Pharmaceutical News

RSS

Indevus submits new drug application for NEBIDO

Indevus Pharmaceuticals, Inc. has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for NEBIDO (testosterone undecanoate) intramuscular injection, a long-acting testosterone therapy intended to treat male patients with primary and secondary hypogonadism.

29 Aug 2007

FDA approves cobas TaqScreen WNV test for West Nile virus

The U.S. Food and Drug Administration has announced approval of a second test for the detection of West Nile virus (WNV) in blood and organs.

29 Aug 2007

FDA approves new Roche direct detection of West Nile Virus in donated human blood

Roche Diagnostics announced that the US Food & Drug Administration (FDA) has approved its biologics license application for the company's test for direct detection of West Nile Virus in donated human blood and plasma.

From Roche Sequencing and Life Science 29 Aug 2007

Seroquel XR tablets approved in Netherlands for the treatment of schizophrenia

AstraZeneca today announced the Netherlands regulatory authority MEB (Medicines Evaluation Board) has approved Seroquel XR (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients.

29 Aug 2007

FDA grants orphan drug designation to TREANDA

Cephalon, Inc. announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company's investigational therapy, TREANDA (bendamustine HCl), for the treatment of chronic lymphocytic leukemia (CLL).

29 Aug 2007

Avicena signs distribution agreement with RITA Corporation for dermaceutical compounds

Avicena Group, Inc., a late-stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases as well as dermaceutical products announced today that it has signed an exclusive worldwide distribution agreement with RITA Corporation, a leading supplier of specialty chemicals to the personal care industry.

29 Aug 2007

FDA approves Evithrom (human thrombin)

The U.S. Food and Drug Administration has approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery.

28 Aug 2007

Pharmacist Services Technical Advisory Coalition awarded grant from Community Pharmacy Foundation

The Pharmacist Services Technical Advisory Coalition (PSTAC), an alliance of seven national pharmacy organizations, has recently been awarded a grant from the Community Pharmacy Foundation to support an educational campaign on Current Procedural Terminology (CPT) codes used for Medication Therapy Management Services (MTMS) provided by pharmacists.

28 Aug 2007

IDM Pharma receives not approvable letter for Mifamurtide for treatment of osteosarcoma

IDM Pharma, Inc. ( NASDAQ:IDMI ) announced today that it received a not approvable letter from the U.S. Food and Drug Administration (FDA) after completing the review of the new drug application (NDA) for the investigational drug mifamurtide (L-MTP-PE), formerly known as Junovan, for the treatment of non-metastatic osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults.

28 Aug 2007

Avastin approved in Europe for advanced lung cancer

Avastin (bevacizumab), Roche's innovative anti-cancer drug, was approved today in Europe for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), in combination with platinum-based chemotherapy.

26 Aug 2007

MedImmune licenses reverse genetics technology to Novartis

MedImmune, Inc. has announced that it has licensed its proprietary reverse genetics intellectual property to Novartis to support the development and construction of new vaccine strains to produce inactivated human seasonal, pre-pandemic and pandemic influenza vaccines.

24 Aug 2007

Risperdal approved for psychiatric conditions in children and adolescents

The U.S. Food and Drug Administration has approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17.

24 Aug 2007

UVA protection in sunscreens to be shown

The U.S. Food and Drug Administration today proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

24 Aug 2007

Roche and WHO reinforce Tamiflu as primary H5N1 treatment

The World Health Organization (WHO) has reinforced that Tamiflu (oseltamivir) is the primary recommended antiviral of choice in managing patients infected with H5N1 in updated guidance published on the WHO website today.

24 Aug 2007

More informative labels proposed for sunscreens

The Food and Drug Administration (FDA) in the United States has proposed new regulation governing the development and testing of sunscreens; they also want warnings on the labels about the risk of skin cancer linked to sun exposure.

23 Aug 2007

Antipsychotic drug Risperdal approved for use in children

The Food and Drug Administration (FDA) in the U.S. has given approval for the antipsychotic drug Risperdal to be used to treat schizophrenia and bipolar disorder in children and teenagers.

23 Aug 2007

Warning - OTC diet supplement contains undeclared diet drug

Canadians are being warned that an over-the-counter (OTC) dietary supplement has been recalled because it contains a prescription drug used in the treatment of obesity.

21 Aug 2007

Watson Pharmaceuticals receives FDA approval for generic Duragesic

Watson Pharmaceuticals, Inc. announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for fentanyl transdermal system in the 25, 50, 75 & 100 mcg/hour strengths.

21 Aug 2007

Pharmion and MethylGene announce orphan drug designation for treatment of Hodgkin's lymphoma

Pharmion Corporation, along with its collaborator MethylGene Inc., today announced that the U.S. Food and Drug Administration (FDA) has designated the Companies' histone deacetylase (HDAC) inhibitor, MGCD0103, as an Orphan Drug for the treatment of Hodgkin's lymphoma in the United States.

21 Aug 2007

Americans popping more pills

Americans are it seems popping more pills than ever, as according to an analysis of federal data, sales of leading painkiller medications soared by 90 percent in the eight years between 1997 and 2005.

21 Aug 2007