Pharmaceuticals News and Research

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U.S. FDA agrees to the study design for cardiovascular outcomes trial of alogliptin

Takeda Pharmaceutical Company Limited ("Takeda") and Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, today jointly announced that the latter has received notification that the U.S. Food and Drug Administration (FDA) has agreed to the study design for a cardiovascular (CV) outcomes trial titled EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) for alogliptin, a selective dipeptidyl peptidase IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.

28 Aug 2009

Study on basic mechanisms that control fertility in worms may help to know how some woman regain their fertility after cancer treatment

Scientific dogma has long asserted that females are born with their entire lifetime's supply of eggs, and once they're gone, they're gone. New findings by researchers at Fred Hutchinson Cancer Research Center, published online Aug. 27 in Science, suggest that in nematode worms, at least, this does not hold true.

28 Aug 2009

Sagent Pharmaceuticals adds fluconazole injection to its line of premixed bags

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has launched fluconazole injection in premix bags. IMS Health estimates that 2008 U.S. sales of fluconazole injection approximated $18 million. Sagent will begin marketing and shipping fluconazole bags immediately.

28 Aug 2009

Licensing agreement between Orexo and Novartis signed to develop and commercialise a novel product related to Orexo’s OX17 program

Orexo (STO: ORX) announces it has signed an exclusive worldwide licensing agreement with a Novartis affiliate to develop and commercialise a novel product related to Orexo’s OX17 program.

28 Aug 2009

Ipsen Group announces first-half 2009 financial results

The Board of Directors of Ipsen (Paris:IPN), chaired by Jean-Luc Bélingard, met on 27 August 2009 to review the Group’s results for the first half 2009, published today. The full 2009 half year financial report is available on the Group’s web site, www.ipsen.com, under the Regulated Information heading in the Investor Relations pages.

28 Aug 2009

Forest Laboratories announces phase 3 trial results for roflumilast

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer and Nycomed, a privately owned pharmaceutical company, today announced that results of four phase III trials have been published in the prestigious peer-reviewed medical journal The Lancet showing that roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, improved lung function and reduced exacerbations in patients with moderate to severe COPD.

28 Aug 2009

Forest Laboratories to host a conference call for discussing the results of Daxas Phase III clinical trials

Forest Laboratories, Inc., an international manufacturer and marketer of pharmaceutical products and Nycomed, a privately owned pharmaceutical company, will host a conference call at 7:15 AM EDT on Friday, August 28, 2009.

28 Aug 2009

AVANIR raises funds to develop and commercialize Zenvia for PBA

AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced it had raised gross proceeds of approximately $10.6 million via the sale of approximately 4.5 million shares of common stock at a weighted average price of $2.34 per share.

28 Aug 2009

Fast Forward selects IntraLinks to support its funding effort

IntraLinks®, the leading provider of critical information exchange solutions, today announced that Fast Forward™ has selected IntraLinks to help streamline the collection, distribution and tracking of information to support their funding of multiple biotechnology and pharmaceutical companies working on new Multiple Sclerosis (MS) treatments.

28 Aug 2009

Kamada finalizes agreement for the distribution of its intravenous alpha-1 antitrypsin in the United States

Kamada (TASE:KMDA), a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has entered into an exclusive agreement with a large US specialty pharmaceutical distributor company for the distribution of its flagship product, intravenous alpha-1 antitrypsin (AAT-IV) in the United States.

28 Aug 2009

NIMH grants Xhale $1.7 million to develop the SMART medication adherence system for HIV/AIDS therapies

Xhale, Inc. has been awarded a $1.7 million Small Business Innovation Research (SBIR) Phase II grant by the NIH National Institute of Mental Health (NIMH) to continue the development of SMART (Self Monitoring and Reporting Therapeutics), a breath-based medication adherence system for HIV/AIDS therapies.

28 Aug 2009

Hisamitsu Pharmaceutical acquires Noven Pharmaceuticals

Hisamitsu Pharmaceutical Co., Inc. and Hisamitsu U.S., Inc. today announced the completion of their acquisition of Noven Pharmaceuticals, Inc. pursuant to a short form merger of Northstar Merger Sub, Inc., a wholly owned subsidiary of Hisamitsu U.S., Inc., with and into Noven.

