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The tables can be used for new drug applications, biologics license applications, and supplements to these applications.

The companies are working together with Japanese clients to outline projects from early clinical stage up to commercial launch.

The new joint venture, named Oerth Bio, will use Arvinas’ Protac technology to develop innovative new agricultural products. As part of its collaboration with Arvinas, Bayer is also using this technology to develop human therapeutics.

The contraceptive is expected to receive new chemical entity designation from FDA, giving it patent protection beyond 2030. It will be launched in early 2021, pending FDA approval.

Manufacturing of the cell line will take place at Lonza’s GMP facility in Geleen, Netherlands.

The companies agreed to a multi-year research and development collaboration that will focus on AI empowerment and exploration.

Data showed that the drug candidate activated T regulatory cells, believed to serve a crucial role in protecting the body from uncontrolled inflammation or autoimmunity.

The root cause of NDMA contamination may go well beyond manufacturing problems, to the molecule itself.

The new incubators are set to be operational starting in 2021.

Researchers used advanced animal model lab tests to determine the new vector is 10 times more efficient at incorporating corrective genes into bone marrow stem cells than traditional vectors.

The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation.

FDA and DEA warn four website operators to stop illegally selling opioids.

Climbing out of a reputation hole starts with adopting a quality culture.

With no plausibly approvable deal on the table in the UK government at the moment, it is possible that Brexit could be extended even further.

A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office.

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

New therapies, new technologies, global supply chain challenges, and political pressures draw pharma professionals to major industry event.

The partnership combines global CDMO services with a cellular orchestration platform.

The $243 million will be paid upon completion of the agreements along with sales-contingent milestones of up to $33 million in 2021 and 2022.

AstraZeneca has received a complete response letter from FDA regarding its new drug application for a budesonide/glycopyrronium/formoterol fumarate triple-combination therapy for treating chronic obstructive pulmonary disease.

The project will focus on the development of an influenza vaccine that protects against multiple strains of the influenza virus in a single dose.

After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.

T3 Pharmaceuticals, a Swiss company that focuses on immuno-oncology, has announced the closing of its second round of investment financing in which it raised more than CHF 12 million (US$12.1 million).

The European Commission has approved the first plant-derived cannabis-based medicine for the treatment of seizures in patients suffering from two rare, severe forms of childhood-onset epilepsy.

Nanoform and AstraZeneca have agreed to start a technology evaluation of Nanoform’s CESS Technology across a range of AstraZeneca’s pharmaceutical products.

AstraZeneca and GlaxoSmithKline have been ranked in the top 20 companies for outstanding efforts in sustainability performance in the FTSE 100 Index climate change business leaderboard, published by EcoAct.

ABPI has issued a response to the recently published report from the National Audit Office (NAO) on the impact Brexit may have on medicines supply.

GE Healthcare announced that it is partnering with several companies and academic institutions with the aim of developing a portfolio of targeted oncology positron emission tomography (PET) tracers.

BioIVT has announced that it has joined the Medicines Discovery Catapult’s Discovery Services Platform, which is aimed at supporting drug discovery within the United Kingdom.

The companies plan to collaborate for the advancement of an optical system for on-line analysis of mammalian cells during a bioprocess.