Pharma News

The government is looking to bring in a new pharma policy for implementing the proposed healthcare plan across the country in the next couple of months, Union Chemicals and Fertilisers Minister Ananth Kumar said. The big healthcare initiative announced in the budget for 2018-19 seeks to cover 10 crore households requires many verticals -- infrastructure, human resources and pharma and medical device products, Kumar told.

A Memorandum of Understanding (MoU) was signed among Andhra Pradesh MedTech Zone (AMTZ), Quality Council of India (QCI) and Association of Indian Manufacturers of Medical Devices (AIMED) to form Indian Bio-medical Skill Consortium (IBSC).

FSSAI has notified the Food Safety and Standards (Import) First Amendment Regulations, 2018.

This notification amends the requirement relating to
a. shelf life of imported product at the time of port clearance. As per this notification, Custom Authorities shall not clear any article of food unless it has a valid shelf life of not less than sixty per cent, or three months before expiry, whichever is less, at the time of import”
b.  Further, one more provision stating “the importer shall submit certificate of sanitary export from authorized agencies in exporting countries for the categories of food as may be specified by the Food Authority from time to time” has also been inserted. This will help in the risk prioritization and in effectively dealing with high risk products intended for import.

The U.S. Drug Enforcement Administration has launched a new tool to assist drug manufacturers and distributors with their regulatory obligations under the Controlled Substances Act.

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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