Pharmaceutical News

RSS

Popular sleeping pill Stilnox in danger of being classed with morphine, narcotics and amphetamines

A popular sleeping pill that has reportedly triggered bizarre side-effects in some people, could be placed by Australian drug regulators into the same class as morphine, narcotics and amphetamines.

22 Jan 2008

Genmab reaches milestones in Ofatumumab collaboration

The second milestone payment of the collaboration of DKK 87.2 million was triggered by treatment of the first patient in the Phase II study of ofatumumab in Diffuse Large B-Cell Lymphoma (DLBCL), which occurred in 2007.

22 Jan 2008

AIDS Healthcare Foundation criticizes Etravirine's pricing

AIDS Healthcare Foundation (AHF) has urged Tibotec Pharmaceuticals Ltd., a division of Johnson & Johnson, to reconsider and reduce its steep price for its newest AIDS drug, etravirine (TMC 125), a non-nucleoside reverse transcriptase inhibitor, (NNRTI), which received Food and Drug Administration (FDA) approval on Friday after a fast track or 'priority review' and approval process granted to companies for medications and therapies intended to treat life-threatening illnesses such as AIDS.

22 Jan 2008

Anti-smoking drug Chantix adds suicide to it's warning label

The anti-smoking drug Chantix, which was approved by the Food and Drug Administration (FDA) in May 2006, will in future carry a warning about the possibility of suicidal thoughts in patients who take it.

21 Jan 2008

FDA clears for ProFlu+ test for marketing

The U.S. Food and Drug Administration has cleared for marketing a test that simultaneously detects four common respiratory viruses, including the flu, in a patient's respiratory secretions.

21 Jan 2008

FDA approves etravirine tablets for HIV

The U.S. Food and Drug Administration has approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.

21 Jan 2008

Selective publication means unfavorable drug studies rarely get published

A new report claims that almost a third of the research done on antidepressant drugs is never published in medical literature and most of those unpublished reports are unfavorable.

20 Jan 2008

New drug lets kids feel good in their skin

Maria Anichini, a 20-year-old junior at Columbia College, zipped up a fetching black lace cocktail dress with spaghetti straps to go out with friends the other night.

17 Jan 2008

Cancer Research UK invests 10 million pounds in drug discovery

Project leaders at Imperial College London, University of Oxford, University of Strathclyde and The School of Pharmacy in London will each receive 500k pounds per year for five years to develop anti-cancer drugs.

17 Jan 2008

Maryland Court rejects Thimerosal - autism link

Wyeth has announced that The Honorable Stuart R. Berger of the Circuit Court for Baltimore City in Baltimore, Maryland, has granted Wyeth's motion to preclude plaintiffs' expert witnesses in an alleged vaccine injury case from testifying that exposure to thimerosal-containing vaccines can cause autism..

16 Jan 2008

OIG report confirms dangerously thin margins for community pharmacy

The Office of the Inspector General of the Department of Health and Human Services released a "Review of the Relationship Between Medicare Part D Payments to Local, Community Pharmacies and the Pharmacies' Drug Acquisition Costs."

15 Jan 2008

FDA extends review of Genasense NDA appeal in chronic lymphocytic leukemia

Genta Incorporated has announced that the Food and Drug Administration (FDA) has extended its review of Genta's appeal of the non- approvable decision for a New Drug Application (NDA) that proposed the use of Genasense (oblimersen sodium injection) plus chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia.

15 Jan 2008

Caraco Pharmaceutical Labs announces FDA approval to market generic Metaglip

Caraco Pharmaceutical Laboratories, Ltd., has announced that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Glipizide/Metformin Hydrochloride Tablets, 2.5/250 mg, 2.5/500 mg and 5/500 mg (Glipizide/Metformin HCl).

15 Jan 2008

Minister predicts role for stem cell biologists in re-shaped pharmaceutical industry

Stem cell research should have a bright future and could play an important role in tomorrow's pharmaceutical industry, Spain's Minister for Health told an international conference of stem cell biologists on January 11.

15 Jan 2008

FDA approves Tysabri to treat Crohn's disease

The U.S. Food and Drug Administration has approved Tysabri (natalizumab) for the treatment of moderate-to-severe Crohn's disease in patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies.

14 Jan 2008

U.S. Food and Drug Administration approves new genetic breast cancer test

The U.S. Food and Drug Administration has approved a test that helps in assessing the risk of tumor recurrence and long-term survival for patients with relatively high-risk breast cancer. The TOP2A FISH pharmDx is the first approved device to test for the TOP2A (topoisomerase 2 alpha) gene in cancer patients.

14 Jan 2008

Morphotek announces agreement for development of antibodies to treat prostate cancer

Morphotek, Inc., a subsidiary of Eisai Co., Ltd., has announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for the development of therapeutic antibodies to a cancer-associated protein identified by NCI researchers.

10 Jan 2008

Bio-identical hormone replacement therapies targeted by FDA

The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency.

10 Jan 2008

FDA says claims about benefits of bio-identical hormone replacement therapy are false and misleading

Health officials in the United States have issued a warning regarding so-called "bio-identical" hormone therapy (BHRT).

10 Jan 2008

New meningitis vaccine a potential new weapon against the deadly disease

In a joint venture British and Canadian researchers have found that a new type of meningitis vaccine offers immunity to infants as young as six months from the deadly disease.

9 Jan 2008