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Merck has presented the P-IIb (MK-7240-012) study data assessing tulisokibart vs PBO in pts with moderate to severe hidradenitis suppurativa at EADV’26
Trial met its 1EP, with HiSCR50 at Wk. 16 achieved by 72% pts on high-dose tulisokibart (480mg, Q2W) & 64% on medium-dose (480mg, Q4W), representing a 37% & 29% improvement over PBO…
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Tolerance Bio has entered into an exclusive license agreement with Tanabe Pharma for MT-2990, an anti-IL-33 monoclonal antibody, across all indications
Tanabe Pharma has granted Tolerance Bio worldwide development & manufacturing rights, and ex-Japan exclusive commercialization rights for MT-2990 (TLB-33), while Tanabe will retain commercialization rights in Japan
As per the deal, Tanabe will…
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The US FDA has granted Orphan Drug Designation (ODD) to asedebart (Lu AG13909) for the treatment of endogenous Cushing's syndrome
Lundbeck is evaluating efficacy and safety of asedebart in proof-of-concept trials for Cushing's disease & classic congenital adrenal hyperplasia (CAH)
Asedebart is a humanized anti-ACTH monoclonal antibody that blocks ACTH signaling at the adrenal…
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Amgen & AZ have reported the P-III (DeLLphi-305) trial data assessing Imfinzi + Imdelltra vs Imfinzi as the 1L maintenance treatment for pts (n=563) with ES-SCLC who have not progressed following induction treatment with Imfinzi + PT-based CT & etoposide
Trial showed improved OS (1EP) & demonstrated benefits across 2EPs, incl. PFS & ORR;…
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Celltrion has reported the launch of Omlyclo (300mg in PFS & autoinjector), a biosimilar version of Xolair (omalizumab), for the treatment of pts with allergic asthma & chronic spontaneous urticaria (CSU) in Europe
Following the EU launch of Omlyclo 75mg & 150mg last year, Celltrion began rolling out the 300mg dose in Germany, the…
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The deal incl. ~10 biosimilars or related components, incl. 3 initial assets: HLX05-N (cetuximab), HLX16 (evolocumab), & a proposed belimumab biosimilar, plus an option for HLXTE-HAase1001, a recombinant human hyaluronidase
Sandoz will receive exclusive rights to register & commercialize the assets globally outside China, with both parties sharing development & lifecycle activities. Territories vary…
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The US FDA has approved Rituximab, a biosimilar version of Rituxan developed by Dr. Reddy's Laboratories, supported by analytical, non-clinical, and clinical data demonstrating high similarity and no clinically meaningful differences from Rituxan, meeting US biosimilar requirements
Rituximab is a mAb targeting CD20 on B cells, leading to B-cell depletion through immune-mediated mechanisms. It is approved in the US for…
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NMPA has accepted the supplemental application of toripalimab + Pt-containing CT as perioperative treatment & subsequent monotx. as adj. therapy for the treatment of adult pts with resectable stage II-III NSCLC
Filing was based on P-III (NEOTORCH) trial (n=501), which showed perioperative toripalimab + CT met 1EP of improved EFS by 60% (mEFS: not reached…
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Innovent will grant Spero Therapeutics exclusive rights to develop, research, manufacture, & commercialize SP001 worldwide, excl. Greater China, where Innovent will retain the rights
In return, Innovent will receive an upfront payment & development, regulatory & commercial milestone payments, representing the total deal value of ~$1.1B, plus Innovent will also receive tiered royalties on…
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Polpharma has granted Teva exclusive rights to commercialize both IV & SC formulations of Polpharma’s proposed biosimilar to Ocrevus (ocrelizumab) for multiple sclerosis, upon regulatory approval
As per the deal, Polpharma will lead biosimilar development & manufacturing, while Teva will oversee regulatory filings & commercialization across the US, EU, Brazil, Canada, Australia, New Zealand,…

