New Daily-Dose ADHD Drug Gets FDA Approval
The drug is the first new one for child ADHD approved in more than a decade. Separately, the FDA has turned down a request to expand use of an anti-psychosis drug to include dementia sufferers. Elsewhere a Utah pharmacist is sentenced for illegally importing hydroxychloroquine.
AP:
FDA OKs First New ADHD Drug In Over A Decade For Children
U.S. regulators have approved the first new drug in over a decade for children with ADHD, which causes inattention, hyperactivity and impulsivity. The Food and Drug Administration late Friday OK’d Qelbree (KELL’-bree) for treating attention deficit hyperactivity disorder in children ages 6 to 17. It comes as a capsule that’s taken daily. (Johnson, 4/5)
Stat:
FDA Rejects Acadia's Bid To Expand Use Of Anti-Psychosis Drug
Acadia Pharmaceuticals said Monday that U.S. regulators had rejected its application seeking to expand the use of its anti-psychosis drug Nuplazid to a broader group of patients. The decision by the Food and Drug Administration was widely expected following a March 8 letter sent by the agency to Acadia, citing undefined “deficiencies” in the Nuplazid application. (Feuerstein, 4/5)
In other pharmaceutical industry news —
Stat:
Lilly Is A Holdout Among Companies That Agree To Disclose Exec Clawbacks
A coalition of institutional investors is pushing Eli Lilly(LLY) to adopt a policy to disclose when executive pay is clawed back for misconduct. But the company is refusing to do so, even though more than a dozen large drug makers, wholesalers, and retailers have agreed to take such a step. (Silverman, 4/5)
Salt Lake Tribune:
Utah Pharmacist Gets Probation For Illegally Importing Drug That Officials Wanted To Use For COVID-19
A Utah pharmacist will not serve prison time for illegally importing an antimalarial drug the state had planned to buy as part of a controversial coronavirus treatment plan. Dan Richards, CEO of the Draper-based Meds in Motion, in January pleaded guilty to importing hydroxychloroquine and chloroquine from a vendor that wasn’t registered with U.S. drug regulators, in shipments that were falsely labeled as an herbal supplement. (Alberty, 4/5)
360Dx:
Abbott's New Global Diagnostics Coalition Focuses On Future Pandemic Preparedness
Although the pandemic isn't over yet, the question of future pandemics is still on the mind of many infectious disease experts. With that in mind, Abbott is using its infectious disease experience, building on its Global Viral Surveillance Program for HIV and viral hepatitis research, to spearhead a coalition that will prepare for disease outbreaks, particularly those that haven't yet happened and pathogens that have yet to be discovered. According to Gavin Cloherty, the head of infectious disease research at Abbott, the Abbott Pandemic Defense Coalition is "the culmination of several years of preparation" that has grown from the global surveillance program. (Ketchum, 4/4)
In science and research news —
Stat:
Research On Therapies For Herpes And Diabetes Win STAT Madness
From curing herpes to treating diabetes in a new way, their innovations might one day treat some of the world’s most prevalent health problems. This year’s two finalists in STAT Madness, a bracket-style competition that showcases cutting-edge research across the biomedical sciences, harnessed new approaches to devise possible therapies that could help millions of people with all-too-common maladies. (Sohn, 4/5)
Concord (N.H.) Monitor:
COVID Tracker: The Pandemic’s Silver Lining Is That Medical Research Is Getting Supercharged
There is reason for optimism around COVID-19 right now but it’s got nothing to do with our current situation, which isn’t great. The good news amid all the bad is that the pandemic has shaken us out of our medical-research complacency and seems ready to generate a decade or two’s worth of biotech innovation in the blink of an eye. Like many of you, I have been injected with the first fruit of that science supercharging and will get the second dose soon. (Brooks, 4/5)
