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Allergan plc and Adamas Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new, expanded label for NAMZARIC® (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI).
Ajanta Pharma Limited received final approval from US FDA and launched Omeprazole and Sodium Bicarbonate Capsules in the US market, through its wholly owned subsidiary Ajanta Pharma USA Inc.
U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for a 500mg chewable tablet formulation of mebendazole from Janssen Pharmaceuticals.
For HIV-infected mothers whose immune system is in good health, taking a three-drug antiretroviral regimen during breastfeeding essentially eliminates HIV transmission by breast milk to their infants, according to results from a large clinical trial conducted in sub-Saharan Africa and India
Biologists and mathematicians from MIPT, Stony Brook University and other scientific research centres have taught a computer to predict the structure of protein complexes in a cell 10 times faster than before. The study has been published in Proceedings of the National Academy of Sciences of the USA.
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US Food and Drug Administration (FDA) has granted fast track designation for Auris Medical's KeyzilenTM (AM-101) in acute peripheral (inner ear) tinnitus following cochlear injury or otitis media in adults.
ANI Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) of the Abbreviated New Drug Application (ANDA) for nilutamide tablets which is first generic competitor to Nilandron®. Trailing twelve- month sales of Nilandron® were $23 million according to IMS Health.
Sun Pharma Advanced Research Company Ltd. And Sun Pharmaceutical Industries Ltd. and includes its subsidiaries or associate companies) announced a licensing arrangement for SPARC’s ELEPSIA XRTM (Levetiracetam Extended Release tablets).
Celgene International Sàrl, announced that the European Commission (EC) has approved REVLIMID® (lenalidomide) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
MCL is a rare sub-type of aggressive non-Hodgkin's lymphoma (NHL), which starts in the lymph nodes but can move to other organs, causing tumours known as lymphomas. Between 3 and 6 percent of NHL patients have MCL. MCL has the poorest long-term survival of all B-cell lymphoma subtypes, with fewer than 50 percent of patients surviving at 5 years. In Europe there were 93,433 new cases of non-Hodgkin lymphoma, and 37,900 deaths in 2012. MCL has a median age of onset of 70 years and affects men more often than women.
Celgene International Sàrl, announced that the European Commission (EC) has approved REVLIMID® (lenalidomide) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
MCL is a rare sub-type of aggressive non-Hodgkin's lymphoma (NHL), which starts in the lymph nodes but can move to other organs, causing tumours known as lymphomas. Between 3 and 6 percent of NHL patients have MCL. MCL has the poorest long-term survival of all B-cell lymphoma subtypes, with fewer than 50 percent of patients surviving at 5 years. In Europe there were 93,433 new cases of non-Hodgkin lymphoma, and 37,900 deaths in 2012. MCL has a median age of onset of 70 years and affects men more often than women.
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