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Bavarian Nordic
News
Bavarian Nordic Reports the Health Canada’s NDS Acceptance of CHIKV VLP to Prevent Chikungunya
Shots: Health Canada has accepted NDS of CHIKV VLP for active immunization against CHIKV disease in individuals (≥12yrs.); decision is anticipated in H1’26 NDS was based on 2 P-III trials (n>3,500) that met their 1EP, with 97.8% of subjects aged 12–64yrs. & 87.3% aged >65yrs. developing neutralizing antibodies by day 21 post vaccination; seroresponse rates…
5 days ago0Comments
News
Sanofi to Acquire Vicebio for ~$1.6B
Shots: Sanofi has entered into an agreement to acquire Vicebio, expanding its respiratory vaccines pipeline & capabilities with Vicebio’s vaccine candidates (VXB-241 & VXB-251) & Molecular Clamp tech As per the deal, Vicebio will receive $1.15B upfront & ~$450M in development & regulatory milestones; closing is expected in Q4’25 Molecular Clamp tech stabilizes viral proteins…
5 days ago0Comments
VIEWPOINTS
Next-Gen T Cell Engagers for Solid Tumors: Shaun Murphy in a Riveting Dialogue Exchange with PharmaShots
Shots:   Unlike hematologic malignancies, where the elimination of most or all tumor cells results in immunosuppression, making headways in solid tumors requires a new holistic approach when using T Cell Engagers  Abpro’s ABP-102/CT-P72, co-developed by Celltrion leverages a tetravalent format; bivalent for both HER2 and CD3  PharmaShots welcomes Shaun Murphy, Vice President, Nonclinical Research and…
July 21, 20250Comments
News
Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of Ilumya (Tildrakizumab) for Active Psoriatic Arthritis
Shots: Sun Pharma has reported topline data from P-III (INSPIRE-1 & INSPIRE-2) trials assessing Ilumya (100mg) in pts with active psoriatic arthritis (PsA) INSPIRE-1 & INSPIRE-2 trials to evaluate Ilumya (Q12W) vs PBO in ~800 active PsA pts over 52wks., where INSPIRE-1 enrolled pts with prior anti-TNF exposure & INSPIRE-2 enrolled anti-TNF naïve pts Both…
July 21, 20250Comments
Bayer
News
Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Shots: The EC has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…
July 21, 20250Comments
News
ARS Pharmaceuticals and ALK’s EURneffy Secures the MHRA’s Approval to Treat Allergic Reactions in Children
Shots: The UK’s MHRA has approved EURneffy 2mg (adrenaline nasal spray) to treat allergic reactions (anaphylaxis) in children (>30kg); commercially available in the UK by late Q3’25 In Nov 2024, ARS Pharma granted ALK exclusive rights to commercialize neffy outside the US, incl. EU (as EURneffy), Canada, & select markets in exchange for $145M upfront, ~$320M…
July 21, 20250Comments