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Matrix Laboratories receives FDA approval for generic version Zocor Tablets: Mylan

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg, the generic version of Merck & Co.'s Zocor Tablets, a treatment for high cholesterol. The product will be distributed by Mylan Pharmaceuticals Inc.

18 Jun 2010

Cyclacel files Answer and Counterclaims to Celgene's declaratory judgment complaint

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that it filed its Answer and Counterclaims to the declaratory judgment complaint filed by Celgene Corporation.

18 Jun 2010

FVL gene mutation increases risk of blood clots in breast cancer patients treated with tamoxifen: Study

Women who develop blood clots while taking tamoxifen for early-stage breast cancer are more likely to carry a faulty version of a gene involved in clotting than those who do not develop blood clots, a US study has found.

18 Jun 2010

USFDA approves Sun Pharma's generic Xanax ANDA

Sun Pharma announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Xanax®, alprazolam tablets.

18 Jun 2010

90% of HCV patients to be treated with triple therapy regimens, finds Decision Resources

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, based on clinical profiles provided to them, surveyed clinicians estimate that one year after the launch of Vertex Pharmaceuticals/Johnson & Johnson/Mitsubishi Tanabe Pharma's telaprevir and Merck's boceprevir, at least 90 percent of hepatitis C virus patients will be treated with triple therapy regimens.

18 Jun 2010

NAN warns health care practitioners about dangers posed by EPHINEPHrine shortage

A National Alert for Serious Medication Errors was issued yesterday by the American Society of Health-System Pharmacists and the Institute for Safe Medication Practices, warning health care practitioners about dangerous medication errors that could be caused by a shortage of EPINEPHrine pre-filled syringes.

18 Jun 2010

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

Amylin Pharmaceuticals, Inc. today announced that the Company will present data for its FDA-approved diabetes drugs, BYETTA (exenatide) injection and SYMLIN (pramlintide acetate) injection, and its investigational diabetes drug candidate BYDUREON (exenatide extended-release for injectable suspension) at the American Diabetes Association's 70th Annual Scientific Sessions being held in Orlando, FL from June 25 to June 29.

18 Jun 2010

WSJ: Study on eye medicine reveals possible savings for Medicare

The Wall Street Journal reports that Medicare could save $500 million a year by switching from one type of eye medicine to another, both made by Genentech, "according to a draft study by federal officials and a University of Miami eye doctor.

18 Jun 2010

Nurse-monitored ART found to be as safe, effective as therapy monitored by doctors in South African trial

"HIV drugs can be administered as effectively by nurses as by doctors, a finding that could yield major benefits in the fight against AIDS in Africa," according to a study published online Wednesday in the Lancet, Agence France-Presse reports.

18 Jun 2010

UF administers Lumizyme for late-onset Pompe disease

The first commercially available treatment in the United States for patients with late-onset Pompe disease was administered Wednesday, June 16, at the University of Florida.

18 Jun 2010

Drug makers face tightened regulations by FDA and less clout at medical meetings

The Washington Post: "The Food and Drug Administration this week began posting online the results of safety evaluations of recently approved drugs and vaccines. The action follows a law enacted in 2007 that requires the agency to provide more safety information to consumers and health professionals. The evaluations must be conducted 18 months after a new drug comes on the market.

18 Jun 2010

HRA Pharma announces FDA Advisory Committee approval for ulipristal acetate as emergency contraceptive

HRA Pharma announced today that the U.S. Food and Drug Administration's (FDA) Advisory Committee for Reproductive Health Drugs voted 11 to 0 that the company's application provided sufficient information to conclude that ulipristal acetate is effective and safe for use as an emergency contraceptive.

18 Jun 2010

Fraudulent Tamiflu sold over Internet, FDA warns

The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.

18 Jun 2010

FDA approves new indication for Tasigna in treatment of rare blood cancer

The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

18 Jun 2010

Ricerca announces services under U.S. DEA license

Ricerca Biosciences, an industry-leading, integrated preclinical contract research organization (CRO) providing services to the chemical and biopharmaceutical industries, is pleased to announce services it can now provide under its United States Drug Enforcement Administration (DEA) license.

18 Jun 2010

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company's supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence.

18 Jun 2010

FDA approves Jevtana to treat men with prostate cancer

The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.

18 Jun 2010

$FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer$

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for Jevtana® (cabazitaxel) Injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

18 Jun 2010

Study evaluates effect of Viusid on oxidative stress, cytokine parameters in patients with CHC

The pathogenesis of chronic hepatitis C is associated with severe oxidative stress and non-selective immunological disturbance that lead to necroinflammation and the progression of fibrosis. Several trials have suggested that antioxidant and immunostimulant therapies may have a beneficial effect. Two previous clinical studies have reported that the Viusid related effect on histologic features, especially fibrosis, appears to be associated with antioxidant and/or immunomodulatory properties.

18 Jun 2010

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 for the review of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application (NDA).

17 Jun 2010

Pharmaceutical News

Matrix Laboratories receives FDA approval for generic version Zocor Tablets: Mylan

Cyclacel files Answer and Counterclaims to Celgene's declaratory judgment complaint

FVL gene mutation increases risk of blood clots in breast cancer patients treated with tamoxifen: Study

USFDA approves Sun Pharma's generic Xanax ANDA

90% of HCV patients to be treated with triple therapy regimens, finds Decision Resources

NAN warns health care practitioners about dangers posed by EPHINEPHrine shortage

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

WSJ: Study on eye medicine reveals possible savings for Medicare

Nurse-monitored ART found to be as safe, effective as therapy monitored by doctors in South African trial

UF administers Lumizyme for late-onset Pompe disease

Drug makers face tightened regulations by FDA and less clout at medical meetings

HRA Pharma announces FDA Advisory Committee approval for ulipristal acetate as emergency contraceptive

Fraudulent Tamiflu sold over Internet, FDA warns

FDA approves new indication for Tasigna in treatment of rare blood cancer

Ricerca announces services under U.S. DEA license

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

FDA approves Jevtana to treat men with prostate cancer

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

Study evaluates effect of Viusid on oxidative stress, cytokine parameters in patients with CHC

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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