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

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Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

Shots:The EC has approved Imaavy (nipocalimab) as an add-on therapy to treat anti-AChR or anti-MuSK antibody-positive gMG pts (≥12yrs.)Approval was based on the P-III (Vivacity-MG3) trial assessing Imaavy (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), which showed…

ByRidhi RastogiDecember 2, 2025

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Akebia Therapeutics Acquires Q32 Bio’s Complement Inhibitor ADX-097 for ~$592M

Shots:Q32 Bio has sold ADX-097, a P-II complement inhibitor, to Akebia TherapeuticsAs per the deal, Akebia will acquire ADX-097 from Q32 Bio for ~$592M, incl. $12M in upfront & near-term milestones ($7M at signing, $3M after 6mos., $2M payable upon the earlier of a milestone or end-2026), plus development, regulatory & commercial milestones &…

ByRidhi RastogiDecember 2, 2025

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Innocare Doses First Patient in P-II Trial of Soficitinib for Prurigo Nodularis in China

Shots:Innocare has dosed the first patient in the global P-II trial of Soficitinib (ICP-332) for the treatment of pts with prurigo nodularis in ChinaSoficitinib was also evaluated in the P-II trial for mod. to sev. atopic dermatitis, which showed superior efficacy & favorable safety, with data presented at the AAD’25Soficitinib, a selective…

ByRidhi RastogiNovember 28, 2025

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Cothera Bioscience’s Zotiraciclib Receives the US FDA Fast Track Designation for Recurrent IDH-Mutated High-Grade Glioma

Shots:The US FDA has granted FTD to zotiraciclib (ZTR/TG02) for the treatment of pts with recurrent high-grade gliomas (rHGG) harboring IDH1 or IDH2 mutations (IDHmut rHGG)Designation was backed by the completion of the P-I trial of zotiraciclib, showing preliminary efficacy & favorable safety as a monotx. in IDHmut rHGG pts, which was presented at…

ByRidhi RastogiNovember 27, 2025

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BeOne Medicines Reports the US FDA’s NDA Acceptance of Sonrotoclax with Priority Review for R/R Mantle Cell Lymphoma

Shots:The US FDA has accepted NDA & granted priority review to sonrotoclax for adults with r/r mantle cell lymphoma following treatment with a BTK inhibitor NDA was supported by the global P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts (n=125), which met its 1EP of improved ORR per IRC, with benefits seen across…

ByRidhi RastogiNovember 26, 2025

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Insmed Reports the EC’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots:The EC has approved Brinsupri (25mg) for treating NCFB pts (≥12yrs.), with ≥2 exacerbations in the prior 12mos. under EMA'saccelerated assessment pathway; Application is under PMDA & MHRA review, & Insmed is planning to work with EU authorities to enable patient access starting in early 2026Approval was based on extensive clinical data, incl. P-III (ASPEN)…

ByRidhi RastogiNovember 19, 2025

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Merck Reports P-II (CADENCE) Trial Data on Winrevair for Combined Post and Precapillary Pulmonary Hypertension (CpcPH) due to HFpEF

Shots:Merck has reported topline P-II (CADENCE) trial data assessing Winrevair (sotatercept-csrk; 0.3 or 0.7mg/kg) vs PBO in 164 pts with CpcPH due to heart failure with preserved ejection fraction (HFpEF)Trial met its 1EP, showing a reduction in pulmonary vascular resistance at 24wks. along with a favorable safety profile. Data will be presented at a…

ByRidhi RastogiNovember 19, 2025

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J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

Shots:J&J has entered into a definitive agreement to acquire Halda Therapeutics, strengthening its oncology pipelineAs per the deal, J&J will acquire Halda for $3.05B in cash, with the deal treated as a business combination & expected to close in the coming monthsAcquisition will add Halda’s Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform…

ByRidhi RastogiNovember 18, 2025

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Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

Shots:The CHMP has recommended Teizeild to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the other regionsOpinion was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32) for 14 days in 76…

ByRidhi RastogiNovember 17, 2025

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

Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

Akebia Therapeutics Acquires Q32 Bio’s Complement Inhibitor ADX-097 for ~$592M

Innocare Doses First Patient in P-II Trial of Soficitinib for Prurigo Nodularis in China

Cothera Bioscience’s Zotiraciclib Receives the US FDA Fast Track Designation for Recurrent IDH-Mutated High-Grade Glioma

BeOne Medicines Reports the US FDA’s NDA Acceptance of Sonrotoclax with Priority Review for R/R Mantle Cell Lymphoma

Insmed Reports the EC’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Merck Reports P-II (CADENCE) Trial Data on Winrevair for Combined Post and Precapillary Pulmonary Hypertension (CpcPH) due to HFpEF

J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

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