News

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.

FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.

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.

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The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs,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 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 have formed a collaboration to optimize cell culture media to allow for improved process control.

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.

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 has announced plans to open a new strategic R&D center in Cambridge, MA, which will also serve as Alexion’s headquarters.

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 has received the Queen’s Award for Enterprise in the International Trade category.

Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.

The new company has been appointed as a channel partner for Ireland by TSI Inc., a particle counter manufacturer.

Standard BioTools’ new Hyperion+ Imaging System can process more samples and has lower limits of detection than their current product.

FDA granted Quanterix’s neurofilament light chain plasma test a breakthrough device designation as a prognostic aid for relapsing-remitting multiple sclerosis.

Accelerate Diagnostics’ new blood culture kit demonstrated 94% or greater accuracy on positive blood cultures relative to matrix-assisted laser desorption/ionization (MALDI).

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 has released its 2021 Annual Report, which highlights the agency’s successes in public health.