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NEWS

The US FDA Approves Lupin’s Armlupeg (Biosimilar, Neulasta) 

Shots:  The US FDA has approved Armlupeg (pegfilgrastim-unne) as a biosimilar version of Neulasta (pegfilgrastim)   Armlupeg (6 mg/0.6 mL) is administered as a single-dose SC injection. It is indicated to reduce the incidence of febrile neutropenia in pts with non-myeloid cancers undergoing myelosuppressive CT and to improve survival following acute myelosuppressive radiation exposure   Armlupeg will be produced at Lupin’s Biotech facility…
December 1, 2025

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NEWS

RION Launches RION Vet to Advance Platelet-Derived Biologics in Animal Health

Shots: RION has launched RION Vet, a veterinary biotechnology subsidiary, with exclusive global rights to RION’s exosome-based therapeutic platform for animal health RION Vet is developing ePEP-01, a cell-free, shelf-stable platelet-derived biologic, for equine musculoskeletal disorders, which was evaluated in over 50 horses for >4yrs., showing improvement in lameness, with favorable safety RION Vet leverages…
November 12, 2025

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INSIGHTS+

EMA Marketing Authorization of New Drugs in September 2025  

Shots:  The EMA’s CHMP has granted approvals to 5 Biologics and 5 new chemical entities in September 2025, leading to treatments for patients and advances in the healthcare industry    The major highlighted drug, Merck’s Enflonsia, has Adopted Positive Opinion for RSV Prevention in Infants    PharmaShots has compiled a list of 9 drugs that have been…
October 21, 2025

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NEWS

Halozyme Therapeutics to Acquire Elektrofi for ~$900M, Expanding its Drug Delivery Offerings

Shots: Halozyme Therapeutics has entered into a definitive agreement to acquire Elektrofi, incl. its Hypercon technology, which enables biologic formulations at concentrations of 400-500mg/ml As per the deal, Elektrofi will receive $750M upfront, with up to three $50M milestone payments contingent on regulatory approvals of three separate Hypercon products; closing expected in Q4’25 As a result…
October 3, 2025

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New Drug Designations: July 2025
INSIGHTS+

New Drug Designations: July 2025

Shots:       PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA.    The July 2025 edition covers designations awarded to 47 drugs and 3 medical devices, comprising 23 small molecules, 9 biologics, 8 cell and gene therapies, and…
August 26, 2025

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INSIGHTS+

EMA Marketing Authorization of New Drugs in July 2025  

Shots:  The EMA’s CHMP has granted positive opinions and approvals to 3 Biologics and 10 new chemical entities in July 2025, leading to treatments for patients and advances in the healthcare industry   The major highlighted drug was Roche’s Itovebi Secures the EC’s Approval for PIK3CA-mutated Breast Cancer    PharmaShots has compiled a list of 13 drugs…
August 19, 2025

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