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April 13, 2026

FDA issues complete response letter to Replimune’s RP1 for melanoma

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Replimune Group’s biologics licence application (BLA) concerning the RP1 therapy in combination with nivolumab for advanced melanoma.

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During the IGNYTE trial, patients treated with RP1 plus nivolumab showed a 34% response rate. Credit: Evgeniy Kalinovskiy / Shutterstock.com.
April 13, 2026

Telix and Regeneron to co-develop radiopharmaceutical therapies

The collaboration will include several solid tumour targets from Regeneron’s antibody portfolio. Credit: lev radin / Shutterstock.com.
April 9, 2026

EverSea Medicines to acquire Hasten Biopharmaceuticals

The acquisition includes MAH rights, trademarks, and commercial rights for 14 chronic disease products in Asia Pacific. Credit: MiniStocker / Shutterstock.com.

Contracts

January 23, 2025

Kamada to supply immune globulin products in Latin America

KAMRAB must be administered alongside a complete rabies vaccine regimen. Credit: Nappy on Unsplash.

Bavarian Nordic secures $156.8m US vaccine deal

Boehringer Ingelheim receives EC conditional marketing approval for spesolimab

Marinus Pharmaceuticals signs collaboration agreement with Tenacia Biotechnology

Deals

Deals January 20, 2025

Fermion and Simcere to partner on development of pain treatment drug

Pharmaceutical Business Review

WuXi Biologics and Sino Biopharm collaborate on monoclonal antibody discovery

Merck enhances ophthalmology portfolio with EyeBio acquisition

Biocon signs licensing and supply deal for diabetes drug in Brazil

Popular

  1. Roche and C4 Therapeutics to advance degrader-antibody conjugates research
  2. Gan & Lee and JW Pharmaceutical agree on bofanglutide commercialisation
  3. Jeito Capital secures over $1.2bn for new biopharma investments
  4. RoosterBio and MineBio team up to expand MSC solutions access in China
  5. Halozyme and Vertex sign deal for Hypercon technology

PRESS RELEASES

SCHOTT Pharma and SHL Medical Enhance Home-Based Large-Volume Injections for Patients
SCHOTT Pharma and SHL Medical Enhance Home-Based Large-Volume Injections for Patients
SCHOTT Pharma Launches Ready-to-Use Polymer Cartridge
SCHOTT Pharma Launches Ready-to-Use Polymer Cartridge
Accelerating Self-Administration and Homecare: SCHOTT Pharma Launches Large-Volume Prefillable Glass Syringe
Accelerating Self-Administration and Homecare: SCHOTT Pharma Launches Large-Volume Prefillable Glass Syringe
Pharmaceutical Business Review
Christian Mias to Succeed Andreas Reisse as CEO of SCHOTT Pharma
Pharmaceutical Business Review
LTS completes acquisition of Renaissance Lakewood, expanding global CDMO capabilities

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Whitepapers

Smoothly Through the Production Process: EVERIC™ Strong/Smooth Test
Smoothly Through the Production Process: EVERIC™ Strong/Smooth Test
Strengths and Weaknesses of Different Prefilled Syringes for Injections in Hospitals: A Case Study by Niklas Niederwieser and Patrick Gallagher SCHOTT AG
Strengths and Weaknesses of Different Prefilled Syringes for Injections in Hospitals: A Case Study by Niklas Niederwieser and Patrick Gallagher SCHOTT AG
Tracking the Cracking: How to Optimise Pharma Fill-and-Finish Processes by Use of Strength Testing and Fractography
Tracking the Cracking: How to Optimise Pharma Fill-and-Finish Processes by Use of Strength Testing and Fractography