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Putative Securities Class Action Dismissed Against Biopharmaceutical Company Where Statements Regarding Clinical Trials Were Not Actionable And Plaintiffs Failed To Plead Scienter
  • Shearman & Sterling LLP
  • USA
  • November 6 2018

On October 26, 2018, Judge Thomas D. Schroeder of the United States District Court for the Middle District of North Carolina dismissed a putative


A Rare Successful Challenge of a Patent for a Method of Manufacturing Biologic Drugs
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • March 13 2018

Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are typically


Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
  • Hogan Lovells
  • USA
  • February 14 2018

The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws


New Report Says Biosimilars Could Save $54 Billion in Biologics Spending
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • November 7 2017

According to a new report by RAND Corporation, biosimilars could save $54 billion in healthcare spending on biologics over the next ten years


A path forward: Corportate Integrity Agreement sheds light on manufacturer interactions with independent charitable foundations
  • Hogan Lovells
  • USA
  • October 2 2017

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into


At The Bench: 2017 Mid-Year Case Review
  • Harness, Dickey & Pierce, PLC
  • USA
  • September 7 2017

The Supreme Court held that all patent rights are exhausted upon the first sale of a Patented product, regardless of where the sale is made or whether


Biosimilars in the US: the next frontier for big pharma
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • August 17 2017

The market for biological drug products is forecast to reach a global value of $400bn per year by 2025. Major pharmaceutical companies are investing


Patent Term Extension Considerations for BioPharma Patents
  • Sterne Kessler Goldstein & Fox PLLC
  • USA
  • August 15 2017

Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the


Janssen Biologic Tremfya Secures FDA Approval Following Use of Priority Review Voucher
  • Knobbe Martens
  • USA
  • July 25 2017

On July 13, 2017, the U.S. Food and Drug Administration approved Tremfya (guselkumab), a biologic manufactured by Janssen Biotech, for the treatment


FDA Holds Public Meeting on Innovation in Drug Development and Accelerating Access to Generic Medicines
  • Arent Fox LLP
  • USA
  • July 20 2017

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and Accelerating the access