Solutions

Axplora, a German CDMO that specializes in specialty active pharmaceutical ingredients for small molecules and antibody-drug conjugates, will shell out $60 million to expand its Farmabios manufacturing facility in Gropello Cairoli, Italy.

Sandoz has struck a deal with Samsung Bioepis to commercialize up to five biosimilars, with the first being SB36, a copycat of Takeda’s Entyvio, which is being developed by the South Korea-based

From its 17-year development cycle through to its commercial launch, production has always been in Yeztugo’s DNA. And, for the twice-yearly pre-exposure prophylaxis medication—which Gilead Sciences has positioned as a key tool

Simtra BioPharma Solutions was issued a warning letter by the FDA after an inspection uncovered a number of problems at the CDMO’s production plant in Halle, Germany.

The FDA has rejected Hyloris Pharmaceuticals’ antiviral valacyclovir, an oral suspension for infections caused by herpes simplex and varicella-zoster viruses becasue of manufacturing problems.

While much of the company’s recent focus has remained on beefing up its U.S. infrastructure, Eli Lilly has for the second time this week made moves to raise capacity for its medicines

The $3 billion investment will take shape over the next ten years, the company said, and will increase the global supply of its oral GLP-1 prospect orforglipron.

Monday, CSL broke ground on an expansion at its Kankakee, Illinois, facility, a move set to substantially bolster the company’s production capacity for plasma-derived therapy.

Issues at a former Catalent plant now owned by Novo Nordisk have derailed another FDA application. Incyte announced Friday that the FDA issued a complete response letter for its PD-1 inhibitor Zynyz