|Chelsea Therapeutics' NORTHERA(TM) (Droxidopa) Gets Recommdnation Approval; Perrigo Announces FDA Final Approval Vanos Cream|
|By Staff and Wire Reports|
|Tuesday, 14 January 2014 20:01|
Chelsea Therapeutics International (Nasdaq: CHTP) announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend approval of NORTHERA™ (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
The FDA is not bound by the CRDAC's recommendation but will take it into consideration when reviewing the New Drug Application (NDA) for Northera. A Prescription Drug User Fee Act (PDUFA) action date for the Northera NDA has been scheduled for February 14, 2014.
"Chelsea is committed to improving the lives of patients with nOH, a debilitating disorder which often severely limits a person's ability to perform routine daily activities," said Joseph G. Oliveto, Interim Chief Executive Officer of Chelsea Therapeutics. "We are appreciative of the FDA bringing our Northera NDA before the Cardiovascular and Renal Drugs Advisory Committee, and for the Committee's thoughtful discussion of the application."
Northera was previously granted Orphan Drug Designation, which is granted by the FDA to treatments for rare diseases/disorders.
Perrigo Company (NYSE: PRGO; TASE) announced it has received final approval for its abbreviated new drug application ("ANDA") for fluocinonide cream 0.1%, the generic equivalent to Vanos® Cream 0.1%. Perrigo was awarded 180-days of generic drug exclusivity as it was the first company to submit an ANDA containing a paragraph IV certification. Perrigo had previously resolved litigation with the brand and has commenced shipment of the product.
Vanos® Cream 0.1% (fluocinonide cream 0.1%) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older and has estimated annual sales of approximately $107 million.
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This is another example of our Rx team's commitment to launching difficult to manufacture topicals, lotions and foams. We are excited to market this product and are dedicated to making quality healthcare more affordable for all patients."
From its beginnings as a packager of generic home remedies in 1887, Perrigo Company, based in Allegan, Michigan, has grown to become a leading global healthcare supplier. The Company develops, manufactures and distributes over-the-counter ("OTC") and generic prescription ("Rx") pharmaceuticals, nutritional products and active pharmaceutical ingredients ("API") and is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. Perrigo's mission is to offer uncompromised "quality, affordable healthcare products™", and it does so across a wide variety of product categories primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as certain other markets throughout the world, including Canada, China and Latin America.
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to neurodegeneration and apoptosis, today announced that it has completed the in-licensure of Eltoprazine from PGI Drug Discovery LLC (PGI DD).
athenahealth, Inc.(Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, and CECity, a leading provider of cloud-based registry services for performance improvement and value-based reporting, today announced a partnership through which the companies will launch a first-of-its-kind health data exchange integration and reporting service, automating the flow of information directly from practices using athenaClinicals®, athenahealth's award-winning EHR, to clinical registries from national medical specialty societies and other registries.
Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) today announced that Guggenheim Securities, LLC has exercised its option to purchase an additional 872,085 common shares to cover over-allotments in connection with the Company's public offering of its common shares.
Caliber Imaging & Diagnostics (OTCQB:LCDX), formerly Lucid, Inc., announces receipt of $1.4 million in orders for VivaScope® systems from its European distributor MAVIG GmbH.
Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced that it has entered into definitive agreements with two institutional investors to purchase an aggregate of $7 million of its common stock in an at-the-market registered direct offering at $1.22 per share.
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that it has been selected by ProPath® to provide its chromosomal microarray analysis (CMA) testing for miscarriage analysis for ProPath patients.
Galena Biopharma (Nasdaq:GALE) and Dr. Reddy's Laboratories Ltd. (NYSE:RDY) today announced a strategic development and commercialization partnership on NeuVax™ (nelipepimut-S) in India.
Intuitive Surgical, Inc. (Nasdaq:ISRG), the industry leader in surgical robotics, today announced certain preliminary unaudited fourth quarter and full year 2013 financial results ahead of its participation at the 32nd Annual JP Morgan Healthcare Conference on January 14 and 15, 2014 in San Francisco, California.
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, today announced the presentation of two posters at the American Society of Clinical Oncology (ASCO) 2014 Gastrointestinal (GI) Cancers Symposium being held January 16-18, 2014 in San Francisco, CA.
Luminex Corporation (Nasdaq: LMNX) today announced that it expects to report results for the fourth quarter of 2013 on Monday, February 3, 2014.
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive results from a study that examined the potential clinical efficacy of MN-001 for the treatment of NASH (nonalcoholic steatohepatitis).
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, and Heart Imaging Technologies (Heart IT), an industry leader in web-based medical image viewing and management solutions, today announced they have entered into a non-exclusive patent license and settlement agreement.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB) announces its consolidated financial results for the three and nine-month periods ended November 30, 2013 and provides update on action plan to resume operations.
PetMed Express, Inc. (Nasdaq:PETS) will announce its financial results for the quarter ended December 31, 2013 on Tuesday, January 21, 2014 at 8:00 A.M. Eastern Time, then at 8:30 A.M. Eastern Time, Menderes Akdag, the Company's Chief Executive Officer and President, will host a conference call to review the financial results.
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, announced today closing of the previously announced underwritten public offering of 3,320,000 shares of its common stock at a price to the public of $30.75 per share, as well as the full exercise of the option granted to the underwriters to purchase an aggregate of 498,000 additional shares of common stock.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today announced that it has entered into a definitive agreement with a select group of investors (the "Investors") for the sale of RedHill's ordinary shares and warrants in a private placement transaction (the "Private Placement") for a total amount of approximately $11.7 million.
Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative testing and genetic analysis solutions, announced today its wholly owned subsidiary, Sequenom Laboratories, entered into an agreement to offer access to its MaterniT21™ PLUS laboratory-developed test to Mayo Medical Laboratories.
Three Premier, Inc. (Nasdaq:PINC) population health professionals have earned certification from the National Committee for Quality Assurance (NCQA) as Patient-Centered Medical Home (PCMH) Certified Content Experts™.
VIVUS, Inc. (Nasdaq:VVUS), today announced that it has joined with Aetna (NYSE:AET), one of the nation's leading diversified health care benefits companies, to integrate Qsymia® (phentermine and topiramate extended-release) capsules CIV into a pilot program designed to evaluate the benefits of prescription medication combined with lifestyle support for weight loss.