The US company is bringing extra supplies of lopinavir/ritonavir into France but stresses that the combination treatment is not authorized for treating patients with the coronavirus.

Wave’s Duchenne muscular dystrophy drug and Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.

Agency officials can now discuss the ideas that have been accepted, though not in great detail.

Likelihood of webcast-only advisory committee meetings may depend on the extent of the coronavirus outbreak, Office of New Drugs Director Peter Stein tells the Pink Sheet in an interview.

Asking whether FDA’s decision to allow emergency use of two old anti-malarial drugs was ‘political’ misses the point. The issue already was political, and FDA’s action may well be the best way to keep some measure of federal control on supplies of a drug with important other uses.

A UK regulator with the MHRA is concerned that bioanalytical laboratories are not being given enough time to do their job properly by drug companies under pressure to ensure their clinical trials remain on schedule. 

Guidelines for US health care providers could help prevent shortages as demand for possible treatments surge, groups say. Stakeholders also argue “Buy America” executive order would hamper drug access.

Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.

Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.

Wave’s Duchenne muscular dystrophy drug and Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.

Study everything together and a scale-up manufacturing after preliminary efficacy results, former FDA commissioners Gottlieb and McClellan and their coauthors recommend in a pair of white papers on how the US should respond to the coronavirus pandemic.

Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.

Guidelines for US health care providers could help prevent shortages as demand for possible treatments surge, groups say. Stakeholders also argue “Buy America” executive order would hamper drug access.

Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.

DTC spending had shown an uptick in 2020 compared with 2019. Many advertisers are not, however, providing clear drug pricing information in their TV spots, despite some voluntary commitments to do so.

The regulatory agency also urges qualified persons at drug companies to let the agency know as soon as possible if they are finding that the new measures are not flexible enough to deal with the current logistical challenges quickly.

Study everything together and a scale-up manufacturing after preliminary efficacy results, former FDA commissioners Gottlieb and McClellan and their coauthors recommend in a pair of white papers on how the US should respond to the coronavirus pandemic.

The US FDA has added hydroxychloroquine sulfate to the list of drugs outsourcing facilities can compound as pharmacy group calls for more such approvals with COVID-19 driving demand for additional prescription and over-the-counter drugs.