed at accelerating rare disease treatments; HHS greenlights the compounding of six unapproved peptides; and uniQure’s embattled gene therapy for Huntington’s disease has finally been accepted for review.
Pfizer is calling upon lessons learned from one of the first drugs ever made available on the internet—Viagra—as it commercializes a new obesity drug in China.
Eli Lilly’s shares rose 4% in early morning trading after reporting revenue of $24.4 billion, well past consensus estimates.
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