Shots:
IDEAYA Biosciences has enrolled the first patient in its P-I dose escalation/expansion trial of IDE034, a B7H3/PTK7 bispecific TOP1 ADC, for solid tumors
The company is planning to assess the safety, tolerability, & PK of IDE034 as monotx. in a P-I trial & explore combinations with DDR-targeting agents, incl. its proprietary PARG inhibitor, IDE161…
NEWS
Shots:
The US FDA has granted full approval to Braftovi + cetuximab & fluorouracil-based CT for the treatment of adults with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation
Approval was backed by the P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in pts, randomized to Braftovi + cetuximab (n=158), Braftovi + cetuximab + mFOLFOX6 (n=236),…
Shots:
SteinCares has entered into a strategic licensing agreement with Shilpa Medicare to commercialize a biosimilar across Latin America (LATAM)
As per the deal, SteinCares secures exclusive rights to register, commercialize, & distribute the biosimilar across the region, while SBPL will finalize development & undertake commercial manufacturing at its Dharwad, India facility
Partnership combines SBPL’s…
Shots:
GSK has entered into an agreement to acquire 35Pharma, incl. its asset HS235, expanding scalable growth opportunities within its Respiratory, Immunology & Inflammation portfolio
As per the deal, GSK will acquire 100% of 35Pharma’s equity for $950M in cash, payable at closing
HS235, a therapy targeting the activin receptor signalling pathway, has completed P-I…
Shots:
FDA approved Dupixent for pts (≥6yrs.) with AFRS & have a history of sino-nasal surgery, based on the P-III (LIBERTY-AFRS-AIMS) trial, assessing age & weight-based Dupixent dosing (200 or 300mg; Q2W or Q4W; n=33) vs PBO (n=29) in 62 pts
Trial met its 1EP with improved sinus opacification by 50% vs 10% at Wk. 52,…
Shots:
The US FDA has received an sBLA of Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA)
sBLA was supported by P-II/III (ENERGY) trial assessing the efficacy & safety of Imaavy vs PBO in adults with wAIHA, followed by an OLE period
Trial achieved stringent 1EP of a durable hemoglobin response & showed…
Shots:
Frontier has entered into an exclusive licensing agreement with GSK for two Small Interfering RNA (siRNA) assets in immunology, incl. one IND-stage candidate & one preclinical program
As per the deal, GSK will gain exclusive global rights to develop, manufacture, & commercialize two of Frontier’s siRNA candidates, while Frontier will receive $40M upfront, up…
Shots:
Sciwind Biosciences has granted Pfizer China exclusive commercialization rights to Ecnoglutide injection in Mainland China
As per the deal, Sciwind will retain the MA & will be responsible for R&D, registration, manufacturing, & supply, plus is eligible to receive ~$495M in upfront, regulatory, & sales milestones
Independently developed by Sciwind, Ecnoglutide is a cAMP-biased…
Shots:
Merck has reorganized its Human Health division into two units: Oncology, and Specialty, Pharma & Infectious Diseases, to sharpen commercial execution & support a growing portfolio of launches across diverse therapeutic areas
Jannie Oosthuizen has been appointed EVP & President, Oncology & MSD International, while Brian Foard will serve as EVP & President, Specialty,…
Shots:
Sebela Pharmaceuticals has entered into an agreement granting Organon exclusive global rights to Miudella, a hormone-free copper intrauterine device (IUD) contraceptive
As per the deal, Sebela will receive $27.5M at closing & ~$505M in sales-based milestone payments, with tiered net sales-based double-digit royalties
Miudella was approved by the US FDA in Feb 2025, for…

