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New drugs the next casualty of the credit crunch

Scientists at an international conference have been warned that the next casualty of the credit crunch could be new drugs.

27 Oct 2008

Gardasil safety questioned, CDC urged to back up statement with data

The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects.

26 Oct 2008

Mylan receives tentative FDA approval for generic versions of Benicar and Uroxatral

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg.

22 Oct 2008

CytoDyn files new IND for Cytolin

CytoDyn, Inc. has filed a new IND for a study to reconfirm dose ranging and to "prove the principle" with a randomized, double-blind placebo controlled study of Cytolin, the Company's first-in-class drug for treating HIV/AIDS. This comes 13 years after the first IND was issued for the drug.

22 Oct 2008

Aires Pharmaceuticals signs license agreement with NIH

Aires Pharmaceuticals Inc. today announced the signing of an exclusive license agreement with the U.S. National Institutes of Health for the patented use of a nitric oxide prodrug to treat cardiopulmonary conditions.

22 Oct 2008

Trius Therapeutics awarded $28 million to develop novel drugs targeting bacterial DNA Gyrase and Topoisomerase IV

Trius Therapeutics, Inc., today announced the award of a $28 million contract from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, for the development of novel antibiotics directed against multiple Gram-negative bacterial pathogens.

22 Oct 2008

FDA grants orphan drug status to new 'Trojan Horse' like Ewing's Sarcoma drug

The Cure Our Children Foundation, a nonprofit charitable foundation dedicated to children, announced today that the U.S. Food and Drug Administration (FDA) has approved the Orphan Drug Designation of the foundation's unique drug product for children with Ewing's Sarcoma cancer. The efforts to develop this drug were made possible by the generous volunteers and researchers in private industry and at two universities.

20 Oct 2008

Teva granted FDA approval for Fentanyl transdermal system

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the AB-rated generic equivalent of Ortho McNeil's chronic pain treatment Duragesic. Shipment of this product has commenced.

20 Oct 2008

Better TB vaccine in the pipeline

Scientists in the U.S. believe they have a vaccine in the pipeline that offers better protection from tuberculosis (TB).

20 Oct 2008

FDA approves Astepro, new formulation of Astelin

The U.S. Food and Drug Administration (FDA) has approved Astepro - the new formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients using the new spray.

19 Oct 2008

FDA approves new labeling for psoriasis drug Raptiva

The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance.

19 Oct 2008

FDA grants orphan drug status to Reata's pancreatic cancer drug

Reata Pharmaceuticals, Inc. has announced that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease.

16 Oct 2008

Vioxx heart risks confirmed in long-term study

The study, an analysis of people who took the arthritis drug carried out by Dr. Robert Bresalier of the M.D. Anderson Cancer Center at the University of Texas, has found Vioxx doubles the risk of strokes and heart attacks.

14 Oct 2008

TB Alliance enters into collaboration with sanofi-aventis to fight tuberculosis

The Global Alliance for TB Drug Development (TB Alliance) and sanofi-aventis announced today that they have entered into a collaboration agreement to accelerate the discovery, development and clinical use of drugs against tuberculosis (TB). The TB Alliance is a not-for-profit, product development partnership, whose goal is the development of new TB drugs.

14 Oct 2008

OncoGenex achieves key regulatory milestone for lead product candidate

OncoGenex Pharmaceuticals Inc. today announced that it concluded a meeting with the U.S. Food and Drug Administration (FDA) on October 7, 2008, and that the FDA agreed that "durable pain palliation is an acceptable and desirable study endpoint" to support a product marketing approval for OGX-011 as a treatment for hormone refractory prostate cancer (HRPC).

13 Oct 2008

New maturation inhibitor drugs may help solve HIV treatment conundrum

Since AIDS was first recognized in 1981, significant advances have been made in developing an effective arsenal of drugs to manage the disease and extend patients' lives.

13 Oct 2008

Drug companies plan to invest in HIV/AIDS drug development, improve access, U.N. Secretary-General says

United Nations Secretary-General Ban Ki-moon on Thursday said that many large pharmaceutical companies -- including Abbott Labs, Boehringer Ingelheim, GlaxoSmithKline and Pfizer -- plan to increase their efforts to develop HIV/AIDS drugs and diagnostics for impoverished regions, Reuters reports.

13 Oct 2008

Kinaxo partners with Boehringer Ingelheim

Kinaxo Biotechnologies GmbH announced today that it has entered into a two-year collaboration with Boehringer Ingelheim. Under the agreement Kinaxo will apply its new platform technologies to studies on drug mode of action and target identification. Financial details of the agreement were not disclosed.

13 Oct 2008

FDA continues review of Takeda's NDA for Alogliptin

Takeda Pharmaceutical Company Limited has announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

12 Oct 2008

FDA licenses Kogenate FS to prevent joint damage in children with hemophilia A

The U.S. Food and Drug Administration has approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.

12 Oct 2008