Industry News

The company has appointed Liam Tayler as CEO to guide the growth of the company’s iPSC technologies, products, and services.

Merck’s anti-PD-1 therapy, Keytruda, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency.

The European Commission (EC) and Moderna have concluded exploratory talks on the potential purchase of Moderna’s COVID-19 vaccine candidate for Europeans.

FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.

BioMarin received the complete response letter for valoctocogene roxaparvovec, its gene therapy intended for treating severe hemophilia A.

UK government has set up a new organization to replace Public Health England.

EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

Novavax has signed an agreement with the UK government for 60 million doses of a COVID-19 vaccine and a Phase III clinical trial.

A new FDA guidance provides answers to questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

SCA Pharmaceuticals is voluntarily recalling 10 lots of heparin sodium because of the presence of incorrect preservative, benzyl alcohol.

The agency describes the requirements for retaining reserve samples of test articles and reference standards used in an in-vivo bioavailability and in-vivo or in-vitro bioequivalence study.

FDA published guidance regarding the development of treatments for acute myeloid leukemia.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.

Questions about safety and efficacy surround Putin’s announced approval of a COVID-19 vaccine, with no supporting clinical trial results.

Citing undisclosed allegations against Kodak, the DFC placed a hold on a potential $765 million loan to launch US-based API manufacturing.

The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

Ferring Pharmaceuticals US is voluntarily recalling DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE Nasal Spray 1.5 mg/mL because of superpotency or high amounts of desmopressin.

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.

FDA sent a warning letter to ACRX Specialty Pharmacy Inc. detailing violations of the Federal Food, Drug, and Cosmetic Act and deficiencies in sterile manufacturing practices.

The document gives guidance on the limited population pathway for antibacterial and antifungal drugs.

As biopharma companies and research institutes work to develop vaccines against COVID-19, policy makers and health officials debate strategies for ensuring fair and equitable distribution of anticipated preventives.

COVID-19 has brought to light the issues of European manufacturing capabilities, leading industry to question whether it is now time to reinvest in domestic medicines supply.

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

EU regulators are requesting more effective action be taken to tackle serious impurities in APIs and finished products.

COVID-19’s impact on the global economy is dealing a blow to merger and acquisition activity in the biopharma industry.

The new manufacturing company has been launched under the Defense Production Act to produce APIs in the US.