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Adamis Pharmaceuticals' Epinephrine injection categorized as a generic

Adamis Pharmaceuticals Corporation announced on July 23 that its wholly owned subsidiary, Adamis Labs launched and shipped the first orders of the company’s Epinephrine Injection, USP, 1:1000 (0.3mg prefilled single dose syringe) (“PFS”). Today, Adamis Labs reports that at least two major data base reference companies (Medi-Span® and First DataBank) placed the Company’s PFS in their generic category.

11 Sep 2009

Ascent Therapeutics demonstrates Pepducin efficacy

Ascent Therapeutics announced today that the Company has demonstrated efficacy in preclinical models in two Pepducin projects. One of the projects targets CXCR4, a key regulator of stem cell and inflammatory cell homeostasis. A second project has yielded the first potent Pepducin agonists for an undisclosed cardiovascular target.

11 Sep 2009

Zevalin radioimmunotherapy drug approved for treating non-Hodgkin's lymphoma

SNM applauds the U.S. Food and Drug Administration's (FDA) recent decision to approve the radioimmunotherapy (RIT) drug, Zevalin, as a front-line treatment of non-Hodgkin's lymphoma (NHL).

11 Sep 2009

Abbreviated New Drug Application for nateglinide tablets approved

Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for nateglinide tablets.

11 Sep 2009

Nuvilex and Legacy Biotechnologies to develop natural remedies for flu- type symptoms

Nuvilex, Inc., announces today that it has entered into a Joint Venture Agreement with Legacy Biotechnologies, Inc., a private company based in Tampa, Florida, to develop and market all natural remedies for symptoms of broad spectrum flu viruses.

11 Sep 2009

New Drug Application for trabectedin approved by the FDA

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer.

11 Sep 2009

Phase 2b clinical trial results of TC-5214 to be presented at nAChR2009

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics, today confirmed plans to present data from its completed Phase 2b clinical trial of TC-5214 as an augmentation treatment for major depressive disorder at the Nicotinic Acetylcholine Receptors as Therapeutic Targets Symposium (nAChR2009) in Lincolnshire, Illinois on October 15, 2009.

10 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

FDA removes clinical hold on HEPLISAV hepatitis B vaccine

Dynavax Technologies Corporation today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney disease.

10 Sep 2009

Phase Forward's Empirica Suite to be showcased at the 3rd annual conference

Phase Forward, a leading provider of data management solutions for clinical trials and drug safety, will participate in the 3rd annual World Drug Safety Congress Europe, to be held September 15-18 at the Bloomsbury Hotel in London, U.K.

10 Sep 2009

METOZOLV drug approved for treating gastroesophageal reflux disease

Wilmington Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV ODT (metoclopramide HCl), an orally disintegrating formulation of metoclopramide for the treatment of gastroesophageal reflux disease (GERD) and diabetic gastroparesis.

10 Sep 2009

Inspire Pharmaceuticals to increase production of azithromycin ophthalmic solution

Inspire Pharmaceuticals, Inc. announced today that it has been communicating with the U.S. Food and Drug Administration (FDA) and is increasing its production of AzaSite® (azithromycin ophthalmic solution) 1% in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%).

10 Sep 2009

IBM study reveals the need for smart drug manufacturer supply chain systems

Reducing the risk of counterfeit drugs and contaminated medications amidst the complexity of global manufacturing are among the top concerns of the pharmaceutical and life sciences industries today, according to a new IBM (NYSE: IBM) study. More than 50 percent of executives polled say their companies fail to respond quickly enough to pandemics and other emergencies because of lapses in their supply chain.

10 Sep 2009

Labopharm to present its novel trazodone formulation data

Labopharm Inc. today announced that three separate posters will be presented at three upcoming internationally prestigious medical meetings showcasing data on its novel trazodone formulation.

10 Sep 2009

Ketamine shows rapid antidepressant effects

Researchers have now explored ketamine's effects on suicidality in patients with treatment-resistant depression, and are publishing their results in the September 1st issue of Biological Psychiatry. Ketamine acutely reduced suicidal thoughts when patients were assessed 24 hours after a single infusion. This reduction in suicidality was maintained when patients received repeated doses over the next two weeks.

10 Sep 2009

TI Pharma: A role model of public-private cooperation and partnership

The Danish Council for Strategic Research is visiting the Dutch Top Institute Pharma (TI Pharma) on Thursday, September 10. The purpose of their visit is to learn about the unique Dutch approach on public-private cooperation and the concrete results that are being booked by this institute.

10 Sep 2009

Efficacy of Ore Pharmaceuticals' lead drug candidate discussed

Ore Pharmaceuticals Inc., announced today the publication of an article in the online version of the journal Inflammation Research titled, “Effects of the ACE2 inhibitor GL1001 on acute dextran sodium sulfate-induced colitis in mice.”

10 Sep 2009

Physicians and patients underestimate promotional volume of Actonel

Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that patients and physicians most frequently recall Roche's Boniva messages among the ten surveyed osteoporosis brands likely as a result of the Sally Field marketing campaign.

10 Sep 2009

Polio vaccination resumes in Pakistan's Swat Valley

"Authorities in Pakistan's Swat Valley have resumed vaccinating children for polio, an act once banned by Taliban militants, now beaten back by an army offensive," the Associated Press reports. The three-day campaign, which started on Monday, is targeting about 215,000 children, said government official Khurshid Khan.

10 Sep 2009

Therapeutic principles of monoclonal antibodies

Professor Joachim R. Kalden, Member of the Department for Molecular Immunology, Nikolaus-Fiebiger-Zentrum, University Medical School Erlangen-Nuremberg, presents therapeutic principles based on monoclonal antibodies.

10 Sep 2009