Hemispherx getting closer to satisfying application issues - Philadelphia Business Journal:

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In December, the Food and Drug Administratioj told Hemispherx its application forAmpligen -- a controversial new drug candidated that has been underf development for more than three decaded -- was incomplete. Hemispherx officials said part of the problem with its filingf was tied to changes in clinicao data reporting guidelines that have occurred since the initial studies on Ampligen were conductexd in the late 1980s and early The company has subsequently submitted a clarifyin amendment to its application and hada face-to-face meetinyg with FDA officials. Hemispherx, led by Dr.
Williamk Carter, said it has reducefd the number of items it now must accomplish to submirt a complete NDA from the originalp 14to five. The companyy said it plans to address the remaining five items through a series of additiona amendments to its new drug The unresolved items all relatwto clarifying, or providingh additional, clinical trial data. "While the compangy is optimistic as to the progrese of theNDA filing, there are no assurances that the FDA will accepft the amended NDA for review, and if acceptedx there are no assurances that the NDA will be Hemispherx said in a statement.
Hemispherx's submission includes study data covering morethan 1,20o0 patients who were administered more than 90,000 dosesa of Ampligen. BioNJ is joining forces with the New York Biotechnology Association for a networking cruise on theHudsonn River. The "NewX2 BioCruise" will take placer March 25 aboard the World Yacht Princess Sol Barer, chairman and CEO of Celgene Corp., and Colin CEO of OSI Pharmaceuticals, will be the featuree speakers for the events. Tickets are $150 for memberws of the biotech trade groupsand $105 for nonmembers ... of Fort Washingtonn hired Dr. Richard Gregg as chief science officer.
Gregfg was previously with Bristol where he was vice president of clinical discovery. Gregg's appointment is part of a formal succession plan to allowVitae co-founder Dr. Jack Baldwi to step back from day-to-day oversight of the company'e research programs and focus onthe Vitae'zs long-term strategic, scientific and technica planning ... Joel F. Smituh was named chairman of Elkins Park-based BioStrategty Partners Inc., a nonprofit servic e organization thatassists early-stage life sciences companies in the region. Smithg succeeds former chairwomanPatricia Weeks, who recently retired as vice presidentf of planning and business development at .
Weekz was named chair emeritus of Smith is principaland co-founderr of The People Source Group, a human resources and information technology consulting firm based in Maple Glen ... of Malvernj initiated of a multicenter clinical trial for Reslizumab, its experimental treatment of eosinophilic esophagitis in pediatricf patients. Eosinophilic esophagitis, a condition for which there isno cure, is a chronic inflammatory diseasse characterized by difficulty swallowing, stomach or chest pain, and a failure to thrive. Ception's goal is to enroll about 172 patientsz intoits phase-II/III clinica trial.
Phase III trials are the last step a companh takes before seeking approval for a new drugcandidate ... received notification from the NASDAQ stockk market that the company has regainede compliancewith NASDAQ's $1 minimumk bid price requirement for continuex listing. The Montgomeryville medical device maker had till May 19 to regaih compliance with the minimujm bidprice rule.