The U.S. Food and Drug Administration cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset, expanding the device’s indication to a broader group of patients.
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The U.S. Food and Drug Administration cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset, expanding the device’s indication to a broader group of patients.
As per notification dated 13 February 2018, NPPA fix retail prices of 9 formulations under Drugs Prices Control Order, 2013.
Sumitomo Dainippon Pharma Co., Ltd filed patent infringement lawsuits jointly with its U.S. subsidiary, Sunovion Pharmaceuticals Inc. (“Sunovion”) on February 13, 2018 (U.S. Eastern Time) in the U.S. District Court for the District of New Jersey against Emcure Pharmaceuticals Ltd. and in the U.S. District Court for the District of Delaware against Amneal Pharmaceuticals LLC regarding their submissions of Abbreviated New Drug Applications (“ANDAs”) for generic copies of LATUDA® (lurasidone HCl tablets). The lawsuits allege infringement of Sumitomo Dainippon Pharma’s U.S. Patent No. 9,815,827 (“the ’827 Patent”). These lawsuits are separate and different from the pending lawsuits, filed on January 14, 2015 in relation to Sumitomo Dainippon Pharma’s U.S. Patent No. 5,532,372.
The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, along with Federation of Indian Chambers of Commerce & Industry (FICCI), is organizing ‘India Pharma & India Medical Device 2018’, with the theme - ‘Affordable and Quality Healthcare’, the 3rd International exhibition and conference on Pharmaceutical & Medical Device sector from 15th-17th February, 2018 in Bengaluru.
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The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved ERLEADA™ (apalutamide), a next-generation androgen receptor inhibitor, for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). ERLEADA™ is the first FDA-approved treatment for these patients. Today’s approval follows an FDA Priority Review designation based upon data from the Phase 3 SPARTAN study, which demonstrated a 72 percent reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by more than two years (difference of 24.31 months) in patients with NM-CRPC.
Researchers at the Children's Medical Center Research Institute (CRI) at UT Southwestern have discovered that cells in the liver with whole genome duplications, known as polyploid cells, can protect the liver against cancer. The study, published online today in Developmental Cell, addresses a long-standing mystery in liver biology and could stimulate new ideas to prevent cancer.
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The increasing commercial collaboration between U.S. and Indian pharmaceutical companies is indicative of the ways in which U.S. companies are increasing their revenues from India and spreading their development costs. In view of such several development points, Indian pharma body urged U.S. Trade Representative (USTR) to remove India from Priority Watch List.
Jubilant Life Sciences Ltd has received Abbreviated New Drug Application (ANDA) final approval for Amantadine Hydrochloride Tablets, 100 mg, the generic version of Symmetrel® of Endo, which is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. It is also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions.
Directorate General of Health Services (DGHS) Office of Drugs Controller General (India) orders port offices to release all the consignments of imported Insulin formulations including consignments released on letter to avoid shortage of such lifesaving drugs.
There has been a 66% decline in the estimated number of annual new HIV infections in the country from 2000 to 2015, against the global average of 35%.