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Death rate linked to comtaminated heparin almost doubles

The drug watchdog in the U.S., the Food and Drug Administration (FDA) have updated the number of deaths in patients who took the drug heparin.

17 Jun 2008

ExpIND process speeds Alzheimer's drug research

Researchers are actively cutting the time and cost it normally takes to develop radiopharmaceuticals by taking advantage of "Exploratory Investigational New Drug" (ExpIND), an FDA-sanctioned procedure that enhances post-discovery drug development while observing scientific and patient safety standards.

16 Jun 2008

Bionovo discovers new estrogen regulatory elements for breast cancer and osteoporosis drugs

Bionovo Inc. today announced results on the role of estrogen regulatory elements important in developing drugs for breast cancer and osteoporosis.

16 Jun 2008

Cymbalta approved for fibromyalgia

The U.S. Food and Drug Administration (FDA) has approved Cymbalta (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company announced.

16 Jun 2008

Mylan announces FDA approval for generic Effexor and tentative approval for generic antihypertensive Avalide

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 Venlafaxine Hydrochloride (HCl) Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).

16 Jun 2008

Antipsychotic drugs get FDA label changes

The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

16 Jun 2008

Collaborative effort by FDA and EMEA expected to yield additional safety data when assessing new drugs

In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

15 Jun 2008

Bill should be passed allowing terminally ill access to experimental drugs, journal op-ed states

The case of Sen. Edward Kennedy (D-Mass.), who has been diagnosed with brain cancer, is "identical from a regulatory standpoint to the plight of hundreds of thousands of other Americans" and "shouts to the heavens the humane necessity of urgent reform in the drug approval process to make it work better for people who have serious and terminal diseases," according to a Wall Street Journal opinion piece by Steven Walker and Ronald Trowbridge, chief adviser and adjunct scholar, respectively, of the Abigail Alliance for Better Access to Developmental Drugs.

11 Jun 2008

Compugen announces discovery of novel drug targets for cancer antibody therapeutics

Compugen Ltd. announced today the discovery of more than ten novel targets of antibody therapy for various types of solid and hematopoietic cancer.

11 Jun 2008

Maxygen receives approval for trial of factor VIIa in UK

Maxygen, Inc. today announced that it has filed a Clinical Trial Authorization (CTA) and received the necessary approvals in the United Kingdom to initiate a first-in-human Phase I trial of MAXY-VII in hemophilia patients.

11 Jun 2008

Hope on the horizon for migraine sufferers

A generation of anti-migraine drugs with fewer side effects than existing treatments could be available to sufferers within three years.

11 Jun 2008

Sen. Grassley issues report on conflict-of-interest probe into improper payment disclosures by three Harvard psychiatrists

Three well-known psychiatric researchers from Harvard Medical School may have violated federal and educational institution regulations by failing to properly disclose drug industry payments and other conflicts of interest, according to an investigation report published last week by Sen. Chuck Grassley (R-Iowa) in the Congressional Record, the Wall Street Journal reports (Armstrong, Wall Street Journal, 6/9).

10 Jun 2008

Calls for tougher rules on complementary medicines in Australia

Pressure from a consumer group has prompted the Australian Federal Government to consider the introduction of far more stringent disclosure rules regarding complementary medicines.

10 Jun 2008

Administration proposes additional funding for FDA for fiscal year (FY) 2009

HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

9 Jun 2008

Mylan announces final FDA approval for Zaleplon capsules, generic version of Sonata

Mylan Inc. has announced that its subsidiary, Genpharm ULC, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zaleplon Capsules, 5 mg and 10 mg.

9 Jun 2008

Cancer warning on diabetic ulcer gel

The U.S. watchdog the Food and Drug Administration (FDA) says a warning will be added to the label of a topical gel used to treat leg and foot ulcers which refuse to heal in diabetic patients.

9 Jun 2008

Nearly 75% of Medicare drug plan beneficiaries will pay 16% more for coverage this year

Monthly premiums for Medicare beneficiaries enrolled in the 10 largest prescription drug plans this year increased by an average of 16% to $26.39, according to an analysis released on Wednesday by Avalere Health, the Los Angeles Times reports.

8 Jun 2008

Boehringer, Gilead freeze antiretroviral prices for some U.S. agencies

Pharmaceutical companies Boehringer Ingelheim and Gilead Sciences are freezing the prices of their antiretroviral drugs for select agencies in the U.S., the AIDS Healthcare Foundation announced on Tuesday, Bloomberg reports.

8 Jun 2008

GlaxoSmithKline Acquires Sirtris Pharmaceuticals

GlaxoSmithKline has announced that it has completed its acquisition of Sirtris Pharmaceuticals, Inc. (Sirtris) for approximately USD720 million (or approx. GBP362 million) through a cash tender offer and merger of USD22.50 (or approx. GBP11.33) per share.

8 Jun 2008

FDA announces label changes for Regranex - boxed warning

The U.S. Food and Drug Administration has announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

8 Jun 2008

Pharmaceutical News

Death rate linked to comtaminated heparin almost doubles

ExpIND process speeds Alzheimer's drug research

Bionovo discovers new estrogen regulatory elements for breast cancer and osteoporosis drugs

Cymbalta approved for fibromyalgia

Mylan announces FDA approval for generic Effexor and tentative approval for generic antihypertensive Avalide

Antipsychotic drugs get FDA label changes

Collaborative effort by FDA and EMEA expected to yield additional safety data when assessing new drugs

Bill should be passed allowing terminally ill access to experimental drugs, journal op-ed states

Compugen announces discovery of novel drug targets for cancer antibody therapeutics

Maxygen receives approval for trial of factor VIIa in UK

Hope on the horizon for migraine sufferers

Sen. Grassley issues report on conflict-of-interest probe into improper payment disclosures by three Harvard psychiatrists

Calls for tougher rules on complementary medicines in Australia

Administration proposes additional funding for FDA for fiscal year (FY) 2009

Mylan announces final FDA approval for Zaleplon capsules, generic version of Sonata

Cancer warning on diabetic ulcer gel

Nearly 75% of Medicare drug plan beneficiaries will pay 16% more for coverage this year

Boehringer, Gilead freeze antiretroviral prices for some U.S. agencies

GlaxoSmithKline Acquires Sirtris Pharmaceuticals

FDA announces label changes for Regranex - boxed warning

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