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Results: 1-10 of 355

Lawmakers introduce bill to expedite FDA’s medical device review process
  • Shook Hardy & Bacon LLP
  • USA
  • October 20 2011

U.S. Senators Amy Klobuchar (D-Minn.), Richard Burr (R-N.C.) and Michael Bennet (D-Colo.) have introduced a bill (S. 1700) aimed at reducing “regulatory burdens that unnecessarily delay new medical devices from reaching the market.”


Takeda acquires access to Envoy’s CNS drug pipeline and bacTRAP technology
  • Shook Hardy & Bacon LLP
  • USA
  • November 15 2012

Takeda America Holdings, Inc. has reportedly acquired Envoy Therapeutics, Inc. in a deal worth $140 million, including an up-front payment and progressdependent milestone payments


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


Cleave Biosciences secures $10 million to support cancer therapies
  • Shook Hardy & Bacon LLP
  • USA
  • April 18 2013

Cancer drug developer, Cleave Biosciences Inc., has secured $10 million in Series A financing from new investor New Enterprise Associates (NEA


NASDAQ Biotechnology Index surpasses all-time high in 1Q13
  • Shook Hardy & Bacon LLP
  • USA
  • May 16 2013

The NASDAQ Biotechnology Index reportedly rose in the first quarter of 2013 (1Q13) above levels last seen during the 2000 genomics bubble peakthe


French company prevails in dispute with FDA over drug-classification ruling
  • Shook Hardy & Bacon LLP
  • USA
  • October 3 2012

A federal court in the District of Columbia has determined that the Food and Drug Administration (FDA) erred when it classified a combination drug-device product as primarily a drug, thus subjecting its French manufacturer to more burdensome regulatory requirements


IOM publishes report on the effects of falsified and substandard medicines
  • Shook Hardy & Bacon LLP
  • Global, USA
  • February 21 2013

At the request of the U.S. Food and Drug Administration (FDA), national think tank the Institute of Medicine (IOM) has published a report that


FDA considers changes to generic drug labeling rules
  • Shook Hardy & Bacon LLP
  • USA
  • February 21 2013

A footnote in an amicus brief filed by the U.S. Department of Justice (DOJ) in a case involving whether a design-defect claim asserted against a


U.S. Supreme Court to consider just one question in Myriad Genetics
  • Shook Hardy & Bacon LLP
  • USA
  • December 6 2012

The U.S. Supreme Court has agreed to review a Federal Circuit Court of Appeals ruling on the patentability of human genes and limited its grant of certiorari to the question “Are human genes patentable?”


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • September 20 2012

The Food and Drug Administration makes available additional draft and revised draft product-specific bioequivalence (BE) recommendations on the design of BE studies to support abbreviated new drug applications