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Results: 1-10 of 576

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

Macro-algae attracting millions in government and industry financing

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

According to news reports, macro-algae, or seaweed, is being viewed by major investors as a better source of sugars for ethanol, biofuels, biochemicals, and biopolymers than land-based crops, because it grows faster, has a higher sugar content, absorbs more airborne carbon, and can be harvested up to six times each year

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."

Energy interests and investors concerned about new derivatives regulation

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

While European and U.S. regulators develop new rules to govern derivative transactions, energy companies and investors are reportedly expressing concerns about the potential for measures that are intended to rein in the risks taken by financial institutions to affect their business

University start-ups and licensing remain strong

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

The Association of University Technology Managers (AUTM) has reportedly announced that university start ups and licensing activity were unaffected at the height of the recession in 2009

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)."

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