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FDA Clears Soligenix IND to Test Crohns Disease Therapy

[ Price : $8.95]

FDA clears a Soligenix IND to begin Phase 1/2 studies of SGX203 for induction treatment of pediatric Crohns disease.

Impax and Genzyme Settle Renvela Patent Litigation

[ Price : $8.95]

Impax says it has an agreement with Genzyme under which it will be licensed to produce generic forms of Renvela and Renagel in 201...

FDA Holds Fast to Voluntary Strategy on Animal Antibiotics

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Amid rising criticism, FDA holds fast to its previously announced voluntary compliance approach to the use of human-use antibiotic...

Alimta Study Fails to Meet Primary Endpoint

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Lilly says a Phase 3 trial of its cancer drug Alimta failed to meet its primary endpoint of improved overall survival.

High Court Likely to Review Hatch-Waxman Safe Harbor Conflict: Attorney

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Fenwick & West attorney Michael Shuster sees the U.S. Supreme Court reviewing two conflicting federal circuit cases (Classen and M...

Endo Asks FDA Support for Crush-resistant Opana ER

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Endo asks FDA to take steps to promote use of crush-resistant pain management drugs such as its Opana ER.

Perrigo Files ANDA for Generic ProAir

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Perrigo says it has filed an ANDA for albuterol sulfate HFA inhalation aerosol, a generic copy of Tevas ProAir HFA.

FDA Wins in Court Over Compounded Makena Enforcement Discretion

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A Washington, DC federal judge dismisses a KV Pharmaceuticals lawsuit against FDA that sought to reverse a recent agency notice ex...

FDA Extends Review on Salix Crofelemer NDA

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FDA says it is extending past the 9/5 PDUFA deadline its review of a Salix NDA for crofelemer.

FDA Approves Oncology Drugs Faster than Non-oncology

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The Tufts Center for the Study of Drug Development says that approval time for oncology drugs in the U.S. fell during the last dec...