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FDA advisory committee's approval of Contrave for obesity encourages OAC, TOS, ASMBS

The Obesity Action Coalition, The Obesity Society and the American Society for Metabolic and Bariatric Surgery found encouragement in the outcome of today's advisory committee hearing, favoring approval for the first new obesity treatment in more than 10 years.

8 Dec 2010

Cephalon, Mesoblast to develop, commercialize novel adult MPC therapeutics

Cephalon, Inc. and Mesoblast Limited, today announced they have entered into a strategic alliance to develop and commercialize novel adult Mesenchymal Precursor Stem Cell therapeutics for degenerative conditions of the cardiovascular and central nervous systems.

8 Dec 2010

Alexza Pharmaceuticals to meet with FDA to discuss CRL regarding its NDA for AZ-004

Alexza Pharmaceuticals, Inc. announced today that the Company has scheduled an End-of Review meeting with the U.S. Food and Drug Administration in December to discuss the Complete Response Letter regarding the Company's New Drug Application for AZ-004 (Staccato loxapine).

8 Dec 2010

Concentrated nicotine in E-cigarattes poses unknown risks to consumers

What do some pesticides and "electronic cigarettes" have in common? According to a new report published in the American Journal of Public Health, the answer is unregulated concentrations of nicotine that may pose unknown risks to consumers who are exposed to them.

8 Dec 2010

Contrave, new weight loss pill gets FDA panel nod

A Food and Drug Administration (FDA) panel yesterday recommended the approval of Orexigen Therapeutics’ weight loss drug Contrave. This is the first time a weight loss drug has received the nod. The vote went 13 to 7 for Contrave’s approval and 11 to 8, with an abstention that additional studies be conducted on heart risks. Although experts agree to risks they believe the benefits outweigh the risks. Although the FDA is not compelled to go with the panel’s recommendation, it more often than not does. The FDA will deliver its verdict by Jan. 31 2011.

7 Dec 2010

Orthovita granted FDA marketing clearance for Vitoss Bioactive Foam-2X Bone Graft Substitute

Orthovita, Inc. , an orthobiologics and biosurgery company, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Vitoss Bioactive Foam-2X Bone Graft Substitute for use as a non-structural bone void filler for use in the spine, pelvis and extremities. Orthovita expects to launch the newest addition to its bone graft substitute product line by late February or early March of 2011.

7 Dec 2010

Inergetics, Muscle Maker Grill sign Product Development Agreement

Inergetics, Inc., a leader in targeted product development for the Clinical Nutrition and Sports Supplement Markets, today announced that the Company has entered into a Product Development Agreement with Muscle Maker Grill, one of the country's fastest growing health-food franchises, to be the exclusive provider of "Muscle Maker Ultra Pro, powered by Inergetics," a powdered proprietary nutritional product to be used in various platforms in Muscle Maker Grill restaurants.

7 Dec 2010

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro needle-free delivery system in Denmark

Aradigm Corporation today announced that Zogenix, Inc. and Desitin Pharmaceuticals GmbH ("Desitin") were granted approval of the Marketing Authorization Application ("MAA") for SUMAVEL® DosePro™ (sumatriptan injection) needle-free delivery system by the Danish Medicines Agency of Denmark.

7 Dec 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg. The NDA is based on the reference listed drug Ziagen® by ViiV Healthcare.

7 Dec 2010

OXIS introduces ErgoFlex for relief of joint pain

OXIS International, Inc. announces the market launch of ErgoFlex™, a unique new dietary supplement for the relief of joint pain. It is the first in a series of commercial products planned by OXIS. ErgoFlex is the only joint health complex containing the powerful antioxidant Ergothioneine (ERGO), and is specifically formulated to help the body fight the pain of joint inflammation and maintain optimal joint health.

7 Dec 2010

Watson, Natco confirm development agreement for generic Revlimid

Watson Pharmaceuticals, Inc. and Natco Pharma Limited today confirmed an exclusive, U.S. development and license agreement, to develop and commercialize lenalidomide 5, 10, 15 and 25 mg tablets. The companies also confirmed that Natco has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lenalidomide 5, 10, 15 and 25 mg product. Natco's lenalidomide tablets are generic versions of Celgene's Revlimid ® Tablets.

7 Dec 2010

Breast cancer patients taking tamoxifen anxious to have CYP2D6 genetic test

While the medical community continues to debate the benefits of CYP2D6 genetic testing for women on the breast cancer treatment tamoxifen, patients using the medication are anxious to have the tests. According to a new survey of more than 700 women with breast cancer currently taking tamoxifen, almost 80 percent of respondents would choose to have a genetic test that determines CYP2D6 genotype, yet only 14 percent of these women have been tested. CYP2D6 is an enzyme that influences how well the body processes tamoxifen into its more active form.

