News is a concise, evidence-aware briefing on what matters in healthcare—new trials, guideline changes, drug approvals, device safety, and health-policy shifts.
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
Under the deal with Lone Star Funds, Lonza maintains a 40% stake in its capsules and health ingredients business while receiving 1.7 billion Swiss francs ($2.2 billion) upfront.
Sanofi has agreed to sell its Medley generics unit in Brazil to leading local drugmaker EMS, according to an announcement from international law firm Mayer Brown. An EMS exec said the deal
The three-pronged plan to strengthen domestic drug supply will be supported by an investment of 24 billion new Taiwan dollars ($755 million), President Lai Ching-te said.
Forma Life Sciences, which inherited BioDuro’s California operations earlier this year, officially launched as a CDMO with a focus on oral solid dosage drugs this week.