Pharmaceuticals News and Research

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FDA accepts Handa's generic DEXILANT ANDA for review

Handa Pharmaceuticals, LLC, a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda's DEXILANT®, has been accepted for review by the U.S. Food and Drug Administration.

2 Mar 2011

Common fungus might serve as therapeutic agent for plant and human health

Researchers have come closer to understanding how a common fungus "makes its living in the soil," which could lead to its possible "career change" as a therapeutic agent for plant and human health.

2 Mar 2011

International Surf Resorts to acquire BioZone Laboratories

International Surf Resorts, Inc., to be renamed BioZone Pharmaceuticals, Inc., today announced a binding option and letter of intent with BioZone Laboratories, Inc. and related companies.

2 Mar 2011

Novabay commences NVC-422 catheter Phase 2 trial to treat UCBE

NovaBay Pharmaceuticals, Inc., a clinical stage biotechnology company developing its first-in-class, anti-infective Aganocide compounds for the local non-systemic treatment and prevention of antibiotic-resistant infections, today provided an update on its Phase 2 clinical trial for the use of its lead compound, NVC-422, to prevent urinary catheter blockage and encrustation which is often a contributing factor to urinary tract infections in chronically catheterized patients.

2 Mar 2011

Achillion fourth quarter revenue is $2 million for three months ended December 31, 2010

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today reported financial results for the three and twelve months ended December 31, 2010.

2 Mar 2011

Study: Medication adherence alone may not benefit employees with chronic conditions

Medication adherence alone may not be enough to impact the productivity of employees with chronic conditions such as depression, diabetes, hypertension and coronary artery disease.

2 Mar 2011

Mylan confirms lawsuit relating to Estradiol Transdermal System ANDA

Mylan Inc. today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day.

2 Mar 2011

Ipsen 2010 total revenues increase 5.2% to €1,170.3 million

In 2010, Group drug sales grew 5.1% year-on-year - at constant currency - exceeding the objective set a year ago of 3.0% to 5.0%, fuelled notably by the sales of Specialty Care products throughout all the geographical regions where the Group operates.

2 Mar 2011

Allergan initiates AGN-214868 Phase II trials in post herpetic neuralgia and overactive bladder

Syntaxin, a biotechnology company developing novel biopharmaceuticals to control cell secretion, today announces its partner Allergan, Inc has initiated two Phase II trials to evaluate the safety and efficacy of its re-targeted endopeptidase drug candidate AGN-214868. The Phase II trials will be focused on patients with post herpetic neuralgia (PHN) and overactive bladder.

2 Mar 2011

Trial date set for Teva's generic COPAXONE patent infringement litigation against Momenta

Teva Pharmaceutical Industries Ltd. today announced that the United States District Court for the Southern District of New York has set a trial date of September 7, 2011 in the Company's ongoing patent infringement litigation against Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Pharmaceuticals, Inc./Mylan Inc./Natco Pharma Ltd. regarding their purported generic versions of COPAXONE® (glatiramer acetate injection).

2 Mar 2011

Four pharmaceutical companies partner to create new single-source industry

Four successful contract packaging and re-packaging companies in the pharmaceutical industry recently joined forces to create a new, single-source industry leader called Aphena Pharma Solutions.

2 Mar 2011

Court case question: Who holds the patent — drug company or research institution

The invention of an AIDS test is a big deal, and it takes a lot of time, smarts and money to develop a good one. So there's a lot at stake in the legal tussle between Stanford University and the pharmaceutical giant Roche, with oral arguments opening Monday before the U.S. Supreme Court.

2 Mar 2011

CRT market in Europe to reach over €4.4 billion by 2017

According to a new report by iData Research, the leading global authority in medical device and pharmaceutical market research, the European cardiac rhythm management, electrophysiology and ablation market was valued at over €2.8 billion in 2010.

