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Results: 1-10 of 354

Sequestration impact on FDA uncertain

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 7 2013

Speaking during the Generic Pharmaceutical Association's annual conference in February 2013, Food and Drug Administration (FDA) Commissioner Margaret

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

Pharma merger activity attributed to “patent cliff”

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 18 2010

Noting that many of the pharmaceutical industry's best-selling products will soon lose their patent protection, industry analysts have reportedly suggested that the potential loss of nearly one-third of industry revenues in the near term could account for recent merger activity among the world's largest pharmaceutical companies

Appeals Court considers federal funding of stem cell research

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • December 16 2010

A D.C. Circuit Court of Appeals panel recently heard argument on whether new National Institutes of Health (NIH) guidelines pertaining to federal funding of embryonic stem-cell research violate a law that places certain restrictions on such research

New biotech initiative in San Francisco

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • December 16 2010

San Francisco has reportedly started a new initiative to expand biotech and life-sciences startups in areas that include Mission Bay, Pier 70 and the former Hunters Point Naval Shipyard

Israeli biotechnology startups seek partnerships in Ohio

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • December 16 2010

Israeli biotechnology companies are reportedly heading to Ohio because of state incentives and a venture capital fund focused on investing in Israel

News bytes

  • Shook Hardy & Bacon LLP
  • -
  • European Union, USA
  • -
  • December 16 2010

The European Medicines Agency (EMA) adopts two draft guidelines as part of the regulatory approval process for certain biosimilar medicinal products

Avalon Ventures closes ninth and largest fund

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 13 2011

Avalon Ventures, located near San Diego, California, has reportedly closed capital commitments of $200 million for its ninth and largest fund, Avalon Ventures IX, LP

Large pharmaceutical companies look to buy niche Indian biotech firms

  • Shook Hardy & Bacon LLP
  • -
  • India, USA
  • -
  • January 13 2011

Major pharmaceutical companies are reportedly buying niche biotech firms in India to take advantage of emerging opportunities involving biosimilar drugs, which are expected to have a market share of approximately $78 billion by 2013

House members clarify intent of biosimilars law

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 13 2011

Democratic and Republican House representatives have submitted a letter to the Food and Drug Administration (FDA) to clarify congressional intent in enacting the Biologics Price Competition and Innovation Act