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New Jersey AG’s Proposal Would Add New Restrictions on Drugmaker’s Gifts

  • Post author:Sam
  • Post published:October 10, 2017
  • Post category:Drug Industry Daily

A proposal from New Jersey Attorney General Christopher Porrino would place new restrictions on gifts from drug manufacturers to doctors. Source: Drug Industry Daily

Continue ReadingNew Jersey AG’s Proposal Would Add New Restrictions on Drugmaker’s Gifts

EMA Answers More Stakeholder Questions in Lead Up to EudraVigilance Launch

  • Post author:Sam
  • Post published:October 10, 2017
  • Post category:Drug Industry Daily

The European Medicines Agency added answers to 60 new questions in its list of inquiries from stakeholders regarding the November launch of its new EudraVigilance drug safety reporting program. Source:…

Continue ReadingEMA Answers More Stakeholder Questions in Lead Up to EudraVigilance Launch

Unapproved Ingredients Used by Washington State Compounder, FDA Says

  • Post author:Sam
  • Post published:October 9, 2017
  • Post category:Drug Industry Daily

A Washington state pharmacy used ingredients that are not covered by a designated monograph in compounding drugs, meaning it lost its exemption for labeling requirements, and also failed to maintain…

Continue ReadingUnapproved Ingredients Used by Washington State Compounder, FDA Says

Amgen Asks Court to Scuttle Genentech’s Defense of Avastin Patents

  • Post author:Sam
  • Post published:October 9, 2017
  • Post category:Drug Industry Daily

Amgen asked a federal court to declare that its newly approved biosimilar Mvasi does not violate 27 patents Genentech holds on Avastin, the reference cancer drug Genentech is trying to…

Continue ReadingAmgen Asks Court to Scuttle Genentech’s Defense of Avastin Patents

EMA Updates Listings of Required Excipient Safety Labeling

  • Post author:Sam
  • Post published:October 9, 2017
  • Post category:Drug Industry Daily

The European Medicines Agency added new safety information for 15 excipients, including five new ingredients, in its listings of required product labeling. Source: Drug Industry Daily

Continue ReadingEMA Updates Listings of Required Excipient Safety Labeling

China to Allow Use of Overseas Trial Data in Drug Applications

  • Post author:Sam
  • Post published:October 9, 2017
  • Post category:Drug Industry Daily

In a significant policy shift, China plans to accept data from foreign clinical trials in its drug approval process if the drug is already approved overseas. Source: Drug Industry Daily

Continue ReadingChina to Allow Use of Overseas Trial Data in Drug Applications

California Joins States Looking to Rein in Drug Price Hikes

  • Post author:Sam
  • Post published:October 9, 2017
  • Post category:Drug Industry Daily

California Gov. Jerry Brown (D) signed price transparency measures into law that require drugmakers to notify purchasers ahead of large increases and to justify those increases to the state. Source:…

Continue ReadingCalifornia Joins States Looking to Rein in Drug Price Hikes

AbbVie Loses Second Consecutive Bellwether Suit Over AndroGel Risks

  • Post author:Sam
  • Post published:October 6, 2017
  • Post category:Drug Industry Daily

A jury awarded $140 million to the plaintiff in a suit against AbbVie over its testosterone replacement drug AndroGel. Source: Drug Industry Daily

Continue ReadingAbbVie Loses Second Consecutive Bellwether Suit Over AndroGel Risks

McCaskill Bill Seeks to Close Loophole That Allowed Allergan Deal; Asks PhRMA to Act

  • Post author:Sam
  • Post published:October 6, 2017
  • Post category:Drug Industry Daily

Sen. Claire McCaskill (D-Mo.) introduced legislation that would bar patent arrangements like the controversial deal between Allergan and a Native American tribe. Source: Drug Industry Daily

Continue ReadingMcCaskill Bill Seeks to Close Loophole That Allowed Allergan Deal; Asks PhRMA to Act

Lilly Prevails in Patent Challenge to Alimta Vitamin Regimen

  • Post author:Sam
  • Post published:October 6, 2017
  • Post category:Drug Industry Daily

It would be obvious to treat a patient with folic acid before administering Lilly’s antifoliate chemotherapy drug Alimta (pemetrexed) to reduce Alimta’s toxic effects, the PTO’s Patent Trial and Appeals…

Continue ReadingLilly Prevails in Patent Challenge to Alimta Vitamin Regimen
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