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BYETTA-basal insulin combination therapy receives EMA CHMP positive opinion

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion in the European Union for the expanded use of BYETTA (exenatide twice-daily) as an add-on therapy to basal insulin, with or without metformin and/or Actos (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.

17 Feb 2012

Bill to bar synthetic recreational drugs hits roadblock

A broadly popular bill by Sen. Amy Klobuchar, D-Minn., to outlaw synthetic recreational drugs across the nation has run into an increasingly common obstacle in the U.S. Senate: the objection of a single senator. Klobuchar and two other senators backing similar measures took the unusual step of taking to the Senate floor Wednesday to publicly denounce a "hold" placed on their bills by freshman Kentucky Republican Rand Paul. ... Paul spokeswoman Moira Bagley said he believes "law enforcement of most drug laws can and should be local and state issues."

17 Feb 2012

Four new drugs can extend survival and prognosis of prostate cancer

After a decade and a half of near stagnation, four new drugs could help make advanced prostate cancer a chronic illness instead of a terminal disease, a leading Colorado prostate cancer expert says.

17 Feb 2012

Shortage looming, drug maker agrees to release emergency supplies of kids' cancer drug

A shortage of a drug used to treat children's cancer seems to have been averted for a time as the Food and Drug Administration says it reached an agreement with the drug supplier to release emergency supplies. Elsewhere, rules sometimes force hospitals to throw away scarce drugs.

17 Feb 2012

Burkina Faso government urged to increase health budget as country faces ARV stock outs

"Burkina Faso's Network for Access to Essential Medicines (RAME) has called on the Burkinabè government to increase the budget allocation to the health sector to avoid interruptions to AIDS treatment," Inter Press Service reports.

17 Feb 2012

New preclinical data from Regulus' miR-21 study on kidney fibrosis

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that new preclinical data investigating the role of microRNA-21 (miR-21) in the treatment of kidney fibrosis has been published in the journal Science Translational Medicine.

17 Feb 2012

Indian authorities vaccinate children crossing India-Pakistan border; Distrust of polio vaccines grows in Pakistan

After going a year without recording a polio case, Indian health officials have begun vaccinating young children who cross the border to or from Pakistan at the Munabao railway station in Rajasthan state, BBC News reports.

17 Feb 2012

Epilepsy community concerned over AHRQ's AED drug comparison study

Leading representatives of the American Epilepsy Society, American Academy of Neurology, and the Epilepsy Foundation today reported they have grave concerns about the implications and potential misuse of the anticonvulsant (AED) drug comparisons study recently released by the U.S. Agency for Health Research and Quality.

17 Feb 2012

AstraZeneca launches ARIMIDEX Direct to help cancer patients

AstraZeneca today announced its first-ever direct-to-patient program offering patients with a valid prescription for ARIMIDEX or anastrozole the opportunity to have the brand ARIMIDEX delivered directly to their home by Express Scripts, a specialty pharmacy services provider, for $40 per month, including shipping.

17 Feb 2012

Pfizer, Mylan enter settlement agreement to resolve e-cue patent litigation

Mylan Inc. and Pfizer Inc. today announced that Meridian Medical Technologies, a Pfizer subsidiary, has entered into a settlement agreement with Intelliject and Sanofi-Aventis that will resolve pending patent litigation related to Intelliject's 505(b)(2) new drug application (NDA) for its epinephrine auto-injector known as e-cue, which will be manufactured and marketed by Sanofi-Aventis.

16 Feb 2012

FDA grants orphan drug designation to CSL Behring's rVIIa-FP

CSL Behring announced today that the company has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its novel recombinant fusion protein linking coagulation factor VIIa with albumin.

16 Feb 2012

DEA tries to stem prescription drug abuse by suspending pharmacies

Federal drug agents and one of the nation's biggest drug distributors are heading for a legal showdown that will test the government's strategy of going after larger corporations to fight rampant prescription drug abuse.

16 Feb 2012

AHF dismayed at FDA decision to expedite review for expanded use of Gilead's AIDS drug, Truvada

AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS nonprofit medical provider, today expressed its disappointment and dismay at the Food and Drug Administration's (FDA) decision to grant an expedited review for Gilead Sciences' application for expanded use of its blockbuster AIDS drug, Truvada, as a means of preventing HIV infection in non-infected people.

16 Feb 2012

Drugmaker warns that fake cancer drug is on the market

The Wall Street Journal reports that the manufacturer of Avastin says it has found counterfeit vials of the drug in the United States.

16 Feb 2012

Hospitals would have to voluntarily return overpayments under new proposal

Even as officials announced record recoveries of fraudulent Medicare claims, they proposed new rules to force providers to voluntarily return overpayments within 60 days of discovering them. The proposal is intended to cut down on the need for criminal or civil investigations.

16 Feb 2012

Researchers share libraries of chemical compounds to spur development of drug candidates

Nature reports how "in the hunt for drugs that target diseases in the developing world, ... pharmaceutical companies are making entire libraries of chemical compounds publicly available, allowing researchers to rifle through them for promising drug candidates."

16 Feb 2012

Pure Health launches new fresh freeze dried Black Raspberry capsules

Pure Health, a leading online provider of pure, authentic superfruit supplements, launched today a new fresh freeze dried 100 percent pure Black Raspberry capsule supplement.

16 Feb 2012

ASH addresses severe shortage of methotrexate drug

As the world's largest professional society concerned with the causes and treatment of blood disorders, many of ASH's more than 16,000 members are on the front lines of dealing with the country's severe shortage of methotrexate, a drug critical in the treatment of children with acute lymphocytic leukemia.

16 Feb 2012

U.S. FDA accepts Pfizer's tafamidis NDA for treatment of TTR-FAP

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tafamidis meglumine, the company's investigational, novel, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy.

16 Feb 2012

Valeant receives FDA approval for secondary supplier of Methoxsalen

The FDA has approved the addition of a secondary supplier of Methoxsalen USP, an integral component of a treatment for the relief of moderate to severe psoriasis prescribed under the brand name Oxsoralen-Ultra (methoxsalen) Capsules, USP, 10mg.

15 Feb 2012