Lexicon Supports Phase III Advancement of Non-Opioid Pain Therapy Following Post-Hoc Analysis
Lexicon Backs Phase III Go Decision for Non-Opioid Pain Med With Post-Hoc AnalysisSupporting Lexicon Pharmaceuticals’ decision to advance the non-opioid analgesic pilavapadin into late-stage development—despite a topline miss in March—is…
Key Challenges in AAD Sourcing: Ensuring GMP Compliance, Reliable Supply, and Quality Control
Key challenges in AAD sourcing: GMP compliance, supply reliability & quality control Amino acid derivatives (AADs) are essential starting materials for solid-phase peptide synthesis, crucial for the development of peptide-based therapeutics…
Intellia Completes Phase 3 HAELO Study Enrollment for Lonvo-z in Hereditary Angioedema
Intellia Therapeutics Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing…
EU Approves Biogen’s ZURZUVAE® as First Treatment for Postpartum Depression
Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC)…
Saphnelo Self-Administration TULIP-SC Phase III Trial Hits Primary Endpoint in Lupus Patients
Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis Positive high-level results from a pre-specified interim analysis of the…
Roche to Acquire 89bio and Its Phase 3 FGF21 Analog for Moderate to Severe MASH
Roche enters into a definitive merger agreement to acquire 89bio, and its phase 3 FGF21 analog for the therapy of moderate to severe MASH 89bio’s pegozafermin allows for a potentially…
EU Approves Deciphera’s ROMVIMZA™ for TGCT Treatment
Deciphera Receives European Commission Approval of ROMVIMZA™ (vimseltinib) for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”),…
GSK Pledges $30B to Expand U.S. R&D and Manufacturing Capacity
GSK Commits $30B To Boost US R&D, Manufacturing Operations The multi-billion, multi-year investment comes as many of GSK’s pharma peers pull away from the U.K., either suspending or completely canceling…
Republicans Intensify Pressure as Monarez Makes Explosive Allegations Against Kennedy
Republicans Ratchet Up Pressure as Monarez Levels Damning Allegations Against Kennedy During a hearing in front of the Senate’s HELP committee, Susan Monarez addressed her controversial firing and recalled a…
Choosing China: Akeso’s $3M Start and the Ascent of the Nation’s Biotech Industry
Choosing China: Akeso’s $3M Beginnings and the Rise of China’s Biotech Sector When Akeso was starting out some 13 years ago, the leadership team had $3 million and a bold…
FDA Finally Moves to Regulate Compounded Drug Advertising, But Only Slightly
FDA Takes Long Overdue Baby Step Toward Regulating Compounder Drug Ads A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma…
Saphnelo Self-Administration Meets Primary Endpoint in TULIP-SC Phase III Trial
Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis Positive high-level results from a pre-specified interim analysis of the…