The FDA is making another move to ensure the safety of sleep drugs, and this time the target is Lunesta, requiring maker Sunovion to change the drug's label and lower the recommended starting dose.
Just weeks after a federal jury in Louisiana gut-punched Takeda and Eli Lilly with a $9 billion verdict over diabetes drug Actos, an Illinois jury promptly let the company off the hook.
It turns out that Boehringer Ingelheim's popular anticoagulant Pradaxa is safer than many people think. That is the finding of the FDA after taking another look at the side effects of the drug compared to the old standard warfarin and this time looking at a much larger and older patient base.
New technology like organs-on-chips and bioprinted tissues have the potential to test the safety of drugs more accurately and cost-efficiently for a myriad of diseases. FierceBiotech Research highlights some organizations that are working on alternative drug testing technology.
Eli Lilly says its experimental diabetes therapy basal insulin peglispro beat out Sanofi's blockbuster Lantus for reducing levels of HbA1c in a trio of late-stage trials. But at least one prominent analyst swiftly raised questions about potential safety issues for this Lantus rival, which hopes to bite off a big piece of the market as Sanofi settles in for a lengthy legal battle to protect one of its bestselling products.
Novartis is facing yet another investigation in Japan. Little more than a month after a panel of Japanese lawyers uncovered serious misconduct during a trial of its leukemia drug, Tasigna, the Japanese government is probing whether the company broke the law by failing to report side effects of the product.
The saga of New England Compounding Center (NECC), the compounder tied to a nationwide fungal meningitis outbreak and a revamp of FDA powers, may be nearing its end. The owners of the bankrupt NECC have reached a settlement agreement with insurers that could provide about $100 million for the hundreds of victims and their families.
Some analysts raised their eyebrows at Oramed's preliminary midstage oral insulin data in late January. Now the Jerusalem company has announced further details of the trial that bring to light a dosing issue, and shares have continued their downward spiral ever since.
Cynapsus Therapeutics' sublingually delivered reformulation of the drug used to treat advanced Parkinson's disease cleared an initial clinical hurdle, the company said April 24.
In a 1993 clinical trial of fialuridine--a drug originally designed as a therapy for hepatitis B--5 out of 15 patients died from sudden liver failure. A new study in PLOS Medicine found that mice with humanized livers demonstrate the drug's toxicity.