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

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

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

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

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

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.

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

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

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.

Novo Holdings has entered into a merger agreement with Catalent and will acquire Catalent in a deal valued at $16.5 billion.

NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.

ProductLife Group has announced its acquisition of Australian company Commercial Eyes.

The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.

Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.

The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.

The industry’s M&A activity is on the up and expected to continue to rise in 2024.

Agilent Technologies and Incyte have signed an agreement to collaborate on the development of companion diagnostics programs.

Given its positioning at each new year’s commencement, the J.P. Morgan Healthcare conference helps establish the tone with which the pharmaceutical industry is viewed.

With the formation of the new R&D unit, Regeneron will assume full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage cell therapy pipeline.

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).

The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.

The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, Pharmaceutical Technology Group, interviews an esteemed panel of experts from IPEC Americas about excipient grades.

IMU Biosciences has secured £11.5 million in its Series A financing round.

The company issued the recall because of a package mislabeling problem.

The acquisition adds a potential rare disease asset to Sanofi’s alpha-1 antitrypsin deficiency pipeline.

Getinge has announced the inauguration of its new Global Centre of Excellence for Chemistry in the United Kingdom