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Denali Therapeutics Announces Publishing of P-I/II Study of Tividenofusp Alfa (DNL310) in NEJM for Hunter Syndrome (MPS II)
Shots: The NEJM published results from the P-I/II study of Denali Therapeutics’ tividenofusp alfa (DNL310) for the treatment of Hunter syndrome (MPS II) The study evaluated treatment in 47 ERT-naïve (n=15) and previously treated (n=32) study participants (aged 0.3–13 [median, 5] years) demonstrating reduced levels of mean CSF levels of HS, mean urine HS levels,…
January 2, 2026
BioAtla and GATC Health Announce $40M SPV Transaction to Advance Ozuriftamab Vedotin into P-III Study for 2L+ OPSCC
Shots: BioAtla and GATC Health announce  into a $40M special purpose vehicle (SPV) transaction to advance ozuriftamab vedotin (Oz-V), a CAB-ROR2-ADC, into a registrational P-III study for 2L+ oropharyngeal squamous cell carcinoma (OPSCC) Under the agreement, BioAtla will receive $5M upfront to support operations and P-III study execution, with the remaining $35M expected to close…
January 2, 2026
Samsung Bioepis
Samsung Bioepis Began Direct Commercialization of Byooviz (Biosimilar, Lucentis) Across Europe
Shots: Samsung Bioepis has reported the direct commercialization of Byooviz, a biosimilar version of Lucentis (ranibizumab) across Europe, with market availability expected in Q2’26 Byooviz (0.5 mg/0.05 ml) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due…
January 2, 2026
Intelligent Bio Solutions and Syrma Johari MedTech Collaborate to Advance Global Production Capability and Margin Expansion
Shots: Intelligent Bio Solutions has entered into a strategic manufacturing partnership with Syrma Johari MedTech to scale production of its Intelligent Fingerprinting Drug Screening Reader and support long-term margin improvement Under the agreement, the partnership advances INBS’ global manufacturing strategy by diversifying suppliers, strengthening supply chain resilience, expanding capacity, and increasing flexibility ahead of anticipated multi-region…
January 2, 2026
Mabwell’s Adalimumab Injection (Biosimilar, Humira) Granted Marketing Approval in Indonesia
Shots: Mabwell’s Adalimumab Injection 9MW0113 (marketed as JUNMAIKANG in China), a Humira biosimilar, has received marketing authorization from Indonesia’s BPOM Adalimumab Injection 9MW0113, co-developed by Mabwell and Junshi Biosciences. Mabwell has submitted registration applications in multiple countries, including Jordan and Peru, and has agreements in over ten markets Adalimumab is a TNF blocker, binds TNF‑alpha…
January 1, 2026
Axsome
Axsome Therapeutics Reports the US FDA’s sNDA Acceptance with Priority Review of AXS-05 for the Treatment of Alzheimer’s Disease Agitation
Shots: The US FDA has accepted sNDA & granted priority review to AXS-05 (dextromethorphan HBr and bupropion HCl) to treat Alzheimer’s disease agitation (PDUFA: April 30, 2026) The sNDA reflects AXS-05’s clinical development program in Alzheimer’s disease agitation, which included four randomized, double-blind P-III trials and a long-term safety study AXS-05 is an oral investigational…
January 1, 2026
Elanco
Elanco Animal Health Reports the USDA Approval of Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis
Shots: The USDA has granted Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis, expected to launch in H1’26 Befrena (mAb) is an anti-IL31 injection for dogs, treats allergic and atopic dermatitis every 6–8 wks. In September, the FDA approved changes to Zenrelia (ilunocitinib tablets) US label, eliminating the fatal vaccine-induced disease risk, Elanco announced Ref:…
January 1, 2026
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