Latest Drug safety Stories

New opportunity to discuss the Impact of the New European Pharmacovigilance Legislation

2012-09-13 23:01:03

Impact of the New European Pharmacovigilance Legislation one-day meeting hosted by MAPI Research Trust. London, UK (PRWEB) September 12, 2012 Held approximately 100 days after the 2 July effective date, Impact of the New European Pharmacovigilance Legislation is designed to promote discussion regarding current and ongoing implementation efforts. An array of industry and regulatory experts will be on hand 15 October at the BMA House in London to discuss ongoing efforts, successes and...

Safe Driving 'Prescription' for Senior Drivers

2012-09-12 02:20:34

AURORA, Ill., Sept. 12, 2012 /PRNewswire/ -- More than 80 percent of drivers age 65 and older regularly take medications, yet only half have talked to a medical professional about possible safety issues related to driving. With 10,000 Americans turning 65 every day, AAA today promotes Roadwise Rx, a first-of-its-kind tool to help seniors understand how medications may affect their ability to drive safely. (Logo: http://photos.prnewswire.com/prnh/20100506/AAACHILOGO) Developed by...

Alexza Pharmaceuticals Receives EU Certificate of GMP Compliance for its ADASUVE(TM) Manufacturing Facility

2012-08-21 14:21:05

MOUNTAIN VIEW, Calif., Aug. 21, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the company has received its EU Certificate of GMP Compliance of a Manufacturer. In May 2012, Alexza hosted an EU GMP inspection, which was conducted by the Agencia Espanola de Medicamentos y Productos Sanitarios. Based upon the outcome from this inspection of the company's Mountain View, CA facility and additional Company responses, the Spanish authorities, on...

Alexza Pharmaceuticals to Present at the Stifel Nicolaus 2012 Healthcare Conference

2012-08-20 10:24:43

MOUNTAIN VIEW, Calif., Aug. 20, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the company will participate in the Stifel Nicolaus 2012 Healthcare Conference, being held in Boston, MA, on September 5 - 6, 2012. The Alexza corporate presentation will be Wednesday, September 5, 2012 at 1:30 p.m. Eastern Time. The presentation will be webcast live. To access the presentation via the Web, please go to the Alexza Investor Relations tab at...

Alternate Distribution Channels Claim Opportunities for OTC Drug Sales in the United States, Finds Kline

2012-07-30 06:24:27

PARSIPPANY, N.J., July 30, 2012 /PRNewswire/ -- Manufacturers' sales of over-the-counter (OTC) medicine through alternate retail channels have grown by a compound annual growth rate (CAGR) of 9.4% from 2006 through 2011, far exceeding the 2.4% overall growth rate through all retail outlets. Online sales saw the highest increase with a CAGR of 16.1%, according to the recently published OTC Retailing: U.S. Alternate Channel Analyses and Opportunities report by global consulting and...

Alexza to Announce 2012 Second Quarter Financial Results on Wednesday, August 8, 2012

2012-07-24 10:23:50

MOUNTAIN VIEW, Calif., July 24, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it will report results for its fiscal quarter ended June 30, 2012, on Wednesday, August 8, 2012, following the close of the U.S. financial markets. The Company will host an investor conference call and live webcast to discuss the financial results and provide a corporate update at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time on the same date. The conference...

Aeterna Zentaris Requests Fast Track Designation from the FDA for AEZS-130 as Diagnostic Test for Adult Growth Hormone Deficiency

2012-07-24 02:28:54

QUÉBEC CITY, July 24, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that it has filed a request with the United States Food and Drug Administration (FDA) for Fast Track designation for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD). The request is part of the Company's New Drug Application ("NDA") strategy for AEZS-130 to advance the product towards regulatory approval as...

Alexza Announces Submission of Responses to the EMA Day 120 List of Questions for the ADASUVE(TM) MAA

2012-07-18 14:22:59

MOUNTAIN VIEW, Calif., July 18, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has submitted its responses regarding the ADASUVE Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). In March 2012, Alexza received the Committee for Medicinal Products for Human Use Consolidated List of Questions (Day 120 List of Questions) regarding Alexza's ADASUVE MAA. In May 2012, Alexza and its European corporate partner, Grupo...

Omeros Successfully Completes Preclinical Studies of OMS824 for Schizophrenia and Phase 1 Clinical Trial Preparations Underway

2012-07-18 02:25:47

SEATTLE, July 18, 2012 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today reported that OMS824, the lead compound in the Company's phosphodiesterase 10 (PDE10) program for schizophrenia, has successfully completed all of the preclinical studies that Omeros expects will be necessary for the drug's planned Investigational New Drug Application (IND). OMS824 selectively inhibits PDE10, which is an enzyme expressed in areas of the brain linked to diseases that affect cognition,...

Alexza Announces Resubmission of ADASUVE(TM) NDA and Provides Regulatory Updates on US and EU Submissions

2012-06-22 02:22:39

MOUNTAIN VIEW, Calif., June 22, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has resubmitted its ADASUVE New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in May 2012. ADASUVE is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. In the coming weeks, Alexza expects to hear from the FDA regarding...