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Scientists recommend research on bacterial vaccine to prevent influenza

Secondary infections with bacteria such as Streptococcus pneumoniae, which causes pneumonia, were a major cause of death during the 1918 flu pandemic and may be important in modern pandemics as well, according to a new article in the Journal of Infectious Diseases co-authored by David M. Morens, M.D., senior advisor to the director of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

3 Nov 2010

OMJPI enters agreement with Watson to distribute generic version of CONCERTA tablets

Ortho-McNeil-Janssen Pharmaceuticals, Inc. today announced it has entered into a supply and distribution agreement with Watson Laboratories, Inc. to distribute an authorized generic version of CONCERTA (methylphenidate HCl extended-release tablets).

3 Nov 2010

CONRAD receives $5 million award from USAID

CONRAD, leaders in reproductive health and HIV prevention research, today announced a $5 million award from the US Agency for International Development (USAID). The grant will fund research and development of vaginal rings that are contraceptive and also prevent HIV and STI infections.

3 Nov 2010

Somaxon awarded $245,000 grant for Silenor under QTDP program

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that it has been awarded a non-taxable grant of approximately $245,000 related to Silenor® (doxepin) under the Qualifying Therapeutic Discovery Project (QTDP) program included in the Patient Protection and Affordable Health Care Act of 2010.

3 Nov 2010

FDA grants Cadence marketing approval for OFIRMEV injection in management of pain and fever

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. OFIRMEV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

3 Nov 2010

UK watchdog agency to lose power to reject new drugs

The British government is expected to strip the National Institute for Health and Clinical Excellence, or NICE, of its ability to reject new drugs.

3 Nov 2010

Huber's Health & Nutrition business receives approval to produce active pharmaceutical ingredients

Huber Engineered Materials, a division of the J.M. Huber Corporation, has received approval for its Health & Nutrition business to begin producing active pharmaceutical ingredients (APIs), such as calcium carbonate granulation for use in the manufacturing of antacids and other pharma applications.

3 Nov 2010

Inviragen receives two grants to develop dengue and chikungunya vaccines

Inviragen, a biotechnology company developing vaccines to protect against infectious diseases worldwide, announced today that it has received two grants totaling $488,958 through the United States government's Qualifying Therapeutic Discovery Project Program.

3 Nov 2010

Talecris announces launch of PROLASTIN-C in Canada

Talecris Biotherapeutics announced today the Canadian launch of PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human])(A1PI), a more concentrated and purified formulation of PROLASTIN®, the only approved alpha1-augmentation therapy in Canada for more than 20 years. PROLASTIN-C delivers twice the active protein per milliliter as PROLASTIN, cutting the infusion volume and time in half when given at the recommended rate of 0.08 mL/kg/min.

3 Nov 2010

GSK's Revolade receives Japanese approval for treatment of chronic ITP

Ligand Pharmaceuticals Incorporated today announced its partner GlaxoSmithKline was granted approval from the Japanese Ministry of Health, Labour and Welfare for Revolade® (eltrombopag) for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura (ITP).

2 Nov 2010

Watson enters exclusive agreement with OMJPI to market authorized generic Concerta

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has entered into an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), to market the authorized generic version of Concerta® (methylphenidate hydrochloride extended-release tablets). Watson will launch its authorized generic of Concerta on May 1, 2011. Concerta is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

2 Nov 2010

FDLI issues first e-Advance article on Food and Drug Law Journal

The Food and Drug Law Institute (FDLI) today issued the first e-Advance article to its Food and Drug Law Journal, called Global Regulatory Standards for the Approval of Biosimilars.

2 Nov 2010

VaxInnate’s prototype flu vaccine named as Top 10 Infectious Diseases Projects to Watch in 2011

VaxInnate Corporation announced today that VAX125, its investigational prototype vaccine for seasonal flu, has been named one of the Top 10 Infectious Diseases Projects to Watch in 2011 by Elsevier Business Intelligence and the Windhover Conferences.

2 Nov 2010

New targeted therapy shows positive results in patients with lung cancer

A UC Irvine oncologist's work with a targeted therapy is showing great promise in patients with a deadly form of lung cancer. The results were published Thursday in the New England Journal of Medicine.

2 Nov 2010

NSAIDs drugs prevent colon cancer: Research

Nonsteroidal anti-inflammatory drugs (NSAIDs) prevent colon cancer by triggering diseased stem cells to self-destruct, according to researchers at the University of Pittsburgh Cancer Institute (UPCI) and the University of Pittsburgh School of Medicine.

2 Nov 2010

Teva third quarter net sales increase 20% to $4.3 billion

Teva Pharmaceutical Industries Ltd. today reported results for the quarter ended September 30, 2010.

2 Nov 2010

Impax initiates litigation against Shire over supply of generic Adderall XR

Impax Laboratories, Inc. today announced that it has initiated litigation against Shire LLC and Shire Laboratories, Inc. ("Shire") in order to resolve recent and recurring supply issues of its authorized generic version of Adderall XR®. The Company is seeking to compel Shire to deliver duly ordered amounts of product under the parties' Settlement Agreement and License and Distribution Agreements.

2 Nov 2010

FDA announces partnership agreement with University of Rochester to form ACTION Initiative

The U.S. Food and Drug Administration today announced a partnership agreement with the University of Rochester to form the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) Initiative.

2 Nov 2010

Study finds inhaled corticosteroids increase type 2 diabetes risk

Patients taking inhaled corticosteroids are at increased risk of developing type 2 diabetes, and more so with higher doses, say researchers at the Jewish General Hospital's Lady Davis Institute for Medical Research (LDI) In Montreal. The risk is of special concern for patients suffering from chronic obstructive pulmonary disorder (COPD), and much less significant for asthmatics.

2 Nov 2010

Study finds increasing dosage of blood thinners can help cardiovascular disease patients with genetic defect

Cardiovascular disease patients who have a genetic defect that makes them less responsive to blood thinners may be helped with an increased dosage, according to results of an innovative pilot study led by a cardiologist at The University of Texas Health Science Center at Houston (UTHealth).

2 Nov 2010