Pharmaceutical Technology Editors

FDA, US Customs and Border Protection, and the US Immigration and Customs Enforcement, Homeland Security Investigations signed a Memorandum of Understanding to prevent illegal drug imports from entering the US through International Mail Facilities.

The agency, in response to an executive order, published a list of essential medicines, medical countermeasures, and critical inputs that should be available at all times in an adequate amount to serve patient needs.

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.

FDA published guidance for submitting standardized study data in electronic format.

The complaint aims to stop the company from manufacturing and distributing animal drugs in conditions unsatisfactory to the minimum regulatory requirements to ensure safety and quality.

Through the agreement, Takeda will handle securing the regulatory approvals before distributing the doses, while Moderna will supply the finished product.

FDA has granted priority review for the companies’ sBLA for Enhertu, an ADC for treating gastric cancers.

Catalent has signed an agreement with Bone Therapeutics for the acquisition of Skeletal Cell Therapy Support SA (SCTS).

3P Biopharmaceuticals, and Oxford University spin-out, SpyBiotech, have signed a vaccine contract manufacturing agreement.

The UK BIA Antibody Taskforce has identified differentiated antibody combinations that will be taken into development as COVID-19 antibody therapy candidates.

NanoMab Technology has signed heads of terms with a supplier of Tungsten-188/Rhenium-188 generators, OncoBeta.

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.

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.

The Direct-to-Patient services include Pharmacy-to-Patient, Depot-to-Patient, and Clinical Site-to-Patient services.

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.

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.