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Transcept Pharmaceuticals, Inc. Resubmits Intermezzo(R) NDA to FDA PDF Print E-mail
Saturday, 01 October 2011 00:01
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced that the company has resubmitted the New Drug Application for Intermezzo® (zolpidem tartrate sublingual tablet) to the U.S. Food and Drug Administration (FDA).
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Astellas Pharma Inc. Halts Development of Anti-Clotting Drug PDF Print E-mail
Friday, 30 September 2011 00:22
Japan's Astellas Pharma said it halted the global development of the experimental anti-clotting drug darexaban maleate, or YM150, after a study raised questions about its role in treating patients with heart problems.
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Glaxo Receives Complete Response Letter From FDA For Hib-MenCY-TT PDF Print E-mail
Thursday, 29 September 2011 00:44

GlaxoSmithKline PLC (GSK.LN), a research-based pharmaceutical and healthcare firm, said Friday said it has received a Complete Response letter from the U.S. Food and Drug Administration or FDA for the Biologics License Application for the candidate meningococcal and Hib combination vaccine, MenHibrix or Hib-MenCY-TT.

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Roche's T-DM1 Cancer Drug Delays Breast Cancer's Advance PDF Print E-mail
Thursday, 29 September 2011 00:36
Genentech, a member of the Roche Group, today announced the results of the Phase II study TDM4450g in people with previously untreated HER2-positive metastatic breast cancer (mBC).
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RXi Pharmaceuticals Plans to Split into Two Public Firms PDF Print E-mail
Wednesday, 28 September 2011 00:32

RXi Pharmaceuticals Corp. said it plans to split into two publicly traded companies later this year, separating its oncology and gene therapy businesses.

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European CHMP Adopts Positive Opinion for Gilead Sciences, Inc. (GILD)'s Eviplera(R), a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection PDF Print E-mail
Tuesday, 27 September 2011 00:20
Gilead Sciences, Inc. (Nasdaq:GILD - News) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorisation Application for the once-daily single-tablet regimen, Eviplera®, combining Gilead’s Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) with Tibotec Pharmaceuticals’ non-nucleoside reverse transcriptase inhibitor Edurant® (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in antiretroviral-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL.
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EU Agency Calls for Restrictions on Sanofi (France) 's Multaq PDF Print E-mail
Tuesday, 27 September 2011 00:14
Risks of liver, cardiovascular or lung issues stemming from Sanofi's Multaq irregular heart beat drug mean its use should be restricted, Europe's drug regulator said on Thursday following a safety review.
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FDA Issues Clinical Hold on Cancer Drug by Immunomedics, Inc. PDF Print E-mail
Monday, 26 September 2011 00:03
 Immunomedics, Inc., a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that the Company has been notified by the U.S. Food and Drug Administration (FDA) that a partial clinical hold has been placed on the Company's Phase Ib/II clinical trial of clivatuzumab tetraxetan in patients with advanced pancreatic cancer, due to the administration of an incorrect dose to a patient enrolled at one of its trial sites.

 

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Hospira Ramps Up Competition on Biologic Drug PDF Print E-mail
Saturday, 24 September 2011 00:39

Though still years behind Europe in the availability of cheaper copycat versions of some of the world’s most expensive prescriptions, savings on expensive drugs derived from biotechnology are inching closer to reality in the United States.

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Bristol-Myers Squibb Company Gains More Rights to Cancer Drug From Ono Pharmaceutical Company, Ltd. PDF Print E-mail
Saturday, 24 September 2011 00:35
Bristol-Myers Squibb Company /quotes/zigman/220498/quotes/nls/bmy BMY -0.06% and Ono Pharmaceutical Co., Ltd., today announced an agreement to expand Bristol-Myers Squibb's territorial rights to develop and commercialize the anti-PD-1 antibody known as BMS-936558/ONO-4538, and to create a strategic alliance for the co-development and co-commercialization of ORENCIA(R) (abatacept) in Japan.
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Novo Nordisk A/S Seeks US And EU Approval for Degludec Insulin PDF Print E-mail
Friday, 30 September 2011 00:30
Danish drugmaker Novo Nordisk (NOVOb.CO) has filed applications for approval in Europe of its ultra long-acting insulin Degludec and insulin combination analogue DegludecPlus and aims to file applications with U.S. regulators soon.
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Neurosearch A/S to Axe Workforce by 82.5 Pct. in Next 2 Years PDF Print E-mail
Friday, 30 September 2011 00:17
NeuroSearch is committed to create a profitable, specialty pharmaceutical company building on the platform that the company would achieve from a successful development of Huntexil®. 
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Novartis AG's Afinitor Shows Promise in Breast Cancer PDF Print E-mail
Thursday, 29 September 2011 00:42
A pivotal Phase III study shows Afinitor® (everolimus) tablets plus exemestane, a hormonal therapy, more than doubled the time women lived without tumor growth (progression-free survival; PFS) and significantly reduced the risk of cancer progression by 57% versus exemestane alone in patients with advanced breast cancer(1).
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Janssen Biotech Inc.'s REMICADE(R) Receives FDA Approval as First Biologic Treatment for Pediatric Ulcerative Colitis PDF Print E-mail
Wednesday, 28 September 2011 00:39
Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.
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Novartis Cut 2,500 Jobs Over Past Year PDF Print E-mail
Wednesday, 28 September 2011 00:24

Swiss pharmaceutical company Novartis AG (NVS) cut 2,500 jobs over the past year, Swiss daily Tages Anzeiger reported Saturday.

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Judge Orders SIGA Technologies, Inc. to Split Drug Profit with PharmAthene, Inc. PDF Print E-mail
Tuesday, 27 September 2011 00:18
SIGA Technologies, Inc. (Nasdaq:SIGA - News), a company specializing in the development of pharmaceutical agents to fight biowarfare pathogens, announced today that the Delaware Court of Chancery has issued its post-trial opinion in the litigation commenced by PharmAthene, Inc. in 2006.
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FDA Approves Alexion Pharmaceuticals Inc. 's Soliris for Rare Pediatric Blood Disorder PDF Print E-mail
Monday, 26 September 2011 00:05

Alexion Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Soliris(R) (eculizumab) for the treatment of all pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS). aHUS is an ultra-rare, life-threatening, genetic disease that progressively damages vital organs, leading to stroke, heart attack, kidney failure and death.

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Enzon Pharmaceuticals, Inc. to Cut Almost Half of Workforce PDF Print E-mail
Monday, 26 September 2011 00:00
Enzon Pharmaceuticals, Inc. /quotes/zigman/71584/quotes/nls/enzn ENZN -0.13% today announced that it is implementing a plan to reduce its workforce and operating costs to more closely align its resources with the Company's research and development activities.
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Bayer Plant Workers Fight For A New Contract PDF Print E-mail
Saturday, 24 September 2011 00:37
Amid the thousands of layoffs taking place in the pharmaceutical industry, a relatively rare battle is brewing in Berkeley, California. Some 400 unionized employees of a Bayer plant are bracing for contract talks amid fears they will encounter the same fate as workers at a nearby plant that is being closed because work is being shifted to a contract manufacturer.
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Sanofi Signs Research Deal With University of California, San Diego for Acne Vaccine PDF Print E-mail
Friday, 23 September 2011 00:33
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today it is donating to the World Health Organization (WHO) a vaccine strain used for polio eradication.
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