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Counterfeit version of Alli sold over the Internet: FDA warns

FDA is alerting consumers to an unsafe, counterfeit version of the weight-loss drug Alli sold over the Internet.

27 Jan 2010

USPTO grants Cenestra Health patent relating to high-purity omega-3 fatty acid formulations

Cenestra Health announced today that the U.S. Patent and Trademark Office has issued a key patent related to the company's high-purity omega-3 fatty acid formulations and their methods of use. U.S. Patent No. 7652068, entitled "Omega-3 Fatty Acid Formulations," covers a unique, high-purity formulation of the omega-3 fatty acids EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid).

27 Jan 2010

Potential risk factors in skipping insulin injections

More than half of people with diabetes who take insulin injections to control their diabetes say they have intentionally skipped an injection, with one-fifth of them reporting that they do so "sometimes" or "often," according to a study being published this month in Diabetes Care.

27 Jan 2010

Study: PROSTVAC-VF vaccine effective in treating patients with metastatic prostate cancer

In a newly published clinical trial, patients with metastatic prostate cancer who received a vaccine of harmless poxviruses engineered to spur an immune system attack on prostate tumor cells lived substantially longer than patients who received a placebo vaccine, report researchers at Dana-Farber Cancer Institute and affiliated organizations.

27 Jan 2010

Asan Medical Center, Chemizon enter into multi-year research collaboration agreement

Asan Medical Center and Chemizon, the drug discovery division of Optomagic, Co. Ltd., announced today that they have entered into a multi-year research collaboration to discover and develop novel, small molecule oncology therapeutics.

27 Jan 2010

FDA recalls Huber infusion set needles

The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint "Securetouch+" Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.finf

27 Jan 2010

Fibromyalgia drug to earn 38% patient share in the U.S. and 30% patient share in Europe

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a fibromyalgia drug that improves sleep quality more than Pfizer's Lyrica would earn a 38 percent patient share in the U.S. and a 30 percent patient share in Europe due to its efficacy, safety and tolerability, and delivery.

27 Jan 2010

U.S. court decision favors Teva in generic Temodar ANDA litigation

Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Schering-Plough’s brain tumor treatment Temodar® (temozolomide). The Court found that U.S. Patent No. 5,260,291 is not enforceable due to prosecution laches and inequitable conduct.

27 Jan 2010

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Patients with gastrointestinal stromal tumours (GIST) can now take action at an earlier stage of this rare form of cancer to reduce the risk of their disease returning following surgery. Novartis Pharmaceuticals Canada announced today that Gleevec* (imatinib mesylate) has received conditional approval by Health Canada for the adjuvant (post-surgical) treatment of adult patients who are at intermediate to high risk of disease recurrence following the surgical removal of GIST.

27 Jan 2010

FDA approves the NDA of Roxane Laboratories' Morphine Sulfate Oral Solution CII

Roxane Laboratories, Inc. announced today the New Drug Application (NDA) approval of Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL and 120mL bottles as of January 25th, 2010 by the Food and Drug Administration.

27 Jan 2010

Women on antidepressant drugs may experience lactation difficulties

According to a new study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM), women taking commonly used forms of antidepressant drugs may experience delayed lactation after giving birth and may need additional support to achieve their breastfeeding goals.

27 Jan 2010

Sumavel DosePro and Levadex to earn up to $400M by 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Zogenix/Astellas Pharma/Desitin Pharmaceuticals' needle-free Sumavel DosePro, which launched earlier this month in the United States, and MAP Pharmaceuticals' orally-inhaled Levadex will earn approximately $400 million in combined sales by 2018 in the migraine drug market.

27 Jan 2010

Sinobiopharma's solid dosage Perindopril production facility receives Chinese SFDA approval

Sinobiopharma, Inc. is pleased to announce that its production facility for solid dosage Perindopril has passed the required Chinese State Food and Drug Administration (SFDA) inspection and is now approved for production and marketing.

27 Jan 2010

UCSB research: Rapamycin drug, a potential treatment for ADPKD

Research performed at UC Santa Barbara points to the drug rapamycin as a potential treatment for kidney disease. The study builds on past research and shows that studies performed on mice are more likely to translate to humans than previously thought.

27 Jan 2010

Prometheus Laboratories executes commercialization agreement with Novartis

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, today announced the execution of a commercialization agreement with Novartis under which Prometheus acquired exclusive rights to distribute, promote and sell PROLEUKIN® (aldesleukin) in the United States.

27 Jan 2010

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

EpiCept Corporation announced today that EpiCeptTM NP-1 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of post-herpetic neuralgia (PHN). NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies.

27 Jan 2010

FDA approves oral pain relief solution for opioid-tolerant patients

The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

27 Jan 2010

Patients with COPD could benefit from treatment with drugs that block sestrin function

Chronic obstructive pulmonary disease (COPD) is defined by emphysema and/or chronic bronchitis. It destroys the normal architecture of the lung and inhibits the mechanical aspects of breathing, which prevents necessary gas exchange. Patients suffer from coughing fits, wheezing, and increased incidence of lung infections.

27 Jan 2010

Neoprobe completes license amendment with The Dow Chemical

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, announced today that it has completed a license amendment with The Dow Chemical Company for a variety of antibodies used in its proprietary surgical oncology system called radioimmunoguided surgery or RIGS®.

27 Jan 2010

UCF researcher develops first dual vaccine to fight malaria and cholera

A University of Central Florida biomedical researcher has developed what promises to be the first low-cost dual vaccine against malaria and cholera.

27 Jan 2010

Pharmaceutical News

Counterfeit version of Alli sold over the Internet: FDA warns

USPTO grants Cenestra Health patent relating to high-purity omega-3 fatty acid formulations

Potential risk factors in skipping insulin injections

Study: PROSTVAC-VF vaccine effective in treating patients with metastatic prostate cancer

Asan Medical Center, Chemizon enter into multi-year research collaboration agreement

FDA recalls Huber infusion set needles

Fibromyalgia drug to earn 38% patient share in the U.S. and 30% patient share in Europe

U.S. court decision favors Teva in generic Temodar ANDA litigation

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

FDA approves the NDA of Roxane Laboratories' Morphine Sulfate Oral Solution CII

Women on antidepressant drugs may experience lactation difficulties

Sumavel DosePro and Levadex to earn up to $400M by 2018

Sinobiopharma's solid dosage Perindopril production facility receives Chinese SFDA approval

UCSB research: Rapamycin drug, a potential treatment for ADPKD

Prometheus Laboratories executes commercialization agreement with Novartis

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

FDA approves oral pain relief solution for opioid-tolerant patients

Patients with COPD could benefit from treatment with drugs that block sestrin function

Neoprobe completes license amendment with The Dow Chemical

UCF researcher develops first dual vaccine to fight malaria and cholera

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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