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Immune-based therapy approved in Europe for pediatric cancer patients

The European Commission, which oversees legislation and regulation for the European Union, has approved a therapy for pediatric patients with non-metastatic, resectable osteosarcoma, a type of bone cancer.

11 Mar 2009

A vaccine for multiple sclerosis

Apitope Technology Ltd is a biopharmaceutical company that specialises in developing treatments for allergy and autoimmune diseases.

11 Mar 2009

CytoDyn responds to FDA as high court rules agency cannot guarantee drug safety

CytoDyn, Inc. has sent the FDA what the Company believes is a complete response to the agency's preliminary comments on Cytolin, a monoclonal antibody designed to restore immune function in those afflicted with HIV/AIDS.

10 Mar 2009

Azaya Therapeutics selected for Nanotechnology Characterization Lab by National Cancer Institute

Azaya Therapeutics, Inc. has announced that it has been selected by the National Cancer Institute (NCI) for a research collaboration to study Azaya's lead cancer therapy, ATI - 1123.

10 Mar 2009

Ranbaxy secures FDA approval for quinapril hydrochloride + hydrochlorothiazide tablets

Ranbaxy Pharmaceuticals has announced approval from the U.S. Food and Drug Administration to manufacture and market Quinapril Hydrochloride & Hydrochlorothiazide (Quinapril + HCTZ) Tablets, 10mg/12.5mg, 20mg/12.5mg and 20mg/25mg.

5 Mar 2009

European Commission and US FDA approve intravenous formulation of temozolomide

Schering-Plough Corporation (NYSE:SGP) today announced that the European Commission and the US FDA both approved the intravenous (IV) formulation of temozolomide as an alternative to the already approved oral form of the drug.

5 Mar 2009

Pharmacies offering no-cost antibiotics should promote responsible use, CDC says

CDC last week sent out letters to several chain pharmacies that offer no-cost prescription antibiotics to low-income consumers urging them to promote responsible use of antibiotics, the New York Times reports.

5 Mar 2009

Dorgan, McCain, Snowe introduce bill to allow prescription drug reimportation

Sens. Byron Dorgan (D-N.D.), John McCain (R-Ariz.) and Olympia Snowe (R-Maine) on Wednesday introduced a bill (S 525) that would allow the reimportation of lower-cost prescription drugs from other nations, Bloomberg reports.

5 Mar 2009

Supreme Court rules against Wyeth in pre-emption case

The U.S. Supreme Court on Wednesday ruled 6-3 that consumers harmed by an FDA-approved pharmaceutical product can sue the drugmaker for liability in state courts, the San Francisco Chronicle reports (Egelko, San Francisco Chronicle, 3/5).

5 Mar 2009

FDA warning on risk of wearing medicated patches during MRIs

Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration today.

5 Mar 2009

Off-label drug uses wasting millions, raising health risks

A recent study in Oregon suggests that drugs designed for treating the most severe mental illnesses are often prescribed at inappropriately low doses and at considerable expense, for use in conditions where their benefit has not been established.

4 Mar 2009

FDA accepts IND application for Tigris Pharmaceutical's GGTI-2418

Tigris Pharmaceuticals, Inc., has announced that its Investigational New Drug (IND) application for the Company's geranylgeranyltransferase inhibitor (GGTI-2418) has been accepted by the U.S. Food and Drug Administration.

4 Mar 2009

Generic biologics face 'tough, long road to realization'

The development of new generic versions of expensive biologic drugs "faces a long, tough road to realization" because the complex generics "will likely face tough regulatory scrutiny, as well as high development and marketing costs," the Wall Street Journal reports.

4 Mar 2009

FDA warning letter to Genzyme related to Allston manufacturing facility

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced today that the FDA warning letter issued to Genzyme addressing deficiencies related to Genzyme's Allston Landing manufacturing facility during an inspection performed in September and October 2008 has no foreseeable impact on the supply of Aldurazyme.

3 Mar 2009

FDA provides positive review of InNexus' lead preclinical drug candidate

InNexus Biotechnology Inc. has announced the United States Food & Drug Administration (FDA) has completed its comprehensive review of the development plans for InNexus' lead preclinical candidate, DXL625 (CD20) for the prospective treatment of Non-Hodgkin's Lymphoma (NHL) and/or Chronic Lymphocytic Leukemia (CLL).

3 Mar 2009

FDA clears Cellectar's IND application for lead drug candidate

Cellectar, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for its (131)I-CLR1404 drug candidate for testing in patients with advanced solid malignancies.

3 Mar 2009

Endo Pharmaceuticals licenses investigational drug axomadol from Grunenthal

Endo Pharmaceuticals announced that it has licensed from Grunenthal the exclusive rights to develop and market the investigational drug axomadol in the United States and Canada.

2 Mar 2009

FDA takes action against KV Pharmaceutical Company

The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs.

2 Mar 2009

Wyeth's Prevenar vaccine for pneumococcal disease registered in Russia

Wyeth announced today that its 7-valent pneumococcal conjugate vaccine, Prevenar (Pneumococcal saccharide conjugated vaccine, Adsorbed), has been registered by the Russian Ministry of Health and Social Development (Roszdravnadzor) and is expected to be commercially available later this year.

2 Mar 2009

FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs

The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.

1 Mar 2009