FDA approved combination therapy of Mekinist (trametinib) and Tafinlar (dabrafenib) for treatment of advanced melanoma that is unresectable or metastatic. In May 2013, FDA had already approved both drugs as single agents to treat patients with unresectable or metastatic melanoma, skin cancer.
New serendipitous discovery which may open a new concept of resisting bacteria from growing in body. Associate professor Aaron Oakley and his team reported that non-steroidal anti-inflammatory drugs (NSAIDs) are exhibit some antibacterial property and acting on DNA replication of bacteria.
Researchers found that twin pairs had similar progressions of Alzheimer’s Disease (AD) and dementia prior to death and even they also had similar combinations of pathogenesis in two or more unconnected areas of damage to the brain. This unique study was conducted by international team of researchers led by USC psychologist Margaret Gatz.
Novartis announced that Jakavi ® (ruxolitinib) showed positive reponse in compare to present therpies for Polycythemia Vera, a rare and incurable blood cancer with increase number of erythrocytes production. In phase III trial, Jakavi ® succeed to maintain hematocrit control, erythrocytes volume, without the need of phlebotomy and reducing spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea.
Karkhadi (Gujarat) based plant of Sun Pharmaceuticals imposed ban by USFDA. This ban is applied on import of all drug products from this plant. This detention was carried out without physical examination of drugs because company failed to met good manufacturing practices rules, as per FDA website on Wednesday.
During their last investigation in April 2013 at Canton Laboratories- Vadodara, U.S. food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) and in view of it, FDA issued a warning letter.
U.S. Food and Drug Administration allowed marketing of the first device, Cefaly-manufactured by STX-Med in Belgium, as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.
A blood test that can predict with 90 percent accuracy if a healthy person will develop mild cognitive impairment (MCI) or Alzheimer’s disease (AD) within three years has been discovered and validated by researchers at Georgetown and six other institutions. They discovered and validated 10 lipid biomarkers out of which 2 are strongly associated with neuropathology of AD.
A team of University of Notre Dame researchers led by Mayland Chang and Shahriar Mobashery have discovered a new class of antibiotics to fight bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and other drug-resistant bacteria that threaten public health.
Synthetic Biologics, Inc., a developer of anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and other diseases, announced today that the U.S. Patent & Trademark Office has issued U.S. Patent No. 8,658,627 entitled, Pregnancy Hormone Combination for Treatment of Autoimmune Diseases, to the Regents of the University of California (UCLA).
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