Pharma News

FDA approves first implantable hearing device

The U.S. Food and Drug Administration approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids.

Scientists identified genetic diversity of K.Pneumoniae (drug-resistant bacteria)

New findings, by group of scientists, will facilitate the development of new clinical strategies design to prevent or treat infections caused by multidrug-resistant Klebsiella Pneumoniae. Scientists from National Institutes of Health (NIH) and their colleagues have tracked the evolution of the Carbapenem-resistant bacterium K.pneumoniae sequence type 258 (ST258), an important agent of hospital-acquired infections by using genome sequencing.

Health Ministry notified on implementation of Schedule H1 drugs in D&C rules | No more OTC selling of antibiotics

The Drugs and Cosmetics Rules, 1945 (D&C rules) were amended vide Drugs and Cosmetics (Fourth Amendment) Rules, 2013 published under Gazette notification G.S.R. 588(E) dated 30.08.2013 regarding the inclusion of Schedule H1 under the D&C rules containing certain antibiotics, anti-TB drugs and habit forming drugs. The notification states that these rules will come into force after six months of their publication in the official Gazette i.e. from 1st March, 2014

New discovery can delay Alzheimer's development

Researchers from Michigan University have found out cellular structure called the Golgi that mysteriously becomes fragmented in all Alzheimer's patients and looks like major cause of Alzeimer's Disease (AD). this mechanism helps decode amyloid plaque formation in the brains of Alzheimer's patients—plaques that kills cells and contributes to memory loss and other Alzheimer's symptoms.
The researchers discovered the molecular process behind Golgi fragmentation, and also developed two techniques to 'rescue' the Golgi structure.

Government lifting ban from Analgin

Indian health ministry revoked the ban from Analgin, potent analgesic and antipyretic. Last year in June 2013, government issued a ban on manufacturing and selling of analgin in country because it is involved in risk to human beings and whereas safer alternatives of analgin are available. After revoking ban from pioglitazone, this is the second time when ministry has lifted ban from a drug.

U.S. FDA approval for Eliquis® (apixaban) to reduce risk of thrmobosis in Hip or Knee Replacement Surgery

Bristol-Myers Squibb Company and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

GSK marketed products Mekinist in combination with Tafinlar received FDA nod for Advanced Melanoma

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.

Novartis's Jakavi ® shows positive Phase III results in Polycythemia Vera

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.

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