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PharmaShots’ Key Highlights of Third Quarter 2025 
Shots:  Q3’25 was marked by major pharma and biotech M&A, led by BD’s $17.5B Reverse Morris Trust deal merging its Biosciences & Diagnostic Solutions unit with Waters, and Merck’s ~$10B acquisition of Verona Pharma  The quarter spotlighted collaborations, notably GSK’s ~$12.5B agreement with Hengrui Pharma to co-develop up to 12 novel therapies across multiple disease areas.  PharmaShots brings…
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+…
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…
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…
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…
Hinge Bio Collaborates with Kyorin Pharmaceutical to Advance HB2198 in Japan for Autoimmune Diseases
Shots: Hinge Bio & Kyorin have entered into a collaboration & license agreement to develop HB2198 in Japan for various autoimmune diseases, starting with systemic lupus erythematosus (SLE), which is expected to enter trials by H2’25 As per the deal, Hinge will lead global HB2198 development & receive $10M upfront, ~$95M in SLE milestones, plus additional…
Disease of the Month – Alopecia 
Shots:  Hair loss (alopecia) is a condition that causes thinning or loss of hair on the scalp or the entire body. It can be temporary or permanent and may result from genetics, hormonal changes, medical issues, or aging    PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions that affect…