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Results: 11-20 of 606

Stakeholders provide input on FDA review standards for biosimilars
  • Shook Hardy & Bacon LLP
  • USA
  • November 18 2010

The Food and Drug Administration (FDA) recently conducted a two-day hearing to begin the process of determining how it will go about creating review standards for the generic copies (biosimilars) of prescription drugs developed from biological materials (biologics


Indian Supreme Court rules Novartis cancer drug change not patentable
  • Shook Hardy & Bacon LLP
  • India
  • April 4 2013

The Supreme Court of India has rejected the patent application filed by Novartis AG for a beta crystalline form of its cancer drug Gleevec, also


U.S. intervenes in False Claims Act suit against biotech company
  • Shook Hardy & Bacon LLP
  • USA
  • April 4 2013

The U.S. government has intervened in part of a False Claims Act (FCA) lawsuit against Agave BioSystems, a biotechnology-based small business with


Biotech secures $5.3 million for immunosuppressant drug research
  • Shook Hardy & Bacon LLP
  • USA
  • April 18 2013

San Francisco-based startup, Nurix, Inc., which reportedly develops T-cellspecific immunosuppressants used to treat autoimmune diseases such as


Report highlights growth in oncology R&D among midcap biotechs
  • Shook Hardy & Bacon LLP
  • USA
  • March 21 2013

Business intelligence company GlobalData has released a report on mid-cap biotech companies and concludes that their research and development (R&D


FDA issues guidance on acceptance of foreign clinical studies not conducted under IND
  • Shook Hardy & Bacon LLP
  • USA
  • March 15 2012

The Food and Drug Administration (FDA) has issued guidance titled “Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions.”


FDA reopens comment period for proposed rule on prescription drug ads to assess “distraction study”
  • Shook Hardy & Bacon LLP
  • USA
  • February 2 2012

The Food and Drug Administration (FDA) has reopened the comment period for a proposed rule that would establish standards for direct-to-consumer (DTC) TV and radio advertisements relating to side effects of prescription drugs for humans


New program to provide accelerated “speed-to-market” for medical device entrepreneurs
  • Shook Hardy & Bacon LLP
  • USA
  • March 1 2012

The nonprofit Memphis Bioworks Foundation and Innova, a pre-seed, seed and early-stage investor, have announced a program designed to help entrepreneurs bring medical device products and companies to market


India issues draft guidelines on clinical trial and data submission requirements for new drug approval
  • Shook Hardy & Bacon LLP
  • India
  • August 18 2011

The Central Drugs Standard Control Organization (CDSCO) of India’s Ministry of Health and Family Welfare has issued draft guidelines on the clinical trial and data submission requirements that drug makers must meet before new drugs can be manufactured, marketed or imported into India


Korea plans to increase investments in stem cell research, regenerative medical treatments
  • Shook Hardy & Bacon LLP
  • South Korea
  • April 19 2012

According to a news source, South Korea’s Ministry of Health and Welfare plans to invest 33 billion won (approximately US$29 million) in research that can verify stem cell treatment effectiveness and safety