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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
Abbvie
AbbVie Reports the US FDA’s BLA Submission of Pivekimab Sunirine to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm
Shots: The US FDA has received BLA of Pivekimab sunirine (PVEK) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) The BLA is backed by the P-I/II (CADENZA) trial, which evaluated PVEK monotx. to establish the MTD, RP2D, & dosing schedule, while assessing safety, tolerability, PK, immunogenicity, & antileukemia activity in pts with CD123+…
October 1, 2025
Abbott
Abbott Receives Health Canada’s Approval for Esprit BTK System to Treat Chronic Limb Threatening Ischemia Below the Knee
Shots: Abbott has received Health Canada’s approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with chronic limb-threatening ischemia (CLTI) below the knee (BTK) Esprit was evaluated in the LIFE-BTK trial against balloon angioplasty, which showed improved patient outcomes, with 48% fewer repeat procedures over the study period. Data was highlighted…
October 1, 2025
Zoetis
Zoetis’ Dectomax-CA1 Injectable Receives the US FDA’s Conditional Approval to Prevent New World Screwworm Infestations in Cattle
Shots: The US FDA has granted conditional approval to Dectomax-CA1 Injectable for the prevention & treatment of infestations caused by the larvae of Cochliomyia hominivorax (New World Screwworm; myiasis) Dectomax-CA1 Injectable is approved for use in beef cattle, female dairy cattle (<20mos. of age), pregnant beef cows, newborn calves & bulls, plus it is indicated for the prevention…
October 1, 2025
Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome
Shots: The US FDA has accepted sNDA & granted priority review to leniolisib for the treatment of children (4-11yrs.) with activated phosphoinositide 3-kinase delta (APKD) syndrome (PDUFA: Jan 31, 2026); regulatory review is ongoing in the EEA, Japan & Canada sNDA was supported by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced…
October 1, 2025
Novo Nordisk
Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors
Shots: The US FDA has accepted the BLA for Mim8 (denecimig; pre-filled, single-use pen) as routine prophylaxis to prevent or reduce bleeding episodes in adult & pediatric pts with hemophilia A (congenital FVIII deficiency), with or without inhibitors BLA was supported by FRONTIER2 trial assessing Mim8 (QW/QM) in pts (≥12yrs), FRONTIER3 trial assessing it in…
September 30, 2025
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