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…
Shots:
Novartis has agreed to acquire Avidity Biosciences, strengthening its neuroscience pipeline with Avidity’s Antibody Oligonucleotide Conjugates (AOCs) platform & 3 late-stage programs
As per the deal, Novartis will acquire Avidity for $72/share, valuing the company at ~$12B with an enterprise value of ~$11B; closing expected in H1’26
Before the merger, Avidity will transfer its early-stage precision…
Shots:
Dumbo Health has launched a fully digital sleep clinic for the treatment of sleep apnea, integrating testing, diagnosis, therapy, & follow-up into one seamless digital clinic, showcased at HLTH USA & available in Texas & Florida, with gradual expansion planned across the US throughout 2026
Dumbo Health offers a $149 test & diagnosis with…
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 Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Read More: Daiichi Sankyo and Merck
Gilead…
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’25
Data 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”,…
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…
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 planned
Approval 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…
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 &…
Shots:
Alkermes has entered into a definitive agreement to acquire Avadel, incl. its asset Lumryz, accelerating its entry into the sleep medicine market
As 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…
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 review
Approval 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…

