Pharmaceuticals News and Research

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Enhancing function of protein CNT1 increases effectiveness of cancer-killing drugs in pancreatic tumors

New University of Georgia research has identified a protein that can be modified to improve the effectiveness of one of the most common drugs used to treat pancreatic cancer.

4 Mar 2011

State roundup: N.Y. malpractice fight; costly prisoners in Calif.; abortion battles

Last week, hospital leaders stood alongside Gov. Andrew M. Cuomo at the Capitol, pledging their support for billions in cuts proposed by his Medicaid redesign team.

4 Mar 2011

Talecris granted EU orphan drug designation for Plasmin (human) to treat acute peripheral arterial occlusion

Talecris Biotherapeutics, Inc. (TLCR) announced today that it has been granted orphan drug designation by the European Commission for the development of Plasmin (human) to treat acute peripheral arterial occlusion (aPAO). Talecris is currently investigating Plasmin in a phase II clinical trial designed to assess its ability to treat aPAO, a condition in which arterial blood flow to the extremities, usually the legs, is blocked by a clot.

4 Mar 2011

Hemispherx, Chronix jointly file US patent application for CFS blood test

Chronix Biomedical announced today that it filed a provisional United States patent application jointly with Hemispherx Biopharma, Inc. on a blood test for Chronic Fatigue Syndrome.

4 Mar 2011

Sinovac submits clinical trial application for 13-valent pneumococcal conjugate vaccine to China SFDA

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today it submitted the application to commence clinical trials for its 13-valent pneumococcal conjugate vaccine (PCV) to China's State Food and Drug Administration (SFDA) on March 3, 2011.

3 Mar 2011

Endo's FORTESTA Gel for treatment of 'Low T' in males is now available in pharmacies

Endo Pharmaceuticals announced that FORTESTA Gel – recently approved by the U.S. Food and Drug Administration for the treatment of low testosterone, or 'Low T' in adult males – is now available by prescription in pharmacies across the country.

3 Mar 2011

FDA approves Amneal's Indomethacin ER capsules

Amneal Pharmaceuticals, LLC is pleased to announce that it received U.S. FDA approval for Indomethacin Extended Release capsules, USP in the 75 mg strength effective December 1, 2010.

3 Mar 2011

Clinical trials in Australia take too long– need uniform standards: Report

A government report says that clinical trials for new medicines are taking too long and should be sped up so patients can access urgently needed treatment. The states and territories have been urged to adopt uniform rules on approving trials so the scientific experiments can be conducted more efficiently and effectively.

3 Mar 2011

Glenmark Generics granted final FDA approval for generic Xyzal ANDA

Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced they have been granted final approval for their Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Levocetirizine Dihydrochloride 5 mg tablets, the generic version of UCB Inc.'s Xyzal(R) tablets.

3 Mar 2011

Rockwell Medical fourth quarter net loss increases to $1.7 million

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency anemia, reported today fourth quarter and full-year 2010 results.

3 Mar 2011

Protalex initiates enrollment in 3rd cohort of PRTX-100 Phase 1b dose escalation clinical study in RA

Protalex, Inc, a clinical stage biopharmaceutical company which is engaged in developing a class of drugs for treating autoimmune and inflammatory diseases, today announced enrollment of the first patients in the 3rd cohort of its ongoing multicenter Phase 1b dose escalation clinical study of PRTX-100 in adult patients with active Rheumatoid Arthritis (RA) being conducted in South Africa. The dose was increased by a factor of two from the 2nd cohort.

3 Mar 2011

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

Infinity Pharmaceuticals, Inc. today announced the initiation of a randomized, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of IPI-926 compared to placebo in patients with metastatic or locally advanced, inoperable chondrosarcoma. The trial is expected to enroll over 100 patients worldwide.

3 Mar 2011

EC grants marketing authorization for InterMune's Esbriet to treat IPF

InterMune, Inc. today announced that the European Commission has granted marketing authorization for Esbriet. Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis, a progressive and fatal lung disease.

