Pfizer Inc. announced the discontinuation of A4021018 (also known as ADVIGO 1018), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) in combination with erlotinib as a second/third-line treatment in patients with previously treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC). An independent Data Safety Monitoring Committee (DSMC) recommended A4021018 be stopped [...]

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UCB today announced that the antiepileptic drug (AED) Vimpat(R) (lacosamide) (C-V) demonstrated significantly fewer partial-onset seizures versus placebo in adults living with epilepsy, according to a Phase III clinical study published online in Epilepsia.
This study was one of three that supported the approval of Vimpat by the U.S. Food and Drug Administration (FDA) in 2008 [...]

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Merck & Co on Thursday said an independent data safety monitoring board has approved continuation of a big study meant to determine whether its blockbuster Vytorin cholesterol drug prevents heart attacks and stroke.
Merck said a green light for the so-called “IMPROVE-IT” study to continue was given after the panel conducted an interim analysis of safety [...]

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Shares of BioSante Pharmaceuticals surged this morning in pre-market trading after the developer said that a 19-patient study demonstrated the promise of its GVAX leukemia vaccine to mop up the stubbornly lingering cancer cells of CML patients taking Gleevec.
Researchers said that the 19 patients selected for the study had measurable levels of cancer cells even though [...]

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Roche and Biogen Idec announced their decision to suspend Ocrelizumab treatment of patients in the Rheumatoid Arthritis (RA) programme. The decision follows the recommendation of the independent Ocrelizumab RA & Lupus Data and Safety Monitoring Board (DSMB) based on their assessment of the studies in RA (SCRIPT, FEATURE, FILM and STAGE) and lupus (BELONG and [...]

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Eli Lilly, Amylin and Alkermes will be holding their collective breath this Friday when the FDA will reveal whether it will approve Byetta LAR, the long-acting form of the bestselling diabetes drug Byetta. Thanks to technology from Alkermes that helps the drug stay in the patient’s bloodstream, Byetta LAR can be administered just once a week rather than requiring [...]

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An FDA expert panel voted 9-3 Tuesday in favor of InterMune’s Esbriet (pirfenidone), a treatment for idiopathic pulmonary fibrosis. IPF is a rare and fatal lung disease that affects approximately 200,000 people in the U.S. and Europe. If approved, Esbriet would be the first treatment for U.S. IPF sufferers. The treatment has already received approval in Japan on [...]

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Another day, another stock-price jump.
First, the preliminaries: An advisory panel this afternoon recommended the FDA approve a lung drug developed by InterMune, with majorities of the outside experts saying the proposed treatment appeared effective and safe.
The FDA is expected to decide by early May whether to go along with the panel’s recommendation on pirfenidone, which [...]

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AstraZeneca says that its experimental oncology drug Recentin flunked a late-stage, head-to-head showdown with Avastin as a treatment for colon cancer. But the European drug company says that it will wait until it sees late-stage results as a combo therapy with chemo–versus chemotherapy alone–before it makes a final decision on the future of the program.
According to [...]

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NeuroSearch says that its Phase III drug for Huntington disease, Huntexil, not only has symptomatic effects but also slows the underlying disease progression depending on the patients’ disease genotype. This analysis comes after the firm reported in February that the treatment significantly improved patients’ motor function.
NeuroSearch has filed a patent application covering the ability of [...]

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