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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

Will Inter Partes Review Go Away? Supreme Court Weighs Fate

Biopharma and generic industries stand on opposing sides in case that could eliminate the patent challenge proceeding. Interactive timeline covers IPR's five-year history leading to oral arguments Nov. 27.

Legal Issues Intellectual Property

Regenerative Medicine Clinical Trials: US FDA Supports Studies Comparing Multiple Agents

Draft guidance suggests comparing therapies for a rare disease to each other and active control, offers examples of novel efficacy endpoints and what therapies may qualify for breakthrough and RMAT designations.

BioPharmaceutical Regulation

Public Citizen Asks US FDA To Ban Olmesartan Hypertension Medicines

Given risk of serious gastrointestinal disorder, Public Citizen argues there is no reason to keep the drugs on the market when so many alternative treatments are available

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BioPharmaceutical Regulation

Apotex's Neulasta, Neupogen Biosimilars Clear Legal Hurdles, But Approval Questions Remain

Federal appeals court affirms ruling that Apotex's biosimilars do not infringe Amgen's manufacturing process patent, but its applications have stalled at FDA for the past three years.

BioPharmaceutical Policy

Samsung's Biosimilar Manufacturing Documents Lead Janssen To Drop Infringement Suit

Janssen concludes the manufacturing processes for Renflexis do not infringe its Remicade patents, clearing Samsung and partner Merck from potential damages resulting from their at-risk launch of the biosimilar; innovator's legal action remains against Inflectra partners Pfizer and Celltrion.

BioPharmaceutical Policy

US FDA Gives Sponsors Some Leeway In Studying Drug Effects On Driving

Final guidance on evaluating drug effects on ability to operate a motor vehicle has been slightly modified in response to suggestions by Eisai, Pfizer and Merck.

Drug Safety Neurology
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