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AstraZeneca and RQ Biotechnology Sign License Agreement for Monoclonal Antibodies
AstraZeneca has signed a license agreement with RQ Biotechnology for monoclonal antibodies to treat COVID-19.
PTC Therapeutics Receives Positive Opinion for Upstaza
PTC Therapeutics has received a positive opinion from EMA for Upstaza for the treatment of AADC deficiency.
FDA Issues Labeling Guidance
The final guidance addresses safety aspects of container and carton labeling design.
FDA Stresses Risk Management Plans
The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.
Catalent Invests $175 Million to Expand Manufacturing Capabilities and Capacity in US Facility
Catalent has announced a $175 million project to expand its manufacturing facility for large scale oral dose forms at its Winchester, Ky, site.
FDA Approves Lilly’s Novel, Dual-Targeted Treatment for Type 2 Diabetes
FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.
Pfizer and BioNTech Granted EUA for Booster Dose of COVID-19 Vaccine in Young Children
Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.
Pfizer and BioNTech Update COVID-19 Vaccine Supply Agreement with EC
The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.
Pfizer to Acquire Biohaven Pharmaceuticals for $11.7 Billion
Pfizer will acquire Biohaven Pharmaceuticals, a clinical-stage biopharmaceutical company specializing in migraine treatments, for $11.7 billion.
Avacta Establishes New Therapeutics Headquarters
Avacta is relocating its therapeutics headquarters to Scale Space in Imperial College’s White City Campus, London, United Kingdom.
Avantor and Cytovance Biologics Partner on Plasmid DNA Development
Through a collaboration, Avantor and Cytovance Biologics will accelerate plasmid optimization and sourcing services for viral vectors and mRNA-based vaccines and therapeutics.
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FDA Publishes Draft Guidance on Quality Assessments
The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs,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.
