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Brenda Sandburg

New York, NY
Brenda Sandburg is a senior writer who covers legal issues and FDA regulatory policy, with a particular focus on patents, biosimilars, and government investigations. She spent 10 years writing for legal publications between stints at The Pink Sheet and blends these experiences to provide in-depth analysis of events. An aspiring photographer, she enjoys taking photos to accompany news stories.
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Latest From Brenda Sandburg

Biosimilar Litigation: Janssen Vs. Samsung Anticipates Supreme Court Decision

Hoping to hold off a biosimilar to Remicade, Janssen challenges Samsung's decision not to participate in patent dance as it claims infringement of three manufacturing patents.

Biosimilars Legal Issues

Coherus Knocks Out One Humira Patent But Others Block Biosimilars

Patent Trial and Appeal Board invalidates patent on method to treat rheumatoid arthritis; next hurdle is overcoming formulation patents that do not expire until 2022.

Biosimilars Intellectual Property

Invokana Adds Warnings On Amputation Risk, But Will It Give Jardiance An Edge?

New data from J&J's cardiovascular outcomes trials shows leg and foot amputations occurred about twice as often in diabetes patients treated with canagliflozin versus placebo.

BioPharmaceutical Regulation

Can Biosimilar Studies Be Conducted Solely In Healthy Volunteers?

Coherus refutes Apotex argument that Neulasta biosimilars must be studied in at least one patient population. Its application could face delay as no advisory committee meeting has been scheduled ahead of its June 9 user fee date.

BioPharmaceutical Regulation

First Imaging Agent For Brain Tumor Surgery Gets US FDA Panel Backing

Advisory committee votes for approval of 5-ALA for real time detection and visualization of malignant tissue during glioma surgery; data shows improvement in tumor resection, but not on survival metrics.

BioPharmaceutical Advisory Committees

Sanofi's Drug Pricing Pledge Ties Increases To National Health Expenditure

While other companies have promised not to raise their drug prices beyond 10%, Sanofi is using the rate of medical inflation (expected to be 5.4% in 2017) in setting its annual list price hikes. Company retains option to increase prices beyond benchmark.

Pricing Strategies Pricing Debate
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