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Marijuana must not be legalized in California, says opposition to the legalization initiative

The Opposition to the California Marijuana Legalization Initiative (2010) has learned that the ballot measure for The Regulate, Control and Tax Cannabis Act of 2010 has officially been certified by the State of California to qualify for the November ballot.

26 Mar 2010

FDA Advisory Committee to review VIVUS' NDA for Qnexa

VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration is tentatively scheduled to review the Company's New Drug Application for Qnexa® for the treatment of obesity on July 15, 2010.

26 Mar 2010

BLS acquires AMPAKINE compounds from Cortex Pharmaceuticals

Biovail Corporation today announced that its subsidiary, Biovail Laboratories International SRL, has acquired certain AMPAKINE® compounds, including associated intellectual property, from Cortex Pharmaceuticals, Inc. for use in the field of respiratory depression, a brain-mediated breathing disorder.

26 Mar 2010

Researchers made vital discovery in the development of new drug to cure TB

This World TB Day (March 24), researchers at Sydney's Centenary Institute announce they have made an exciting discovery that could lead to the first new drug for Tuberculosis (TB) in almost fifty years.

26 Mar 2010

Senate briefing to discuss TB and drug-resistant TB

A Senate briefing today will discuss TB and drug-resistant TB, including multidrug-resistant TB (MDR-TB) and extensively drug resistant (XDR-TB), the impact on global health and the current state of surveillance, diagnosis and treatment around the world.

26 Mar 2010

Genentech, Biogen Idec file declaratory relief complaint against GSK regarding Arzerra

Genmab A/S announced today that on March 23, 2010 Genentech, Inc. and Biogen Idec, Inc. filed a declaratory relief complaint at the US District Court, Southern District of California against Genmab's collaboration partner GlaxoSmithKline (GSK) for patent infringement under US patent No 7,682,612 based on GSK's manufacture, marketing and sale of Arzerra™ in the United States for the treatment of fludarabine and alemtuzumab refractory chronic lymphocytic leukemia (CLL).

26 Mar 2010

Bevacizumab/paclitaxel/carboplatin regimen attains gold-standard status for treatment of non-small-cell lung cancer

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the bevacizumab (Genentech/Roche/Chugai's Avastin)/paclitaxel (Bristol-Myers Squibb's Taxol, generics)/carboplatin (Bristol-Myers Squibb's Paraplatin, generics) regimen will remain Decision Resources' proprietary clinical gold standard for the treatment of advanced non-small-cell lung cancer through 2018.

26 Mar 2010

Two separate articles describing preclinical data of ACE-041 published

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including red blood cells, bone, muscle, fat, and the vasculature, announced the publication of two separate peer-reviewed articles describing preclinical data demonstrating that treatment with ACE-041, an inhibitor of signaling through the activin receptor-like kinase 1 receptor, slows tumor growth and progression by inhibiting angiogenesis.

26 Mar 2010

Sirolimus-based immunosuppression improves survivals after transplantation for HCC

A recent study found that sirolimus-based immunosuppression following liver transplantation in patients with non-resectable hepatocellular carcinoma (liver cancer) significantly increases survival rates for this patient population.

26 Mar 2010

USPTO allows Pisgah Labs' patent application regarding imipramine pamoate

Pisgah Labs, a drug product development company and an active pharmaceutical ingredient manufacturer (API) located in western North Carolina, has received a patent allowance in a series of patent applications. The US Patent & Trademark Office (USPTO) has notified Pisgah Labs, Inc. that a patent application related to a therapeutically significant family of pharmaceutical polymorphic compositions of imipramine pamoate has been allowed. The patent application also includes methods of manufacturing, purifying and use in pharmaceutical preparations.

26 Mar 2010

Changing drug therapy can help breast cancer patients get full benefit of tamoxifen treatment

Recently published research has shown that some breast cancer patients taking tamoxifen may not be getting the full benefit of their treatment because they have also been taking selective serotonin reuptake inhibitors, prescribed drugs that inhibit the effect of an important enzyme.

26 Mar 2010

FDA to take enforcement action regarding Genzyme's Allston plant

Genzyme Corporation announced today that the FDA notified the company yesterday afternoon that, while the agency recognizes Genzyme’s efforts, it intends to take enforcement action to ensure that products manufactured at the plant are made in compliance with good manufacturing practice regulations. The FDA enforcement action will likely result in a consent decree, under which a third party would inspect and review the plant’s operation for an extended period and certify compliance with FDA regulations.

