Gilead Sciences to Acquire Repare Therapeutics’ Polθ ATPase Inhibitor RP-3467 for ~$30M

Shots: Repare Therapeutics has entered into a definitive asset purchase agreement with Gilead Sciences for the acquisition of Repare's RP-3467, a polymerase theta (Polθ) ATPase inhibitor, strengthening Gilead’s precision oncology pipeline Under the Agreement, Repare will receive up to $30M in total consideration, including $25M upfront (subject to customary adjustments) and an additional $5M upon…

ByPrince Giri1 day ago

NEWS

SN BioScience Receives US FDA ODD for SNB-101 in Gastric Cancer

Shots: US FDA has granted Orphan Drug Designation (ODD) to SN BioScience’s SNB-101 for the treatment of gastric cancer, including gastroesophageal junction cancer SNB-101 is currently under P-Ib/II development for small cell lung cancer and is being evaluated across multiple solid tumor indications in Korea, Europe and US SNB-101 is a polymer nanoparticle formulation of…

ByPrince Giri1 day ago

NEWS

Jacobio Pharma Forge ~$2B+ Partnership with AstraZeneca for JAB-23E73

Shots: Jacobio Pharma entered a global exclusive licensing agreement with AstraZeneca for JAB-23E73, granting AstraZeneca exclusive development & commercialization rights outside China, while both companies will jointly develop & commercialize in China As per the deal, Jacobio will receive $100M upfront, and is eligible up to $1.91B in development & commercial milestones, and tiered royalties…

ByRidhi Rastogi4 days ago

NEWS

BMS Reports the US FDA’s sBLA Acceptance with Priority Review of Opdivo for Classical Hodgkin Lymphoma (cHL)

Shots: The US FDA has accepted sBLA & granted priority review to BMS' Opdivo (nivolumab) + doxorubicin, vinblastine & dacarbazine (AVD) for the treatment of pts (≥12yrs.) with previously untreated Stage III or IV cHL (PDUFA: Apr 8, 2026) sBLA was supported by the P-III (SWOG S1826/ CA2098UT) trial assessing Opdivo + AVD in above…

ByRidhi RastogiDecember 12, 2025

INSIGHTS+

The US FDA New Drug Approvals in November 2025

Shots: Innovation surged in November, with cutting-edge science and strategic collaborations reshaping the drug development landscape across oncology, renal disease, hereditary conditions, and more The US FDA cleared five standout therapies, including Bayer’s Hyrnuo (Sevabertinib), UCB’s Kygevvi (Doxecitine + Doxribtimine), and Arrowhead’s Redemplo, underscoring a month of meaningful clinical progress November 2025 closed with five approvals, matching last year’s total, signaling sustained momentum and a steady…

ByDipanshu DixitDecember 9, 2025

NEWS

Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

Shots: Nurix reported updated P-Ia/I b data for bexobrutideg in which P-Ia (n=48) showed an ORR of 83% incl. 2 CRs & a median PFS of 22.1mos. across all doses (50 mg to 600 mg OD) in heavily pretreated relapsed/refractory CLL/SLL pts.; P-Ib data (n=42) indicated higher ORR i.e. 83.3% & longer PFS at the 600mg…

ByPrince GiriDecember 8, 2025

NEWS

Kelun-Biotech and Crescent Biopharma Enter Strategic Deal to Accelerate CR-001 and SKB105 Programs

Shots: Crescent granted Kelun exclusive rights to research, develop, manufacture & commercialize CR-001 in Greater China, while Kelun granted Crescent similar exclusive rights for SKB105 globally (excl. Greater China) Kelun will receive $80M upfront, ~$1.25B in milestones, tiered mid–single to low-double-digit royalties & potential change-of-control payments, while Crescent will get $20M upfront, ~$30M in milestones…

ByRidhi RastogiDecember 5, 2025

INSIGHTS+

Key Biosimilars Events of November 2025

Shots: Regulatory momentum accelerates globally, with major approvals across the US, EU, UK, and Canada for biosimilars targeting high-value biologics such as Simponi, Stelara, Perjeta, Prolia/Xgeva, Remicade, Xolair, Eylea, Lucentis, and Lantus SoloStar, strengthening patient access in immunology, oncology, ophthalmology, diabetes, and allergy/asthma Sandoz, Alvotech, Celltrion, Henlius/Organon, Teva, and others expand portfolios and market reach, including multiple EC and…

ByDipanshu DixitDecember 2, 2025

NEWS

Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Denosumab)

Shots: Samsung Bioepis has launched Obodence (60mg PFS) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva, for bone health treatments, with commercial availability expected by Dec 2025 & Jan 2026, respectively Obodence treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & bone loss in men on…

ByRidhi RastogiDecember 1, 2025

NEWS

Abbott Expands Leadership in Cancer Diagnostics with ~$23B Acquisition of Exact Sciences

Shots: Abbott has entered into a definitive agreement to acquire Exact Sciences, making Exact a subsidiary of Abbott upon deal completion As per the deal, Abbott will acquire Exact Sciences for $105 per share, representing a total equity value of ~$21B & an estimated enterprise value of $23B, with financing that includes absorbing Exact’s ~$1.8B in…

ByRidhi RastogiNovember 21, 2025

Gilead Sciences to Acquire Repare Therapeutics’ Polθ ATPase Inhibitor RP-3467 for ~$30M

SN BioScience Receives US FDA ODD for SNB-101 in Gastric Cancer

Jacobio Pharma Forge ~$2B+ Partnership with AstraZeneca for JAB-23E73

BMS Reports the US FDA’s sBLA Acceptance with Priority Review of Opdivo for Classical Hodgkin Lymphoma (cHL)

The US FDA New Drug Approvals in November 2025

Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

Kelun-Biotech and Crescent Biopharma Enter Strategic Deal to Accelerate CR-001 and SKB105 Programs

Key Biosimilars Events of November 2025

Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Denosumab)

Abbott Expands Leadership in Cancer Diagnostics with ~$23B Acquisition of Exact Sciences

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