The so-called 21st Century Cures Act, now making its way through Congress, is designed to speed up the FDA review process for potentially lifesaving medicines by encouraging approvals based on midstage data. But a new case study takes a look at what might have happened if a trio of once-promising Alzheimer's drugs had made it to market before their eventual Phase III failures, painting a grim picture of the bill's potential.
A federal jury convicted SAC Capital trader Mathew Martoma of insider trading, finding him guilty of seeking out confidential clinical trial information to get ahead of the market and bringing an end to biotech's latest Wall Street blowup.
Last fall noted neurologist and Alzheimer's investigator Sid Gilman figured prominently in a massive insider trading case brought by the SEC. Today a second, unnamed physician surfaced in a related indictment.
The long and frustrating search for something--anything--that can treat Alzheimer's or blunt its symptoms ran into yet another Phase III roadblock this morning as Baxter International reported that its Phase III study of the immune-bolstering treatment Gammagard ended in failure.
There has been growing buzz among Alzheimer's researchers that they need to shift their attention to early-stage patients, whose brains are not yet severely damaged by the disease. The FDA added its voice to the move, offering a new draft guidance today aimed at shooing investigators toward a more realistic goal.
Eli Lilly's ($LLY) solanezumab has secured an endorsement from Alzheimer's researchers, who will study the experimental drug as a preventive therapy against the memory-robbing disease in patients before symptoms emerge.
Noted neurologist and Alzheimer's investigator Sid Gilman has parted ways with the University of Michigan, just days after he figured prominently in the largest insider trading case ever brought by the SEC.
In what has become a holiday tradition here at FierceBiotech, we're offering readers a look back at our most popular stories of the year. Check it out >>
Alzheimer's research has been dominated for years by the amyloid beta hypothesis: Toxic loads of the protein build up in the brain, blighting its ability to retain memories. Cut amyloid levels, say advocates, and you can delay or prevent the disease.
Johnson & Johnson is making deep cuts in an Alzheimer's immunotherapy unit in the aftermath of a colossal Phase III failure of a program to advance bapineuzumab against the memory-stealing disease, Pharmalot reported. And the company's budget ax is falling on a total of 130 jobs, hitting the hardest at an R&D operation in South San Francisco.