Drugs

BPCIA Has Protective Order Negotiating Room: Attorneys

Three McCullough Robertson attorneys say that “sparse” provisions of the Biologics Price Competition and Innovation Act’s (BPCIA) default protective order addressing issues of prosecution and regulatory bars “leave ample room for the parties to set the scope of the pre-litigation protective agreement and the protective order in effect during the litigation according to the circumstances of the case at hand.” Writing in an online blog post, the attorneys say that while protective orders regulating disclosure and use of confidential information exchanged during patent litigations are commonplace, the “patent dance” provisions in the BPCIA provide for exchange of information between the biosimilar applicant and the reference product sponsor before the parties engage in patent litigation.

“The BPCIA default provisions leave room for significant negotiation regarding the scope of the protection that the parties wish to implement before and during litigation,” the post says. The attorneys discuss the default provisions and how they can be negotiated in terms of prosecution bars and regulatory bars. They say the parties should consider prosecution and regulatory bars as well as how many tiers of confidentiality should be designed and who may access confidential documents within each tier.

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