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Analytics Firm Pulls Back on Drug Revenue Projections

  • Post author:Sam
  • Post published:June 26, 2017
  • Post category:Drug Industry Daily

Patent expirations, biosimilars and uncertainty around the Trump administration’s drug policies will create a pricing squeeze in the drug industry, according to a new analysis. Source: Drug Industry Daily

Continue ReadingAnalytics Firm Pulls Back on Drug Revenue Projections

EMA Publishes Checklist Ahead of November EudraVigilance Update

  • Post author:Sam
  • Post published:June 26, 2017
  • Post category:Drug Industry Daily

The European Medicines Agency published a step-by-step guide for drugmakers to prepare for the implementation of the new EudraVigilance adverse event monitoring system, scheduled for Nov. 22. Source: Drug Industry…

Continue ReadingEMA Publishes Checklist Ahead of November EudraVigilance Update

Nonprofit Sues Celgene for Blocking Generic Competition

  • Post author:Sam
  • Post published:June 26, 2017
  • Post category:Drug Industry Daily

A new class-action lawsuit from a terminal blood cancer patient claims that Celgene abused consumer safety regulations to monopolize cancer drugs. Source: Drug Industry Daily

Continue ReadingNonprofit Sues Celgene for Blocking Generic Competition

Indiana Compounder Indicted on Conspiracy, Drug Potency

  • Post author:Sam
  • Post published:June 26, 2017
  • Post category:Drug Industry Daily

Pharmakon Pharmaceuticals executives routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results showed the strength was often…

Continue ReadingIndiana Compounder Indicted on Conspiracy, Drug Potency

Pharma Could Get Policy Boost From Executive Order

  • Post author:Sam
  • Post published:June 26, 2017
  • Post category:Drug Industry Daily

The White House could be pushing for lower prices by way of speeding drugs to market and promoting competition—even internationally—according to a draft executive order that could have the president’s…

Continue ReadingPharma Could Get Policy Boost From Executive Order

Gottlieb Previews Plans for Generics Competition, Innovative Tech Approvals

  • Post author:Sam
  • Post published:June 26, 2017
  • Post category:Drug Industry Daily

To help drive down drug prices, the FDA plans to list drugs and drug categories where patent and exclusivity protection have expired, but no generic entrants are available, FDA Commissioner…

Continue ReadingGottlieb Previews Plans for Generics Competition, Innovative Tech Approvals

EMA’s CHMP Issues Eight Positive Opinions, Including Two Hep C Antiviral Combinations

  • Post author:Sam
  • Post published:June 23, 2017
  • Post category:Drug Industry Daily

The European Medicines Agency recommended eight new drugs for approval, including two combination treatments for hepatitis C, two therapies for advanced cancers and one drug for relapsing multiple sclerosis. Source:…

Continue ReadingEMA’s CHMP Issues Eight Positive Opinions, Including Two Hep C Antiviral Combinations

OTC Sleep Drug Named after Antidepressant is Misbranded and Misleading, Warns FDA

  • Post author:Sam
  • Post published:June 23, 2017
  • Post category:Drug Industry Daily

The maker of an over-the-counter sleep aid has been warned by the FDA for marketing and branding a product with a name that may cause consumers to confuse it with…

Continue ReadingOTC Sleep Drug Named after Antidepressant is Misbranded and Misleading, Warns FDA

Jury Awards GSK $235 Million after Teva Added Heart Failure Indication to Generic Coreg

  • Post author:Sam
  • Post published:June 23, 2017
  • Post category:Drug Industry Daily

A federal jury awarded GlaxoSmithKline $235 million in a suit against Teva, saying the generics manufacturer infringed on GSK’s patent for the cardiovascular drug Coreg when Teva marketed its generic…

Continue ReadingJury Awards GSK $235 Million after Teva Added Heart Failure Indication to Generic Coreg

Congressional Diabetes Caucus Calls for Meeting with Industry Groups on Insulin Price Hikes

  • Post author:Sam
  • Post published:June 23, 2017
  • Post category:Drug Industry Daily

The co-chairs of the Congressional Diabetes Caucus requested meetings with key stakeholders to discuss rising insulin prices. Source: Drug Industry Daily

Continue ReadingCongressional Diabetes Caucus Calls for Meeting with Industry Groups on Insulin Price Hikes
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