An analyst said the news could negatively affect shares of a successor to the company that developed rapastinel - which Allergan bought in 2015 - given that its drugs belong to the same class.
The company's shares were down more than 4 percent in Monday morning trading after the agency's decision, which itself followed a negative AdCom vote in November.
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A federal court last year put the kibosh on a deal whereby Allergan transferred to the tribe the Restasis patents, which the tribe then licensed back to Allergan, asserting tribal sovereign immunity to have generic companies' challenge to the patents dismissed.
The four North America-based finalists in the competition, which is part of Accenture's broader HealthTech Innovation program, are Ayasdi, b.well Connected Health, Newtopia and NowPow.
The drug offers greater convenience and efficacy than the old chemotherapy combination, but its high cost and first impressions among doctors may explain why Jazz had to lower its sales guidance.
The company plans to file a New Drug Application next year. An analyst wrote that it's unclear if the drug will require review by an advisory committee.
The home care industry is booming. As Baby Boomers age and more families seek in-home solutions for loved ones, demand for home care services is at an all-time high.
Briefing documents from the Psychopharmacologic Drugs Advisory Committee earlier this week had cast doubt on the chances of a positive vote.
The Psychopharmacologic Drugs Advisory Committee will meet on Thursday to vote on whether to recommend the FDA approve the drug, ALKS 5461, an opioid for major depressive disorder.
The selection process whittled the prospective candidate pool down from 700 companies to five finalists tackling healthcare problems ranging from women's health to ophthalmology.
Medtronic and SPR Therapeutics are treating chronic pain but while the former has adopted a permanent, implantable neuromodulation treatment, the latter is going the temporary wearable route.
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Medtronic becomes the first in the U.S. to win FDA approval for a quadripolar cardiac resynchronization therapy pacemaker that is also safe to use under MRI if certain conditions are met.
There really is enough CRISPR to go around. On Tuesday Allergan and Editas struck a deal to apply the gene-editing approaching in certain ocular conditions, including Leber congenital amaurosis.
B Capital Group led the round but other investors that took part included Other investors include ACT Venture Capital and returning investors, Investec Ventures and AIB Seed Capital Fund, managed by DBIC, NDRC and Enterprise Ireland.
Four companies from the UC-Berkeley side of the CRISPR patent interference case have signed an alliance to recognize each other's rights to the technology. The agreement highlights the potential for many companies to coexist in the expansive CRISPR field.
FDA approves the first automated insulin delivery system giving Medtronic the distinction of being the first in a category that is set to revolutionize daily disease management for type 1 diabetes patients.