Industry News

The European Union publishes long-awaited changes to Annex 1.

Moderna is suing Pfizer and BioNTech for allegedly infringing on patents the company filed from 2010 to 2016.

Watson-Marlow and Franz Ziel GmbH have launched a new integrated solution to fast-track cell, gene, and biological therapies.

ChargePoint Technology has acquired single-use container company PuroVaso.

Anthony Fauci announced that he plans to step down as Director of the National Institute of Allergy and Infectious Diseases in December 2022.

Grand River Aseptic Manufacturing has completed phase II of its facility expansion with the installation of two new sterile filling lines.

ProBioGen will collobarate with NextPoint Therapeutics to develop and manufacture its lead antibody candidate.

Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA.

The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain.

Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.

Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.

Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.

Merck, known as MSD outside of the United States and Canada, will collaborate with Cerevance to identify novel targets for Alzheimer’s disease.

Catalent will acquire Metrics Contract Services for $475 million to expand high-potent capabilities and oral development and manufacturing capacity.

FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.

Sanofi and Innovent have entered into a strategic collaboration to accelerate development of oncology medicines and expand their presence in China.

Democrats approve curbs for Medicare plans, but not for commercial drug coverage.

La Jolla’s acquisition of Carterra’s LSA Platform is designed to advance their immunological and infectious disease research.

Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

CRYOPDP is expanding its footprint to Spain with its acquisition of Polar Expres.

FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.

The United States has agreed to purchase 66 million doses of Moderna’s bivalent COVID-19 booster candidate for $1.74 billion.

The European Commission has granted marketing authorization to Upstaza (eladocagene exuparvovec) for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

WuXi STA is opening a new large-scale oligonucleotide and peptide manufacturing facility.

Scrutiny of accelerated approvals has generated a range of reform proposals to accelerate the conduct of confirmatory studies.

WHO has determined that monkeypox constitutes a public health emergency of international concern.

The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.

A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.