NATCO Pharma receives 7 observations from USFDA for API unit at Manali

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels

Moderna bags $1.5 billion 5-Yr loan to boost financial flexibility

The non-dilutive financing includes three tranches

Bayer’s experimental stroke drug could reshape secondary stroke prevention

Millions of stroke survivors across the world may soon have a new defense

Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi

Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis

Texas hits Sanofi, Bristol-Myers Squibb with lawsuit over blood thinner drug efficacy

Paxton alleges the companies marketed Plavix as a reliable defense against heart attacks, strokes, and blood clots while failing to disclose evidence that the drug could be ineffective or virtually useless for many people

Contineum MS drug stumbles in mid-stage trial

Topline results from the Phase 2 VISTA trial show that PIPE-307 did not meet its primary or secondary efficacy endpoints

Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab

AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions

Hester Biosciences appoints Ashish Desai as CFO

Desai is currently serving the company as Group Finance Controller

Croda partners with Amino to expand biopharma capabilities

The partnership combines Croda’s deep expertise in smart science and global market reach with Amino’s advanced capabilities in precision manufacturing of amino acids