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Results: 1-10 of 354

Grifols acquires 51 percent stake in Araclon Biotech

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 29 2012

Grifols, a Spanish plasma-product manufacturer specializing in the hospitalpharmaceutical sector, has announced that it has acquired 51 percent of the equity of Zaragoza-based Araclon Biotech, a company spun off from the University of Zaragoza in 2004 to develop therapies and diagnostics for Alzheimer’s disease

Financial group analyzes M&A deals in biotech and medical device industries

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 16 2011

According to an SVP Financial Group report, contrary to conventional wisdom, biotech exits occur faster than device exits and have lower, but solid, multiples on invested capital

FDA publishes final rule on investigational new drug applications, issues draft guidance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

Study shows rise in biotech patent litigation

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • September 20 2012

PricewaterhouseCoopers LLP has released its “2012 Patent Litigation Study,” which shows that the 4,105 patent lawsuits filed in 2011 marked a high point and a 22-percent increase from the previous year

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

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

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

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

PROLOR Biotech to raise $75 million for clinical trials on growth hormones

  • Shook Hardy & Bacon LLP
  • -
  • Israel, USA
  • -
  • April 19 2012

In an April 6, 2012, filing with the U.S. Securities and Exchange Commission, Israel-based PROLOR Biotech, Inc. has registered the sale of common stock on the American Stock Exchange in an amount not to exceed $75 million