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Gilead Amends Study Design for Ongoing Hepatitis C Clinical Trials That Include GS 9190, Pegylated Interferon and Ribavirin, and Another Direct-Acting Antiviral Agent PDF Print E-mail
Wednesday, 07 September 2011 00:47

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that, in consultation with the U.S. Food and Drug Administration (FDA), the company will amend the design of ongoing clinical trials to discontinue dosing of GS 9190 in hepatitis C-infected patients who are receiving that compound in combination with pegylated interferon and ribavirin, and another direct-acting antiviral agent.

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FDA Warns of Severe Allergy Risk with Merck & Co., Inc. Antipsychotic PDF Print E-mail
Tuesday, 06 September 2011 00:36
The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris (asenapine maleate).
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Disappointing Crestor Results For AstraZeneca PDF Print E-mail
Tuesday, 06 September 2011 00:30
And so, a calculated bet has not paid for the drugmaker. In a head-to-head trial called Saturn, imaging tests showed patients on Crestor had a lower percentage of artery-clogging plaque than those on Lipitor, but the difference was not statistically significant.
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Addex Pharmaceuticals Regains Rights to Parkinson's Drug Candidates from Merck & Co., Inc. PDF Print E-mail
Monday, 05 September 2011 00:43
Addex Pharmaceuticals (SIX:ADXN), a leading biopharmaceutical company pioneering allosteric modulation-based drug discovery and development, announced today that it will regain all rights to its metabotropic glutamate receptor 4 (mGluR4) positive allosteric modulator (PAM) program from Merck, known as MSD outside the United States and Canada, due to further pipeline prioritization.
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Merck Scores A Partial Win In Fosamax Litigation PDF Print E-mail
Saturday, 03 September 2011 00:30
No, Merck has not won another Fosamax trial. But a federal judge has tossed part of a so-called bellwether lawsuit against the drugmaker over its osteoporosis drug, which has been blamed for causing a type of jaw damage known as osteonecrosis in which tissue is severely damaged.
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FDA Chemist's Insider Trading Case Nears Plea Bargain PDF Print E-mail
Friday, 02 September 2011 00:26
A U.S. Food and Drug Administration chemist and his son accused of making millions of dollars with inside information about drug approvals are close to reaching plea agreements, according to court papers.
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FDA Alerts Health Care Professionals of Infection Risk from Repackaged Avastin Intravitreal Injections PDF Print E-mail
Friday, 02 September 2011 00:20

The U.S. Food and Drug Administration (FDA) is alerting health care professionals that repackaged intravitreal injections of Avastin (bevacizumab) have caused a cluster of serious eye infections in the Miami, Florida area.

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FDA Asks Novartis AG for More Data on Gout Drug PDF Print E-mail
Thursday, 01 September 2011 00:21
Novartis AG has been asked to give a U.S. regulator more clinical data on its prospective gouty arthritis treatment and potential blockbuster, ACZ885, so that it can evaluate the benefit-risk profile in a subset of patients.
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Actelion Ltd. 's Macitentan Fails Phase 3 Study PDF Print E-mail
Wednesday, 31 August 2011 00:15
Actelion (SIX: ATLN) announced today that the exploratory Phase II study with macitentan in patients with idiopathic pulmonary fibrosis (IPF) shows a promising safety and tolerability profile of macitentan, no difference being observed between placebo and macitentan with regard to liver enzyme elevations.
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FDA Approves Pfizer Inc.'s Targeted Lung Cancer Drug PDF Print E-mail
Wednesday, 31 August 2011 00:10
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved XALKORI® (crizotinib) capsules, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test.
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BioAlliance Pharma: Presentation of Livatag® survival results at the international liver cancer congress in Hong Kong PDF Print E-mail
Wednesday, 07 September 2011 00:44

BioAlliance Pharma SA (Paris:BIO), a company dedicated to specialty and orphan oncology products, today announces oral communication of the Phase II clinical trial results of its orphan product Livatag® at the annual congress of ILCA (International Liver Cancer Association), the only international organization devoted exclusively to liver cancer research with participation of worldwide best specialists.

