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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

Counterfeit anti-cancer drug Avastin raises concerns

The market is flooded with a counterfeit version of cancer drug Avastin worry doctors and patients. Injectable drugs have become increasingly attractive to counterfeiters, in part because they often fetch a higher price than regular pills.

15 Feb 2012

FDA approves preservative-free drug for glaucoma

The U.S. Food and Drugs Administration (FDA) has approved tafluprost ophthalmic solution (Zioptan, Merck) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution for glaucoma.

15 Feb 2012

VPCI announces successful petition to the FDA for removal from Import Alert

The U.S. Food and Drug Administration (FDA) maintains strict labeling requirements for Active Pharmaceutical Ingredients (APIs). If an API does not maintain adequate labeling as per section 502(f)(1) of the Act, the FDA will consider the material to be misbranded. Foreign APIs which are misbranded are subject to detention without physical examination under FDA's Import Alert 66-66 "Red List."

15 Feb 2012

Steady increase in Low Molecular Weight Heparin use for blood clots: Study

The use of an injectable, clot-preventing drug known as Low Molecular Weight Heparin to treat patients with advanced cancer complicated by blood clots increased steadily between 2000 and 2007, according to a new study published in The Oncologist, funded by the National Cancer Institute and led by Kaiser Permanente Colorado.

15 Feb 2012

Mylan responds to current preservative-free Methotrexate Injection shortage

Mylan Inc. today commented on its response to the current shortage of preservative-free Methotrexate Injection.

15 Feb 2012

Curcumin prolongs life and enhances activity of fruit flies with AD

Curcumin, a substance extracted from turmeric, prolongs life and enhances activity of fruit flies with a nervous disorder similar to Alzheimers. The study conducted at Link-ping University, indicates that it is the initial stages of fibril formation and fragments of the amyloid fibrils that are most toxic to neurons.

15 Feb 2012

New group of compounds may protect brain cells from inflammation

Scientists at Emory University School of Medicine have identified a new group of compounds that may protect brain cells from inflammation linked to seizures and neurodegenerative diseases.

15 Feb 2012

New vaccine can prevent bacterial infection of orthopaedic implants

Methicillin resistant staph aureus (MRSA) infections are resistant to antibiotics and can cause a myriad of problems -- bone erosion, or osteomyelitis, which shorten the effective life of an implant and greatly hinder replacement of that implant. MRSA can result in prolonged disability, amputation and even death.

15 Feb 2012

Antibiotic prescriptions do not reduce sinus symptoms

Antibiotics that doctors typically prescribe for sinus infections do not reduce symptoms any better than an inactive placebo, according to investigators at Washington University School of Medicine in St. Louis.

15 Feb 2012