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ERYtech Pharma receives ODD for its GRASPA from FDA

ERYtech Pharma announces that FDA has granted an Orphan Drug Designation (ODD) for GRASPA®, the company’s lead product in Acute Lymphoblastic Leukaemia.

27 Jan 2010

FDA approves Novo Nordisk's Victoza for type 2 diabetes

Novo Nordisk, a global healthcare company, announced today the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza® (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

27 Jan 2010

Researchers simplify confusing warnings labels on prescription bottles

Replacing confusing language and icons on standard warnings labels for prescription medicine and listing only the most important warnings could make a big difference in how well patients understand the instructions that are critical to their health, according to a new study from Northwestern University Feinberg School of Medicine.

27 Jan 2010

Abbott submits Premarket Approval application for the ARCHITECT HIV Ag/Ab Combo assay to FDA

An assay to aid in the early detection of HIV infection may soon be available in the United States. Abbott announced today it has submitted a Premarket Approval application for the ARCHITECT HIV Ag/Ab Combo assay to the U.S. Food and Drug Administration (FDA) for expedited review. Upon approval, the assay is expected to be the first test available in the United States to simultaneously detect the combined presence of HIV antigens (proteins produced by the HIV virus) and antibodies (proteins produced by the body to fight HIV antigens), which would allow for the early detection and ongoing monitoring of the virus.

26 Jan 2010

Spectrum Pharmaceuticals to submit additional data for FUSILEV sNDA

Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has met with the FDA regarding it’s supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for injection for the treatment of patients with advanced metastatic colorectal cancer. In October 2009, the FDA issued a Complete Response letter regarding its sNDA for FUSILEV.

25 Jan 2010

Formulations market: Network to place the Yorkshire and Humber region at the forefront launched

A collaborative network that aims to put the Yorkshire and Humber region at the forefront of the development of product formulations to improve everyday products is being launched in Leeds.

25 Jan 2010

Elan Drug Technologies issues statement on FDA approval of AMPYRA

Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) approval of AMPYRA™ (dalfampridine) as a treatment to improve walking in patients with multiple sclerosis (MS).

25 Jan 2010

AMT reaches another milestone in the official marketing authorisation process for Glybera

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, has reached another important milestone in the official marketing authorisation process for its lead product Glybera(R), AMT's proprietary product for lipoprotein lipase deficiency (LPLD).

25 Jan 2010

Erbitux improves survival of mCRC patients with KRAS wild-type tumors

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that Erbitux® (cetuximab) provided an improvement in overall survival (OS) when added to the standard 1st-line FOLFIRI chemotherapy regimen for metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors in the CRYSTAL study.

24 Jan 2010

Biogen Idec's statement on FDA approval of AMPYRA

Biogen Idec today issued the following statement regarding the United States (U.S.) Food and Drug Administration (FDA) approval of AMPYRA™ (dalfampridine) to improve walking in patients with multiple sclerosis (MS).

23 Jan 2010

Island Labs receives NHP approval for Stemcelex

Island Labs, a leader in natural dermatological products, has become the first company in Health Canada's history to receive Natural Health Product (NHP) approval.

23 Jan 2010

Department of Health to continue H1N1 vaccination clinics every Saturday in Pennsylvania

In an effort to ensure that Pennsylvania's citizens are protected against the H1N1 flu virus, the Department of Health will continue public vaccination clinics at all 60 state health centers every Saturday through Feb. 6 from 9 a.m. to noon.

23 Jan 2010

PhRMA funds a two-year research initiative to evaluate the safety and benefits of existing drugs

The Pink Sheet recently reported that the Pharmaceutical Research and Manufacturers of America (PhRMA) and individual drug firms, through the Foundation for the National Institutes of Health, are funding a two-year public/private research initiative to evaluate the safety and benefits of drugs that are currently on the market.

23 Jan 2010

FDA's Ampyra approval wonderful news for people with MS experiencing walking problems

The U.S. Food and Drug Administration has approved the marketing of Ampyra™ (dalfampridine, formerly known as fampridine SR, from Acorda Therapeutics) for its ability to improve walking speed in people with any type of multiple sclerosis.

23 Jan 2010

FDA approves fampridine-SR drug for treatment of multiple sclerosis

The Food and Drug Administration has approved the drug fampridine-SR for the treatment of multiple sclerosis. Researchers at the University of Rochester Medical Center (URMC) have been evaluating the effects of the drug in MS for more than 10 years- it is the first medication shown to enhance some neurological functions in people with the disease - and their efforts helped pave the way for today's action by the FDA.

23 Jan 2010

Ampyra receives FDA approval for improving walking in MS patients

The U.S. Food and Drug Administration today approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with an inactive pill (placebo). This is the first drug approved for this use.

23 Jan 2010

Study shows certain heart medications may decrease risk of Parkinson's disease

UCLA researchers have discovered that a specific type of medication used to treat cardiovascular conditions such as hypertension, angina and abnormal heart rhythms may also decrease the risk of developing Parkinson's disease.

22 Jan 2010

BioSyent Pharma receives exclusive rights to manufacture and market Virsani sanitizer in Canada and U.S.

BioSyent Inc. ("BioSyent") announces that its subsidiary BioSyent Pharma Inc. has signed a license and distribution agreement with Notlers for VirsaniTM personal sanitizer.

22 Jan 2010

Acorda Therapeutics receives marketing approval from FDA for AMPYRA

Acorda Therapeutics, Inc. today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA™ (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS).

22 Jan 2010

DIA Annual EuroMeeting programme in Monaco

The Drug Information Association (DIA) in Europe will host its 22nd Annual EuroMeeting from 8-10 March 2010 in Monaco. The DIA Annual EuroMeeting features more than 110 hot-topic sessions across 13 themes and attracts more than 3,000 professionals from the biopharmaceutical industry, contract service organisations, regulatory agencies, health ministries and academia, as well as patients and students worldwide.

22 Jan 2010