dermatologyadvisor13h
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
STAT8d
Sanofi is warned by the FDA over ‘significant’ problems at a key manufacturing plant
The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility in Massachusetts.
FiercePharma8d
Sanofi API plant hit with FDA warning letter detailing quality, consistency flubs
Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a U.S. | The FDA has slapped a warning letter on Sanofi’s Genzyme facility in Framingham,
Becker's Hospital Review7d
FDA warns Sanofi over manufacturing violations
The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, 2025, follows an inspection conducted from June 12 to July 9, 2024, and outlines multiple manufacturing violations for pharmaceuticals.
ENDPOINTS NEWS8d
Sanofi says no sup­ply in­ter­rup­tions af­ter land­ing FDA warn­ing let­ter for US site
A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in Massachusetts.
Boston biotech Atalanta raises $97M to bring CNS drugs into clinic
Atalanta Therapeutics is building on the growing attention around RNAi-based medicines with its $97 million Series B financing and plans to enter the clinic.
Reuters3d
Novo Nordisk to cap insulin prices in Minnesota settlement; joins Lilly, Sanofi
Patients to pay no more than $35 a month Eli Lilly, Sanofi previously settled overcharging claims Novo Nordisk denies wrongdoing, pledges affordable insulin Jan 27 (Reuters) - Novo Nordisk (NOVOb ...
The MetroWest Daily News1d
Why Mayor Charlie Sisitsky, in his State of the City, said Framingham is 'strong'
Framingham Mayor Charlie Sisitsky delivered his fourth State of the City address Monday evening at Nevins Hall.
WBJournal2d
TJX expands Framingham presence by purchasing two office buildings for $24.3M
Framingham-based retail parent TJX Cos. has purchased two office parcels on Framingham’s Speen Street for $24.3 million.
The Business Journals3d
Sage rejects Biogen’s buyout offer, but says it's open to deals
The proposed merger of the two Cambridge drugmakers is off, but Sage says it's open to "strategic alternatives" — including a sale. Sage Therapeutics Inc. is looking for a deal — but it’s ...
The MetroWest Daily News6d
Framingham wins 'conditional approval' for MBTA Communities Act plan. What it means
Sisitsky submitted his plan to comply with the law late last month after city councilors voted to table discussing the issue until February.
pharmaphorum2d
Sanofi takes SK Bio-partnered pneumococcal shot into phase 3
Sanofi has moved ahead with plans to challenge Pfizer and MSD for a piece of the market for pneumococcal vaccines, taking a 21-valent shot licensed from SK Biosciences into phase 3 testing.