Industry News

The companies have signed a Statement of Intent with Gavi to make 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine available for distribution.

The Swiss marketing and distribution partner of Diurnal Group, EffRx Pharmaceuticals, has submitted a MAA for Alkindi to Swissmedic.

The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

200 employees will be hired by the end of 2020, with 300 more planning to be hired by 2023.

FDA issued guidance for applicants that must report annually on the status of postmarketing studies and clinical trials under section 506B of the FD&C Act.

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.

Regeneron will distribute Inmazeb treatment doses over the course of six years to BARDA.

The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.

The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.

Recent data, from BIA and Clarivate, has revealed that investment in UK biotech continues to be strong.

The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians.

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.

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

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

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

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

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.

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.

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

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.

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.

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