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In December, the Food and Drug Administrationn told Hemispherx its application forAmpligehn -- a controversial new drug candidate that has been undedr development for more than three decadesd -- was incomplete. Hemispherx officials said part of the problenm with its filing was tied to changex in clinical data reporting guidelines that have occurred sincre the initial studies on Ampligen were conductex in the late 1980s andearly 1990s. The company has subsequentlty submitted a clarifying amendmenf to its application and hada face-to-facse meeting with FDA officials. Hemispherx, led by Dr.
William said it has reducesd the number of items it now must accomplish to submiy a complete NDA from the original 14 to The company said it plansto "promptly" address the remaininyg five items through a series of additionalo amendments to its new drug application. The unresolved itemsw all relateto clarifying, or providing clinical trial data. "Whil the company is optimistic as to the progresss of the NDA there are no assurances that the FDA will accepty the amended NDAfor review, and if acceptecd there are no assurances that the NDA will be Hemispherx said in a Hemispherx's submission includes studuy data covering more than 1,200 patientsx who were administered more than 90,000 doses of BioNJ is joining forces with the New York Biotechnologu Association for a networking cruise on the Hudsonj River.
The "NewX2 will take place March 25 aboarrd the World YachtPrincess Vessel. Sol Barer, chairmanm and CEO of Celgene Corp., and Colin CEO of OSI Pharmaceuticals, will be the featured speakers forthe events. Tickets are $150 for membere of the biotech trade groupsand $105 for nonmembera ... of Fort Washington hired Dr. Richarc Gregg as chief science officer. Gregg was previouslyh with Bristol Myers-Squibb, wher e he was vice president ofclinical Gregg's appointment is part of a formal succession plan to allows Vitae co-founder Dr.
Jack Baldwin to step back from day-to-dau oversight of the company's research programw and focus onthe Vitae's long-terkm strategic, scientific and technical planninhg ... Joel F. Smith was named chairmah of Elkins Park-based BioStrategy Partners a nonprofit service organization thatassists early-stag e life sciences companies in the region. Smith succeedsd former chairwomanPatricia Weeks, who recently retirec as vice president of planningf and business development at . Weeke was named chair emeritus of Smith is principaland co-founder of The People Source a finance, human resources and information technology consulting firm basedx in Maple Glen ...
of Malvern initiated of a multicente r clinical trialfor Reslizumab, its experimentall treatment of eosinophilic esophagitis in pediatridc patients. Eosinophilic esophagitis, a conditionj for which there isno cure, is a chronic inflammatory diseasr characterized by difficulty swallowing, stomach or chest pain, and a failur to thrive. Ception's goal is to enroll aboug 172 patients intoits phase-II/III clinical Phase III trials are the last step a company takes before seeking approval for a new drug candidate ...
receiver notification from the NASDAQ stock market that the companyg has regained compliancewith NASDAQ'ws $1 minimum bid price requirement for continued The Montgomeryville medical device maker had till May 19 to regainj compliance with the minimum bid price rule.
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