2 Mar 2011

Neuralstem announces initiation of NSI-189 Phase Ia trial for major depressive disorder

Neuralstem, Inc. announced that the first subject was dosed yesterday in a Phase Ia trial to evaluate the safety of its drug, NSI-189, which is being developed for the treatment of major depressive disorder and other psychiatric indications. NSI-189 is the lead compound in Neuralstem's neurogenerative small molecule drug platform. This phase of the trial is in healthy volunteers and seeks to determine the maximum tolerated single dose.

2 Mar 2011

Advion to establish new laboratory at Purdue Research Park near Indianapolis

Advion BioServices Inc., a provider of contract bioanalytical research services, announced that it will establish a laboratory here, creating 49 immediate jobs and up to 66 jobs by 2015.

From Advion 2 Mar 2011

NCI sponsors multi-center phase 2 study of entinostat-anastrozole combination in triple negative breast cancer

Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company, announced the National Cancer Institute (NCI) will sponsor a multi-center phase 2 study of Syndax's lead product entinostat, a novel inhibitor of histone deacetylases (HDAC), and anastrozole, an aromatase inhibitor, in postmenopausal women with operable triple negative breast cancer to evaluate biomarkers and surrogates for response.

2 Mar 2011

Bayhill's BHT-3034 receives FDA IND clearance for treatment of myasthenia gravis

Bayhill Therapeutics Inc, a clinical-stage biopharmaceutical company utilizing its proprietary BHT-DNA™ platform to develop novel and targeted autoimmune and immune-mediated disease treatments, today announced the successful clearance of an IND with the US FDA for BHT-3034, a disease-modifying DNA plasmid vaccine immunotherapy for patients with the autoimmune neuromuscular junction disease myasthenia gravis.

1 Mar 2011

FDA approves roflumilast to treat COPD

The U.S. Food and Drug Administration approved roflumilast, a pill taken daily to decrease the frequency of flare-ups or worsening of symptoms from severe chronic obstructive pulmonary disease.

1 Mar 2011

IRX Therapeutics signs research collaboration agreement with world's leading pharma companies

IRX Therapeutics, a developer of immune therapies to make cancer treatments better, announced today it has signed a research collaboration agreement with one of the world's leading research-based pharmaceutical companies.

1 Mar 2011

Pfizer acquires King Pharmaceuticals

Pfizer Inc. today announced that it has combined operations with King Pharmaceuticals, Inc. On February 28, 2011, Pfizer completed its acquisition of King through the merger of its wholly owned subsidiary, Parker Tennessee Corp., with and into King. King is now a wholly owned subsidiary of Pfizer.

1 Mar 2011

Pharmaceuticals News and Research

FDA accepts Handa's generic DEXILANT ANDA for review

Common fungus might serve as therapeutic agent for plant and human health

International Surf Resorts to acquire BioZone Laboratories

Novabay commences NVC-422 catheter Phase 2 trial to treat UCBE

Achillion fourth quarter revenue is $2 million for three months ended December 31, 2010

Study: Medication adherence alone may not benefit employees with chronic conditions

Mylan confirms lawsuit relating to Estradiol Transdermal System ANDA

Ipsen 2010 total revenues increase 5.2% to €1,170.3 million

Allergan initiates AGN-214868 Phase II trials in post herpetic neuralgia and overactive bladder

Trial date set for Teva's generic COPAXONE patent infringement litigation against Momenta

Four pharmaceutical companies partner to create new single-source industry

Court case question: Who holds the patent — drug company or research institution

CRT market in Europe to reach over €4.4 billion by 2017

Neuralstem announces initiation of NSI-189 Phase Ia trial for major depressive disorder

Advion to establish new laboratory at Purdue Research Park near Indianapolis

NCI sponsors multi-center phase 2 study of entinostat-anastrozole combination in triple negative breast cancer

Bayhill's BHT-3034 receives FDA IND clearance for treatment of myasthenia gravis

FDA approves roflumilast to treat COPD

IRX Therapeutics signs research collaboration agreement with world's leading pharma companies

Pfizer acquires King Pharmaceuticals

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