Chemotherapy is the best broad defense against cancer recurrence after surgical resection. However, it is difficult to predict which patients will benefit from which regimen of anticancer drugs, if at all. Building on existing knowledge, a study published in the September edition of the Journal of Thoracic Oncology (JTO), analyzed the usefulness of adjuvant chemotherapy [...]

BioDelivery Sciences International, Inc. today announced a positive meeting with the U.S. Food and Drug Administration (FDA), Meda and BDSI that occurred on Wednesday, July 21, 2010 to discuss significant modifications to the existing Risk Evaluation and Mitigation Strategy (REMS) program for ONSOLIS (fentanyl buccal soluble film). “Much has been learned over the past year [...]

Around the world, malaria, transmitted by mosquitoes, is the most significant parasitic disease of humans and claims the lives of more children worldwide than any other infectious disease. Most prevalent in sub-Saharan Africa, 98% of malaria infections, approximately 243 million cases every year, occur in Africa. An estimated 863,000 malaria deaths are among children in [...]

Metformin, a drug commonly used to treat type 2 diabetes, shows potential in the prevention of tobacco-induced lung tumors, according to early research conducted at the National Cancer Institute (NCI). Results of this study will be published in the September issue of Cancer Prevention Research, a journal of the American Association for Cancer Research. Scott [...]

The Swiss health authority Swissmedic has granted approval for Tasigna® (nilotinib) 300 mg twice daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna is the first new therapeutic option for newly diagnosed patients since the introduction of Glivec® (imatinib), providing a major advance [...]

Actavis has received approval from the U.S. Food & Drug Administration to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder (ADHD). Actavis intends to market Atomoxetine HCl in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths. No release date for Atomoxetine, Actavis’ generic equivalent [...]

Sun Pharmaceutical Industries Ltd. SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Strattera ®, atomoxetine hydrochloride capsules. These generic atomoxetine hydrochloride capsules are equivalent to Eli Lilly’s Strattera ® capsules and include six strengths: 10 mg, [...]

A drug widely used to treat high blood sugar in type 2 diabetics may hold some promise in the prevention of tobacco-induced lung cancer, according to extremely preliminary findings in a mouse study. In the September issue of Cancer Prevention Research, researchers report that metformin was associated with a substantial reduction (up to 73 percent) [...]

CHICAGO – An antibiotic that gets its microbe-fighting power from insect proteins was effective at attacking a common infection that afflicts blast victims in war zones, U.S. researchers said Wednesday. The antimicrobial peptide — a fragment of a larger protein found in certain insects — helped speed wound healing and clear infections in mice infected [...]

A growing body of evidence suggests that the widely used diabetes drug metformin can reduce the risk of cancer, researchers said Wednesday. A study in mice exposed to tobacco carcinogens shows that the drug can reduce the development of lung tumors by more than 70%, and results from a small clinical trial in Japan suggest [...]

The specialty pharmaceutical company Allergan has agreed to pay $600 million to settle civil and criminal accusations that it illegally marketed Botox, the drug used in antiwrinkle injections, for medical uses for which the drug had not been approved. In the settlement with the Justice Department, the company agreed to plead guilty to one misdemeanor [...]

Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company’s Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba®. The FDA indicated its agreement with Bionovo’s plan. This agreement provides the necessary groundwork for the Company to progress to [...]

The Food and Drug Administration will consider placing restrictions of the sale of over-the-counter cold remedies containing dextromethorphan, such as Robitussin and Coricidin, according to an agency memo. An advisory committee will meet on Sept. 14 to review data on the misuse of cough-and-cold remedies among children and adolescents — an activity known as robo-tripping. [...]

Sangart, Inc., today announced positive results from its Phase IIa proof-of-concept study of MP4OX (oxygenated pegylated hemoglobin) in severely injured trauma patients with hemorrhagic shock causing lactic acidosis. The study demonstrated that MP4OX, when given in addition to standard of care, was effective at decreasing lactate levels in treated patients. During hemorrhagic shock, inadequate perfusion [...]

The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) awarded a contract to develop an antibiotic that could be used against possible two types of bioterrorism as well as common infections that are becoming resistant to antibiotics. The contract to Achaogen Inc. of San Francisco is for $27 million [...]