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Results: 1-10 of 391

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

BIO Investor Forum sessions focus on reinventing the biotech business model

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 21 2010

Acknowledging a difficult capital formation and financing climate, speakers at the recent BIO Investor Forum in San Francisco reportedly contended that strong science will prevail regardless and creative approaches to financing will help move promising technologies forward

Public hearing scheduled on imlpementing biosimilars legislation

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 21 2010

FDA has announced that it will conduct a two-day hearing for stakeholders to provide input on agency's implementation of the Biologics Price Competition and Innovation Act 2009 (BPCI

Biotech trade group seeks USDA involvement in gene patents lawsuit

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 21 2010

The Biotechnology Industry Organization (BIO) has asked U.S. Department of Agriculture (USDA) Secretary Tom Vilsack to urge the Department of Justice, which is considering the federal government's position in litigation about patent protection for isolated DNA sequences, to "strongly defend the patentability of such basic biotech inventions."

Genescience pleads guilty to charges of selling human growth hormones in U.S.

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 21 2010

GeneScience Pharmaceutical Co, Ltd and its CEO have pleaded guilty to selling Jintropin, a human growth hormone used to build muscle, without the approval of the Food and Drug Administration

Three-year collaboration to create synthetic seed virus bank for influenza shot

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 21 2010

Novartis AG and Synthetic Genomics Vaccines, Inc. have apparently agreed to collaborate on a project that is intended to reduce the time needed to develop influenza vaccines

FDA publishes final rule on investigational new drug applications, issues draft guidance

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 21 2010

The Food and Drug Administration (FDA) has issued a final rule that amends its "regulations governing safety reporting requirements for human drug and biological products subject to an investogational new drug application (IND)."

HHS issues guidance for gene and genome synthesis industry

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 21 2010

The Department of Health (HHS) has issued a guidance document with recommended baseline standards for companies providing synthetic double-stranded DNA (dsDNA) to effectively screen orders so they comply with U.S. regulations and encourage best practices in addressing biosecurity concerns associated with potential misuse of their products

Life science on U.S. Supreme Court 2010-2011 docket

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 21 2010

Among other closely watched cases curretnly pending before the U.S. Supreme Court is Bruesewitz v Wyeth, Inc., No.09-152

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

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