Acorda Therapeutics (NSDQ:ACOR) said this week that the FDA approved its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low levels of dopamine between doses of the standard oral Parkinson’s […]
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 it […]
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 […]
Sunovion seeks FDA nod for sublingual film to treat Parkinson’s disease
Sunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease. The Marlborough, Mass.-based company is testing the film as a therapy for Parkinson’s patients experiencing “off” episodes – when symptoms that are otherwise controlled by medications resurface. As […]
Acorda seeks EU approval for inhaled Parkinson’s disease drug
Acorda Therapeutics (NSDQ:ACOR) submitted a marketing authorization application to the European Medicines Agency for its inhaled Parkinson’s disease therapy, Inbrija, according to the Ardsley, N.Y.-based company. The investigational drug is designed to treat people with Parkinson’s disease who are experiencing “off” periods, or a re-emergence of symptoms. Get the full story at our sister site, Drug […]
Acorda Therapeutics wins FDA NDA nod for Inbrija
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA accepted the New Drug Application for its Inbrija investigational inhaled levodopa product designed for treating symptoms of OFF periods in patients with Parkinson’s disease who are taking carbidopa/levodopa regimens. The approval comes with a target date of October 5, 2018, the Ardsley, N.Y.-based company said. Read the whole story […]
Acorda posts Q4 revenue beat, but misses EPS estimates
Shares in Acorda Therapeutics (NSDQ:ACOR) fell today after the biotech company met sales expectations on Wall Street with its fourth-quarter results, but missed EPS estimates. The Ardsley, N.Y.-based company posted a net loss of -$171 million on sales of $188.4 million for the 3 months ended Dec.31, for sales growth of 34% compared with the same period last […]
Sunovion touts pivotal Ph3 trial for Parkinson’s drug
Gearing up for a springtime FDA submission, Sunovion Pharmaceuticals reported today that its apomorphine sublingual film succeeded in a pivotal Phase III trial in patients with Parkinson’s disease who experience motor fluctuations. Without revealing the study’s full results, the Marlborough, Mass.-based company said that the trial met its primary and key secondary endpoints and that the drug […]
Acorda resubmits NDA for inhaled Parkinson’s disease therapy
Acorda Therapeutics (NSDQ:ACOR) said today that it resubmitted its new drug application for Inbrija, an inhaled therapy for people with Parkinson’s disease. The Ardsley, N.Y.-based company was dealt a setback in August when the FDA told Acorda that it wouldn’t review its application for Inbrija, a move that sent ACOR shares tumbling. Get the full story at […]
Biotech, pharma chime in over Trump’s move to halt immigration program
On Tuesday, biotech and pharmaceutical companies urged president Donald Trump to reconsider his decision to end former president Barack Obama’s policy protecting undocumented immigrants who arrived in the U.S. as children. Attorney general Jeff Sessions said Tuesday morning that Trump would move to halt the Deferred Action for Childhood Arrivals program in six months, unless […]
Acorda shares plunge -30% after FDA refuses to review NDA
Shares in Acorda Therapeutics (NSDQ:ACOR) dropped nearly -30% today after the FDA told the company that the new drug application for its inhaled Parkinson’s disease treatment is incomplete. The FDA’s refusal to file letter surprised analysts. The note from the regulatory agency had to do with the date when the manufacturing site would be ready for inspection […]
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