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FDA approves Matrix NDA for Zidovudine Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its New Drug Application for Zidovudine Tablets, 100 mg.

10 Mar 2011

Novartis new MS treatment receives Notice of Compliance in Canada

Novartis Pharmaceuticals Canada Inc. announced today that its new MS treatment, Gilenya, has received Notice of Compliance in Canada.

10 Mar 2011

FDA approves Covidien's LEU-based Mo-99 medical isotope

Covidien, a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration has approved the use of molybdenum-99 derived from low-enriched uranium (LEU) in the production of technetium-99m generators.

10 Mar 2011

Medtronic resolves FDA warning letters over Mounds View, Juncos facilities

Medtronic, Inc. today announced that the U.S. Food and Drug Administration (FDA) has informed the company that issues noted in two warning letters -- one from November 2009 regarding the company's Mounds View, Minnesota facility and another from June 2009 regarding the company's manufacturing facility in Juncos, Puerto Rico -- have been resolved.

10 Mar 2011

Despite aspirin therapy, specific inflammatory pathways may influence risk of colorectal cancer

The reduced risk of colorectal cancer associated with taking aspirin or other nonsteroidal anti-inflammatory drugs may be confined to individuals already at risk because of elevations in a particular inflammatory factor in the blood.

10 Mar 2011

Pepscan signs Research and License Agreement with Crucell to devlop novel vaccines

Pepscan Therapeutics, the Dutch biotechnology firm focusing on protein mimicry technology, today announces that it has signed a Research and License Agreement with Crucell Holland B.V. the Dutch developer of vaccines and antibodies.

10 Mar 2011

Scientists identify chemical compound that may lead to cancer-fighting drugs

Researchers at UT Southwestern Medical Center have identified a chemical compound that may eventually lead to a drug that fights cancers that are dependent on a particular anti-viral enzyme for growth.

10 Mar 2011

AHF unveils new national advertising campaign about AIDS drugs

AIDS Healthcare Foundation today unveiled a new national advertising campaign headlined, "There Is No Magic Pill," an advocacy and awareness campaign to educate and prompt discussion among gay men and others regarding Gilead Sciences and its likely plans to seek Food and Drug Administration approval for use of its blockbuster AIDS drug Truvada as a form a 'pre-exposure prophylaxis' to prevent HIV transmission.

10 Mar 2011

CRT, ICR sign deal with ZoBio to discover and develop cancer drugs

Cancer Research Technology and The Institute of Cancer Research have signed a deal with Dutch drug discovery company, ZoBio BV, to discover and develop drugs to block a DNA repair target which may play a role in cancer cell survival.

10 Mar 2011

Opinions: Investing in science, technology; Indian public-private partnership for NTDs; U.S. global food security investments; Clinton's statements on PEPFAR; U.S. foreign aid; primary care

"Now is the time to support science and technology - especially in difficult economic times. It is the right thing to do, and it makes good economic sense," Alex Dehgan, science and technology adviser to the USAID administrator, and Kaitlin Christenson, coalition director for the Global Health Technologies Coalition, write in an opinion piece appearing on The Hill's "Congress Blog."

10 Mar 2011

FDA informs additional delay of ARYx's request for naronapride SPA

ARYx Therapeutics, Inc. today announced that the US Food and Drug Administration has informed the Company of an additional delay in providing needed guidance on the Phase 3 development of ARYx's product candidate for the treatment of various gastrointestinal disorders, naronapride. In this latest communication with ARYx, the FDA suggests a response will not be forthcoming until July 2011 at the earliest.

10 Mar 2011

FDA approves BENLYSTA for active, autoantibody-positive systemic lupus erythematosus

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced that the U.S. Food and Drug Administration has approved BENLYSTA® (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

10 Mar 2011

Israel grants patent to Kamada's Transferrin for use in Pharmaceutical Compositions

Kamada, a biopharmaceutical company developing, manufacturing and marketing specialty life-saving therapeutics, announced today it has received an Israeli Patent for its Ultrapure Transferrin to be used in Pharmaceutical Compositions.

10 Mar 2011

NCPA encourages patients on safe disposal of unwanted medications

In recognition of Patient Safety Awareness Week, the National Community Pharmacists Association encourages patients to properly dispose of expired or unwanted medications at a local independent community pharmacy as part of its Dispose My Meds program.

10 Mar 2011

FDA accepts Merck's SAFLUTAN NDA for standard review

Merck, known as MSD outside the United States and Canada, announced today that the New Drug Application for SAFLUTAN, Merck's investigational preservative-free prostaglandin analogue ophthalmic solution, has been accepted for standard review by the U.S. Food and Drug Administration.

10 Mar 2011

Illicit drug users may face increased risk of microbial infections

Illicit drug users are at increased risk of being exposed to microbial pathogens and are more susceptible to serious infections say physicians writing in the Journal of Medical Microbiology.

10 Mar 2011

EDT receives European approval for XEPLION injection to treat schizophrenia

Elan Drug Technologies, the drug delivery unit of Elan Corporation, plc, today announced that the first injectable product using EDT's NanoCrystal technology has been approved by the European Commission.

9 Mar 2011

KineMed extends collaboration with BMY to identify and characterize Alzheimer's biomarkers

KineMed, Inc. announced today the extension of its collaboration with Bristol-Myers Squibb in the area of Alzheimer's disease and other neurodegenerative conditions.

9 Mar 2011

U.S. FDA approves Hospira's docetaxel to treat variety of cancers

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced U.S. Food and Drug Administration approval of docetaxel. The medication is a generic version of Sanofi-Aventis's Taxotere, and Hospira expects to launch the product later this month.

9 Mar 2011

New Australian drug approvals subject to budget cuts

According to Health Minister Nicola Roxon’s statement to pharmaceutical company bosses, new medicines will no longer be subsidised unless budget savings can be found.

9 Mar 2011