Industry News
FDA Limits Use of Janssen COVID-19 Vaccine
FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.
Escalating Abortion Battle Threatens FDA Authority
Issues related to mifepristone prescribing and dispensing are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.
AstraZeneca Announces Plans for New Strategic R&D Center
AstraZeneca has announced plans to open a new strategic R&D center in Cambridge, MA, which will also serve as Alexion’s headquarters.
Janssen Submits Marketing Authorization Application for Treatment of Metastatic Castration-Resistant Prostate Cancer
Janssen has submitted a marketing authorization application to EMA for the approval of a treatment for patients with HRR gene-mutated metastatic castration-resistant prostate cancer.
Purolite Awarded Queen’s Award for Enterprise
Purolite has received the Queen’s Award for Enterprise in the International Trade category.
Kapruvia Approved by EC for Treatment of Pruritus
Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.
FDA Grants Quanterix Plasma Test Breakthrough Device Designation
FDA granted Quanterix’s neurofilament light chain plasma test a breakthrough device designation as a prognostic aid for relapsing-remitting multiple sclerosis.
Congress Presses FDA on Key Policies and Operations
Members of Congress asked FDA about multiple contentious issues, including expedited approvals, vaccines for young children, orphan drug exclusivity, access to medical abortions, conflicts of interest, and hiring initiatives.
FDA’s Office of Compliance Releases 2021 Annual Report
FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.
FDA Issues Final Guidance on Electronic Postmarketing Safety Reports
FDA has issued the final guidance on electronic postmarketing safety reports in a series of guidance documents.
Migraine Treatment Granted Marketing Authorization by European Commission
VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.
Moderna Submits EUA of COVID-19 Vaccine for Use in Young Children
Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.
ENHERTU Granted Breakthrough Therapy Designation in US
ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.
FDA Grants RMAT Designation to Autolus’ CAR-T Cell Therapy
FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.
Societal CDMO Awarded Manufacturing and Packaging Task by National Cancer Institute
Societal CDMO has been awarded a new manufacturing and packaging task order agreement by National Cancer Institute.
Thermo Fisher Scientific Expands R&D Facility in India
Thermo Fisher Scientific has expanded its state-of-the-art R&D facility in Hyderabad, India.
USPTO Issues Malaria Vaccine Patent to GeoVax
GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.
Pfizer and BioNTech Submit EUA Application for Pediatric COVID-19 Vaccine Booster Dose
Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.
Johnson & Johnson Launches Next Satellite Center for Global Health Discovery
Johnson & Johnson has launched its next Satellite Center for Global Health Discovery at Holistic Drug Discovery and Development Centre, University of Cape Town.
Tremelimumab Accepted Under Priority Review in the US
Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.
FDA Approves Veklury for Treatment of COVID-19 in Pediatric Patients
FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.
Pfizer Issues Voluntary Nationwide Recall of Lots of Accupril
Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.
EMA Recommends EU Conditional Approval of Roche’s Mosunetuzumab
EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.
Novo Nordisk Announces Positive Scientific Opinion from EMA on Human Insulin
EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.
FDA Approves Kite’s CAR T-Cell Therapy Manufacturing Facility in Maryland
FDA has approved commercial production at Kite’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland.
Catalent to Invest $350 Million in Manufacturing Facility in Bloomington, Indiana
Catalent will invest $350 million into integrated biologics drug substance and drug product manufacturing at Bloomington, Indiana facility.
EIB Provides €15 million to IRBM
The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.
Otsuka Pharmaceutical and Osaka University Enter Exclusive License Agreement
Otsuka Pharmaceutical and Osaka University have entered an exclusive license agreement on a new anti-tumor antibody.
Clinical Trial Diversity Advances in Regulatory Agenda
New guidance from FDA and legislation from Congress promote clinical trial diversity.
AmoyDX and AstraZeneca Enter Master Collaboration Agreement
AmoyDX has entered a Master Collaboration Agreement with AstraZeneca for multiple companion diagnostics programs in China, EU, and Japan.