Pharmaceuticals News and Research

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Researchers discover recycling mechanism of signaling receptors

An international team of researchers led by Carnegie Mellon University's Manojkumar Puthenveedu has discovered the mechanism by which signaling receptors recycle, a critical piece in understanding signaling receptor function. Writing in the journal Cell, the team for the first time describes how a signaling receptor travels back to the cell membrane after it has been activated and internalized.

23 Dec 2010

Santen files IND for Clinical Data's ATL313 for primary open angle glaucoma and ocular hypertension

Clinical Data, Inc., today announced that Santen Pharmaceutical Co., Ltd., has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Clinical Data's highly selective adenosine A2A agonist, ATL313, for the indication of primary open angle glaucoma and ocular hypertension.

From Santen Pharmaceutical Co., Ltd. 23 Dec 2010

Procognia grants Euro-Diagnostica license to provide diagnostic services for gastric cancer

Procognia is proud to announce that yesterday it signed a binding memorandum of understanding with Euro-Diagnostica (ED), a European diagnostic company that currently operates in the Scandinavian and Benelux markets, and is expected to expand its activity into other markets which may include Germany, Austria, Switzerland, and the UK in the near future.

23 Dec 2010

Combination of antigen and wax nanoparticles improves immunogenicity

Particle Sciences, a leading pharmaceutical CRO has formulated a series of wax nanoparticles that, when coupled with an antigen, enhanced its immunogenicity, increasing both systemic and the mucosal immune response.

23 Dec 2010

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

FDA approves Novartis' Amturnide for treatment of high blood pressure

Today Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

23 Dec 2010

Immunomedics announces additional claim for RS7 antibodies patent family

Immunomedics, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that additional claims for the patent family, "RS7 antibodies," were issued as Patent No. 1,002,443 in Korea.

23 Dec 2010

FDA approves Watson's novel oral contraceptive

Watson Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approval of a novel oral contraceptive product – the first and only low dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron) placebo tablets. Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy.

22 Dec 2010

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference therapeutics, announced today it has initiated patient dosing in a Phase 1 human clinical trial for its lead oncology product, TKM-PLK1. TKM-PLK1 targets polo-like kinase 1, or PLK1, a cell cycle protein involved in tumor cell proliferation and a validated oncology target.

22 Dec 2010

Arena, Eisai complete lorcaserin NDA end-of-review meeting with FDA

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA).

22 Dec 2010

NIH Clinical Center opens doors to Damon Runyon Clinical Investigators

A new pilot partnership between the National Institutes of Health Clinical Center, the National Cancer Institute's Center for Cancer Research, and the Damon Runyon Cancer Research Foundation will offer some of the capabilities and expertise of America's research hospital to an external group of clinical investigators in cancer research. The special talent and resources of the NIH will allow Damon Runyon-funded investigators to undertake studies and collaborations that will advance understanding of the prevention, diagnosis, and treatment of cancer.

22 Dec 2010

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

22 Dec 2010

BioCryst commences BCX4208/allopurinol combination Phase 2b study in gout patients

BioCryst Pharmaceuticals, Inc. announced the initiation of a Phase 2b study of BCX4208 as add-on therapy in gout patients who have not responded to allopurinol therapy alone.

22 Dec 2010

Top ten advances in cardiovascular, stroke research in 2010

Research on reducing risks, improving medical treatment and improving lifestyle behaviors to fight the battle against heart disease and stroke are among the key scientific findings that make up this year's top cardiovascular and stroke research recognized by the American Heart Association/American Stroke Association.

22 Dec 2010

Intellipharmaceutics announces delay of patent approvement to market Protonix drug

Intellipharmaceutics International, today announced that it has notified the U.S. Food and Drug Administration that it has not received notification, as provided for under the Hatch-Waxman Act, of any patent infringement proceedings by the brand owner, Wyeth Pharmaceuticals, a wholly-owned subsidiary of Pfizer, for its application to market a generic of Wyeth's Protonix® tablets.

22 Dec 2010

Vertex announces modification of telaprevir and VX-222 combination Phase 2 trial for treatment of HCV

Vertex Pharmaceuticals Incorporated today announced a modification of its Phase 2 clinical trial evaluating 12-week, response-guided regimens of its lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, in combination with its lead investigational HCV polymerase inhibitor, VX-222.

22 Dec 2010

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS® (pioglitazone HCl), ACTOplus met® (pioglitazone HCl and metformin HCl), and duetact® (pioglitazone HCl and glimepiride).

22 Dec 2010

Ramius/RP Group extend tender offer to acquire Cypress Bioscience

Ramius V&O Acquisition LLC, affiliates of Ramius LLC (collectively, "Ramius") and affiliates of Royalty Pharma (together with Ramius and Purchaser, the "Ramius/RP Group") announced today that the Ramius/RP Group is extending its previously announced tender offer to acquire all of the outstanding shares of common stock of Cypress Bioscience, Inc., a pharmaceutical company engaged in the development of innovative drugs to treat central nervous system (CNS) disorders, until Midnight, January 5, 2011, unless the offer is otherwise extended.

22 Dec 2010

Merrion, Novo Nordisk enter Collaboration and Option agreement for GIPET technology

Merrion Pharmaceuticals Plc, a publicly listed product development company, today announced the signing of a Collaboration and Option agreement with Novo Nordisk. The agreement will evaluate the ability of Merrion's patented GIPET® technology to boost the oral bioavailability of an undisclosed proprietary compound.

22 Dec 2010

CHMP recommends to grant marketing authorization for Espriet drug against PF to CPF

The Coalition for Pulmonary Fibrosis announced to more than 128,000 patients news that the first drug for the treatment of the deadly lung disease Pulmonary Fibrosis has passed a major hurdle in the European regulatory process and is likely to be approved in all 27 member countries of the European Union.

22 Dec 2010

Pharmaceuticals News and Research

Researchers discover recycling mechanism of signaling receptors

Santen files IND for Clinical Data's ATL313 for primary open angle glaucoma and ocular hypertension

Procognia grants Euro-Diagnostica license to provide diagnostic services for gastric cancer

Combination of antigen and wax nanoparticles improves immunogenicity

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

FDA approves Novartis' Amturnide for treatment of high blood pressure

Immunomedics announces additional claim for RS7 antibodies patent family

FDA approves Watson's novel oral contraceptive

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Arena, Eisai complete lorcaserin NDA end-of-review meeting with FDA

NIH Clinical Center opens doors to Damon Runyon Clinical Investigators

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

BioCryst commences BCX4208/allopurinol combination Phase 2b study in gout patients

Top ten advances in cardiovascular, stroke research in 2010

Intellipharmaceutics announces delay of patent approvement to market Protonix drug

Vertex announces modification of telaprevir and VX-222 combination Phase 2 trial for treatment of HCV

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Ramius/RP Group extend tender offer to acquire Cypress Bioscience

Merrion, Novo Nordisk enter Collaboration and Option agreement for GIPET technology

CHMP recommends to grant marketing authorization for Espriet drug against PF to CPF

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