Ampligen Chronic Fatigue Syndrome Data May Be Sufficient For FDA Approval FDA is reviewing Hemispherx's reanalysis of data from its Ampligen Phase III trial to determine if an additional confirmatory study is necessary.
Lilly's Intended Successor To Zyprexa Faces Uncertain Future After Phase III Failure Failure to perform better than placebo in the first of two pivotal Phase III trials diminishes chances of success for pomaglumetad methionil, a metabotropic glutamate 2/3 receptor agonist that Lilly hoped to position as a successor to its patent-expired schizophrenia therapy Zyprexa.
Sanofi TheraCys Shortage Prompts Merck To "More Than Double" Supply Of TICE BCG In its latest attempt to get out in front of drug shortage problems, FDA's announcement that Sanofi Pasteur's bladder cancer drug TheraCys is unavailable due to manufacturing problems also notifies patients that Merck is stepping into the breach.
A New Collaborative Model? Janssen Joins Evotec And Harvard To Advance Regenerative Diabetes Projects Germany's drug discovery services company Evotec has formed a tight bond with Harvard researchers, with both parties expected to share the rewards of their CureBeta pancreatic beta-cell regeneration project if new strategic partner Janssen Pharmaceuticals develops new diabetes therapies from their research.
Don't Mess With The Zofran (Dosing), FDA Tells Generic Applicants After a cardiac safety signal results in a label change for GlaxoSmithKline's chemotherapy nausea treatment, FDA denies citizen petitions from generic manufacturers that sought approval for different doses than the respective reference products.
FDA Clarifies Label Warning For Acetaminophen Liver Damage The agency seeks to clarify potential confusion for consumers linked to label statements about the level of acetaminophen that can pose a threat. FDA proposes an alternative warning to be used on labels of some acetaminophen-containing products.
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