Heron Therapeutics, Inc.

Heron Therapeutics Settles Patent Litigation with Mylan for CINVANTI and APONVIE

16 days ago

• Heron Therapeutics has reached a settlement agreement with Mylan Pharmaceuticals to resolve ongoing patent litigations related to CINVANTI and APONVIE injectable emulsions. • Under the settlement terms, Heron grants Mylan a license to market generic versions of both aprepitant products in the United States beginning June 1, 2032, approximately three years before patent expiration. • The agreement concludes litigation initiated by Heron in response to Mylan's abbreviated new drug applications seeking FDA approval for generic versions prior to the 2035 patent expiration.

Design Therapeutics Appoints Dr. Chris Storgard as Chief Medical Officer to Advance GeneTAC® Pipeline

a month ago

• Design Therapeutics has appointed Chris Storgard, M.D., as Chief Medical Officer, bringing over two decades of leadership in drug development with experience advancing multiple assets through global regulatory approvals. • Dr. Storgard previously served as CMO at ADARx Pharmaceuticals and Heron Therapeutics, where he secured U.S. and European approvals for several products in oncology and acute care. • The appointment comes at a strategic time as Design Therapeutics advances its portfolio of GeneTAC® small molecules targeting serious degenerative genetic diseases, including its lead program for Friedreich ataxia.

FDA Approves Heron Therapeutics' Zynrelef Vial Access Needle for Postoperative Pain Management

8 months ago

• The FDA has approved Heron Therapeutics' Prior Approval Supplement Application for the Zynrelef Vial Access Needle (VAN). • The VAN simplifies aseptic preparation and significantly reduces Zynrelef's withdrawal time to 20-45 seconds. • Expected to launch in Q4 2024, the VAN aims to enhance safe use, increase adoption, and improve the preparation process of Zynrelef. • Zynrelef is a dual-acting local anesthetic combining bupivacaine and meloxicam, designed to reduce postoperative pain for up to 72 hours.

FDA Nears Decisions on Key Therapies for Gastroparesis, Niemann-Pick Disease, Schizophrenia, COPD, Mesothelioma, and Post-Surgical Pain

8 months ago

• The FDA is expected to decide on Vanda Pharmaceuticals' tradipitant for gastroparesis by September 18, potentially offering a novel NK-1R antagonist treatment option. • Zevra Therapeutics awaits a verdict by September 21 on arimoclomol for Niemann-Pick disease type C, an ultrarare neurodegenerative disorder with no approved therapies. • A decision is anticipated by September 26 on Bristol Myers Squibb's KarXT for schizophrenia, representing a new pharmacological approach targeting muscarinic receptors.

FDA Nears Decisions on Vanda, Zevra, Heron, Merck, BMS, Sanofi/Regeneron

8 months ago

• Vanda Pharmaceuticals awaits FDA decision on tradipitant for gastroparesis, a condition affecting millions in the U.S., with a verdict expected by September 18. • Zevra Therapeutics anticipates potential approval of arimoclomol for Niemann-Pick disease type C (NPC) by September 21, following positive advisory committee support. • The FDA is set to decide on Heron Therapeutics' extended-release needle for Zynrelef by September 23, designed to simplify drug preparation and administration. • Merck seeks approval for Keytruda in pleural mesothelioma, with a decision due September 25, based on Phase II/III KEYNOTE-483 trial data showing improved survival. • Bristol Myers Squibb awaits FDA decision on KarXT for schizophrenia by September 26, potentially offering a novel mechanism of action targeting muscarinic receptors. • Sanofi and Regeneron anticipate a decision on Dupixent for COPD by September 27, supported by Phase III BOREAS and NOTUS trials demonstrating reduced exacerbations.