A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.

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 has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.

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 has signed a license agreement with RQ Biotechnology for monoclonal antibodies to treat COVID-19.

PTC Therapeutics has received a positive opinion from EMA for Upstaza for the treatment of AADC deficiency.

The final guidance addresses safety aspects of container and carton labeling design.

The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.

Catalent has announced a $175 million project to expand its manufacturing facility for large scale oral dose forms at its Winchester, Ky, site.

Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.

Avacta is relocating its therapeutics headquarters to Scale Space in Imperial College’s White City Campus, London, United Kingdom.

Pfizer will acquire Biohaven Pharmaceuticals, a clinical-stage biopharmaceutical company specializing in migraine treatments, for $11.7 billion.

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 is investing $100 million in manufacturing capabilities and capacity expansion to its Bedford, NH facility.

The “Tablet Press & Tooling: Applied Learning Experience” session will be held from June 14-16 at Natoli’s global headquarters in St. Charles, Mo.

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.

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs,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.

The drug is the first immunomodulatory COVID-19 treatment approved by FDA.

908 Devices and CPI have formed a collaboration to optimize cell culture media to allow for improved process control.

Societal CDMO has signed a three-year manufacturing and supply agreement with InfectoPharm for Ritalin LA in Europe.

Lonza and Integral Molecular will collaborate to better assess the risks of off-target binding of biologic drug candidates.

MilliporeSigma’s ZooMAb antibodies have been recognized for their low environmental impact by My Green Lab.

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

Schott has announced the inauguration of its new high-end polymer prefillable syringe manufacturing facility in Mülheim, Germany.

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 has signed an agreement with Intercept Pharmaceuticals to acquire most of the its subsidiaries and non-US operations.

Issues related to mifepristone prescribing and dispensing are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.