Industry News

WHO has determined that monkeypox constitutes a public health emergency of international concern.

The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.

A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.

TFF Pharmaceuticals is expanding its R&D operations with a new facility in Austin, Texas.

Health Canada has authorized Moderna’s COVID-19 vaccine for use in young children aged six months to five years.

US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.

FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.

The European Medicines Agency guidance highlights key principles and examples of good practices to prevent and manage shortages of human medicines.

Application for OTC contraceptive highlights efforts to broaden access to medicines.

Some states look to block access to approved drugs.

Croda has entered into an agreement with the US government to support the expansion of its lipid systems capability.

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

The European Commission has approved Cosentyx for the treatment of various childhood arthritic conditions.

The European Commission has approved Xenpozyme as the first treatment for ASMD.

The action plan will span over five years and will fulfill a requirement of the Accelerating Access to Critical Therapies for ALS Act.

Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

The partnership between Echosens and Novo Nordisk is intended to increase awareness and early diagnosis of non-alcoholic steatohepatitis (NASH).

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.