Pharmaceuticals News and Research

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Mice and men should have more in common in clinical trials

Just as no two humans are the same, a Purdue University scientist has shown treating mice more as individuals in laboratory testing cuts down on erroneous results and could significantly reduce the cost of drug development.

30 Mar 2009

Intercell receives FDA approval of IXIARO, novel vaccine for Japanese encephalitis

Intercell AG (VSE: ICLL) today announced that the U.S. Food and Drug Administration (FDA) approved IXIARO(R), a new vaccine for the prevention of Japanese Encephalitis (JE).

30 Mar 2009

BioMarin receives notice of allowance for Kuvan patent

BioMarin Pharmaceutical Inc. has announced that it has received a notice from the United States Patent Office reporting allowance of claims covering once daily dosing methods for Kuvan (sapropterin dihydrochloride) in the treatment of phenylketonuria (PKU).

30 Mar 2009

Steroids and antihistamines alleviate clopidogrel-related allergic reaction symptoms

A clinical study of cardiac patients who suffered an allergic reaction to the widely-prescribed drug clopidogrel, also known by the pharmaceutical name Plavix, found that treatment with a combination of steroids and antihistamines can alleviate the allergic reaction symptoms thereby allowing patients to remain on the drug, say doctors from Thomas Jefferson University Hospital.

30 Mar 2009

Health Reform Dialogue Coalition releases recommendations for U.S. health care system overhaul

A coalition representing health care firms, patients and medical providers on Friday presented a five-page report to Congress recommending changes to the health care system, CQ HealthBeat reports (Adams, CQ HealthBeat, 3/27).

30 Mar 2009

Angiogenesis inhibitor improves glioblastoma survival by reducing edema

The beneficial effects of anti-angiogenesis drugs in the treatment of the deadly brain tumors called glioblastomas appear to result primarily from reduction of edema - the swelling of brain tissue - and not from any direct anti-tumor effect, according to a study from Massachusetts General Hospital (MGH) researchers.

30 Mar 2009

Senate measure would allow generic versions of biotechnology drugs after five years

Sens. Charles Schumer (D-N.Y.) and Susan Collins (R-Maine) on Thursday introduced legislation (S 726) that would allow FDA to approve generic versions of biotechnology drugs after a five-year period of brand-name patent exclusivity, the New York Times reports.

30 Mar 2009

NTRILIPIX (fenofibric acid) in combo with Rosuvastatin calcium shows improvement on key lipids for cholesterol management

Data from a new study showed that Abbott's TRILIPIX (fenofibric acid) delayed-release capsules in combination with rosuvastatin calcium met all of the study's primary endpoints.

29 Mar 2009

Medgenics’ phase I/II clinical trial shows EPODURE continuous anemia treatment lasting 5 months in kidney disease patients

Medgenics has announced that the latest, encouraging results of the Company's ongoing EPODURE Biopump Phase I/II Clinical Trial were presented at the 45th Conference of the Israeli Society of Nephrology and Hypertension, in Israel on March 27, 2009.

29 Mar 2009

Dapagliflozin trial results indicate improvement in key glycemic measures in treatment-naive type 2 diabetes

Findings published in Diabetes Care from a 12-week, Phase IIb dose-ranging study showed that dapagliflozin, a novel, selective, sodium glucose co-transporter2 (SGLT2) inhibitor, produced clinically meaningful reductions across all key glycemic measures studied [glycosylated hemoglobin level (HbA1c), fasting plasma glucose (FPG), and postprandial plasma glucose (PPG)] in treatment-naive type 2 diabetes patients, compared to placebo.

29 Mar 2009

Takeda expands into Canada

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. today announced the establishment of Takeda Canada Inc., expanding the company's North American presence into the world's eighth largest pharmaceutical market.

29 Mar 2009

Salk Institute forms strategic alliance agreement with sanofi-aventis

The Salk Institute has announced that it has signed a strategic alliance agreement with sanofi-aventis, establishing a joint program that supports cutting-edge research and promotes an exchange of discoveries focused on scientific advances and therapeutic applications.

