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Sometimes what appears to be an obstacle in the path to drug development has the opposite effect. In the case of the FDA's response to Mipomersen this may well be the case...and it may be the harbinger of a more "collaborative" approach by the FDA.
Alnylam (Nasdaq: ALNY) has hit upon a novel concept (in collaboration with MIT) in enabling RNAi therapeutics to reach their intended targets. Look for an explosion of applications.
The USPTO’s proposed rule changes, struck down in this important Glaxo federal court decision, would have added significant burdens to pharmaceutical companies in developing their IP portfolios and ultimately their drug treatments. The proposed changes were seemingly motivated to make the...
Corcept Therapeutics is at it again with yet another clinical trial for its lead candidate mifeprisotone (Corlux), a GR-II (glucocorticoid) receptor antagonist, hoping to show efficacy on the psychotic features of psychotic major depression (PMD). Corlux clearly offers a potentially novel...
Copaxone has become the leading treatment for relapsing remitting MS in the US. The results of the PRECISE trial will likely add to TEVA's sales momentum and boost sales further.
Merck continues to have problems as a result of Vioxx. It recently came out that the research studies which had been allegedly authored by independent medical scientists were actually ghostwritten by individuals paid by Merck. Many physicians have a poor opinion of industry sponsored research...
The development of a new generation of serortinin 5HT1a agonists for major depression and anxiety disorders has met yet another failure, now from EPIX Pharmaceuticals’ PRX-00023. Gepirone ER (GlaxoSmithKline), another 5HT1a partial agonist, suffered the same fate last November when...
1. PHRMA's R&D budget may have grown by a smaller percentage and positions have been cut due to mergers and acquisitions. 2. Biotech and non-PHRMA pharmaceutical company growth with increasing headcount , growing budgets and improved cost efficiencies may account for a portion of these...
Disease modification is the desired direction for drugs to treat Alzheimer's and gamma secretase inhibitors have really just begun to be studied. The field is very promising.
Although the concept is exciting--an inverse agonist at the cannabinoid-1 (CB-1) receptor to reduce appetite, this medicine has a lot of bad press from rimonabant to overcome. The major problem with rimonabant was psychopathological reactions in patients. We do not yet know whether this...