dermatologyadvisor1d
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.
FiercePharma9d
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,
The Business Journals8d
Sanofi’s Framingham facility hit with FDA warning
Sanofi (NYSE: SNY) acquired the Framingham facility when it bought Massachusetts-based Genzyme in a deal worth over $20 billion in 2011. Genzyme became a subsidiary of Sanofi and kept the Genzyme ...
Becker's Hospital Review8d
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 NEWS9d
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.
The Victoria Advocate7d
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
THURSDAY, Jan. 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about ... plant in Framingham, Massachusetts. On Jan. 15, 2025 ...
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 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 News2d
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.
WBJournal3d
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.
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.