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British drug giant GlaxoSmithKline has submitted the world’s first application for approval of a malaria vaccine, a product developed in partnership with the Bill & Melinda Gates Foundation and the PATH Malaria Vaccine Initiative. Read More
Sponsors designing trials involving certain vulnerable patient populations such as limited or non-English speakers, dementia or traumatic brain injury sufferers and children will soon face greater scrutiny from institutional review boards under newly issued FDA guidance. Read More
A key European panel has recommended approval for Eli Lilly and Boehringer Ingelheim’s biosimilar of Sanofi’s blockbuster long-acting insulin drug Lantus, creating a potential threat to the French drugmaker’s multi-billion dollar product. Read More
Not all clinical trials need to be registered on clinicaltrials.gov, so sponsors need to understand the specific elements that determine if their trial is applicable to those reporting requirements, an expert says. Read More
Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel tenuously concluded June 12, noting that it may be wiser to require postmarket observational studies. Read More
A coalition of muscular dystrophy advocates, researchers, clinicians and drug manufacturers has submitted the first-ever patient-initiated draft guidance on drug development to the FDA, a move prompted by the agency’s efforts to get more patient perspectives into the drug approval process. Read More
Bills introduced in four states would grant terminally ill patients access to post-Phase-I experimental drugs without having to go through the FDA. Read More
Federal and state lawmakers are questioning whether the FDA’s Expanded Access program, which allows terminally ill patients to use experimental drugs in certain cases, adequately addresses the current need, with several states considering legislation that would let patients bypass the agency in acquiring investigational therapies. Read More