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PCI Pharma Services Invests $100 Million in Bedford, NH Manufacturing Facility
PCI Pharma Services is investing $100 million in manufacturing capabilities and capacity expansion to its Bedford, NH facility.
FDA Publishes Draft Guidance on Quality Assessments
The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.
FDA Launches Accelerated Rare Disease Cures Program
The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.
908 Devices and CPI Partner to Optimize Cell Culture Media for Improved Process Control
908 Devices and CPI have formed a collaboration to optimize cell culture media to allow for improved process control.
Lonza and Integral Molecular Enter Biotherapeutics De-Risking Collaboration
Lonza and Integral Molecular will collaborate to better assess the risks of off-target binding of biologic drug candidates.
MilliporeSigma’s ZooMAb Antibodies Earn ACT Label from My Green Lab
MilliporeSigma’s ZooMAb antibodies have been recognized for their low environmental impact by My Green Lab.
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.
Validair Launches New Company in Ireland
The new company has been appointed as a channel partner for Ireland by TSI Inc., a particle counter manufacturer.
Standard BioTools Launches Hyperion+ Imaging System
Standard BioTools’ new Hyperion+ Imaging System can process more samples and has lower limits of detection than their current product.
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.
Accelerate Diagnostics Blood Culture Kit Demonstrates Increased Efficacy
Accelerate Diagnostics’ new blood culture kit demonstrated 94% or greater accuracy on positive blood cultures relative to matrix-assisted laser desorption/ionization (MALDI).
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.
Bio-Rad’s Three New Fluorescent Dyes are Intended to Enhance Multiplex Flow Cytometry
Bio-Rad Laboratories introduces three new fluorescent dyes under the StarBright product range to support multicolor flow cytometry panels.
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.
