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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
LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol 
Shots:  The US FDA has approved Lerochol as an LDL-C lowering therapy for adults with hypercholesterolemia, including HeFH; US launch as a PFS is expected in spring 2026, with an autoinjector later in 2026, while EMA approval is anticipated in Jun 2026 alongside additional global regulatory filings   Approval was supported by the global P-III (LIBerate) trial, enrolling over 2,900 CVD patients and without…
December 12, 2025
Innoviva Specialty Therapeutics Receives the FDA Approval for Nuzolvence (Zoliflodacin) for Uncomplicated Urogenital Gonorrhea 
Shots:  The US FDA has approved Nuzolvence for the treatment of uncomplicated urogenital gonorrhea in pts (age ≥12yrs.; Wt.≥35 kg), with US commercialization planned for the H2’26  Approval was based on a pivotal P-III multinational trial (n=930) evaluating a single 3g oral dose of Nuzolvence vs ceftriaxone (500 mg IM) + azithromycin (1 g oral) for uncomplicated urogenital gonorrhea, which demonstrated non-inferiority, comparable tolerability…
December 12, 2025
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