Drugs

Coherus Wants Delay in Neulasta Case Discovery

Coherus BioSciences has asked the Delaware federal court to delay the start of discovery in Biologics Price Competition and Innovation Act patent litigation with Amgen until after the court resolves a Coherus motion to dismiss Amgen’s suit against it. Attorneys with Patterson Belknap Webb & Tyler say in an online blog post that Coherus is asking for the delay so it can conserve financial resources while it prepares to resubsmit its biosimilar application to FDA.

FDA issued a 6/2017 complete response letter to Coherus, the post says, asking for a reanalysis of existing samples with a revised immunogenicity assay, but stopping short of asking for a further clinical study.

Once Coherus filed its biosimilar application in 10/2016, it began to exchange information with Amgen (“patent dance”), and Amgen filed its suit in 5/2017, asserting infringement of one patent. Coherus asked the court 6/2017 to dismiss the Amgen complaint.

When the court told both parties to agree to a case scheduling order, Coherus countered that it is in no position to move forward with discovery while its motion to dismiss is pending. The post notes that Coherus is a biosimilar startup and has no products or revenues. The company told the court that the FDA decision will delay launch of its proposed Neulasta biosimilar by at least a year and said it has had to cut expenses by 50% and has reduced its workforce by one-third. “Coherus argues that staying the litigation until its motion to dismiss is decided would allow it to avoid potentially unnecessary expenditure of scarce resources,” the writers conclude.

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