News

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs,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

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.

FDA has issued the final guidance on electronic postmarketing safety reports in a series of guidance documents.

VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.

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 has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.

FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.

Bio-Rad Laboratories introduces three new fluorescent dyes under the StarBright product range to support multicolor flow cytometry panels.

Societal CDMO has been awarded a new manufacturing and packaging task order agreement by National Cancer Institute.

Thermo Fisher Scientific has expanded its state-of-the-art R&D facility in Hyderabad, India.

GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.

Johnson & Johnson has launched its next Satellite Center for Global Health Discovery at Holistic Drug Discovery and Development Centre, University of Cape Town.

Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.