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MacroGenics And Lilly Achieve Targeted Patient Enrollment In PROTEGE, A Global Phase 2/3 Clinical Trial Of Teplizumab In Type 1 Diabetes
MacroGenics, Inc. and Eli Lilly and Company (NYSE: LLY) announced that the PROTEGE trial achieved its targeted patient enrollment. The trial is a pivotal Phase 2/3 clinical study evaluating teplizumab, an investigational compound under development for the treatment of individuals with recent-onset type 1 diabetes.

Asian Pneumonia Prevention Organization Calls For Required Pneumonia Vaccine In India
The Asian Strategic Alliance for Pneumococcal Disease Prevention (ASAP) is calling for the pneumonia vaccine to become an official part of India"s required list of immunizations, the Times of India reports. According to the newspaper, Nithin Shah, chairman of ASAP India chapter, said there is an "immediate need to take steps to control and prevent pneumonia morbidity and mortality," which is the leading cause of death among children younger than age five in India, according to international child health experts (7/26).
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Personalized Anti-Cancer Vaccine, BiovaxID(R), Targeting B-Cell Lymphomas Available In Europe On A Named-Patient Basis
Biovest International, Inc. (Other OTC:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ), today announced that BiovaxID®, Biovest"s personalized therapeutic anti-cancer vaccine, is available on a named-patient (compassionate-use) basis in Europe. Following compliance with local regulatory protocols, BiovaxID will be supplied by idis Limited to European healthcare professionals for the treatment of follicular non-Hodgkin"s lymphoma and potentially for other B-cell blood cancers such as chronic lymphocytic leukemia, mantle cell lymphoma and multiple myeloma. Physicians in non-European countries may also contact idis to inquire about the potential availability of BiovaxID, as idis manages named-patient programs in more than 100 countries.
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FDA Extends Review Period For Eurand's ZENPEPTM Pancreatic Enzyme Replacement Therapy

Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies, announced that the U.S. Food and Drug Administration (FDA) has advised the Company that it has extended the June 2009 user fee goal date for the New Drug Application for ZENPEP™ (pancrelipase capsules) by three months. The FDA did not request that the Company provide any further information, but attributed the reason for the delay to the need for additional time to review the current submission. About ZENPEP (pancrelipase capsules) ZENPEP is a proprietary pancreatic enzyme product developed for the treatment of exocrine pancreatic insufficiency, a condition associated with cystic fibrosis, chronic pancreatitis and other diseases. The product was developed in response to the 2004 FDA initial guidance on pancreatic enzyme products, which outlined the need to reduce the variability in enzyme levels and stability of currently marketed enzyme therapies and regulate them under NDAs. ZENPEP is a highly stable formulation of a porcine pancreatic extract that is biologically similar to the endogenous human pancreatic secretions necessary for proper human digestion. Eurand


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