News

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 expansion has doubled Cambrex’s footprint to 15,000 ft2, including an added 3500 ft2 of laboratory space.

Bio/pharma industry leaders support FDA’s newly published EUA guidance for COVID-19 vaccine authorization.

Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.

The partnership aims to provide a platform of hiPSC-based assays, drug discovery technologies, high-throughput screening, and high-content screening.

Purdue University’s Continuity Pharma received a $1.5-million grant from DARPA to develop continuous manufacturing technology for generic drug products.

Under the contract, Pharm-Olam will offer routine and response clinical services for the development of medical countermeasures.

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.

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 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.

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.