Pharma News

The central government has ordered pharmacies to display generic drugs on separate shelves so that consumers can opt for generic medicine to expensive brand name drugs.
Drug Comptroller General has issued a letter to all states and union territories to provide a shelf for display of generic medicines.

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WHO Director-General Dr Tedros Adhanom Ghebreyesus is joining Prime Minister António Costa of Portugal to launch the new "WHO Global action plan on physical activity and health 2018-2030: More active people for a healthier world."  Physical inactivity is more than a health challenge: the financial costs are also enormous.

FDA and the USDA announced the alignment of the USDA Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of the FDA Food Safety Modernization Act’s (FSMA’s) Produce Safety Rule.

The U.S. Food and Drug Administration filed a complaint against Innovative BioDefense, Inc. of Lake Forest, California, and Colette Cozean, the company’s president and chief executive officer, to prohibit them from selling Zylast topical antiseptics with claims that they are effective against infection by pathogens such as norovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus (MRSA), and Ebola. Claims that a hand sanitizer can protect consumers against infection from pathogens are drug claims and therefore, these products are regulated by the FDA as drugs. These products from Innovative BioDefense, Inc. have not been proven to be safe and effective for these uses and are not approved by the FDA.

Dug price regulator has directed all importers of medical devices to submit data in proper format.

Now hospitals will register disease of each patient  online. The pharmacist at the drug distribution centre gives medicine to him without putting anything about his disease in the online system.

Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Aimovig, intended for prophylaxis of migraine. The applicant for this medicinal product is Novartis Europharm Limited.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Tegsedi (inotersen), a medicine for treatment of stage 1 or stage 2 polyneuropathy (a condition in which the peripheral nerves are damaged) in patients with hereditary transthyretin amyloidosis (hATTR). This medicine aims to affect the course of the disease and improve quality of life.

Early data from two clinical trials show reduced survival with Keytruda (pembrolizumab) and Tecentriq (atezolizumab) when used as first-line treatments for urothelial cancer (cancer of the bladder and urinary tract) in patients with low levels of a protein called PD-L1. The data indicate that Keytruda and Tecentriq may not work as well as chemotherapy medicines in this group of patients.

Octapharma announced that pre-clinical data for SubQ-8 were presented during a symposium at the recent World Federation of Hemophilia (WFH) 2018 World Congress in Glasgow, UK. SubQ-8, currently under development, is a recombinant FVIII from a human cell line for subcutaneous administration. SubQ-8 is based on Octapharma’s human cell line-derived rFVIII product simoctocog alpha combined with a fragment of the von Willebrand Factor (VWF) protein, and harnesses the protective power of VWF in an innovative approach to facilitate transportation of FVIII into the circulation.