MGI Pharma news from FierceBiotech
NewsEisai wins expert panel's approval for new sedative
Backed by a positive review from FDA staffers, an expert panel at the agency has recommended the agency approve Eisai's fospropofol disodium, a sedative designed for use in a number of procedures, Read more...
FDA staffers say that Eisai sedative appears safe
FDA staffers say that an experimental sedative developed by Eisai appears to be safe, but wants outside experts to consider whether it's safe enough to be administered by workers untrained in Read more...
Eisai expands U.S. ops with $3.9B MGI buyout
A little over a week after announcing that it would explore its "strategic alternatives," MGI Pharma Read more...
Lehman helps MGI study its 'strategic alternatives'
The speculation swirling around MGI Pharma is heating up with this morning's terse announcement that it has brought in Lehman Brothers to help the board evaluate its "strategic alternatives." Let's Read more...
DEALS: Solvay, Merck Serono ink deals with Gene Logic
Solvay, Merck Serono ink deals with Gene Logic DEALSWHOWITHWHATSCOOPInvusLexicon Pharmaceuticals$550 investmentLexicon will use the money to finance its 10 to 10 program, which Read more...
MGI lands $255M buyout option in drug deal
MGI Pharma has shelled out $45 million as a down payment for a Phase II therapy for thrombocytopenia, an abnormal drop in blood cells involved in forming blood clots. MGI says the deal to Read more...
ALSO NOTED: Quest Diagnostics buys HemoCue; Affymax pockets $10M milestone;Pozen to file response on Trexima; and much more...> Quest Diagnostics has acquired Sweden's HemoCue, from the private equity firm EQT II for $420 million in cash. Release > Affymax has nailed a $10 million milestone payment from Takeda. Release > The FDA has called MGI Pharma's ad for a … Read more...Late-stage data backs new application for AloxiMGI Pharma and Helsinn Healthcare plan to file a new marketing application for the nausea drug Aloxi after two late-stage trials demonstrated its effectiveness against nausea and vomiting after surgery. The data demonstrated a complete response by patients up to 72 hours after surgery. The drug is already approved to prevent nausea and vomiting after chemotherapy. - here's the AP report on the new … Read more...MGI therapy "approvable," but FDA wants new trialThe FDA has issued an approvable letter for MGI Pharma's therapy for oral mucositis, but is requiring the drug developer to do a new Phase III trial before a full approval is made. The news of a new trial requirement sent its shares down as investors considered the likely impact on MGI. MGI CEO Lonnie Moulder said that the company will evaluate ways to "maximize the value of Saforis." He also noted that MGI hadn't been anticipating a significant financial contribution from the therapy next year. - here's the AP report on MGI FDA gives Dacogen orphan drug statusMGI Pharma announced that the FDA had given orphan drug status to Dacogen as a therapy for leukemia. Dacogen is currently in late-stage trials for leukemia and was approved for bone marrow disorders in May. European regulators have given Dacogen orphan drug status for Myelodysplastic Syndromes and leukemia. Orphan drug status provides seven years of market exclusivity for a drug aimed at a small group of patients. - read the AP report on Dacogen | Press ReleasesPRESS RELEASE: MGI PHARMA Issues Statement MGI PHARMA Issues Statement MINNEAPOLIS -- Nov. 29, 2007--MGI PHARMA, a biopharmaceutical company focused in oncology and acute care, today stated that its board of directors has authorized Read more... |
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