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Biotechnology advisory committee members announced
  • Shook Hardy & Bacon LLP
  • USA
  • July 14 2011

The Department of Agriculture’s Office of the Under Secretary, Research, Education, and Economics has announced the appointment of 22 members to the Advisory Committee on Biotechnology and 21st Century Agriculture


Federal Circuit says certain human genes may be patented
  • Shook Hardy & Bacon LLP
  • USA
  • August 4 2011

In a ruling likely to be appealed to the U.S. Supreme Court, a divided Federal Circuit Court of Appeals panel has determined that genetic discoveries may, to a certain extent, be patented


IOM deems 510(k) medical-device clearance process flawed; FDA seeks comments
  • Shook Hardy & Bacon LLP
  • USA
  • August 4 2011

The Institute of Medicine (IOM) has issued a report titled “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years,” calling for an overhaul of Food and Drug Administration (FDA) procedures for approving medical devices that are considered a moderate risk to patients and are substantially equivalent to any previously cleared device or one that was on the market before the Medical Device Amendments were enacted in 1976


Lawmakers introduce legislation to increase R&D tax credits
  • Shook Hardy & Bacon LLP
  • USA
  • August 4 2011

Bipartisan legislation has been introduced in the U.S. House of Representatives and the U.S. Senate (H.R. 2632, S. 1410) to encourage life sciences investment by increasing the existing research and development (R&D) tax credit


FDA may change conflict-of-interest rules for advisory panel members
  • Shook Hardy & Bacon LLP
  • USA
  • August 4 2011

Food and Drug Administration (FDA) Commissioner Margaret Hamburg has reportedly told an advocacy group that scientists with financial ties to drug and device-makers may soon be allowed to advise U.S. regulators about those products


Senate Committee approves bill to end pay-for-delay deals
  • Shook Hardy & Bacon LLP
  • USA
  • August 4 2011

The Senate Judiciary Committee has approved a bill (S. 27) that aims to “prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market


FDA challenges classification of stem cell-based bone regeneration product
  • Shook Hardy & Bacon LLP
  • USA
  • August 4 2011

The Food and Drug Administration (FDA) has warned Parcell Laboratories that it mischaracterized its stem cell-based bone regeneration product as a human cell, tissue and cellular or tissue-based product, when the product is actually a drug or a biologic and must conform to applicable regulations


Albuquerque biotech startup announces $13 million in funding for bacteria
  • Shook Hardy & Bacon LLP
  • USA
  • August 4 2011

nanoMR Inc., an early-stage life sciences company based in Albuquerque, New Mexico, has announced that it has raised $13 million in Series B venture capital to support commercializing a device that rapidly diagnoses bacteria in blood


IPO proposed by n.c.-based company developing experimental medicines
  • Shook Hardy & Bacon LLP
  • USA
  • August 4 2011

North Carolina-based Argos Therapeutics has filed a Securities and Exchange Commission registration relating to its proposed initial public offering of common stock to raise more than $86 million to help pay for clinical tests of an experimental treatment for kidney cancer


Venture capital biotechnology investments increase 46 percent in second quarter
  • Shook Hardy & Bacon LLP
  • USA
  • August 4 2011

Venture capital funding of biotechnology companies has jumped 46 percent in 2011’s second quarter, attracting $1.2 billion in 116 deals, according to a MoneyTree Report released by PricewaterhouseCoopers LLC (PwC) and the National Venture Capital Association (NVCA