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Latest Regulatory requirement Stories

2014-07-02 23:05:52

Cognition is proud to announce Michelle Lott will be joining us as the Executive Advisor for Regulatory Strategy. Bedford, MA (PRWEB) July 02, 2014 Cognition is proud to welcome Michelle Lott as our Executive Advisor for Regulatory Strategy. Michelle’s input will help Cognition better understand regulatory requirements, the ever changing medical device industry standards, and the unique solutions that Cognition’s products like Cockpit provide. Cognition will leverage Michelle’s...

2014-06-20 08:23:33

BUENA, N.J. and HAYWARD, Calif., June 20, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its seventh abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration (FDA). The seventh ANDA submission was in connection with an existing development, supply and marketing agreement with Impax Laboratories, Inc. (NASDAQ: IPXL). The agreement designates IGI...

2014-06-13 08:24:01

SAN DIEGO, June 13, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the company is scheduled to present a corporate overview at the 2014 Wells Fargo Securities Healthcare Conference on Wednesday, June 18, 2014, at 2:25 p.m. Eastern Time (11:25 a.m. Pacific Time), at the InterContinental Hotel in Boston, Massachusetts. A live audio webcast of the presentation will be available under the investors section of Arena's website at www.arenapharm.com. A...

2014-06-11 08:28:42

SAN FRANCISCO, June 11, 2014 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR), a biopharmaceutical company developing novel pain and cancer therapeutics, today announced that NASDAQ has halted trading of the company's common stock. The U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) is meeting on June 11-12, 2014 to discuss potential cardiovascular risk associated with peripherally-acting opioid receptor antagonists which...

2014-06-04 08:30:14

SANTA ROSA, Calif., June 4, 2014 /PRNewswire/ -- Ruthigen, Inc., (NASDAQ: RTGN), a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, is pleased to announce the distribution of a letter from Hojabr Alimi, the Company's Chairman, Chief Executive Officer and Chief Science Officer, to its stockholders on Form 8-K on June 3, 2014. A download of the full PDF of this...

2014-06-03 08:32:05

SAN DIEGO, June 3, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation of dosing in an investigational Phase 1b clinical trial of APD334, a novel, oral drug candidate that targets the sphingosine 1-phosphate subtype 1 (S1P(1)) receptor, to evaluate the compound for the treatment of a number of autoimmune diseases. This randomized, double-blind and placebo-controlled Phase 1b trial will evaluate the safety, tolerability and pharmacokinetics...

2014-05-27 08:28:43

SAN DIEGO, May 27, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the company is scheduled to present a corporate overview at the Jefferies 2014 Global Healthcare Conference on Tuesday, June 3, 2014, at 11:30 a.m. Eastern Time (8:30 a.m. Pacific Time) at the Grand Hyatt in New York, New York. A live audio webcast of the presentation will be available under the investor relations section of Arena's website at www.arenapharm.com. A replay of the...

2014-05-19 08:28:29

SAN FRANCISCO, May 19, 2014 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a biopharmaceutical company developing novel pain and cancer therapeutics, announced that Ivan Gergel, M.D., will serve as the Company's new Senior Vice President, Drug Development & Chief Medical Officer effective today. Dr. Gergel will have oversight for the company's clinical strategy and activities, including direct supervision of clinical research, clinical operations, medical affairs, regulatory...

2014-05-12 16:28:57

-- Conference Call and Webcast Scheduled for Today at 5:00 p.m. Eastern Time -- SAN DIEGO, May 12, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today provided a corporate update and reported financial results for the first quarter ended March 31, 2014. "We are off to a productive start in 2014 with significant new marketing initiatives for BELVIQ® for chronic weight management, the advancement of our lorcaserin life-cycle management programs and the development of our...

2014-05-05 08:28:20

SAN DIEGO, May 5, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that it will provide a corporate update and report first quarter 2014 financial results after the NASDAQ Global Select Market closes on Monday, May 12, 2014. That same day, Arena will host a conference call and webcast at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for international...


Word of the Day
snash
  • To talk saucily.
  • Insolent, opprobrious language; impertinent abuse.
This word is Scots in origin and probably imitative.