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Cellares, which last year became the first company to receive the FDA’s new advanced manufacturing technology designation, expects to support clinical production this year and offer commercial-scale manufacturing services in 2027.
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With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Presented at this week’s European Congress on Obesity, the two studies also demonstrate that Novo Nordisk’s Wegovy (semaglutide) provides cardiovascular benefits irrespective of starting weight and the amount of weight lost.
Crackdowns on drug pricing have forced one major insulin out of the market. Are more to come?
Takeda on Monday said it is paying AC Immune $100 million upfront for an option on a Phase Ib/II Alzheimer’s disease candidate that could activate the immune system to clear amyloid beta plaques.
A pre-planned analysis revealed patients receiving the vibostolimab-Keytruda coformulation in a late-stage trial had a high rate of dropouts due to immune-related adverse events, Merck announced Monday.
The major biopharma players have promised to increase their investments in France to help boost their respective global manufacturing and R&D capabilities, with Sanofi committing more than $1 billion.
Results from a Phase I study presented Friday at the ASGCT 2024 annual meeting showed that despite a good safety profile, Excision BioTherapeutics’ HIV gene editor failed to suppress viral activity.
An updated draft of the BIOSECURE Act introduced on Friday would give U.S. drug manufacturers additional leeway for existing contracts with certain Chinese “companies of concern” until 2032.
Two of the five fatalities were found to be unrelated to MacroGenics’ investigational antibody-drug conjugate vobra duo, while the other three are still under investigation.
While these technologies are now a therapeutic reality, the ASGCT 2024 annual meeting this week was a reminder of just how far we are from widespread use.
Anticipating approval for its COPD therapy ensifentrine, Verona has entered into a $650 million financing deal with Oaktree Capital Management and OMERS Life Sciences.