Industry News

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.

NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.

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

CPHI China and P-MEC China has opened its online partnering platform after China experienced gains in the CPHI Pharma Index.

UK researchers have discovered a gene involved in chronic pain, which has created a new treatment target.

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

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

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.

Cases of monkeypox are rising around the world, but it is unlikely the virus will become a pandemic problem.

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.

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.

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.

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.

AstraZeneca has signed a license agreement with RQ Biotechnology for monoclonal antibodies to treat COVID-19.

PTC Therapeutics has received a positive opinion from EMA for Upstaza for the treatment of AADC deficiency.

The final guidance addresses safety aspects of container and carton labeling design.

The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.

FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.

Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.