BC Week In Review | Apr 13, 2015
Clinical News

Mucogard: Phase II started

PlasmaTech said investigators at the University of California , Los Angeles, began an open-label, U.S. Phase II trial to evaluate oral MuGard in about 66 women with hormone receptor-positive breast cancer receiving Afinitor everolimus. MuGard is...
BC Week In Review | Apr 13, 2015
Clinical News

Mucogard regulatory update

PlasmaTech said Korea approved a regulatory application from partner Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940, Seoul, South Korea) for Mucogard mucoadhesive oral rinse to treat oral mucositis. Hanmi has exclusive, commercialization rights to the product under...
BC Week In Review | Nov 24, 2014
Company News

Access Pharmaceuticals, Norgine deal

PlasmaTech (formerly Access Pharmaceuticals Inc.) and Norgine added Australia and New Zealand to an August deal granting Norgine an exclusive license to commercialize, develop and manufacture MuGard in the EU, Switzerland, Norway, Iceland and Lichtenstein....
BC Week In Review | Sep 8, 2014
Company News

Access Pharmaceuticals, Norgine deal

Access granted Norgine exclusive rights to develop and commercialize Access' MuGard for oral mucositis in the EU, Switzerland, Norway, Iceland and Lichtenstein. Access is eligible for up to $10 million in milestones, plus escalating double-digit...
BC Week In Review | Mar 17, 2014
Company News

Access Pharmaceuticals, Hanmi Pharmaceutical sales and marketing update

Access granted Hanmi exclusive rights to commercialize MuGard in South Korea. Access will receive an undisclosed upfront payment and is eligible to receive double-digit royalties on net sales. The mucoadhesive oral rinse has been approved...
BC Week In Review | Mar 3, 2014
Clinical News

MuGard: Phase IV data

Data from 78 evaluable head and neck cancer patients receiving chemoradiation therapy in a double-blind, U.S. Phase IV trial showed that oral MuGard significantly reduced area under the curve of daily patient-reported OMDQ scores, the...
BC Week In Review | Jun 17, 2013
Company News

Access Pharmaceuticals, AMAG Pharmaceuticals sales and marketing update

AMAG licensed exclusive, U.S. commercialization rights to MuGard mucoadhesive oral rinse from Access for an upfront payment of $3.3 million. Access is also eligible for a tiered, double-digit royalty on net sales of MuGard. AMAG...
BC Week In Review | Apr 30, 2012
Clinical News

MuGard: Interim Phase IV data

Interim data from 40 patients receiving chemoradiation therapy in a double-blind, U.S. Phase IV trial showed that oral MuGard significantly reduced mouth and throat soreness vs. an aqueous control rinse. MuGard also reduced the use...
BC Week In Review | Mar 5, 2012
Clinical News

MuGard regulatory update

Access Pharmaceuticals said China's State Food and Drug Administration (SFDA) approved a regulatory application from partner Rhei Pharmaceuticals Inc. (Hong Kong, China) for MuGard mucoadhesive oral rinse to treat oral mucositis (OM) in cancer patients....
BioCentury | Jan 9, 2012
Finance

PDUFAs produce yawns

Stephen Hansen Senior Writer  There are more than twice as many PDUFA dates this year than last - at least 40 vs. 17 - but only a handful of potential approvals are drumming up interest among buysiders....
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