Industry News
Moderna and European Commission Amend COVID-19 Vaccine Agreement
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.
FDA Approves Roche’s Influenza Treatment for Use in Young Children
Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.
Merck Enters Alzheimer’s Collaboration with Cerevance
Merck, known as MSD outside of the United States and Canada, will collaborate with Cerevance to identify novel targets for Alzheimer’s disease.
Catalent to Acquire Metrics Contract Services for $475 Million
Catalent will acquire Metrics Contract Services for $475 million to expand high-potent capabilities and oral development and manufacturing capacity.
FDA Approves Coherus’ Interchangeable Biosimilar for Lucentis
FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.
Sanofi and Innovent Enter Oncology Collaboration
Sanofi and Innovent have entered into a strategic collaboration to accelerate development of oncology medicines and expand their presence in China.
Senate Advances Drug Price Negotiations
Democrats approve curbs for Medicare plans, but not for commercial drug coverage.
La Jolla Institute for Immunology Acquires Carterra LSA Platform
La Jolla’s acquisition of Carterra’s LSA Platform is designed to advance their immunological and infectious disease research.
Top Priority for Califf Is Combatting Health Misinformation
Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.
CRYOPDP Acquires Polar Expres
CRYOPDP is expanding its footprint to Spain with its acquisition of Polar Expres.
FDA Confirms Ongoing Reliance on Remote Inspection Methods FDA Confirms Ongoing Reliance on Remote Inspection Methods
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 US Purchases 66 Million Doses of Moderna’s COVID-19 Vaccine for $1.74 Billion
The United States has agreed to purchase 66 million doses of Moderna’s bivalent COVID-19 booster candidate for $1.74 billion.
PTC Granted Marketing Authorization by European Commission for AADC Deficiency Treatment
The European Commission has granted marketing authorization to Upstaza (eladocagene exuparvovec) for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.
WuXi STA Opens a New Large-Scale Continuous Manufacturing Plant
WuXi STA is opening a new large-scale oligonucleotide and peptide manufacturing facility.
FDA Continues to Grapple with Accelerated Approval Issues
Scrutiny of accelerated approvals has generated a range of reform proposals to accelerate the conduct of confirmatory studies.
WHO Declares Monkeypox Spread a Global Health Emergency
WHO has determined that monkeypox constitutes a public health emergency of international concern.
EMA Recommends Eleven New Medicines
The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.
EMA Endorses Statement on International Collaboration of Real-World Evidence
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.
Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP
Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.
TFF Pharmaceuticals Expands R&D Operations with New Facility
TFF Pharmaceuticals is expanding its R&D operations with a new facility in Austin, Texas.
Health Canada Authorizes Moderna’s COVID-19 Vaccine in Young Children
Health Canada has authorized Moderna’s COVID-19 vaccine for use in young children aged six months to five years.
Gamesmanship Escalates over FDA User Fee Legislation
US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.
FDA Issues Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted
FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.
EMA Publishes Guidance on Preventing Medicine Shortages
The European Medicines Agency guidance highlights key principles and examples of good practices to prevent and manage shortages of human medicines.
FDA Regulation of Nonprescription Drugs in Spotlight
Application for OTC contraceptive highlights efforts to broaden access to medicines.
FDA Drug Regulation Challenged by Anti-Abortion Campaign
Some states look to block access to approved drugs.
US Government to Support Expansion of Croda Lipid Systems Capability
Croda has entered into an agreement with the US government to support the expansion of its lipid systems capability.
FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses
Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.
Cosentyx Receives Expanded Approvals in EU for Use in Childhood Arthritic Conditions
The European Commission has approved Cosentyx for the treatment of various childhood arthritic conditions.