3 Mar 2011

'Implementation science' approach to play a critical role in next phase of PEPFAR program

An "implementation science" approach will play a critical role in the next phase of The U.S. President's Emergency Plan for AIDS Relief, according to an editorial in JAIDS: Journal of Acquired Immune Deficiency Syndromes. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

3 Mar 2011

NHCAA's Seven Guiding Principles for Policymakers to combat health care fraud

As the U.S. House of Representatives Ways and Means and House Energy and Commerce Committees and the U.S. Senate Finance Committee all hold hearings today on combating health care fraud, waste, and abuse, an analysis that examines the "Seven Guiding Principles for Policymakers" to fighting health care fraud invites new questions about legislative efforts to reduce accountability and oversight of independent drugstores, the Pharmaceutical Care Management Association said today.

3 Mar 2011

Vertex announces positive interim results from telaprevir Phase 2 study in patients with HCV, HIV

Vertex Pharmaceuticals Incorporated announced today interim results from an ongoing, two-part, Phase 2 study evaluating telaprevir in combination with pegylated-interferon and ribavirin compared to pegylated-interferon and ribavirin alone in people who are infected with both genotype 1 hepatitis C virus and human immunodeficiency virus, also known as HCV-HIV co-infection.

3 Mar 2011

Corporations brace for health law gains and losses

Two corporations offer very different views of how changes resulting from the health overhaul will impact their bottom lines.

3 Mar 2011

ITI, Takeda collaborate to develop and commercialize PDE1 inhibitors for schizophrenia

Intra-Cellular Therapies, Inc. ("ITI") and Takeda Pharmaceutical Company Limited, today announced that they have entered into an exclusive collaboration to develop and commercialize selective phosphodiesterase type 1 (PDE1) inhibitors, discovered by ITI, for the treatment of cognitive impairment associated with schizophrenia. This agreement is targeted worldwide, but ITI has retained the option to co-promote with Takeda in the United States.

3 Mar 2011

Portola, Accumetrics sign agreement to develop and supply VerifyNow System

Accumetrics, Inc., a privately-held developer and marketer of the VerifyNow System, the first rapid and easy-to-use point-of-care diagnostic system for measuring platelet reactivity to multiple antiplatelet agents, announced today that the company has signed an agreement with Portola Pharmaceuticals, Inc. to develop and supply the VerifyNow System and VerifyNowTests for use in clinical trials.

3 Mar 2011

Promising new way to lower cholesterol production

A promising new way to inhibit cholesterol production in the body has been discovered, one that may yield treatments as effective as existing medications but with fewer side-effects.

3 Mar 2011

Pharmaceuticals News and Research

Enhancing function of protein CNT1 increases effectiveness of cancer-killing drugs in pancreatic tumors

State roundup: N.Y. malpractice fight; costly prisoners in Calif.; abortion battles

Talecris granted EU orphan drug designation for Plasmin (human) to treat acute peripheral arterial occlusion

Hemispherx, Chronix jointly file US patent application for CFS blood test

Sinovac submits clinical trial application for 13-valent pneumococcal conjugate vaccine to China SFDA

Endo's FORTESTA Gel for treatment of 'Low T' in males is now available in pharmacies

FDA approves Amneal's Indomethacin ER capsules

Clinical trials in Australia take too long– need uniform standards: Report

Glenmark Generics granted final FDA approval for generic Xyzal ANDA

Rockwell Medical fourth quarter net loss increases to $1.7 million

Protalex initiates enrollment in 3rd cohort of PRTX-100 Phase 1b dose escalation clinical study in RA

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

EC grants marketing authorization for InterMune's Esbriet to treat IPF

'Implementation science' approach to play a critical role in next phase of PEPFAR program

NHCAA's Seven Guiding Principles for Policymakers to combat health care fraud

Vertex announces positive interim results from telaprevir Phase 2 study in patients with HCV, HIV

Corporations brace for health law gains and losses

ITI, Takeda collaborate to develop and commercialize PDE1 inhibitors for schizophrenia

Portola, Accumetrics sign agreement to develop and supply VerifyNow System

Promising new way to lower cholesterol production

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