Pfizer has announced that FDA has accepted for filing and granted priority review designation for a new drug application and EMA has accepted the MAA for abrocitinib.

Novartis and Molecular Partners are collaborating on the development, manufacture, and commercialization of Molecular Partners’ anti-COVID-19 DARPin program.

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.

Delivery will commence over the course of two months following the EUA and the government will have the ability to purchase up to 650,000 additional vials of the treatment through June 30, 2021 based on product availability and medical need.

The new company will house more than 350 experts and will offer pharmaceutical, life sciences, food and beverage, and manufacturing solutions.

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.

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.

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.

The new premix can be used with tablets and a range of other solid oral dosage forms.

Bayer will own the rights to AskBio’s AAV-based gene therapy platform, its intellectual property portfolio, and an established CDMO.

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 third part of the CPhI annual report has predicted a significant amount of pressure will be placed on bioprocessing networks should COVID-19 biologics gain approval.

JSR Life Sciences has increased its European footprint with a new expanded facility in Switzerland, that will combine the company’s two affiliates in one campus.

EC has granted orphan drug designation to Pharming Group for its treatment of activated phosphoinositide 3-kinase delta syndrome, leniolisib.

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

Nanoform Finland will be initiating the first human trial of a drug candidate nanoformed using the company’s CESS technology in 2020.

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 company is investing in its Capsules and Health Ingredients Division to expand its capsule production capacity by 30 billion capsules annually.

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

The companies will work to accelerate the clinical development and manufacturing of the treatment, while determining its safety and efficacy.

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

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.

Vetter has moved into new headquarters located in Ravensburg, Germany, and plans to continue its long-term investment for corporate development.

Subsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.

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.

Orgenesis has completed its previously announced acquisition of Koligo Therapeutics with the additional acquisition of Tissue Genesis’ cell isolation technology, Icellator.