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.

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.

The initiative looks to improve treatments for chronic pain, curb the rates of opioid use disorder (OUD) and overdose, and achieve long-term recovery from opioid addiction.

PPD is expanding its bioanalytical lab in Richmond, VA, to enhance its immunochemistry, biomarker, and chromatography services.

A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.

Cellink’s BIO X6, a six-printhead bioprinting platform, offers the capability to combine more materials, cells, and tools to enhance research applications across the bioprinting field.

Cell DIVE is a new cell imaging technology from GE Healthcare that allows for more precise biomarker analysis.

BIA will be hosting a series of events and webinars to support small-and-medium sized enterprises in life sciences in the preparations for a possible ‘no-deal’ Brexit.

The new device decreases the chances of filter leaks and room contamination while ensuring the lowest possible energy consumption.

The new line can fill, band, and check the weight of 80,000 to 120,000 capsules per hour.

If clinical trials are successful, roluperidone (MIN-101) will be the first treatment approved to treat symptoms of schizophrenia in the United States.

The inspections took place at the company’s Charnwood, UK, Craigavon, Northern Ireland, and Audubon, PA, locations.

GSK’s expanded R&D and manufacturing facility in Upper Merion, PA houses a new analytical lab and flexible manufacturing equipment, including single-use bioreactors.

The new microscope gives fast, deep, and clear images for live observation over long periods and allows scientists to study a larger range of applications.