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).
Two life sciences powerhouses are coming together to develop an off-the-shelf beta cell replacement therapy for insulin-dependent diabetes patients, which they hope will become a functional cure for both types of the disease.
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.
Bristol Myers Squibb shared the news that the company’s Phase III clinical trial investigating the safety and efficacy of Opdivo and Yervoy combination therapy (NCT03036098) in patients with metastatic urothelial carcinoma failed to meet the predetermined primary endpoint. A posthoc analysis was shared by Synairgen suggesting that, despite SNG001 failing to meet the primary endpoint of patient recovery and subsequent hospital discharge in a Phase III study for patients hospitalized with COVID-19 who required supplemental oxygen treatment, they may benefit from receiving the treatment.
Since the emergence of the COVID-19 pandemic, there has been increased interest in developing a universal antiviral that would stop a pandemic in its tracks.
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.
Inovio Pharmaceuticals announced a leadership change at the helm and the discontinuation of a Phase III COVID-19 vaccine study.
In the company’s financial results for 2021 released on May 11, Takeda announced the decision to discontinue the development of TAK-609, a therapeutic for Hunter Syndrome. Additionally, Takeda is collaborating with JCR Pharmaceuticals in another therapeutic attempt for the condition.
The fresh blow to Roche’s hopes in a closely watched class of cancer immunotherapies cast a long shadow across the crowded field on May 11, but the latest setback is not the end of the road for these oncology treatments, analysts say.
