Pharmaceutical Technology Editors

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.

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.

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.

The board will work with Lonza’s research scientists and product managers to offer guidance on the company’s research and scientific programs for in vitro ADME and toxicology testing.

GRAM is expanding fill/finish capacity and is working with Janssen on tech transfer in preparation for production of Janssen’s SARS-CoV-2 vaccine candidate at GRAM’s Grand Rapids, MI facility.

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.

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

CPhI has launched the first part of its Annual Report.

A strategic serialization partnership has been announced by advanco and Syntegon, aimed at tackling the global issue of counterfeit drugs.

Telstar has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the EU GMP Annex 1 guidance.

The facility for early-phase clinical biologics formulation development and drug product fill/finish services will be integrated with an existing Catalent facility nearby.

The companies plan to increase the production output of Ligand’s Captisol for the formulation of Gilead’s COVID-19 treatment Veklury (remdesivir).

Thermo Fisher will handle the technical transfer of the lenzilumab bulk drug substance process, with commercial scale production potentially beginning before the end of 2020.

The renovations are expected to be completed by Feb. 1, 2021 and, upon completion, Aphena will move its corporate headquarters to the new location.

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