FDA panel could give Bayer painkiller an edge over rivals from Pfizer, J&J by Tracy Staton Published on FiercePharma.com
What if every drug in a class posed a risk to the heart–all except one? That’s the question we could soon be asking about nonsteroidal anti-inflammatories, or NSAIDs, among the most commonly used drugs in the world… [ Read More ]
‘USFDA has imposed disproportionate penalties on Indian pharma cos’ by Amiti Sen Published on The Hindu Business Line
Reacting strongly to the recent string of actions against Indian pharmaceutical companies by the US Food & Drug Administration (FDA), India has said that in some cases the authority has imposed disproportionately strong penalties…[ Read More ]
Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2014) by Andrew Williams Published on jdsupra.com
The standard of review at the Federal Circuit is important. Even though it often appears like cases are re-litigated at the Appeals Court, it is actually very difficult (or at least should be) to overturn a lower court’s factual determinations…[ Read More ]