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PFIZER : Signs Agreement With MIT For Future Cambridge Research Center PDF Print E-mail
Tuesday, 06 September 2011 00:34
Pfizer Inc. today announced it has entered into a 10-year lease agreement with the Massachusetts Institute of Technology (MIT) for more than 180,000 square feet in a new building under development in Cambridge, Massachusetts.
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EU Grants Approval for Expanded Use of Roche's Tarceva PDF Print E-mail
Monday, 05 September 2011 00:45
The European Commission has approved Roche's medicine Tarceva for use in patients with a genetically distinct type of lung cancer, the world's largest maker of cancer drugs said on Thursday.
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Head-to-Head Data on AstraZeneca PLC's Crestor Vs. Pfizer Inc.'s Lipitor Results Due Soon PDF Print E-mail
Saturday, 03 September 2011 00:32
Headline results from an important clinical trial comparing AstraZeneca's cholesterol fighter Crestor to Pfizer's Lipitor could be released imminently, according to an analyst note on Wednesday.
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NexBio, Inc.’s DAS181 (Fludase(R)) Improves Symptoms in Four Severely Immunocompromised Patients With Life-Threatening Parainfluenza Pneumonitis PDF Print E-mail
Saturday, 03 September 2011 00:28
NexBio, Inc. announced publication of "Treatment of Parainfluenza 3 Infection with DAS181 in a Patient after Allogeneic Stem Cell Transplantation" in the Journal Clinical Infectious Diseases. The lead author, Dr. Yi-Bin Chen, of the Department of Medicine, Massachusetts General Hospital and Harvard Medical School, is the treating physician for the first of these patients.
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Bristol-Myers Squibb Company's Sprycel Linked to Potentially Fatal Side-Effect: Health Canada Reports PDF Print E-mail
Friday, 02 September 2011 00:23
Health Canada is warning patients and health-care professionals about a potentially fatal side-effect related to the drug Sprycel taken by patients with certain forms of leukemia.
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Dendreon Corporation Wins FDA OK for Atlanta Provenge Factory, Completing National Network PDF Print E-mail
Thursday, 01 September 2011 00:26
Dendreon Corporation /quotes/zigman/83175/quotes/nls/dndn DNDN +3.20% today announced that the U.S. Food and Drug Administration (FDA) approved its Atlanta cancer immunotherapy manufacturing facility, the third location at which the Company will produce PROVENGE(R) (sipuleucel-T) to help meet the needs of patients across the U.S. with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
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Adimab LLC. Inks New Discovery Programs with Biogen Idec, Inc. and Novo Nordisk A/S PDF Print E-mail
Thursday, 01 September 2011 00:18
Adimab, LLC, a technology leader in the discovery of fully human antibodies, today announced the initiation of two independent collaborations with Biogen Idec and Novo Nordisk. Over the past two years, Adimab has established collaborations with multiple leading pharmaceutical companies, including: Merck, Roche, Novartis, Pfizer, Eli Lilly, Genentech, Human Genome Sciences, and now Biogen Idec and Novo Nordisk.
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Blood-Thinner From Bristol-Myers Squibb Company, Pfizer Inc.'s Beats Warfarin PDF Print E-mail
Wednesday, 31 August 2011 00:13
Bristol-Myers Squibb Company (NYSE:BMY - News) and Pfizer Inc. (NYSE:PFE - News) today announced the main results of the Phase 3 clinical trial ARISTOTLE, which evaluated ELIQUIS® (apixaban) compared to warfarin for the prevention of stroke or systemic embolism in 18,201 patients with atrial fibrillation and at least one risk factor for stroke.
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Pfizer Sued After Dog Dies From Rimadyl Toxicity PDF Print E-mail
Tuesday, 30 August 2011 00:28
A controversy over a painkiller for dogs may be bubbling up again. A Colorado couple have filed a lawsuit against Pfizer for allegedly failing to adequately warn that its Rimadyl med, which is a non-steroidal anti-inflammatory, can cause severe harm.
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