26 Mar 2010

$UCSF study: Unusual femur fractures low in patients with osteoporosis$

UCSF study: Unusual femur fractures low in patients with osteoporosis

The occurrence of an unusual type of fracture of the femur, or the thigh bone, is very low in patients with osteoporosis, including those treated with the drug family known as bisphosphonates, according to a new study led by a team of UCSF epidemiologists.

26 Mar 2010

Data on Argos Therapeutics' Phase 2a AGS-004 immunotherapy trial presented at Banff HIV Vaccines meeting

Argos Therapeutics today announced the presentation of data from the Phase 2a trial of AGS-004, providing information on rebound viral genetic diversity in HIV patients treated with the personalized immunotherapy following antiretroviral therapy (ART) interruption. The data were discussed in a poster session at the Keystone Symposia Global Health Series HIV Vaccines meeting, held March 21-26, 2010 in Banff, Canada.

26 Mar 2010

Oculus Innovative Sciences introduces Microcyn Dermatology HydroGel in the U.S.

Oculus Innovative Sciences, Inc., a commercial medical technology company that designs, produces and markets safe and effective tissue care products based upon the Microcyn® Technology platform, today commercially introduced the Microcyn Dermatology HydroGel for the U.S. professional healthcare market.

26 Mar 2010

New topical drug may help treat diabetic eye disease

Early-stage human clinical trials showed that a new topical drug was safe and had biological effects in a type of diabetic eye disease, and may offer researchers a new approach to prevent and treat diabetic macular edema.

26 Mar 2010

Eli Lilly supports SNM's initiative to advance innovative therapies

SNM is pleased to announce that biopharmaceutical company, Eli Lilly and Company, has joined SNM's Clinical Trials Network-making it the third major company to formally support this initiative to facilitate the development of promising therapeutic medicines.

26 Mar 2010

FDA grants tentative approval for Teva Pharmaceutical Industries' generic Argatroban ANDA

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of the anticoagulant, Argatroban® injection, 100mg/mL.

26 Mar 2010

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved once-daily Mirapex ER® (pramipexole dihydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson's disease, which includes early and advanced PD. PD is the second most common chronic neurological disorder in older adults after Alzheimer's. Parkinson's disease has no cure.

26 Mar 2010

Dyax to use proceeds of public offering for commercialization and distribution activities of KALBITOR

Dyax Corp. today announced the pricing of an underwritten public offering of 17,000,000 shares of its common stock at a price to the public of $3.25 per share. The gross proceeds from the sale of shares, after underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $51.8 million. The offering is expected to close on or about March 30, 2010, subject to customary closing conditions.

26 Mar 2010

Pharmaceutical News

Marijuana must not be legalized in California, says opposition to the legalization initiative

FDA Advisory Committee to review VIVUS' NDA for Qnexa

BLS acquires AMPAKINE compounds from Cortex Pharmaceuticals

Researchers made vital discovery in the development of new drug to cure TB

Senate briefing to discuss TB and drug-resistant TB

Genentech, Biogen Idec file declaratory relief complaint against GSK regarding Arzerra

Bevacizumab/paclitaxel/carboplatin regimen attains gold-standard status for treatment of non-small-cell lung cancer

Two separate articles describing preclinical data of ACE-041 published

Sirolimus-based immunosuppression improves survivals after transplantation for HCC

USPTO allows Pisgah Labs' patent application regarding imipramine pamoate

Changing drug therapy can help breast cancer patients get full benefit of tamoxifen treatment

FDA to take enforcement action regarding Genzyme's Allston plant

UCSF study: Unusual femur fractures low in patients with osteoporosis

Data on Argos Therapeutics' Phase 2a AGS-004 immunotherapy trial presented at Banff HIV Vaccines meeting

Oculus Innovative Sciences introduces Microcyn Dermatology HydroGel in the U.S.

New topical drug may help treat diabetic eye disease

Eli Lilly supports SNM's initiative to advance innovative therapies

FDA grants tentative approval for Teva Pharmaceutical Industries' generic Argatroban ANDA

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Dyax to use proceeds of public offering for commercialization and distribution activities of KALBITOR

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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