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Melior Discovery signs option agreement with Pfizer

Melior Discovery, Inc. announced today that it has signed an option agreement that provides Pfizer Inc the exclusive right to negotiate a license to MLR-1023, Melior's drug candidate for Type II diabetes.

24 Jun 2008

Barr and Bayer sign agreements for launch of generic Yasmin and Yaz oral contraceptives

Barr Laboratories, Inc. has entered into supply and licensing agreements with Bayer for generic versions of Bayer's Yasmin (drospirenone and ethinyl estradiol) and Yaz (drospirenone and ethinyl estradiol) oral contraceptive products.

24 Jun 2008

Apollo acquisition boosts NZ biotech Symansis

New Zealand biotech Symansis has purchased Australian company Apollo Cytokine Research for A$500,000 (NZ$627,000) to build on its unique cell signaling science and fast track expansion into new international markets.

24 Jun 2008

FDA lifts clinical hold on Genta's Tesetaxel

Genta Incorporated announced that the Company has received notification from the U.S. Food and Drug Administration (FDA) that Genta may resume clinical trials with tesetaxel, a leading oral taxane in Genta's oncology product portfolio.

23 Jun 2008

Study shows generics now own 63% of Medicare Part D market

Wolters Kluwer Health, a division of Wolters Kluwer, has released the results of a study that looks at key statistical outcomes of the Medicare Part D (MPD) prescription drug program.

23 Jun 2008

Bionomics and Merck Serono to collaborate to discover and develop novel, oral treatment for MS

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that a Development and Licensing Agreement with Bionomics was signed, under which Merck Serono would develop new treatments for multiple sclerosis (MS) and other autoimmune conditions based on compounds from Bionomics Kv1.3 program.

19 Jun 2008

Pharmaceutical companies lobbying States to restrict use of lower-cost generic alternatives

Pharmaceutical companies, which "have been waging war against inexpensive generic drugs for years at the national level," are now "taking their fights to the states, promoting proposals that would" bar pharmacists from automatically replacing prescriptions for brand-name drugs with generics, the Baltimore Sun reports.

17 Jun 2008

Warning about use of psychiatric drugs with the elderly

Health officials in the U.S. are warning doctors that prescribing certain psychiatric drugs to elderly people suffering from dementia can increase their risk of death.

17 Jun 2008

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

Pharmaceutical News

Melior Discovery signs option agreement with Pfizer

Barr and Bayer sign agreements for launch of generic Yasmin and Yaz oral contraceptives

Apollo acquisition boosts NZ biotech Symansis

FDA lifts clinical hold on Genta's Tesetaxel

Study shows generics now own 63% of Medicare Part D market

Bionomics and Merck Serono to collaborate to discover and develop novel, oral treatment for MS

Pharmaceutical companies lobbying States to restrict use of lower-cost generic alternatives

Warning about use of psychiatric drugs with the elderly

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

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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