MannKind Announces Tentative Date for FDA Review of AFREZZA Print E-mail
By Staff and Wire Reports   
Friday, 10 January 2014 20:00
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 10, 2014.

MannKind Corporation (Nasdaq: MNKD) announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is tentatively scheduled on April 1, 2014 to review MannKind's New Drug Application (NDA) for AFREZZA® (insulin human [rDNA origin]) Inhalation Powder. The date and details of the meeting are subject to confirmation by the FDA in a Federal Register notice.

MannKind resubmitted the NDA on October 13, 2013 seeking approval to market AFREZZA in the United States with an indication to improve glycemic control in adults with type 1 or type 2 diabetes. The target date for the FDA to complete its review of the AFREZZA NDA is April 15, 2014.



Also Friday:



Amicus Therapeutics (Nasdaq:FOLD)
, a biopharmaceutical company at the forefront of developing therapies for rare and orphan diseases, today announced that John F. Crowley, Chairman and Chief Executive Officer, will present the Company's full-year 2014 strategic outlook at the 32nd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2014 at 11:30 a.m. PT (2:30 p.m. ET).

Biota Pharmaceuticals, Inc. (Nasdaq:BOTA)
today announced that it has priced a public offering of 5,813,900 shares of its common stock at a purchase price of $4.30 per share for an aggregate offering amount of approximately $25 million.

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
, today announced that Chief Executive Officer Bob Palay is scheduled to present at the 32nd Annual J.P. Morgan Healthcare Conference at 4:30 p.m. PST, Tuesday, January 14, at the Westin St. Francis Hotel in San Francisco.

Galectin Therapeutics Inc. (Nasdaq:GALT)
, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that it had sold, from October 28, 2013 through January 9, 2014, a total of 2,391,204 shares of common stock at an average price per share of $9.99 for total gross proceeds of $23,883,137 through its at-the-market (ATM) financing vehicle.

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT)
, a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver and intestinal diseases, today announced that Mark Pruzanski, M.D., President and Chief Executive Officer, will present at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 15, 2014 at 7:30 a.m. Pacific Time (10:30 a.m. Eastern Time).

Pacific Biosciences of California, Inc. (Nasdaq:PACB) will hold its quarterly conference call to discuss its Fourth Quarter and Year End 2013 Financial Results on Tuesday, February 4, 2014, at 4:30pm Eastern Time.

RedChip Companies, Inc., an international small-cap research, investor relations, and media company, today announced that its exclusive RedChip TV interview with Dr. Phillip Frost, Chairman and CEO of OPKO Health, Inc. (NYSE:OPK), a multinational biopharmaceutical and diagnostics company, will air on "The RedChip Money Report: Small Stocks Big Money" on Saturday, January 11, 2014 at 12:30 a.m. and 8:30 p.m. GMT on Bloomberg U.K. and on Sunday, January 12, 2014 at 8:30 a.m. and 3:30 p.m. GMT on Bloomberg Europe and at 8:30 p.m. GMT on Bloomberg U.K.

Solos Endoscopy, Inc. (OTC Pink: SNDY)
a provider of quality innovative healthcare instruments to Hospitals across the Country, posted an update for the shareholders on OTC Markets.com.

StemCells, Inc. (Nasdaq:STEM)
announced today that a team at the University of Calgary successfully transplanted its first subject in the Company's Phase I/II clinical trial in chronic spinal cord injury, with the Company's proprietary HuCNS-SC® human neural stem cells.

Z Trim Holdings, Inc. (OTC Markets: ZTHO)
, a biotechnology company providing value-added ingredients to a variety of industries, today announced that it recorded, for the 4th quarter of 2013, $387,006 in sales which is a 76% increase over $220,433 in the 4th quarter of 2012.



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