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ADEL and Sanofi Ink ~$1.04B Global Licensing Deal for ADEL-Y01
Shots: ADEL has entered into an exclusive worldwide license agreement with Sanofi for the development & commercialization of ADEL-Y01 & related backup compounds As per the deal, ADEL will receive a non-refundable payment of $80M upfront plus development & commercial milestones, representing the total deal value of ~$1.04B, tiered royalties on net sales ranging up…
December 16, 2025
Sobi Reports the CHMP Positive Opinion of Aspaveli for C3 Glomerulopathy and Primary IC-MPGN
Shots: The CHMP has recommended Sobi's Aspaveli (pegcetacoplan) for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (≥12yrs.), with EC decision expected in Q1’26 Opinion was based on P-III (VALIANT) trial assessing Aspaveli(Q2W) vs PBO in C3G or primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label period, where all…
December 15, 2025
Insilico Medicine and TaiGen Biotechnology Partner for ISM4808 to Treat Anemia of Chronic Kidney Disease (CKD)
Shots: Insilico has entered into an exclusive out-licensing collaboration with TaiGen & its subsidiary TaiGen Biopharmaceuticals for ISM4808 to treat CKD-related anemia As per the deal, TaiGen will gain exclusive rights to ISM4808 & related forms for further development, commercialization & sub-licensing in Greater China, while Insilico will receive upfront payment, development & sales milestones, &…
December 15, 2025
Cytokinetics Reports the CHMP Positive Opinion on Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)
Shots: The CHMP has recommended Cytokinetics’ Myqorzo for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with EC decision expected in Q1’26 Opinion was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min, consistent across all subgroups &…
December 15, 2025
GSK Reports the CHMP Positive Opinion of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP
Shots: CHMP recommended GSK's depemokimab as add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively; EC’s decision expected in Q1’26 SWIFT-1 (n=382) & SWIFT-2 (n=380) trials showed depemokimab reduced asthma exacerbations by 54% over 52wks. (1EP)…
December 15, 2025
J&J
Johnson & Johnson Reports the US FDA Approval of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Shots: The US FDA has approved J&J's Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA2-mutated mHSPC Approval was backed by the ongoing P-III (AMPLITUDE) trial assessing Akeega + prednisone/prednisolone + ADT vs PBO/abiraterone acetate with prednisone + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC Trial met its…
December 15, 2025
Sobi to Acquire Arthrosi Therapeutics for ~$1.5B
Shots: Sobi has entered into a definitive agreement to acquire Arthrosi Therapeutics, incl. its asset pozdeutinurad (AR882), expanding its gout pipeline As per the deal, Sobi will acquire Arthrosi in an all-cash transaction for $950M upfront & ~$550M in clinical, regulatory & sales milestones; closing is expected in H1’26 Pozdeutinurad (QD, PO) is an URAT1…
December 15, 2025
Biocon Biologics Inks Settlement and Licensing Deal with Regeneron and Bayer for Worldwide Commercialization of Yesafili (Biosimilar, Eylea) 
Shots:  Biocon Biologics has signed a settlement and license agreement with Regeneron and Bayer for Yesafili (Biosimilar, Eylea) in the EU and globally, following a prior US and Canada settlement  Biocon Biologics, Regeneron, and Bayer settled all pending litigation, allowing Yesafili’s UK launch in Jan’26 and other countries by Mar’26 or earlier. YESAFILI launched in Canada in 2024, and US market entry secured in April…
December 13, 2025
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