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

Eudratec Fasteric is an oral drug delivery technology that offers enteric protection after rapid, homogeneous release for targeting the upper small intestine.

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.

Through the acquisition, Bristol Myers Squibb will gain access to MyoKardia’s mavacamten, a cardiovascular drug for the treatment of obstructive hypertrophic cardiomyopathy, a chronic heart disease.

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 case for migrating from a paper-based quality management system to a digital platform is presented.

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

Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.

Misleading messages contribute to eroding trust in public health agencies.

The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of drugs developed to treat opioid use disorder.

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

Sterling Pharma Solutions has acquired Alcami’s API facility in Germantown, WI.

Symbiosis has successfully completed a scheduled inspection by MHRA.

Optimus Holding has successfully completed the acquisition of OM Pharma.

Recipharm and BIAL have expanded their long-term supply agreement for the global manufacture and supply of opicapone API.

The technology is a novel, plasmid-free manufacturing system for robust and reproducible manufacture of AAV at scale.

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 acquisition will support the accelerated commercialization of Kyslecel (autologous pancreatic islets), Koligo’s personalized cell therapy for treating pancreatitis.

The OneXpress solution is designed to accelerate oral dosage drug development and manufacturing.

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

pci | bridge makes inventory, production, distribution, and shipping data immediately accessible by integrating the platform with PCI’s other systems, making the data manageable from both sides.

The acquisition will give Sanofi access to Principia’s Bruton tyrosine kinase inhibitors for its portfolio of next-generation transformative treatments for autoimmune diseases.

The 60,000-ft2 facility was built using CRB’s ONEsolution project delivery method and was designed to expand GRAM’s large-scale fill/finish capacity.

Cellnest will join Fujifilm Irvine Scientific’s PRIME-XV portfolio which consists of xeno-free and chemically defined media for stem cell culture.

The companies are entering into a strategic collaboration for the development and commercialization of CStone’s sugemalimab, a PD-L1 antibody for high-incidence cancer indications, in mainland China.

Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US.

With little more than a month to go until the national election, 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.

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.