FDA approved the first commercial drug manufactured via Aji Bio-Pharma's proprietary production process.

Schott and Credence MedSystems have formed a strategic collaboration to make syringe injections safer.

Enterprise Therapeutics has announced that its novel TMEM16A potentiator portfolio has been fully acquired by Roche

Independent research performed at the University of St. Andrews in the UK has reportedly demonstrated the effectiveness of Alfacyte in-vitro against SARS-CoV-2.

A complete listing of event dates for CPhI and Pharmapack Europe 2021 has been released.

Following a recent expansion at its Cambridge, MA, facility, the company now houses a new suite of cellular analysis platforms that enhance its exploratory capabilities into oncology, neuroscience, and rare diseases.

The new personal capillary electrophoresis system, Spectrum Compact CE, performs Sanger sequencing and fragment analysis.

The company’s new CytoML Experiment Suite fully automates each stage of the flow cytometry data lifecycle, allowing for clearer data visualization and analysis.

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.

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.

European pharma companies may have a vested interest in the outcome of the US elections.

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.