Abbott agreed to enter into a consent decree with the U.S. Food and Drug Administration related to the company’s Sturgis, Mich., infant formula plant. The decree is an agreement between the FDA and Abbott on the steps necessary to resume production and maintain the facility. This does not affect any other Abbott plant or operation. The decree is subject to court approval.
Leading life sciences venture firm Sofinnova Partners entered into a long-term strategic and financial partnership with Apollo, a high-growth, alternative asset manager looking to expand its presence in the life sciences.
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.
Pharmacovigilance, the industry term for drug safety, was unfamiliar to most of the general public before March 2020. But as the coronavirus pandemic unfolded, its rapid spread thrust drug safety into the spotlight. The public is more aware of drug safety and health regulators’ role than ever — and as the demand for pharmacovigilance information rises, the industry has had to find ways to keep up — according to Beena Wood, VP of safety at ArisGlobal.
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.
Elon Musk’s Neuralink was beaten to the clinic by a rival brain-computer interface company. Synchron enrolled the first patient in the COMMAND study that will assess the New York-based company’s implant in individuals with severe paralysis.
One day after BridgeBio Pharma struck a nearly $1 billion oncology pact with Bristol Myers Squibb, the California-based company announced plans to sell a priority review voucher received in February.
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.
Cullinan Oncology and Taiho Pharmaceutical announced that Taiho was acquiring Cullinan Pearl and will co-develop and co-commercialize a non-small cell lung cancer (NSCLC) drug.
BridgeBio announced that the Palo Alto, Calif.-based biopharmaceutical company signed an exclusive deal with Bristol Myers Squibb to develop and commercialize a potential treatment for cancer.