News

EMA and HMA Launch Real-Word Data Catalogues

February 16, 2024

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

BioVaxys Acquires Full Portfolio of Former IMV

February 15, 2024

BioVaxys has acquired the full portfolio of discovery, preclinical, and clinical development-stage assets of the former IMV.

Nelson Labs Creates Center of Excellence for Parenteral and Ophthalmic Drug Manufacturing

February 15, 2024

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

Samsung Biologics Partners with LegoChem Biosciences on ADCs

February 12, 2024

Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.

EMA Issues Reminder Over Paxlovid Risks

February 12, 2024

The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.

EMA Accepts Three Organizations into ATMP Pilot Program

February 09, 2024

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

Novartis to Acquire MorphoSys for Roughly $2.9 Billion

February 08, 2024

Through a €2.7 billion (US$2.9 billion) acquisition of MorphoSys, Novartis will get pelabresib, a late-stage drug candidate in development for cancer treatment.

FDA Provides Guidance on Notifying the Agency of Manufacturing Interruptions

February 07, 2024

The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.

Purolite and Repligen Launch New Affinity Resin

February 07, 2024

Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.

Quantum-Si Launches Platform Enhancements for Protein Sequencer

February 06, 2024

The addition of another amino acid recognizer as well as improvements in surface chemistry, reagents, and software expand the proteome coverage of Quantum-Si’s Platinum sequencing platform.