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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.

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

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 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.

Optimus Holding has successfully completed the acquisition of OM Pharma.

Symbiosis has successfully completed a scheduled inspection by MHRA.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19.

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.

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

CPhI has launched the first part of its Annual Report.

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).

A Phase III trial to evaluate safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S, is enrolling participants on three continents.