NEWS Archives - Page 2 of 154

NEWS

Bayer Reports the US FDA’s Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Shots:The US FDA has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause based on P-III (OASIS-1, 2, & 3) trials, with commercial availability expected at the start of Nov 2025; MAA is under the EMA’s review Efficacy was evaluated in OASIS-1 & 2 trials assessing Lynkuet vs PBO…

2 days ago

Novartis to Acquire Avidity Biosciences for ~$12B, Boosting its Neuroscience Pipeline

Shots:Novartis has agreed to acquire Avidity Biosciences, strengthening its neuroscience pipeline with Avidity’s Antibody Oligonucleotide Conjugates (AOCs) platform & 3 late-stage programsAs per the deal, Novartis will acquire Avidity for $72/share, valuing the company at ~$12B with an enterprise value of ~$11B; closing expected in H1’26Before the merger, Avidity will transfer its early-stage precision…

2 days ago

Merck Animal Health Reports Data on Bovillis Nasalgen-C Vaccination Against Bovine Coronavirus at Vlaamse Buiatriecongres 2025

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 was presented from a study titled “Intranasal vaccination against bovine coronavirus significantly improves production parameters in cross-bred veal calves: Results from a randomized field trial”,…

4 days ago

Alife Health Receives CE Mark for Embryo Predict AI Embryo Selection Tool

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 Predict across selected IVF clinics in the EU, building on the company’s progress in the US with the Clinical Decision Support platform & collaborations with…

5 days ago

Boehringer Ingelheim Reports the NMPA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

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 based on P-III (FIBRONEER-IPF) assessing Jascayd (18 or 9mg, PO, BID) vs PBO in IPF pts, which met its 1EP of reduced FVC decline at…

5 days ago

Sanofi Reports P-II (ElevAATe) Trial Data on Efdoralprin Alfa for Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

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 met its 1EP with a greater mean increase in functional AAT (fAAT) levels at Wk. 32 & achieved key 2EPs of higher fAAT levels &…

5 days ago

Alkermes to Acquire Avadel Pharmaceuticals for ~$2.1B, Marking its Entry in Sleep Medicine Market

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 Avadel for $18.5/share, along with one non-tradeable CVR of $1.5/share tied to Lumryz’s US FDA approval for idiopathic hypersomnia in adults by 2028 end, representing…

5 days ago

GSK’s Blenrep (Belantamab Mafodotin) Regimen Receives the US FDA’s Approval to Treat R/R Multiple Myeloma

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 under NMPA’s priority reviewApproval was based on P-III (DREAMM-7) trial assessing Blenrep (2.5mg/kg, IV, Q3W) in combination with BorDex for 8 cycles, then as a single…

5 days ago

Ipsen Acquires ImCheck Therapeutics, Enhancing its Oncology Leadership and Strengthening its Pipeline

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 pts ineligible for intensive CTAs per the deal, shareholders of ImCheck Therapeutics will receive €350M ($406.62M) in closing purchase price, with additional deferred payments…

October 23, 2025

Novartis Reports Cosentyx P-III trial met 1 & 2 EPs for Patients with Polymyalgia Rheumatica (PMR)

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 improved sustained remission at Wk 52 in PMR pts vs PBO, with a reduced steroid dose and a safety profile consistent with prior use. Conducted…

October 23, 2025

NEWS

Bayer Reports the US FDA’s Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Novartis to Acquire Avidity Biosciences for ~$12B, Boosting its Neuroscience Pipeline

Merck Animal Health Reports Data on Bovillis Nasalgen-C Vaccination Against Bovine Coronavirus at Vlaamse Buiatriecongres 2025

Alife Health Receives CE Mark for Embryo Predict AI Embryo Selection Tool

Boehringer Ingelheim Reports the NMPA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

Sanofi Reports P-II (ElevAATe) Trial Data on Efdoralprin Alfa for Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

Alkermes to Acquire Avadel Pharmaceuticals for ~$2.1B, Marking its Entry in Sleep Medicine Market

GSK’s Blenrep (Belantamab Mafodotin) Regimen Receives the US FDA’s Approval to Treat R/R Multiple Myeloma

Ipsen Acquires ImCheck Therapeutics, Enhancing its Oncology Leadership and Strengthening its Pipeline

Novartis Reports Cosentyx P-III trial met 1 & 2 EPs for Patients with Polymyalgia Rheumatica (PMR)

Contact US

OUR INFORMATION

FOLLOW US