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Vaxzevria Gains Approval in EU as a Third Dose COVID-19 Booster in Adults
AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.
EMA Recommends Approval of Niemann-Pick Disease Types A/B and B Therapy
EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.
Pandemic Science Hub Launches at University of Edinburgh
Investment has been made into a new science hub at the University of Edinburgh for the development of treatments for lung infections and future pandemics.
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.
Avacta Establishes New Therapeutics Headquarters
Avacta is relocating its therapeutics headquarters to Scale Space in Imperial College’s White City Campus, London, United Kingdom.
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.
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.
Natoli Announces Tablet Press & Tooling Training Schedule at Company Headquarters
The “Tablet Press & Tooling: Applied Learning Experience” session will be held from June 14-16 at Natoli’s global headquarters in St. Charles, Mo.
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.
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 Approves Olumiant (baricitinib) to Treat COVID-19 in Hospitalized Adults
The drug is the first immunomodulatory COVID-19 treatment approved by FDA.
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.
Societal CDMO Signs Manufacturing and Supply Agreement with InfectoPharm
Societal CDMO has signed a three-year manufacturing and supply agreement with InfectoPharm for Ritalin LA in Europe.
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.
Schott Inaugurates New Prefillable Syringe Manufacturing Facility in Germany
Schott has announced the inauguration of its new high-end polymer prefillable syringe manufacturing facility in Mülheim, Germany.
Nanoform Launches Sparse-Data AI Solution
Nanoform Finland has launched STARMAP Online—a sparse-data artificial intelligence (AI) solution that it is using as a secure online portal for direct use by the company’s current and future partners.
Advanz Pharma Signs Acquisition Agreement for Intercept Pharmaceuticals Non-US Businesses
Advanz Pharma has signed an agreement with Intercept Pharmaceuticals to acquire most of the its subsidiaries and non-US operations.
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.
