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NEWS

Axsome
Axsome Therapeutics Reports the US FDA Approval of Auvelity to Treat Agitation Associated with Alzheimer’s Dementia
Shots: The US FDA has approved Auvelity (dextromethorphan HBr & bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease Approval was supported by an extensive clinical program incl. P-III (ADVANCE-1 & ACCORD-2), where ADVANCE-1 evaluated Auvelity vs PBO or bupropion over 5wks., while ACCORD-2 assessed Auvelity vs PBO in known responders In…
May 1, 2026
CuraTeQ
CuraTeQ Biologics Receives Health Canada Approval for  Bevqolva (Biosimilar, Avastin) 
Shots:  Health Canada has granted NOC to Bevqolva (bevacizumab), a biosimilar version of Genentech’s Avastin  Bevacizumab, a humanized mAb, inhibits angiogenesis by blocking VEGF-A to slow tumor vascular growth in cancers like colorectal and lung. Marketed by Roche/Genentech as Avastin, it is available in 100 mg and 400 mg formulations  In 2025, Bevqolva received MHRA approval and was launched in the…
May 1, 2026
Guardant Health and Nuvalent Partner on Precision Oncology Diagnostics
Shots: Guardant Health has entered into a multi-year strategic collaboration with Nuvalent to support the development & potential commercialization of Nuvalent’s oncology pipeline using the Guardant Infinity platform The partnership will use Guardant’s tissue & liquid biopsy tests to support Nuvalent’s global clinical studies & evaluate companion diagnostic development for Nuvalent’s investigational cancer therapies The…
May 1, 2026
LEO Pharma to Acquire Replay for Rare Skin Disease Gene Therapy Platform
Shots: LEO Pharma has entered into a definitive agreement to acquire Replay, expanding its dermatology pipeline with Replay’s herpes simplex virus-based gene therapy platform for rare genetic skin disorders As per the deal, LEO will acquire Replay for $50M upfront, plus milestone payments & tiered single-digit royalties, while adding Replay’s HSV design and manufacturing expertise…
May 1, 2026
Huahui Health and BeOne Medicines Partner for HH160 in a ~$2.02B Deal
Shots: Huahui Health has entered into a global exclusive option, license & collaboration agreement, granting BeOne an exclusive option for the development, manufacturing, & commercialization of HH160, a novel trispecific antibody in oncology immunotherapy As per the deal, Huahui will receive $20M upfront, $100M upon exercising the option, & ~$1.9B in development, regulatory & sales milestones, as well as tiered…
April 30, 2026
Henlius & Organon
Henlius and Organon Receive the EC Approval for Poherdy (Biosimilar, Perjeta)
Shots: The EC has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Approval was based on extensive data, incl. structural & functional analytical data, PK & clinical studies, which showed similarity & interchangeability in terms of analytical, PK, efficacy, safety, & immunogenicity between Poherdy &…
April 30, 2026
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