Industry News

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

FDA issued guidance for applicants that must report annually on the status of postmarketing studies and clinical trials under section 506B of the FD&C Act.

The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.

Recent data, from BIA and Clarivate, has revealed that investment in UK biotech continues to be strong.

The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.

The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.

Regeneron will distribute Inmazeb treatment doses over the course of six years to BARDA.

The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians.

The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.

The agency published recommendations for the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma.

The approval of Nucala (mepolizumab) for treating hypereosinophilic syndrome represents the first drug approved for this group of rare blood disorders in nearly 14 years.

The Serum Institute of India will receive upfront capital to expand manufacturing capacity, pending vaccine approval, to ensure distribution.

Steven J. Lynn previously held positions at FDA’s Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Office of Regulatory Affairs.

President Trump announced a revised initiative designed to reduce what consumers pay for prescription drugs, while also promising to protect coverage for pre-existing health conditions.

FDA and EMA have accepted the biologics license application and marketing authorization application, respectively, for bimekizumab.

UK's Prime Minister visited the site of the country’s VMIC in Oxfordshire, and met the teams working at the forefront of the national COVID-19 response.

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

Moderna and Chiesi Group are collaborating on the discovery and development of mRNA therapeutics to treat pulmonary arterial hypertension.

The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.

The companies will receive upfront funding from the European Union for the scale-up of manufacturing capabilities at industrial sites in Belgium, Italy, Germany, and France.

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.

The Russian Direct Investment Fund has announced three deals with India, Brazil, and Mexico, for the supply of doses of Sputnik V, a potential COVID-19 vaccine.

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter.