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U.S. joins whistleblower suit against Pfizer for drug marketing

The Wall Street Journal: "The Justice Department is trying to take the lead in a lawsuit accusing Pfizer Inc.'s Wyeth unit of improperly promoting an organ-transplant drug for unauthorized uses and paying illegal kickbacks to doctors. The lawsuit was filed by two former Wyeth sales representatives who were responsible for promoting Rapamune, an immunosuppressant used to prevent the body's rejection of transplanted kidneys.

23 Sep 2010

Abbott's Humira gains first-line biologic use for psoriasis treatment: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that while Amgen/Stiefel/Pfizer's Enbrel is the most popular biologic across all lines of therapy for psoriasis treatment in newly diagnosed patients, Abbott's Humira is gaining increasing use as a first-line biologic at Enbrel's expense.

23 Sep 2010

FDA approves Gilenya capsules for reducing MS relapses

The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS).

22 Sep 2010

G-CSF compound may activate virus, increases risk of infection: Research

Research conducted at Oregon Health & Science University's Vaccine and Gene Therapy Institute may spur debate about the risks associated with administering a specific compound in some forms of bone-marrow transplantation. The research is published in the current edition of Cell Host and Microbe.

22 Sep 2010

George Higginson Professor to receive 2010 Warren Alpert Foundation Prize

Howard Green, a founding father of regenerative medicine and the George Higginson Professor of Cell Biology at Harvard Medical School, will receive the 2010 Warren Alpert Foundation Prize for developing methodologies leading directly to permanent skin restoration therapy which is saving the lives of thousands of burn patients around the world.

22 Sep 2010

Teva asserts infringement of 4 COPAXONE-related patents by Mylan, files complaint in U.S. District Court

Teva Pharmaceutical Industries Ltd. announced today it has filed a complaint in the U.S. District Court for the Southern District of New York against Mylan asserting infringement of four patents related to the characterization of COPAXONE® (glatiramer acetate injection). The latest of these patents expires in February 2020.

22 Sep 2010

PA State Police, PCCD join national effort to collect medications on Sept. 25

Pennsylvanians are urged to turn in expired, unused and unwanted prescription medications at collection sites statewide during the first National Prescription Drug Take-Back Day on Saturday, Sept. 25, State Police and the Pennsylvania Commission on Crime and Delinquency said today.

22 Sep 2010

Mylan obtains temporary restraining order against Apotex and GlaxoSmithKline

Mylan Inc. today obtained a temporary restraining order from the U.S. District Court for the District of New Jersey that prohibits Apotex from "using, offering to sell, selling or shipping or otherwise launching … or importing" all three strengths of a generic version of GlaxoSmithKline's Paxil CR, Paroxetine Hydrochloride (HCl) Extended-release (ER) Tablets, 12.5 mg, 25 mg and 37.5 mg.

22 Sep 2010

Immunization is critical to reduce child deaths

Immunising children against preventable diseases is critical to achieving United Nations-led goals to reduce child deaths, global health and development chiefs said in New York today.

22 Sep 2010

Merus partners with Innocoll to launch 3 advanced wound care products in Canada

Merus Labs International Inc. is pleased to announce that their wholly owned subsidiary, Merus Labs Inc. announces the execution of a definitive agreement with Innocoll Pharmaceuticals Limited to license in, on an exclusive basis, 3 advanced wound care products for the Canadian market. Furthermore, Innocoll agrees to grant to Merus a right of first refusal for all current pipeline advanced wound care products for the Canadian Market.

22 Sep 2010

FDA grants orphan-drug designation to Catalyst's CPP-115 investigational drug

Catalyst Pharmaceutical Partners, Inc. today announced that its investigational drug, CPP-115, a novel GABA aminotransferase inhibitor, has been granted orphan-drug designation for the treatment of infantile spasms (West Syndrome) by the U.S. Food and Drug Administration (FDA).

22 Sep 2010

High dose aspirin effective for treatment of severe headache and migraine

An inexpensive, hundred-year-old therapy for pain - aspirin - is effective in high doses for the treatment of severe headache and migraine caused by drug withdrawal, according to a new study by researchers with the UCSF Headache Center. Study participants were administered aspirin through an IV and 25 percent of the time they reported a significant reduction in pain - three points on the 10-point pain scale.

22 Sep 2010

Access enters $30M supply agreement for MuGard with RHEI

Access Pharmaceuticals, Inc., a biopharmaceutical company specializing in products for cancer and supportive care signed a $30 million supply agreement for MuGard with RHEI Pharmaceuticals, Inc., a specialty pharmaceutical company focused on bringing proprietary medicines to the China market. Access will ensure manufacturing capacity of up to a minimum of $30 million of product in the licensed territories.

21 Sep 2010

Optimer submits fidaxomicin rolling NDA for treatment of Clostridium difficile infection

Optimer Pharmaceuticals, Inc. today announced that it has submitted the first section of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fidaxomicin to treat patients with Clostridium difficile infection (CDI) and to prevent recurrences of CDI. Optimer anticipates completing the submission in the fourth quarter of 2010 and plans to request priority review, which, if granted, could lead to an FDA decision on the NDA in the second quarter of 2011.

21 Sep 2010

MD Analytics releases early results from annual Pharmacists Prescribing report

Health industry marketing research leader MD Analytics® released early results today from its annual Insight Syndication Report: Pharmacists Prescribing.

21 Sep 2010

HealthWarehouse.com, Columbia Medical Associates announce partnership to provide generic prescription medications

HealthWarehouse.com, Inc., a leading retail mail-order online pharmacy and Columbia Medical Associates, an outpatient clinic system offering medical services in the Spokane, Washington metropolitan area, announced a partnership to offer patients a 30-day supply of more than 300 generic prescription medications for $3.50 with free home delivery.

21 Sep 2010

EffRx, Nycomed announce European filing for EX101 marketing approval

EffRx Pharmaceuticals SA and its partner, the global pharmaceutical company Nycomed, headquartered in Zurich, Switzerland, today announced that the first European filing for marketing approval of EX101, a once-a-week 70mg buffered effervescent alendronate, for the treatment of osteoporosis, has been submitted. The filing triggers a milestone payment to EffRx.

21 Sep 2010

FDA grants orphan drug designation for MultiStem stem cell therapy

Athersys, Inc. announced today that MultiStem, Athersys' multipotent adult progenitor stem cell therapy, has been granted orphan drug designation by the U. S. Food and Drug Administration for the prevention of graft vs. host disease (GvHD).

21 Sep 2010

FDA approves Mylan's generic Prograf Capsules ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tacrolimus Capsules, 0.5 mg, 1 mg and 5 mg, the generic version of Astellas' Prograf® Capsules, a treatment to prevent rejection in people who have received certain organ transplants.

21 Sep 2010

DCPC submits comments to DC Attorney General on proposed medical cannabis regulations

The District of Columbia Patients' Cooperative (DCPC), a non-profit, medical cannabis organization registered in the District of Columbia, has submitted comments to the Office of the DC Attorney General addressing numerous issues on proposed regulations announced 45 days ago.

21 Sep 2010