Industry News

The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.

EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories in the European Union OCABR Network.

Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.

The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.

The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.

The agency marked the annual European Antibiotic Awareness Day with the launch of a social media campaign highlighting the prudent use of antibiotics.

The event will be rescheduled for Oct. 19–21, 2021 at the Javits Center in New York City.

The first public announcement from the Biden-Harris transition team was to name members of a COVID-19 advisory board charged with initiating policies and actions to combat the fast-rising infection rate in the United States

Analysis from the CPhI Annual Report has revealed that the global contract services sector is benefitting from a switch toward COVID-19 manufacturing and clinical-stage contracts; however, mega-cap pharma innovation is slowing outsourcing.

Clarity from regulators, prior work on other vaccines, and closer collaboration with contract partners and suppliers have allowed Moderna and J&J to slash timeframes. Moderna may be on track to deliver initial doses to the highest risk patient populations before January 2021.

The program will consist of 10 University of Cambridge researchers and a group of PhD students who will work together to develop AI and machine learning technologies for clinical trials, personalized medicine, and biomedical discovery.

ISPE announced its 2020–2021 International Board of Directors during the virtual 2020 ISPE Annual Meeting & Expo on Nov. 6, 2020.

The vaccine will enter into a Phase III clinical trial in the United States and Mexico by the end of November, which could potentially support global authorization and approval of the vaccine.

With the presentation of research supporting the use of PTA technology, BioSkryb also launched its ResolveDNA platform for commercial use at ASHG 2020, held virtually on Oct. 27–30, 2020.

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

Nostrum Laboratories is recalling Metformin HCl Extended Release Tablets because of NDMA above the acceptable daily intake limit.

Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.

Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.

As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies.

A virtual ribbon cutting, tour, and panel discussions were hosted on Oct. 29, 2020 to announce the opening of BioCentriq on the campus of the New Jersey Institute of Technology in Newark, NJ.

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.

Two FDA-funded projects at RCPE will look at real-time monitoring and control of drug tablet coating and developing a digital twin for drug production control.

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

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

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.