28 Aug 2009

Champions Biotechnology reports higher year-on-year operating revenues for fiscal year 2009

Champions Biotechnology, Inc. (OTC Bulletin Board: CSBR), a company engaged in the development of advanced preclinical platforms and tumor specific data to enhance the value of oncology drugs, today announced its financial results for the fiscal year ended April 30, 2009. Full details of the Company's financial results are available in the Company's Form 10-K available at www.championsbiotechnology.com.

28 Aug 2009

Arno Therapeutics to commence Phase 1 clinical study of AR-12 in adult patients with lymphoma

Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology therapeutics, today announced the dosing of the first patient in a Phase I clinical study of AR-12 (formerly OSU-03012) in adult patients with advanced or recurrent solid tumors or lymphoma.

28 Aug 2009

Rutgers University Professor receives $3.5 million MERIT Award from NIH

Rutgers University Professor Dipak Sarkar has received a $3.5 million MERIT Award from the National Institutes of Health (NIH) to continue researching the damaging effects of alcohol on the nervous systems of the unborn.

27 Aug 2009

Mylan Pharmaceuticals markets FDA approved first generic version of Sanofi Aventis' BenzaClin

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market 1% Clindamycin and 5% Benzoyl Peroxide Gel based on an agreement with licensing partner Dow Pharmaceutical Sciences, a subsidiary of Valeant Pharmaceuticals International. The preparation is the first generic version of Sanofi Aventis' BenzaClin(R) to be approved by the U.S. Food and Drug Administration (FDA).

27 Aug 2009

DURECT signs agreement with King Pharmaceuticals to supply two excipients for REMOXY

DURECT Corporation (Nasdaq: DRRX) today reported that it has signed an exclusive long term excipient supply agreement with respect to REMOXY(R) with King Pharmaceuticals, Inc. (NYSE: KG). This agreement stipulates the terms and conditions under which DURECT will supply to King, based on DURECT's manufacturing cost plus a specified percentage mark-up, two key excipients used in the manufacture of REMOXY.

27 Aug 2009

Cumberland Pharmaceuticals posts $9.8 million revenues for the three months ended June 30, 2009

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announced second quarter 2009 financial results.

27 Aug 2009

MBS/Vox hires two new analysts

MBS/Vox, the research-based consultancy unit of CommonHealth specializing in the linguistic analysis of healthcare communication, today announced two new hires.

27 Aug 2009

Contract research organization signs agreement to utilize NewCardio's QTinno(TM) software suite

NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic and services company, today announced that a top-three contract research organization has signed a Master Services Agreement (MSA) to use NewCardio's QTinno(TM) software suite as its technology in fully automated Thorough QT (TQT) and Phase 1 studies delivered by its centralized ECG core lab.

27 Aug 2009

Pharmaceuticals News and Research

U.S. FDA agrees to the study design for cardiovascular outcomes trial of alogliptin

Study on basic mechanisms that control fertility in worms may help to know how some woman regain their fertility after cancer treatment

Sagent Pharmaceuticals adds fluconazole injection to its line of premixed bags

Licensing agreement between Orexo and Novartis signed to develop and commercialise a novel product related to Orexo’s OX17 program

Ipsen Group announces first-half 2009 financial results

Forest Laboratories announces phase 3 trial results for roflumilast

Forest Laboratories to host a conference call for discussing the results of Daxas Phase III clinical trials

AVANIR raises funds to develop and commercialize Zenvia for PBA

Fast Forward selects IntraLinks to support its funding effort

Kamada finalizes agreement for the distribution of its intravenous alpha-1 antitrypsin in the United States

NIMH grants Xhale $1.7 million to develop the SMART medication adherence system for HIV/AIDS therapies

Hisamitsu Pharmaceutical acquires Noven Pharmaceuticals

Champions Biotechnology reports higher year-on-year operating revenues for fiscal year 2009

Arno Therapeutics to commence Phase 1 clinical study of AR-12 in adult patients with lymphoma

Rutgers University Professor receives $3.5 million MERIT Award from NIH

Mylan Pharmaceuticals markets FDA approved first generic version of Sanofi Aventis' BenzaClin

DURECT signs agreement with King Pharmaceuticals to supply two excipients for REMOXY

Cumberland Pharmaceuticals posts $9.8 million revenues for the three months ended June 30, 2009

MBS/Vox hires two new analysts

Contract research organization signs agreement to utilize NewCardio's QTinno(TM) software suite

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