Biologics

Florida Court Backs Apotex in Biosimilar Patent Case

The Southern Florida District Court has ruled that Apotex’s proposed filgrastim and pegfilgrastim biosimilar products will not infringe the asserted claims of Amgen’s ’138 patent (U.S. Patent. No. 8,952,138). Apotex had contended that the process described in its aBLAs falls outside the scope of the patent’s asserted claims. The court found that Amgen had “not met its burden to prove that Apotex's process for refolding filgrastim and pegfilgrastim infringe, either literally or under the doctrine of equivalents, each limitation of the ’138 patent.” Additionally, the court found that Apotex has established that its process, as described in aBLAs, does not infringe the ’138 patent.

Notwithstanding Apotex’s win on the patent issue, the court permanently enjoined it from launching its product until after its 180-day notice of intent to market its product has elapsed, which may not be given until after Apotex gains approval from the FDA to market its product.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome