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INS cites FDA-approved Totect antidote for anthracycline extravasations

The third edition of Infusion Nursing: An Evidence-Based Approach, published by the Infusion Nurses Society (INS), includes Totect(®), the only FDA-approved treatment for anthracycline extravasation. Anthracyclines are a group of chemotherapy medications including daunorubicin, doxorubicin, idarubicin and epirubicin that have been used in the treatment of various types of cancer since the early 1970s.

15 Dec 2009

FDA publishes cGMPs for PET drugs

The U.S. Food and Drug Administration (FDA) announced publication of a final regulation on current good manufacturing practices (cGMPs) for the production of positron emission tomography (PET) drugs, as well as a guidance document describing acceptable approaches that would enable PET drug producers to meet the requirements in the proposed regulation.

15 Dec 2009

Health hazards of BPA: Call for FDA to make its announcement before Christmas

Environmental health advocates hope that U.S. FDA will make its promised announcement about health hazards of bisphenol A (BPA), a synthetic sex hormone linked to cancer, behavioral changes, reproductive harm and other illnesses, in time for Christmas.

15 Dec 2009

Study compares status of health care systems in U.S. and UK

The well-worn notion that patients in the United States have unfettered access to the most expensive cancer drugs while the United Kingdom's nationalized health care system regularly denies access to some high-cost treatments needs rethinking, a team of bioethicists and health policy experts says in a report out today.

15 Dec 2009

USPTO issues Notice of Allowance to Transcept Pharmaceuticals for Intermezzo claims

Transcept Pharmaceuticals, Inc. today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims under U.S. patent application no. 11/060,641, which covers the composition and use of Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate.

15 Dec 2009

Decision Resources: Atrial fibrillation drug market to increase more than sevenfold

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, owing to the launches of several new agents, the atrial fibrillation drug market will increase more than sevenfold from $790 million in 2008 to $6.1 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

15 Dec 2009

New program to help maintain bone health in men with prostate cancer on ADT announced

Watson Pharmaceuticals, Inc. today announced a new program encouraging health professionals to help maintain the bone health of prostate cancer patients who are on long-term androgen deprivation therapy (ADT).

15 Dec 2009

Rexahn Pharmaceuticals and TheraTarget sign joint research collaboration agreement

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, and TheraTarget, Inc., a developer of innovative polymer therapeutics for the treatment of cancer, today announced the formation of a joint research collaboration agreement.

15 Dec 2009

Researchers advance in developing a vaccine against AIDS disease

Led by Matthias J. Schnell, Ph.D., director of the Jefferson Vaccine Center, the researchers found that a rabies virus-based vaccine administered to monkeys protected against the simian equivalent of the HIV virus (SIV). The data were published in the journal Vaccine.

15 Dec 2009

Manchester Pharmaceuticals' Chenodal now available for patients suffering from gallstones

Manchester Pharmaceuticals, Inc.(TM) announced today the availability of Chenodal(TM) 250 mg (chenodiol tablets). On October 22, 2009, the US Food and Drug Administration (FDA) approved Chenodal, an important therapy for patients suffering from gallstones in whom surgery poses an unacceptable health risk due to disease or advanced age.

15 Dec 2009

Microbicide does not reduce women's risk of HIV infection, study shows

Pro 2000, a vaginal microbicide gel designed to reduce women's risk of HIV infection, showed "no evidence that it reduces the risk of HIV infection," according to the results of a series of clinical trials in Africa, Britain's Medical Research Council (MRC) said on Monday, Reuters reports.

15 Dec 2009

IOM issues review of national vaccine strategy

Reuters: To strengthen U.S. national vaccine strategy, the country "needs to establish a permanent group that advises the government on vaccine safety and spend more money to address safety concerns about vaccines," according to a report released Friday by the Institute of Medicine.

15 Dec 2009

Teva Pharmaceutical Industries receives approval for newly revised prescribing information for AZILECT

Teva Pharmaceutical Industries, Ltd. today announced the U.S. Food and Drug Administration (FDA) approved the newly revised prescribing information for AZILECT® (rasagiline tablets) reducing medication and food restrictions.

15 Dec 2009

Celebrex stops aspirin from doing its job effectively

Millions of Americans take Celebrex for arthritis or other pain. Many, if they are middle-aged or older, also take a low-dose aspirin tablet daily to reduce the risk of heart attack and stroke. Yet they may be getting little protection, because Celebrex keeps the aspirin from doing its job effectively, a new study suggests.

15 Dec 2009

Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

Alexza Pharmaceuticals, Inc. today announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA).

15 Dec 2009

Vion Pharmaceuticals receives complete response letter related to its NDA for Onrigin injection

VION PHARMACEUTICALS, INC. today announced that it had received a complete response letter from the U.S. Food and Drug Administration ("FDA") related to its New Drug Application ("NDA") for Onrigin(TM) (laromustine) injection submitted in February 2009.

14 Dec 2009

Amgen receives worldwide rights to Array’s small-molecule glucokinase activator program

Array BioPharma Inc. and Amgen Inc.(NASDAQ: AMGN) today announced that they entered into an agreement granting Amgen exclusive worldwide rights to Array’s small-molecule glucokinase activator program, including ARRY-403, currently being tested in a Phase 1 clinical trial in patients with Type 2 diabetes.

14 Dec 2009

Postmenopausal women who take antidepressants face increased risk for stroke and death

Postmenopausal women who take antidepressants face a small but statistically significant increased risk for stroke and death compared with those who do not take the drugs. The new findings are from the federally-funded, multi-institution, Women's Health Initiative Study sponsored by the National Institutes of Health, and the results are published in the December 14 online edition of Archives of Internal Medicine.

14 Dec 2009

Data mining by drug companies raises concern

The Los Angeles Times examines a practice called data mining in which drug companies track how doctors prescribe medications by obtaining data from pharmacies and health insurers.

14 Dec 2009

ZYPREXA RELPREVV approved by FDA

The U.S. Food and Drug Administration (FDA) approved ZYPREXA RELPREVV (olanzapine) For Extended Release Injectable Suspension for the treatment of schizophrenia in adults, Eli Lilly and Company announced today.

14 Dec 2009

Pharmaceutical News

INS cites FDA-approved Totect antidote for anthracycline extravasations

FDA publishes cGMPs for PET drugs

Health hazards of BPA: Call for FDA to make its announcement before Christmas

Study compares status of health care systems in U.S. and UK

USPTO issues Notice of Allowance to Transcept Pharmaceuticals for Intermezzo claims

Decision Resources: Atrial fibrillation drug market to increase more than sevenfold

New program to help maintain bone health in men with prostate cancer on ADT announced

Rexahn Pharmaceuticals and TheraTarget sign joint research collaboration agreement

Researchers advance in developing a vaccine against AIDS disease

Manchester Pharmaceuticals' Chenodal now available for patients suffering from gallstones

Microbicide does not reduce women's risk of HIV infection, study shows

IOM issues review of national vaccine strategy

Teva Pharmaceutical Industries receives approval for newly revised prescribing information for AZILECT

Celebrex stops aspirin from doing its job effectively

Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

Vion Pharmaceuticals receives complete response letter related to its NDA for Onrigin injection

Amgen receives worldwide rights to Array’s small-molecule glucokinase activator program

Postmenopausal women who take antidepressants face increased risk for stroke and death

Data mining by drug companies raises concern

ZYPREXA RELPREVV approved by FDA

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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