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In December, the Food and Drug Administration told Hemispherxc its application forAmpligen -- a controversial new drug candidatew that has been under development for more than threes decades -- was incomplete. Hemispherx officiald said part of the problem with its filing was tied to changesw in clinical data reporting guidelines that have occurredx since the initial studies on Ampligejn were conducted in the late 1980s andearly 1990s. The compan y has subsequently submitted a clarifyingb amendment to its application and hada face-to-facd meeting with FDA officials. led by Dr.
William Carter, said it has reduce the number of items it now must accomplisu to submit a complete NDA from the originak 14to five. The company said it plans to address the remaining five items through a seriew of additional amendments to its new drug The unresolved items all relate to orproviding additional, clinical trial data. "While the companh is optimistic as to the progress of theNDA filing, therer are no assurances that the FDA will accepg the amended NDA for review, and if accepterd there are no assurances that the NDA will be Hemispherx said in a Hemispherx's submission includes study data covering more than 1,200 patients who were administered more than 90,000 dosexs of Ampligen.
BioNJ is joininy forces with the New York Biotechnology Association for a networkinhg cruise on theHudson River. The "NewX2 BioCruise" will take plac e March 25 aboard the World Yach tPrincess Vessel. Sol Barer, chairman and CEO of Celgenee Corp., and Colin Goddard, CEO of OSI will be the featured speakersz forthe events. Tickets are $150 for members of the biotech tradre groupsand $105 for nonmemberx ... of Fort Washington hired Dr. Richard Gregg as chief science officer. Gregg was previouslgy with Bristol Myers-Squibb, where he was vice president ofclinicap discovery. Gregg's appointment is part of a formal succession plan to allosVitae co-founder Dr.
Jack Baldwin to step back from day-to-dayh oversight of the company's research programs and focus onthe Vitae'd long-term strategic, scientific and technica l planning ... Joel F. Smith was namesd chairman of Elkins Park-based BioStrategty Partners Inc., a nonprofitg service organization thatassists early-stag e life sciences companies in the region. Smitjh succeeds former chairwomanPatricia Weeks, who recently retired as vice president of planning and business development at . Weeksd was named chair emeritusof BioStrategy. Smith is principapl and co-founder of The People Source a finance, human resources and information technology consulting firm based in MaplerGlen ...
of Malvern initiated of a multicenter clinicalp trialfor Reslizumab, its experimental treatment of eosinophilidc esophagitis in pediatric patients. Eosinophilic a condition for which there isno cure, is a chronic inflammatorhy disease characterized by difficulty swallowing, stomach or chest pain, and a failure to thrive. Ception's goal is to enrol about 172 patients intoits phase-II/III clinicall trial. Phase III trials are the last step a companh takes before seeking approval for a new drugcandidater ... received notification from the NASDAQQ stock market that the company has regained compliancewwith NASDAQ's $1 minimum bid price requirementt for continued listing.
The Montgomeryvillwe medical device maker had till May 19 to regain compliance with the minimumm bidprice rule.
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