Pharma News

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.

The U.S. Food and Drug Administration is warning consumers that over-the-counter (OTC) teething products containing benzocaine pose a serious risk to infants and children. The agency announced that OTC oral health products containing the pain reliever benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed and is asking companies to stop selling these products for such use. If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market. Also, the agency is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

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The U.S. Food and Drug Administration approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down phenylalanine (Phe), an amino acid present in protein-containing foods and high-intensity sweeteners used in a variety of foods and beverages. Palynziq is a novel enzyme therapy for adult PKU patients who have uncontrolled blood Phe concentrations on current treatment.

The U.S. Food and Drug Administration has issued warning letters to three marketers and distributors of kratom products – Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri – for illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal. The companies also make claims about treating pain, as well as other medical conditions like lowering blood pressure, treating cancer and reducing neuron damage caused by strokes.