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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

Update on new clinical developments and other initiatives related to Ceplene

EpiCept Corporation today provided an update on new clinical developments and other initiatives related to Ceplene® (histamine dihydrochloride), the Company’s therapy approved in the European Union for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission.

15 Dec 2009

Tel Aviv University researchers unravel the mysteries of DNA packaging

The RNA "spools" that make up DNA in our genes need careful editing, too. Genes are composed of meaningful sequences, called exons, separated by meaningless junk sections called introns.

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

Study may pave way for effective drug development for childhood leukemia

A new study could point the way to the development of better drugs to fight a deadly form of childhood leukemia called mixed-lineage leukemia (MLL).

15 Dec 2009

Senate holdouts threatening '09 health care reform bill passage

The Washington Post: "The next 48 hours will be critical to the fate of health-care reform in the Senate, as Democratic leaders struggle to settle disputes that stand in the way of holding a final vote this year on the massive package reports on the distance among senators that has to be bridged before a bill can pass."

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

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

Study shows elderly blacks more likely to skip medication compared to white counterparts

Older adults experience a number of medication-related problems, including under treatment, suboptimal drugs, suboptimal dosing, and non-adherence, which can have negative effects on their quality of life. Now new research, from the UNC Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill shows that blacks have more medication-related problems than whites, and non-adherence to medical regimens is a particular issue for this group.

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

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

FDA grants EUA for DxNA’s 2009 H1N1 influenza virus diagnostic test

DxNA announced today that the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its 2009 H1N1 influenza virus diagnostic test for use in DxNA's GeneSTAT(TM) detection platform.

14 Dec 2009

Clarient and BioView team up to develop diagnostic tool for early detection of lung cancer

Clarient, Inc., a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, and BioView Ltd. (TASE: BIOV) today jointly announced that they will collaborate on studies to validate the clinical utility of a non-invasive test for the early detection of non-small cell lung cancer.

14 Dec 2009

Researchers discover enzyme activity behind sleep deprivation

There is hope for those who miss one night too many or whose children keep them up at night. The unwelcome effects of a bad night's sleep - forgetfulness, impaired mental performance - can be dealt with by reducing the concentration of an enzyme in the brain. These are the conclusions of research published by Rubicon-grant winner Robbert Havekes and colleagues in the 22 October issue of Nature.

14 Dec 2009

New technological system to help improve availability of anti-malarial drugs in Tanzania

A new solution developed by IBM ( IBM), Novartis and Vodafone with the Roll Back Malaria Partnership, is helping to save lives using everyday technology to improve the availability of anti-malarial drugs in remote areas of Tanzania.

14 Dec 2009

Allen & Caron selected as Ohr Pharmaceutical's agency for investor relations

Ohr Pharmaceutical Inc. announced today it has selected Allen & Caron Inc, headquartered in Irvine, CA, with offices also in New York and London, as its agency for investor relations and corporate communications.

14 Dec 2009

Psychopharmacology expert calls for more mental health staffing at army bases

The recent shootings at the Ft. Hood, Texas army base, allegedly by an army psychiatrist, have placed much-needed focus on mental health care in the army. In an article published in the December issue of the journal CNS Spectrum, renowned psychopharmacology expert Stephen M. Stahl, MD, PhD, calls for increased mental health staffing at Fort Hood and other army bases.

14 Dec 2009

Hormone therapy: An important treatment option for post-menopausal women

In connection with the New York Times’ recent coverage of hormone therapy1, Pfizer Inc. today released important facts and context to respond to the newspaper’s account. Pfizer believes the coverage is based on a misleading and selective reading of both the science and history of hormone therapy (HT) medicines.

14 Dec 2009