Shares in Aquestive Therapeutics (NSDQ:AQST) rose today after the company announced FDA approval for its Sympazan oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. The clobazam oral film is the first product of its kind to be approved by the FDA as a treatment for seizures associated with LGS, according to […]
Teva wins FDA nod for migraine prevention drug
Teva (NYSE:TEVA) last week won FDA approval for its humanized monoclonal antibody, Ajovy, designed to prevent migraines. The treatment, which blocks the receptor for a protein that is linked to migraine pain, is available in quarterly and monthly-injection options. Amgen‘s (NSDQ:AMGN) competitive once-monthly product won FDA approval earlier this year. Teva studied Ajovy in two Phase […]
FDA pushes back decision date for Acorda’s Parkinson’s drug
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA pushed back its goal date for the agency’s review of Acorda’s inhaled levodopa Parkinson’s therapy. The FDA’s date to make a decision about Acorda’s Inbrija product was moved from Oct. 5, 2018 to Jan. 5, 2019. The Ardsley, N.Y.-based company said the extension is related to submissions […]
Otsuka inks collab deal to bring Abilify Mycite drug-device combo to US
Otsuka Pharmaceutical (TYO:4578) said today it inked a collaborative deal with health management group Magellan Health to distribute its drug-device combo Abilify Mycite in the US. The Tokyo-based pharmaceutical company touted the Abilify Mycite system as the first FDA-approved drug-device combo designed to track drug ingestion, and said that the tracking data will be integrated into […]
Biogen, Eisai shares down after critics voice concerns over Alzheimers drug study
Biogen (NSDQ:BIIB) and Eisai yesterday released six months of detailed results from a clinical study of its BAN2401 experimental drug for treating Alzheimers, but criticisms quickly emerged casting doubt on the results and sending shares in both companies down. Researchers working with Eisai and Biogen released trial results showing that high doses of the drug resulted […]
Acorda’s CEO on failure, perseverance and the profound risks of drug development
Dr. Ron Cohen isn’t easily deterred. The physician-turned-executive has spent decades in the biotech industry and weathered a number of setbacks – he learned in his early years at the now-defunct Advanced Tissue Sciences that to succeed, he needed resilience. “I learned that it took hundreds of millions of dollars if not billions to develop […]
Report: Biogen CEO eyes medical device market
After taking the helm at Biogen (NSDQ:BIIB) in 2016, Michel Vounatsos made use of acquisitions and geographic expansion to grow the company. Now, Vounatsos is reportedly considering another possible opportunity to differentiate the pharmaceutical player. The company’s chief executive hinted in an interview with Globes that Biogen could make a move into the medical technology space. “Up […]
Cingulate raises $7.5m for controlled-release ADHD therapy
Cingulate Therapeutics said today that it landed a $7.5 million investment to help fund the development of its controlled-release ADHD drugs. The Kansas City-based company is working on a set of therapies that utilize its ‘Precision Time Release’ drug-delivery platform. Cingulate’s CEO, Shane Schaffer, told Drug Delivery Business News that his company set out to create an ADHD therapy that […]
Mylan launches generic drug-delivery patch for dementia patients
Mylan (NSDQ:MYL) announced today the U.S. launch of its rivastigmine transdermal drug-delivery patch, a generic version of Novartis‘ (NYSE:NVS) Exelon therapy. The company’s rivastigmine therapy is indicated for the treatment of dementia associated with Alzheimer’s disease and Parkinson’s disease. For the 12 months ending May 31, 2018, rivastigmine transdermal systems brought in $248 million in sales […]
KemPharm touts efficacy data for pediatric ADHD therapy
KemPharm (NSDQ:KMPH) touted top-line data from a pivotal efficacy and safety trial of its KP415 pediatric ADHD product. The company reported that KP415, which consists of serdexmethylphenidate and d-methylphenidate, met the primary efficacy endpoint in people with attention-deficit/hyperactivity disorder between the ages of 6 and 12 years. KemPharm’s KP415 capsule makes use of d-MPH hydrochloride as […]
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