Texas oral drug delivery specialist Neos Therapeutics pulled in $15.5 million in a Series C round of financing to help propel its line of ADHD controlled-release treatments to the market.
After a steady drumbeat of setbacks over the past two years, the Winston-Salem, NC-based biotech says it will tamp down the last spade of dirt on TC-5619 after the therapy--which already failed a study for ADHD--flunked the primary as well as secondary endpoints in a Phase IIb study for schizophrenia.
Is the huge rise in attention-deficit hyperactivity disorder diagnoses a pharma coup or public-health boon?
ADHD is one of the most frequently diagnosed psychiatric illnesses among children, and it's only growing more prevalent, yet subtypes of the disorder have proven tough to distinguish. Now researchers think they may have found a biomarker that does just that.
The diagnosis of attention-deficit hyperactivity disorder keeps growing in the U.S. and drugs to treat it keep going blockbuster. But Europe is another story. And it's a story that Shire has to change if it wants its latest drug in the ADHD lineup to succeed.
A new study suggests that omega-3, the fatty acid found in fish, eggs and some plant oils that is vital for normal metabolism, may be able to improve behavior associated with attention deficit hyperactivity disorder.
A small Georgia company won the FDA's blessing this week to start marketing the first medical device of its kind approved to help diagnose attention-deficit/hyperactivity disorder, or ADHD.
Shire's new CEO wasted no time in putting his stamp on the company's global operations. In his first quarterly report this morning the newly minted Chief Executive Flemming Ornskov divvied up the marketing operations among five units based on disease categories and forged a single R&D organization for the company.
Controlled drugs must be approved by the FDA, but also require a manufacturer that has been vetted by the Drug Enforcement Agency (DEA). Contract manufacturer Cedarburg Hauser Pharmaceuticals had one plant approved and just snagged approval for a second.
Federal authorities were interested in the way Shire was pushing many of its drugs and the company has now disclosed that an agreement is close. It said it will take a $57.5 million charge to its fourth-quarter earnings to settle up for its missteps.