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Kmart to Settle FCA Violation Allegations for $32.2 Million

  • Post author:Sam
  • Post published:December 28, 2017
  • Post category:Drug Industry Daily

Kmart agreed to pay a $32.3 million settlement over charges that its in-store pharmacies failed to report discounted drug prices to federal programs and, therefore, were reimbursed at inflated prices.…

Continue ReadingKmart to Settle FCA Violation Allegations for $32.2 Million

Senators Call on DEA for Guidance on ‘Partial Fill’ of Opioid Prescriptions

  • Post author:Sam
  • Post published:December 28, 2017
  • Post category:Drug Industry Daily

Six U.S. senators called on the Drug Enforcement Administration to update regulations on partial filling of Schedule II drugs to help address the opioid addiction crisis. Source: Drug Industry Daily

Continue ReadingSenators Call on DEA for Guidance on ‘Partial Fill’ of Opioid Prescriptions

FDA to Commit to Faster End-of-Phase Meetings in Guidance to Developers

  • Post author:Sam
  • Post published:December 28, 2017
  • Post category:Drug Industry Daily

FDA released two guidance documents focusing on communications between the agency and drug developers to make drug development more efficient and to help sponsors avoid costly delays. Source: Drug Industry…

Continue ReadingFDA to Commit to Faster End-of-Phase Meetings in Guidance to Developers

Pharma Bro Shkreli's Ex-Lawyer Convicted of Helping Him Defraud Pharma Firm

  • Post author:Sam
  • Post published:December 27, 2017
  • Post category:BioPharma

Evan Greebel was found guilty by a federal jury in Brooklyn of charges he conspired to commit wire fraud and securities fraud. Source: BioSpace

Continue ReadingPharma Bro Shkreli's Ex-Lawyer Convicted of Helping Him Defraud Pharma Firm

5 Biotechs Awaiting FDA Decisions in January 2018

  • Post author:Sam
  • Post published:December 27, 2017
  • Post category:BioPharma

From 1997 through 2013, there was an average of 27 novel drugs approved in the U.S. per year. Source: BioSpace

Continue Reading5 Biotechs Awaiting FDA Decisions in January 2018

2 Small-Cap Biotechs Bestie Celgene is Cutting Back On

  • Post author:Sam
  • Post published:December 27, 2017
  • Post category:BioPharma

Celgene has been unloading some of its shares in two of its investments, CRISPR Therapeutics and Atara Biotherapeutics. Source: BioSpace

Continue Reading2 Small-Cap Biotechs Bestie Celgene is Cutting Back On

FDA Accepts GW Pharma's Epidiolex NDA With Priority Review for Lennox-Gastaut Syndrome and Dravet…

  • Post author:Sam
  • Post published:December 27, 2017
  • Post category:BioPharma

The PDUFA goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018. Source: BioSpace

Continue ReadingFDA Accepts GW Pharma's Epidiolex NDA With Priority Review for Lennox-Gastaut Syndrome and Dravet…

4 Top-Performing S&P 500 Biotech Stocks of 2017

  • Post author:Sam
  • Post published:December 27, 2017
  • Post category:BioPharma

It was a pretty good year for the stock market, but how about for biotech stocks? Source: BioSpace

Continue Reading4 Top-Performing S&P 500 Biotech Stocks of 2017

Keryx, Norwich Pharma Mutually Terminate Manufacturing Agreement

  • Post author:Sam
  • Post published:December 27, 2017
  • Post category:BioPharma

The deal was originally inked on Jan 17, 2014‍​. Source: BioSpace

Continue ReadingKeryx, Norwich Pharma Mutually Terminate Manufacturing Agreement

Fresenius SE Allegedly Ignored Hundreds of Bad Quality Tests at Plant in India

  • Post author:Sam
  • Post published:December 27, 2017
  • Post category:BioPharma

The agency inspected the plant from May 15 to May 24, 2017, and observed that staffers at the plant were basically gaming the quality control system. Source: BioSpace

Continue ReadingFresenius SE Allegedly Ignored Hundreds of Bad Quality Tests at Plant in India
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