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Eli Lilly has long been gearing up for the launch of orforglipron, announcing as early as February 2024 that it was ramping up manufacturing investments for the weight-loss pill.
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The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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Read our takes on the biggest stories happening in the industry.
Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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Generic versions of biologic drugs could hit the market without human trials and allow the market forces to bring down costs, HHS leaders said while announcing new draft guidance.
Late-breaking Phase III data show ianalumab, Novartis’ dual-targeted antibody, reduced disease activity and patient burden in Sjögren’s disease, the pharma reported at the American College of Rheumatology Convergence congress on Wednesday.
Genentech is letting go of 118 employees in South San Francisco. The news comes about two months after the biotech ended a partnership with Adaptive Biotechnologies.
Shingrix sales in the U.S. took a 15% dive in the third quarter. GSK is now the second Big Pharma to report declining vaccine sales, after Sanofi reported a similar decline last week.
Already sky high after the success of its limb-girdle muscular dystrophy therapy, reported on Monday, BridgeBio’s shares rose nearly 8% more as encaleret balanced calcium levels in patients with a genetic thyroid disorder.
Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing troubles for the franchise.
The reprioritization initiative extends Aldeyra’s cash runway into the second half of 2027.
Eli Lilly and Johnson & Johnson are joining fellow Big Pharma peers in upping their investment in AI, with Lilly looking to create the industry’s ‘most powerful supercomputer’ and J&J building a virtual operating room.
As third-quarter earnings continue to roll out, Novartis makes headlines with the second biggest acquisition of the year; Novartis’ CEO also downplayed the impact of Big Pharma pricing deals with the Trump administration; Regeneron continued the trend of dropping cell therapy assets; BioSpace takes a look at how the FDA is functioning mid-shutdown.
While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.