Celgene Corporation announced that data from the phase III RELIEF™ clinical trial of OTEZLA® (apremilast) in patients with active Behçet’s Disease with oral ulcers were presented in a late-breaking oral presentation at the 2018 American Academy of Dermatology (AAD) Annual Meeting. The results showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4).
WHO is announcing a new high-level commission, comprised of heads of state and ministers, leaders in health and development and entrepreneurs. The group will propose bold and innovative solutions to accelerate prevention and control of the leading killers on the planet – noncommunicable diseases (NCDs) like heart and lung disease, cancers, and diabetes.
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.
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.