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Latest Regulatory requirement Stories

2014-08-05 08:34:32

WARRINGTON, Pa., Aug. 5, 2014 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced financial results for the second quarter ended June 30, 2014, as well as recent business updates. The Company will host a conference call today, August 5, 2014 at 9:00 AM ET to discuss the 2014 second quarter financial results and other business updates. Financial update --...

2014-08-04 08:28:51

HAYWARD, Calif., Aug. 4, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a re-inspection of the Company's Hayward, California manufacturing facility from June 16 to July 31, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations. The FDA did not provide any status or classification to these...

2014-07-29 23:05:06

MarketReportsOnline.com adds "Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)" report to its research store. Dallas, Texas (PRWEB) July 29, 2014 This Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials for imported drug registration but also introduced...

2014-07-29 08:32:31

HAYWARD, Calif., July 29, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a general GMP inspection and a Pre-Approval Inspection (PAI) for RYTARY(TM )at the Company's Taiwan manufacturing facility from July 21 to July 26, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in...

2014-07-25 08:25:54

SAN DIEGO, July 25, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that it will provide a corporate update and report second quarter 2014 financial results before the NASDAQ Global Select Market opens on Friday, August 1, 2014. That same day, Arena will host a conference call and webcast at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for...

2014-07-23 08:31:10

ENGLEWOOD, Colo., July 23 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced the opening of its new headquarters, manufacturing and research facility: Ampio Pharmaceuticals,373 Inverness ParkwayEnglewood, CO 80112Direct: (720) 437-6500 Michael Macaluso, Ampio's CEO, noted "This advanced, labor efficient, pharmaceutical drug manufacturing facility will be fully operational this summer, right on schedule, to produce the first batches of Ampion(TM)...

2014-07-17 08:29:14

NEW YORK, July 17, 2014 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) today announced successful completion and initial results of DPX-110, a Phase 1 skin irritation clinical trial of Locilex® (pexiganan cream 0.8%), the company's novel, broad-spectrum topical antibiotic peptide. Dipexium conducted DPX-110 and the company is conducting DPX-120, a Phase 1 skin sensitization clinical trial, in parallel with two required pivotal Phase 3 clinical trials for Locilex®....

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...


Word of the Day
cenobite
  • One of a religious order living in a convent or in community; a monk: opposed to anchoret or hermit (one who lives in solitude).
  • A social bee.
This word comes from the Latin 'coenobium,' convent, which comes from the Greek 'koinobios,' living in community.
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