29 Mar 2009

RegeneRx reports phase II venous stasis trial results

Regenerx Biopharmaceuticals Inc. has announced the results of its Phase II clinical trial evaluating the safety and wound-healing efficacy of RGN-137 for the treatment of patients with venous stasis ulcers.

29 Mar 2009

Mylan confirms four first-to-file challenges

Mylan Inc. has announced that it and/or a subsidiary have been sued in connection with four separate "first-to-file" Abbreviated New Drug Applications (ANDA) filed with the U.S. Food and Drug Administration (FDA).

29 Mar 2009

Data suggesting that omacetaxine can eradicate leukemic stem cells may offer a breakthrough for CML

Data showing the ability of omacetaxine to kill leukemic stem cells in mouse models with drug-resistant chronic myelogenous leukemia (CML) are the subject of an advance online publication in the journal Leukemia, ChemGenex Pharmaceuticals Limited (ASX:CXS and NASDAQ:CXSP) announced today.

29 Mar 2009

Oxycodone effective against shingles pain

The painkiller oxycodone is effective at treating the acute pain of shingles, an illness that often causes severe pain which can become long-lasting and sometimes even permanent.

26 Mar 2009

Sagent Pharmaceuticals receives FDA approval of Azithromycin for injection

Sagent Pharmaceuticals, Inc. has announced U.S. Food and Drug Administration (FDA) approval of azithromycin for injection, a semi-synthetic, macrolide antibiotic that is used to treat a wide variety of bacterial infections. Sagent will offer azithromycin in a 500 mg vial for intravenous use.

26 Mar 2009

New York State to offer low-income, disabled residents prescription drug discount cards

New York state officials on Monday announced a statewide prescription drug discount card program for residents with disabilities, people who are too young to qualify for Medicare and those whose incomes are too high to qualify for Medicaid, the Rochester Democrat and Chronicle reports.

25 Mar 2009

Rexahn Pharmaceuticals starts phase II pancreatic cancer trial

Rexahn Pharmaceuticals, Inc. has announced that it has received FDA approval to begin Phase II trials for Archexin, the Company's leading cancer compound, for the treatment of pancreatic cancer.

24 Mar 2009

Gilead commences phase II trial of Cicletanine for pulmonary arterial hypertension

Gilead Sciences, Inc. has announced that it has begun enrolling patients in a Phase II clinical trial of cicletanine hydrochloride (cicletanine), an oral agent in development for the treatment of pulmonary arterial hypertension (PAH).

24 Mar 2009

Pharmaceuticals News and Research

Mice and men should have more in common in clinical trials

Intercell receives FDA approval of IXIARO, novel vaccine for Japanese encephalitis

BioMarin receives notice of allowance for Kuvan patent

Steroids and antihistamines alleviate clopidogrel-related allergic reaction symptoms

Health Reform Dialogue Coalition releases recommendations for U.S. health care system overhaul

Angiogenesis inhibitor improves glioblastoma survival by reducing edema

Senate measure would allow generic versions of biotechnology drugs after five years

NTRILIPIX (fenofibric acid) in combo with Rosuvastatin calcium shows improvement on key lipids for cholesterol management

Medgenics’ phase I/II clinical trial shows EPODURE continuous anemia treatment lasting 5 months in kidney disease patients

Dapagliflozin trial results indicate improvement in key glycemic measures in treatment-naive type 2 diabetes

Takeda expands into Canada

Salk Institute forms strategic alliance agreement with sanofi-aventis

RegeneRx reports phase II venous stasis trial results

Mylan confirms four first-to-file challenges

Data suggesting that omacetaxine can eradicate leukemic stem cells may offer a breakthrough for CML

Oxycodone effective against shingles pain

Sagent Pharmaceuticals receives FDA approval of Azithromycin for injection

New York State to offer low-income, disabled residents prescription drug discount cards

Rexahn Pharmaceuticals starts phase II pancreatic cancer trial

Gilead commences phase II trial of Cicletanine for pulmonary arterial hypertension

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