Inbrija (Levodopa Inhalation Powder) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 7, 2019 Category: Drugs & Pharmacology Source Type: news
Acorda nabs crucial FDA ok for Parkinson ’s drug
Acorda Therapeutics announced that the U.S. FDA approved Inbrija for intermittent treatment of OFF episodes in people with Parkinson ’s disease treated with carbidopa/levodopa. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 27, 2018 Category: Pharmaceuticals Source Type: news
Acorda wins FDA nod for inhaled Parkinson ’ s therapy
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 therapy, carbidopa/levodopa, according to Acorda.
Get the full story at our sister site, Drug Delivery Business News.
The post Acorda wins FDA nod for inhaled Parkinson’s therapy appeared first on M...
Source: Mass Device - December 26, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Drug-Device Combinations Featured Food & Drug Administration (FDA) Neurological Pharmaceuticals Regulatory/Compliance Wall Street Beat Acorda Therapeutics Source Type: news
FDA Approves Inhaled Levodopa for Parkinson's
(MedPage Today) -- Improved motor function when taken during ' off ' episodes (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - December 26, 2018 Category: American Health Source Type: news
FDA OKs Inhaled Levodopa (Inbrija) for Parkinson's'Off' Episodes FDA OKs Inhaled Levodopa (Inbrija) for Parkinson's'Off' Episodes
Levodopa inhalation powder aims to fill an unmet need for roughly 40% of patients with Parkinson ' s who experience off periods while taking an oral regimen of carbidopa-levodopa.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 24, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Alert Source Type: news
FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson ’s Disease
ARDSLEY, N.Y.--(BUSINESS WIRE) December 21, 2018 --Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration approved Inbrija™ for intermittent treatment of OFF episodes in people with Parkinson’s disease... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2018 Category: Drugs & Pharmacology Source Type: news
' Accordion' Pill May Reduce Levodopa Fluctuations in PD'Accordion' Pill May Reduce Levodopa Fluctuations in PD
A pill that releases an accordion-folded sheet in the stomach prolongs gastroretention of the device and thus, prolonged delivery of drugs to the upper GI tract, where some drugs are absorbed.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 7, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news
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 made in response to requests from the FDA for additional data on chemistry, manufacturing & controls.
Get the full story at our sister site, Drug Delivery Business News.
The post FDA pushes back decision date for Acorda’s Parkinson’s drug appeared first on MassDevi...
Source: Mass Device - September 13, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Featured Food & Drug Administration (FDA) Neurological Pharmaceuticals Regulatory/Compliance Wall Street Beat Acorda Therapeutics Source Type: news
Amneal Initiates Phase 3 Study for IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa (CD-LD) in Advanced Parkinson's Disease Patients
BRIDGEWATER, N.J., May 7, 2018 -- (Healthcare Sales & Marketing Network) -- Amneal (NYSE: AMRX), a specialty pharmaceutical company, today announced it has initiated a Phase 3 trial for IPX203. The IPX203 Phase 3 protocol has been agreed upon with the Foo... Biopharmaceutical, Neurology Amneal Pharmaceuticals, Parkinson's Disease, carbidopa, levodopa (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 7, 2018 Category: Pharmaceuticals Source Type: news
Boston Sci Sees Strong Data From Parkinson & #039;s Treatment Study
This study meets a new level of rigor in evaluating the effectiveness of a DBS system," Jerrold Vitek, MD, Phd, McKnight professor and chair, Department of Neurology, University of Minnesota Medical School and coordinating principal investigator for the INTREPID study, said in a release. "The double-blind design gives us confidence that the improvements in patients on time with good symptom control, as evaluated by the diary data, are an objective measure of the outcomes and suggests patients will benefit from the Vercise System."
Boston Scientific received FDA approval for Vercise late last year. The device is different f...
Source: MDDI - April 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Source Type: news
Boston Scientific touts 1-year data on Vercise DBS in Parkinson ’ s
This study meets a new level of rigor in evaluating the effectiveness of a DBS system,” coordinating principal investigator Dr. Jerrold Vitek, of the University of Minnesota Medical School, said in prepared remarks. “The double-blind design gives us confidence that the improvements in patients on time with good symptom control, as evaluated by the diary data, are an objective measure of the outcomes and suggests patients will benefit from the Vercise System.”
Vercise won CE Mark approval in the European Union to treat essential tremor in 2014. FDA approval to treat Parkinson’s followed last December, ...
Source: Mass Device - April 24, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Neuromodulation/Neurostimulation Boston Scientific Parkinson's disease Source Type: news
Intec Pharma partners for manufacture of ‘ accordion pill ’ for Parkinson ’ s disease
Intec Pharma (NSDQ:NTEC) plans to partner with LTS to manufacture the company’s lead product candidate – an oral pill for Parkinson’s disease formulated with Intec’s “Accordion Pill” drug delivery tech.
According to the terms of the deal, LTS will manufacture the carbidopa/levodopa capsules using Intec’s production technology in LTS’ manufacturing facility in Germany.
Get the full story at our sister site, Drug Delivery Business News.
The post Intec Pharma partners for manufacture of ‘accordion pill’ for Parkinson’s disease appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 13, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Neurological Pharmaceuticals Wall Street Beat Intec Pharma Source Type: news
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 at our sister site, Drug Delivery Business
The post Acorda Therapeutics wins FDA NDA nod for Inbrija appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Regulatory/Compliance Respiratory Acorda Therapeutics Source Type: news
Acorda Announces FDA Acceptance of New Drug Application for Inbrija (levodopa inhalation powder)
ARDSLEY, N.Y.--(BUSINESS WIRE) February 20, 2018 -- Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for Inbrija. Inbrija is an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 20, 2018 Category: Drugs & Pharmacology Source Type: news
Stalevo (Carbidopa, Levodopa and Entacapone) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 15, 2017 Category: Drugs & Pharmacology Source Type: news
