Industry News

The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.

Novartis will endorse the Kigali Declaration on neglected tropical diseases and invest $250 million for R&D.

GSK will invest £1 billion in furthering R&D in malaria, tuberculosis, and HIV, as well as neglected tropical diseases.

FDA is at a pivotal moment because of important gains in medical treatment based on science.

Connect in Pharma will host an awards ceremony to showcase innovations in sustainable pharmaceutical packaging.

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

Lessons learned from the COVID-19 pandemic about the benefits of international collaboration were discussed in a May 2022 workshop.

Orbit Discovery has been awarded the Innovate UK Grant to expand high throughput cell-based functional screening platform capabilities in peptide drug discovery.

FDA has issued an Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old.

Aptamer Group has signed a deal with Flip Gene Therapeutics to support the development of inducible gene therapies.

Boehringer Ingelheim has signed an option to acquire Trutino Biosciences.

Measure tackles infant formula, cosmetics, diagnostics plus drug development and access.

MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.

A new polymer surface material has been invented by researchers in Sweden that uses electrical signals to both capture and release biomolecules.

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

The draft ICH Q9(R1) document details the importance of quality risk management principles.

In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

The Rockwell Experience Center will teach ARMI members how to increase delivery speeds by leveraging smart manufacturing in the scaling of regenerative medicine products.

Sanofi will grant Regeneron worldwide exclusive license rights to Libtayo, a treatment for non-small cell lung cancer.

Thermo Fisher Scientific and Qatar Genome Program will use custom genotyping arrays to accelerate genomic research in Qatar.

Cambrex’s acquisition of Q1 Scientific expands the company’s storage services in the European market.

Pfizer will provide all its current and future patent-protected medicines and vaccines available in the United States or EU on a not-for-profit basis to 45 lower-income countries.

Manufacturers are aligning with pharmacists and providers to blame high drug costs and limited patient access on pharmacy benefit managers.

FDA once again is taking steps to facilitate the import of less costly prescription drugs.

Lubrizol has launched Apisolex technology to improve solubility and simplify the manufacturing of parenteral drug products.

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.

A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.

Investment has been made into a new science hub at the University of Edinburgh for the development of treatments for lung infections and future pandemics.