7 Dec 2010

Intellipharmaceutics files generic 30 mg Focalin XR ANDA with FDA

Intellipharmaceutics International Inc., today announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for approval to market a generic of the 30 mg strength of Focalin XR® (dexmethylphenidate hydrochloride). The application for the 30 mg strength is filed as an amendment to the ANDA that Intellipharmaceutics had previously filed for the 5, 10, 15 and 20 mg strengths of the drug.

7 Dec 2010

Idis to manage ViroPharma's named patient program

ViroPharma Incorporated and Idis, the global leader in developing long-term strategic solutions to therapeutic access, today announced that the two companies have partnered to facilitate access to certain ViroPharma products through a named patient program (NPP). ViroPharma's NPP, developed and managed by Idis, will allow international healthcare professionals to prescribe certain products to individual patients until the time that approval is sought in local countries.

7 Dec 2010

Low dose of aspirin reduces occurrence of several common cancers: Study

The London School of Hygiene & Tropical Medicine has contributed to a study showing that a low dose of aspirin reduces the occurrence of several common cancers. The study is published in today's Lancet.

7 Dec 2010

ADHD drug market will decrease from $5 billion in 2009 to $4.1 billion in 2019: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the attention-deficit/hyperactivity disorder (ADHD) drug market in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan will fluctuate modestly over the next decade, decreasing from $5 billion in 2009 to a trough in 2013 before climbing to $4.1 billion in 2019.

7 Dec 2010

Cylene Pharmaceuticals to present data on CK2 inhibitor at ASH Annual Meeting

Cylene Pharmaceuticals, Inc. has been selected to present data describing the activity of their first-in-class CK2 inhibitor at the 52nd Annual Meeting of the American Society of Hematology, to be held on December 4-7 in Orlando, FL, the company announced today. Kenna Anderes, VP Cancer Biology at Cylene, will discuss research on targeting CK2, a protein kinase that is essential for the progression of multiple myeloma but that has not been previously exploited as an anticancer target.

7 Dec 2010

NIH scientists consider prospects for universal influenza vaccine

The costly, time-consuming process of making, distributing and administering millions of seasonal flu vaccines would become obsolete if researchers could design a vaccine that confers decades-long protection from any flu virus strain. Making such a universal influenza vaccine is feasible but licensing it may require innovation on several fronts, including finding new ways to evaluate the efficacy of vaccine candidates in clinical trials, conclude scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

7 Dec 2010

Campaign to inoculate millions across Africa against meningitis kicks off in Burkina Faso

On Monday, a campaign started in Burkina Faso to "inoculate tens of millions of West Africans with a new vaccine in what scientists hope will be the beginning of the end of ravaging meningitis epidemics" across the continent, the New York Times reports.

7 Dec 2010

Study: Mixing exenatide with insulin provides better blood sugar control in type 2 diabetes patients

A new study finds that combining the newer diabetes drug exenatide with insulin provides better blood sugar control in patients with type 2 diabetes than insulin alone and helps promote weight loss.

7 Dec 2010

Pharmaceutical News

FDA advisory committee's approval of Contrave for obesity encourages OAC, TOS, ASMBS

Cephalon, Mesoblast to develop, commercialize novel adult MPC therapeutics

Alexza Pharmaceuticals to meet with FDA to discuss CRL regarding its NDA for AZ-004

Concentrated nicotine in E-cigarattes poses unknown risks to consumers

Contrave, new weight loss pill gets FDA panel nod

Orthovita granted FDA marketing clearance for Vitoss Bioactive Foam-2X Bone Graft Substitute

Inergetics, Muscle Maker Grill sign Product Development Agreement

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro needle-free delivery system in Denmark

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

OXIS introduces ErgoFlex for relief of joint pain

Watson, Natco confirm development agreement for generic Revlimid

Breast cancer patients taking tamoxifen anxious to have CYP2D6 genetic test

Intellipharmaceutics files generic 30 mg Focalin XR ANDA with FDA

Idis to manage ViroPharma's named patient program

Low dose of aspirin reduces occurrence of several common cancers: Study

ADHD drug market will decrease from $5 billion in 2009 to $4.1 billion in 2019: Report

Cylene Pharmaceuticals to present data on CK2 inhibitor at ASH Annual Meeting

NIH scientists consider prospects for universal influenza vaccine

Campaign to inoculate millions across Africa against meningitis kicks off in Burkina Faso

Study: Mixing exenatide with insulin provides better blood sugar control in type 2 diabetes patients

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