News

The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.

The companies will work to provide development strategy consultations, system-building, and clinical trial operations, while lessening development time and reducing risk by centralizing project tasks between companies.

Under the partnership, Catalent has ordered visual inspection machines from Stevanato Group to install at its Bloomington, IN and Anagni, Italy facilities to support customer programs.

Gilead’s antiviral drug Veklury is the first approved treatment in the US for COVID-19.

Edge-AI technology will enable Industry 4.0 automation in pharmaceutical manufacturing.

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.

The name change touches on the company’s AI and machine learning proficiencies, while including the expansion of the company’s mission to serve additional regulated industries including animal health, cosmetics, medical devices, specialty chemicals, nutraceuticals, and food and beverage.

The 6th-generation Eclipse FFF system handles analytes such as proteins, polymers, viruses, gene vectors, and liposomal drug nanoparticles.

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

OptiGel DR softgel capsules are formed by the combination of pectin, a naturally derived polysaccharide, and gelatin, which eliminates the need for a separate capsule coating step.

The company was selected because of its nucleic acid platform which, when combined with virotherapy, has the potential to treat liver cancer by using a lipid nanoparticle delivery system.

Rigaku is featuring its latest x-ray instrumentation at three virtual booths at the virtual 27th International Trade Fair for Laboratory Technology, Analysis, and Biotechnology conference.

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.

The facility will include a high-speed sterile line for live virus filling, a line for standard fill/finish, cleanroom capacity, labs, warehousing, and offices to support production.

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.

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

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

Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.

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

The judges chose Sheng from a shortlist of seven candidates and highlighted his work in the Taiwanese and global markets while guiding the company through “pivotal changes” that demonstrated his abilities as a “top CEO.”

Roche will use Dyno’s CapsidMap platform to develop next-generation adeno-associated virus vectors for gene therapies for central nervous system diseases and liver-directed therapies.

Virtual Touring allows companies to inspect and visit vendor and contract partner sites remotely during the COVID-19 pandemic.

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 company will supply its LIMS to the Walter Reed Army Institute of Research (WRAIR) to support vaccine production programs for COVID-19 at WRAIR’s pilot bioproduction facility.

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

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

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.