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Ohio Becomes Second State to Sue Opioid Manufacturers

  • Post author:Sam
  • Post published:June 1, 2017
  • Post category:Drug Industry Daily

Ohio’s attorney general filed a lawsuit against Purdue Pharma, Endo Health Solutions, Teva, Johnson & Johnson and Allergan this week, alleging they contributed to the opioid epidemic through fraudulent advertising.…

Continue ReadingOhio Becomes Second State to Sue Opioid Manufacturers

SCOTUS Decision on Printer Cartridges Could Impact Drug Imports

  • Post author:Sam
  • Post published:June 1, 2017
  • Post category:Drug Industry Daily

The Supreme Court’s ruling this week on a patent dispute over printer toner cartridges could have wider effects on the pharmaceutical industry, international sales and product reimportation. Source: Drug Industry…

Continue ReadingSCOTUS Decision on Printer Cartridges Could Impact Drug Imports

Drugmaker Warned Over Long-Term Quality Problems

  • Post author:Sam
  • Post published:May 31, 2017
  • Post category:Drug Industry Daily

The FDA sent a warning to a drug manufacturing facility in Irvine, Calif., for failure to resolve quality issues dating back to 2013. Source: Drug Industry Daily

Continue ReadingDrugmaker Warned Over Long-Term Quality Problems

FDA Approves First Strattera Generic for ADHD, Plus Five Other First-Time Generics

  • Post author:Sam
  • Post published:May 31, 2017
  • Post category:Drug Industry Daily

The FDA approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit hyperactivity disorder in pediatric and adult patients, including multiple strengths manufactured by Apotex, Teva, Aurobindo Pharma and…

Continue ReadingFDA Approves First Strattera Generic for ADHD, Plus Five Other First-Time Generics

EMA Unveils Action Plan to Support Small- and Medium-Sized Companies

  • Post author:Sam
  • Post published:May 31, 2017
  • Post category:Drug Industry Daily

The European Medicines Agency announced a three-year, 16-point action plan to boost small- and medium-sized pharmaceutical companies. Source: Drug Industry Daily

Continue ReadingEMA Unveils Action Plan to Support Small- and Medium-Sized Companies

HHS Estimates Mylan Overcharged $1.27 Billion for the EpiPen Over a Decade

  • Post author:Sam
  • Post published:May 31, 2017
  • Post category:Drug Industry Daily

The HHS inspector general’s office is estimating that taxpayers overpaid for the EpiPen by as much as $1.27 billion between 2006 and 2016. Source: Drug Industry Daily

Continue ReadingHHS Estimates Mylan Overcharged $1.27 Billion for the EpiPen Over a Decade

EMA Answers Drugmakers’ Brexit Questions on Transfers and Relocations

  • Post author:Sam
  • Post published:May 31, 2017
  • Post category:Drug Industry Daily

The European Medicines Agency says marketing authorization holders must be based in the European Economic Area post-Brexit — and UK-based companies will likely need to transfer marketing authorizations to new…

Continue ReadingEMA Answers Drugmakers’ Brexit Questions on Transfers and Relocations

EMA’s Pharmacovigilance Committee Recommends Label Changes

  • Post author:Sam
  • Post published:May 30, 2017
  • Post category:Drug Industry Daily

A European Medicines Agency pharmacovigilance panel has issued new labeling recommendations to sponsors of certain approved drug products. Source: Drug Industry Daily

Continue ReadingEMA’s Pharmacovigilance Committee Recommends Label Changes

EMA Accepts Five Drugs for Priority Medicine Program

  • Post author:Sam
  • Post published:May 30, 2017
  • Post category:Drug Industry Daily

The European Medicines Agency named five treatments as eligible for its priority medicines program, bringing the total to 25. Source: Drug Industry Daily

Continue ReadingEMA Accepts Five Drugs for Priority Medicine Program

Amgen Sues the FDA over Marketing Exclusivity for Sensipar in Pediatric Patients

  • Post author:Sam
  • Post published:May 30, 2017
  • Post category:Drug Industry Daily

Amgen is suing the FDA, requesting that its Sensipar medication be granted six additional months of pediatric market exclusivity after it completed three of four pediatric clinical trials requested by…

Continue ReadingAmgen Sues the FDA over Marketing Exclusivity for Sensipar in Pediatric Patients
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