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FDA grants CLIA waiver to American Bio Medica for drug test

American Bio Medica Corporation has announced today that the US Food and Drug Administration (FDA) has granted CLIA waived status to the Company's Rapid TOX point of collection drug test product line.

From Medica Corporation 27 Aug 2008

Drug Lucentis to save eyesight of thousands in the UK

The eyesight of thousands of people in the UK will be saved with a new drug available under the National Health Service.

27 Aug 2008

Stanford University to limit pharmaceutical industry financing of CME

Stanford University officials on Tuesday plan to announce a new policy under which pharmaceutical and medical device companies no longer will have the ability to select continuing medical education courses that they seek to finance for physicians at the university's School of Medicine, the New York Times reports.

26 Aug 2008

Stanford Medical School severely restricts industry funding of continuing education for physicians

The Stanford University School of Medicine will no longer accept support from pharmaceutical or device companies for specific programs in continuing medical education, as industry-directed funding may compromise the integrity of these education programs for practicing physicians, officials said.

26 Aug 2008

Lack of oversight by CMS to ensure private Medicare drug plans have anti-fraud programs in place 'risks significant use of funds,' according to GAO

CMS has not conducted audits to ensure that Medicare prescription drug plans have implemented programs to prevent fraud as required by law, a lack of oversight that "risks significant misuse of funds in this $39 billion program," according to a Government Accountability Office report scheduled for release on Monday, the AP/Orlando Sentinel reports. For the report, GAO examined five unnamed plans to determine whether they met requirements to participate in the Medicare prescription benefit.

26 Aug 2008

FDA issues new rules on product warning label updates for pharmaceuticals, medical devices

FDA last week issued new rules that aim to ensure medication warning labels provide clear and concise information to consumers, the AP/Denver Post reports.

26 Aug 2008

Galapagos acquires structure-based drug discovery from Sareum

Galapagos NV and Sareum Holdings plc has announced today that Galapagos has acquired Sareum's assets in drug discovery services, for a total cash consideration of EUR 695,000 (£553,000). These assets will position Galapagos' service division BioFocus DPI strongly in the growing field of structure-based drug discovery.

26 Aug 2008

AIDS Healthcare Foundation blasts GlaxoSmithKline print advertisements that promote fear of HIV treatment

AIDS Healthcare Foundation (AHF) is blasting British multi-national drug giant GlaxoSmithKline (GSK) for a recent series of direct-to-consumer print advertisements that, under the guise of patient education, capitalize on patients' fears of HIV treatment.

25 Aug 2008

NicOx updates on PF-03187207 and research collaboration with Pfizer

NicOx S.A. has announced the results of a dose-ranging phase 2 study conducted with PF‑03187207 in Japanese patients with glaucoma by its partner Pfizer Inc. PF-03187207 is a nitric oxide-donating prostaglandin analog. The study was designed to compare the safety and efficacy of several doses of PF-03187207 to Xalatan (latanoprost) and enrolled 112 Japanese patients with primary open-angle glaucoma or ocular hypertension.

25 Aug 2008

FDA approves Nplate (romiplostim), first bone marrow stimulator for chronic immune thrombocytopenic purpura

The U.S. Food and Drug Administration has approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.

24 Aug 2008

Cymbalta approved in Europe for generalised anxiety disorder

Eli Lilly and Co and Boehringer Ingelheim have announced that the European Commission has approved the use of Cymbalta (duloxetine) for the treatment of Generalised Anxiety Disorder (GAD).

24 Aug 2008

OncoGenex Pharmaceuticals' OGX-011 granted FDA fast track status

OncoGenex Pharmaceuticals has announced that OGX-011, also known as custirsen sodium, received Fast Track designation from the U.S. Food & Drug Administration (FDA) in combination with docetaxel for progressive metastatic prostate cancer.

24 Aug 2008

Warning issued on dangers of diabetes drug Avandia

Thousands of Australians who are taking the diabetes drug Avandia (rosiglitazone) have been urged by the drug's manufacturer to see their doctors following safety issues concerning the medication.

20 Aug 2008

Eli Lilly acquires SGX Pharmaceuticals

Eli Lilly and Company has announced that it has completed the acquisition of SGX Pharmaceuticals, Inc. (Public, NASDAQ:SGXP), a San Diego-based biotechnology company focused on drug discovery and development in the area of oncology.

20 Aug 2008

First drug for Huntington's disease approved for use in the U.S.

Huntington's disease is a fatal, inherited neurodegenerative disorder for which there is no cure and usually affects people in their 30s and 40s, but some patients are affected as early as childhood, while others aren't affected until they are older.

18 Aug 2008

Actavis receives approval of generic Wellbutrin in U.S.

Actavis Group today announced that it has received approval from the U.S. Food & Drug Administration to market Bupropion Hydrochloride extended-release tablets (XL) 300mg. Distribution of the product will commence immediately.

18 Aug 2008

Pancreatitis link to Gardasil to be investigated by the TGA

Some Australian doctors are suggesting that a review of the cervical cancer vaccine Gardasil is called for after three patients contracted pancreatitis after having the vaccination.

18 Aug 2008

Breakthrough drug FT-11 has the potential to end the need for dialysis in kidney disease

Australian scientists say they have developed a drug with the potential to save millions of lives from kidney disease.

18 Aug 2008

Researchers create synthetic heparin

Robert Linhardt has spent years stitching together minuscule carbohydrates to build a more pure and safer alternative to the commonly used and controversial blood thinner heparin. At the national conference of the American Chemical Society on August 17, 2008, Linhardt announced that his research team may have accomplished this task by building the first fully synthetic heparin. Their creation is the largest dose of heparin ever created in the lab.

17 Aug 2008

FDA approves tetrabenazine for Huntington's disease

The U.S. Food and Drug Administration has approved tetrabenazine, the first drug approved for use in the United States to treat Huntington's disease, a fatal, inherited neurodegenerative disorder for which there is no cure. The action comes about eight months after an advisory panel unanimously voted to advise FDA to make the medication available to treat the disease.

17 Aug 2008