Pharma News

March 5, 2010 — The US Food and Drug Administration (FDA) has approved a prefilled somatropin (rDNA origin) injection pen (Norditropin FlexPro, Novo Nordisk, Inc) for the treatment of growth hormone disorders in adult and pediatric patients. The product, an updated version of the company's NordiFlex pen introduced in 2004, is expected to be available in the second quarter of 2010.

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The more than 100-year old Haffkine Institute of Mumbai will soon establish a BA/BE study centre which will be useful to the pharma industry in India and abroad in getting a more authentic bioavailability and bioequivalence (BA/BE) study results. The government-controlled Institute has already started the process in this regard and is expected to be completed within a year's time.

The Himalaya Drug Company has ventured into cough suppressants space with the launch of Bresol, a breathing solution for treating chronic respiratory allergies. Bresol will be an ethically promoted product from the company's Pharma division.

The Gujarat Food and Drug Control Administration (FDCA) has completed a mass recruitment process in the first week of March by giving away appointment letters to 156 candidates in one go, probably the biggest recruitment since the inception of the administration, in a move to hasten the monitoring activities of food and drugs marketed in the state.

Even as hundreds of MS (Pharmacy) students of all the NIPERs in the country are on a silent strike to put pressure on the authorities to resolve the issues arising out of the PCI's recent decision not to recognize the MS programme in Industrial Pharmaceutics and Pharmaceutical Analysis & Quality Control, the department of pharmaceuticals (DoP) has called a meeting on March 2 to discuss the issue in threadbare.

Almost two years after announcing the Guidelines for Stem Cell Research Regulation, prescribing stringent procedures for souring and use of stem cells by research institutions in the country, the union health ministry is yet to constitute the National Apex Committee (NAC) for effectively reviewing and monitoring the stem cell research in the country.

INTERPHEX Asia, a platform for showcasing latest technologies and expertise to the pharmaceutical and biopharmaceutical industry players in Asia will be held at Suntec International Convention & Exhibition Centre , Singapore on June 7 & 8, 2010.

The US Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. Without this enzyme, harmful amounts of a certain fatty substance (lipid) can build up in the liver, spleen, bones, bone marrow and nervous system, and can prevent cells and organs from working properly. About one in 50,000 to one in 100,000 people in the general population have Gaucher disease.