Thursday, October 9, 2014

Crizotinib drug effectively halts growth of ROS1-positive lung tumors

In continuation of my update on crizotinib

Treatment with the targeted therapy drug crizotinib effectively halts the growth of lung tumors driven by rearrangements of the ROS1 gene. In an article receiving Online First publication in the New England Journal of Medicine to coincide with a presentation at the European Society for Medical Oncology meeting, an international research team reports that crizotinib treatment led to significant tumor shrinkage in 36 of 50 study participants and suppressed tumor growth in another 9.

"Prior to this study, there were a handful of reports describing marked responses to crizotinib in individual patients with ROS1-positive lung tumors," says Alice Shaw, MD, PhD, of the Massachusetts General Hospital (MGH) Cancer Center, lead author of the NEJM report. "This is the first definitive study to establish crizotinib's activity in a large group of patients with ROS1-positive lung cancer and to confirm that ROS1 is a bona fide therapeutic target in those patients."

Crizotinib currently is FDA-approved to treat non-small-cell lung cancers (NSCLC) driven by rearrangments in the ALK gene, which make up around 4 percent of cases. An MGH Cancer Center report published in 2012 reported that 1 to 2 percent of NSCLCs are driven by rearrangements in ROS1, which encodes a protein with significant structural similarities to that encoded by the ALK gene.

FDA Approves Iluvien for Diabetic Macular Edema

pSivida Corp., a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Iluvien for the treatment of diabetic macular edema (DME). It is indicated for patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). A single injection of the Iluvien micro-insert provides sustained treatment of DME for 36 months. Approximately 560,000 people in the U.S. are estimated to have clinically significant DME, the most frequent cause of vision loss in individuals with diabetes and the leading cause of blindness in young and middle-aged adults in developed countries. Iluvien is expected to be commercially available in the U.S. in early 2015.


Wednesday, October 8, 2014

Candidate H7N9 avian flu vaccine works better with adjuvant

Candidate H7N9 avian flu vaccine works better with adjuvant

Researchers Discover How Bacteria Resist Antibiotics in Hospitals

Tiny circles of DNA called plasmids appear to be the culprit. They can easily enter bacteria and move from one bacteria to another, and some carry a gene that makes bacteria drug-resistant, a new study finds.
"The plasmids we are talking about carry an antibiotic-resistant gene to a class of antibiotic called carbapenems," said the study's co-author, Dr. Tara Palmore, an infection control specialist at the U.S. National Institutes of Health.
Carbapenems are antibiotics of last resort, and carbapenem-resistant Enterobacteriaceae (CRE) are bacterial pathogens that pose a "formidable" threat to hospitalized patients, according to the research.
The incidence of CRE has quadrupled in the last decade in the United States, according to background information in the report. CRE has been detected in nearly 4 percent of hospitals and about 18 percent of long-term acute care facilities. In addition, the researchers noted, CRE are resistant to most, if not all, antibiotics. Investigations have reported a death rate of 40 percent to 80 percent from infection.
Given ongoing concerns that even bacteria like Klebsiella and Enterobacter -- which are found in the environment and in healthy stomachs -- are becoming increasingly resistant to last-resort antibiotics, the researchers set out to find some answers. Their report, published Sept. 17 inScience Translational Medicine, showed that plasmid transfer in hospitals is likely contributing to the increase in antibiotic-resistant bacteria.

Tuesday, October 7, 2014

FDA Approves Triumeq for the Treatment of HIV-1 Infection

In continuation of my update on Triumeq

ViiV Healthcare announced today that the U.S. Food and Drug Administration (FDA) has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection. Triumeq is ViiV Healthcare’s first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.

FDA Approves Contrave (bupropion/naltrexone) for Weight Management

In continuation of my update on bupropion/naltrexone

The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.

Monday, October 6, 2014

The Nobel Prize in Physiology or Medicine 2014

The Nobel Prize in Physiology or Medicine 2014

FDA Approves Otezla (apremilast) for Moderate to Severe Plaque Psoriasis

 In continuation of my update on Apremilast (brand name Otezla) is an orally available small molecule inhibitor of phosphodiesterase 4 (PDE4). Apremilast specifically inhibits PDE4 and inhibits spontaneous production of TNF-alpha from human rheumatoid synovial cells. It has anti-inflammatory activity.



FDA Approves Spiriva Respimat (tiotropium) for the Maintenance Treatment of COPD

We know that, Tiotropium bromide  is a long-acting, 24 hour, anticholinergic bronchodilator used in the management of chronic obstructive pulmonary disease (COPD). Tiotropium bromide capsules for inhalation are co-promoted by Boehringer-Ingelheimand Pfizer under the trade name Spiriva. It is also manufactured and marketed by Cipla under trade name Tiova.


Now Boehringer Ingelheim Pharmaceuticals, Inc. announced  that the U.S. Food and Drug Administration (FDA) approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily


Friday, October 3, 2014

FDA Approves Vitekta (elvitegravir) for HIV-1 Infection

We know that, Elvitegravir (EVG, formerly GS-9137) is a drug used for the treatment of HIV infection. It acts as an integrase inhibitor. It was developed by the pharmaceutical company Gilead Sciences, which licensed EVG from Japan Tobacco in March 2008.[2][3][4]The drug gained approval by U.S. Food and Drug Administration on August 27, 2012 for use in adult patients starting HIV treatment for the first time as part of the fixed dose combination known as Stribild.