Shots:The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA:…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below: Daiichi Sankyo and…
Shots:Merck Animal Health has reported data on Bovillis Nasalgen-C (Lyophilisate & Solvent for Suspension; intranasal vaccination) for the prevention of bovine coronavirus in veal calves at Vlaamse Buiatriecongres’25Data…
Shots:Alife Health has reported the European CE mark approval of Embryo Predict, an AI-based embryo selection software for in vitro fertilization (IVF)Alife will initiate the rollout of Embryo…
Shots:The NMPA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in Japan & the EU, with further filings plannedApproval was…
Shots:Sanofi has reported the P-II (ElevAATe) trial data assessing efdoralprin alfa (Q3W or Q4W) vs SoC plasma-derived augmentation therapy (QW) in 97 adults with AATD emphysema for ~32wks.Trial…
Shots:Alkermes has entered into a definitive agreement to acquire Avadel, incl. its asset Lumryz, accelerating its entry into the sleep medicine marketAs per the deal, Alkermes will acquire…
Shots:The US FDA has approved Blenrep + BorDex for the treatment of r/r MM in adults who have received ≥1 prior therapy, incl. a proteasome inhibitor & an immunomodulatory agent. NDA…
Shots:Ipsen enters into a definitive share purchase agreement with ImCheck Therapeutics to acquire later's all issued and outstanding shares, including lead candidate ICT01, a P-I/II therapy for 1L AML…
Shots:Novartis has reported that Cosentyx met all 1 & 2 EPs in the P-III trial in adults with PMRThe global P-III (REPLENISH) trial showed that Cosentyx (secukinumab) significantly…