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Results: 11-20 of 346

FDA warns competing drug makers over unsubstantiated superiority claims

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 15 2012

The U.S. Food and Drug Administration has sent warning letters to competing drug manufacturers for allegedly promoting their neonatal respiratory distress syndrome treatments using “unsubstantiated superiority claims” that also “omit and minimize important risk information, and present unsubstantiated claims for the drug product”

Putative class alleges pharma statements about new drug violated securities laws

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 16 2013

Aveo Pharmaceuticals, Inc. and several of its executives have been targeted in a securities class action filed in a federal court in Massachusetts

Myriad litigants seek rehearing, stalling case before Federal Circuit panel

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • September 22 2011

Court watchers were reportedly surprised that both sides to litigation involving the patentability of genetic discoveries filed petitions for a rehearing before the divided Federal Circuit Court of Appeals panel that issued a ruling on the matter in July 2011

FDA argues to D.C. Circuit that stem cell treatment is a drug

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 21 2013

Asserting that "FDA may lawfully regulate the creation of a new drug product even if it contains some of a patient's cells," the Food and Drug

Virginia enacts first biosimilar substitution law

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 4 2013

Virginia's governor has reportedly signed legislation (H.B. 1422S.B. 1285) that will allow the state's pharmacists to substitute biosimilars for

Ninth Circuit to consider impact of trial court error in admitting expert testimony

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 4 2013

In related cases that could have implications for intellectual property, consumer safety and complex litigation where resolution of the dispute

$25 million raised to advance treatment of hyperkinetic movement disorders

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 15 2012

La Jolla, California-based Auspex Pharmaceuticals, Inc. has reportedly raised $25 million in a Series D venture financing round that included investors Panorama Capital, CMEA Capital and Sloan Biotech Fund

WSJ calls personalized medicine a challenge for pharmaceutical industry

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 27 2011

According to a Wall Street Journal "Heard on the Street" column, personalized medicine, which uses genetic information to target drugs to individual users, may be the latest industry buzzword, but it could pose more of a threat than an opportunity

FDA draft guidance addresses safety labeling changes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 21 2011

The Food and Drug Administration (FDA) has made available a draft guidance titled "Safety Labeling ChangesImplementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act," that would provide information on new statutory provisions authorizing the agency "to require certain drug and biological product application holders to make safety related labeling changes based upon new safety information that becomes available after the drug or biological product is approved."

Berg, GNS announce joint venture to enhance therapeutic & diagnostic development

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 10 2011

Massachusetts-based Berg Biosystems, LLC and GNS Healthcare, Inc. have announced a joint venture “to accelerate advancements in critical biomedical research” and reposition “existing drugs for use in new indications with collaborators.”

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