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The Pharma Data

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The Pharma Data
  • Press Releases

EC Approves Henlius and Organon’s Denosumab Biosimilars BILDYOS® and BILPREVDA®

  • The Pharma Data
  • September 20, 2025

European Commission Grants Approval for Henlius and Organon’s Denosumab Biosimilars BILDYOS® and BILPREVDA® Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced a significant regulatory milestone with the news…

Read MoreEC Approves Henlius and Organon’s Denosumab Biosimilars BILDYOS® and BILPREVDA®
Nuvation
  • News

Nuvation Bio Wins MHLW Nod for IBTROZI™ in NSCLC

  • The Pharma Data
  • September 20, 2025

Nuvation Bio’s IBTROZI™ Wins Regulatory Approval in Japan for Advanced ROS1-Positive Non-Small Cell Lung Cancer Nuvation Bio Inc. (NYSE: NUVB), a global oncology company dedicated to developing novel therapies for…

Read MoreNuvation Bio Wins MHLW Nod for IBTROZI™ in NSCLC
MindMed
  • Press Releases

MindMed Study at Psych Congress 2025 Links GAD to High Suicidal Ideation

  • The Pharma Data
  • September 20, 2025

MindMed Presents Alarming Data on Suicidal Ideation Among Adults with Generalized Anxiety Disorder at Psych Congress 2025 Researchers from Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), a late-stage clinical biopharmaceutical company…

Read MoreMindMed Study at Psych Congress 2025 Links GAD to High Suicidal Ideation
Merck
  • Regulatory

Merck Gains Two Positive EU CHMP Opinions for KEYTRUDA

  • The Pharma Data
  • September 20, 2025

Merck Secures Dual Positive CHMP Opinions for KEYTRUDA® in Europe: Subcutaneous Administration and New Head & Neck Cancer Indication Merck (NYSE: MRK), known as MSD outside of the United States…

Read MoreMerck Gains Two Positive EU CHMP Opinions for KEYTRUDA
Bayer
  • Press Releases

Celltrion Launches Omlyclo™ Commercially Across Europe at EADV 2025

  • The Pharma Data
  • September 19, 2025

Celltrion Announces Commercial Availability of Omlyclo™ Across Europe at EADV 2025 Celltrion, Inc. today showcased its longstanding commitment to expanding its biosimilar portfolio in the field of immuno-dermatology by attending…

Read MoreCelltrion Launches Omlyclo™ Commercially Across Europe at EADV 2025
  • News

Layoffs at Six Pharma Companies Could Eliminate Over 39,000 Jobs

  • The Pharma Data
  • September 19, 2025

Layoffs From Just 6 Pharmas Could Wipe Out Over 39,000 Jobs This year, Novo Nordisk and Merck announced significant layoffs, with Novo planning to axe about 9,000 employees and Merck…

Read MoreLayoffs at Six Pharma Companies Could Eliminate Over 39,000 Jobs
  • News

Lexicon Supports Phase III Advancement of Non-Opioid Pain Therapy Following Post-Hoc Analysis

  • The Pharma Data
  • September 19, 2025

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…

Read MoreLexicon Supports Phase III Advancement of Non-Opioid Pain Therapy Following Post-Hoc Analysis
  • News

Key Challenges in AAD Sourcing: Ensuring GMP Compliance, Reliable Supply, and Quality Control

  • The Pharma Data
  • September 19, 2025

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…

Read MoreKey Challenges in AAD Sourcing: Ensuring GMP Compliance, Reliable Supply, and Quality Control
  • News

Intellia Completes Phase 3 HAELO Study Enrollment for Lonvo-z in Hereditary Angioedema

  • The Pharma Data
  • September 19, 2025

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…

Read MoreIntellia Completes Phase 3 HAELO Study Enrollment for Lonvo-z in Hereditary Angioedema
  • Regulatory

EU Approves Biogen’s ZURZUVAE® as First Treatment for Postpartum Depression

  • The Pharma Data
  • September 18, 2025

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)…

Read MoreEU Approves Biogen’s ZURZUVAE® as First Treatment for Postpartum Depression
  • News

Saphnelo Self-Administration TULIP-SC Phase III Trial Hits Primary Endpoint in Lupus Patients

  • The Pharma Data
  • September 18, 2025

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…

Read MoreSaphnelo Self-Administration TULIP-SC Phase III Trial Hits Primary Endpoint in Lupus Patients
Roche
  • News

Roche to Acquire 89bio and Its Phase 3 FGF21 Analog for Moderate to Severe MASH

  • The Pharma Data
  • September 18, 2025

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…

Read MoreRoche to Acquire 89bio and Its Phase 3 FGF21 Analog for Moderate to Severe MASH
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