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NEWS

Lundbeck’s Asedebart Receives the US FDA Orphan Drug Designation for Endogenous Cushing’s Syndrome

Shots: 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…
September 11, 2026

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Sandoz & Henlius
NEWS

Henlius and Sandoz Partner on Up to 10 Biosimilar mAbs and ADC Products

Shots: 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…
August 17, 2026

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NEWS

Fresenius Kabi & Dr Reddy’s Laboratories Reports the US FDA Approval of Rituximab (Biosimilar, Rituxan) 

 Shots:  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…
August 3, 2026

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NEWS

NMPA Accepts Junshi Biosciences’ Toripalimab + CT Supplemental Filing for Resectable Stage II–III NSCLC

Shots: 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…
July 22, 2026

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NEWS

Innovent Biologics Licenses SP001 (IBI355) to Spero Therapeutics in a ~$1.1B Deal

Shots: 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…
July 14, 2026

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NEWS

Polpharma and Teva Sign Exclusive Licensing Deal for a Biosimilar Candidate to Ocrevus

Shots: 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,…
July 10, 2026

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VIEWPOINTS

Expanding COPD Treatment Horizons: Caterina Brindicci and Frank Sciurba on Tozorakimab’s Phase III Journey  

Shots:  Tozorakimab reinforced its potential as a first-in-class COPD biologic with a third positive Phase III trial (MIRANDA), complementing OBERON and TITANIA and strengthening AstraZeneca’s regulatory package while validating IL-33 as a critical therapeutic pathway in COPD.  The MIRANDA trial demonstrated efficacy across one of the broadest COPD populations studied for a biologic, including former and current smokers, patients across…
June 29, 2026

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