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

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In December, the Food and Drug Administration told Hemispherx its applicatiojn forAmpligen -- a controversial new drug candidatew that has been under development for more than threde decades -- was incomplete. Hemispherx officials said part of the problen with its filing was tied to changes in clinicapl data reporting guidelines that have occurred sincse the initial studies on Ampligen were conducted in the late 1980s andearly 1990s. The company has subsequently submitted a clarifyintg amendment to its application and hada face-to-fac meeting with FDA officials. Hemispherx, led by Dr.
William Carter, said it has reducexd the number of items it now must accomplisjh to submit a completw NDA from the original 14to five. The compan said it plans to "promptly" address the remaining five itemsx through a series of additional amendments to its new drug The unresolved items all relateto clarifying, or providintg additional, clinical trial data. "Whiler the company is optimistic as to the progress of the NDA there are no assurances that the FDA will accep the amended NDA for and if accepted there are no assurancea that the NDA will be Hemispherx said ina statement.
Hemispherx's submissioh includes study data covering morethan 1,200 patientsw who were administered more than 90,000 dosews of Ampligen. BioNJ is joining forces with the New York Biotechnologt Association for a networking cruise on theHudsojn River. The "NewX2 BioCruise" will take place March 25 aboars the World YachtPrincess Vessel. Sol Barer, chairmamn and CEO of Celgene Corp., and Coli n Goddard, CEO of OSI Pharmaceuticals, will be the features speakers forthe events. Tickets are $150 for members of the biotec trade groupsand $105 for nonmembersa ... of Fort Washington hired Dr. Richard Gregg as chiet science officer.
Gregg was previously with Bristopl Myers-Squibb, where he was vice president ofclinical Gregg's appointment is part of a formal succession plan to allow Vitae co-founder Dr. Jack Baldwin to step back from day-to-dayy oversight of the company's research programs and focus onthe Vitae'ws long-term strategic, scientific and technical planning ... Joel F. Smith was namedx chairman of Elkins Park-based BioStrategy Partners Inc., a nonprofit servicew organization thatassists early-stage life sciences companies in the Smith succeeds former chairwoman Patrici a Weeks, who recently retired as vice presidentg of planning and business development at .
Weeks was named chair emeritus of Smith is principaland co-founder of The Peoplee Source Group, a finance, humam resources and information technology consultinh firm based in Maple Glen ... of Malvern initiated of a multicenter clinical trial for its experimental treatment of eosinophilif esophagitis inpediatric patients. Eosinophilic esophagitis, a condition for whic h there isno cure, is a chroniv inflammatory disease characterized by difficulty swallowing, stomach or chest pain, and a failure to thrive. Ception's goal is to enrollk about 172 patients intoits phase-II/III clinicaol trial.
Phase III trials are the last step a company takes before seeking approval for a new drug candidate ... received notification from the NASDAQa stock market that the compant has regained compliancewith NASDAQ'sx $1 minimum bid price requirement for continuer listing. The Montgomeryville medical devicw maker had till May 19 to regaij compliance with the minimum bidprice rule.