Global biopharmaceutical company Mallinckrodt plc announced results of a retrospective, observational medical chart review subgroup analysis assessing real-world treatment outcomes among African Americans with advanced symptomatic sarcoidosis who initiated therapy with Acthar Gel (repository corticotropin injection).

The U.S. Food and Drug Administration decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying the data has not shown the drug to be an effective therapeutic for fighting the virus.

U.S. health regulators are expected to authorize a booster shot of Pfizer/BioNTech’s COVID-19 vaccine for children aged 5 to 11 as soon as May 17, the New York Times reported on May 16, citing people familiar with the matter.

In recent months, the biotech and biopharma industries have been struggling with layoffs and dropping stocks. However, some companies are still experiencing success. Sanofi, AstraZeneca, Avillion and Diadem recently announced positive clinical results, providing positive news for patients with multiple myeloma, asthma and Alzheimer’s disease.

As the fairness of orphan drug exclusivities is debated in Congress, the U.S. Food and Drug Administration granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.

For years, researchers have been moving towards decentralized clinical trials (DCTs), and in a matter of months, COVID-19 changed the trajectory. Clinical operations teams and investigator sites around the world rose to the challenge and worked quickly to deploy new tactics to serve their study participants. The resulting reward is that DCTs, which can be leveraged smartly to reduce participant burden and improve recruitment and retention, are now becoming more widely adopted in design considerations. But rewards bring about new risks and challenges, and DCTs create new concerns for monitoring participant safety. Dario Lirio – Senior Director, LifeSphere Clinical at ArisGlobal – analyzes the risks and rewards of DCTs.

Ashfield Engage, part of UDG Healthcare, acquired PROPENSITY4 – a ‘smart data’ organization and leader in the healthcare insights and analytics arena.

Valneva said on May 4 the French drugmaker will conduct a trial about the use of the company’s COVID-19 vaccine candidate VLA2001 as a booster jab following a mRNA vaccination or natural infection.

Arcadia, a leading data analytics platform for healthcare and life sciences, and Datavant, a leader in helping organizations securely connect health data, announced a partnership to enable de-identified connectivity of Arcadia’s electronic health record data for life sciences research and commercial analytics.

The European Commission wants to make health data easier to access by 2025 for patients, medics, regulators and researchers in a bid to improve diagnoses, cut unnecessary costs from duplication of medical tests and boost medicine research.