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House Members Join Probe in Allergan-Mohawk Patent Deal

  • Post author:Sam
  • Post published:October 3, 2017
  • Post category:Drug Industry Daily

Republicans and Democrats on the House Oversight Committee pressed Allergan for an explanation of its decision to transfer patents for its lucrative dry-eye drug Restasis to a Mohawk tribe to…

Continue ReadingHouse Members Join Probe in Allergan-Mohawk Patent Deal

HHS Delays 340B Rule Again, Indicates it May Drop it Per Trump Order

  • Post author:Sam
  • Post published:October 3, 2017
  • Post category:Drug Industry Daily

HHS has once again pushed back the effective date of its final rule that would institute fines for drugmakers who overcharge for products covered by a hospital discount program. Source:…

Continue ReadingHHS Delays 340B Rule Again, Indicates it May Drop it Per Trump Order

FDA Loosens Expanded Access Requirements as Gottlieb Testifies on Right-to-Try Bills

  • Post author:Sam
  • Post published:October 3, 2017
  • Post category:Drug Industry Daily

As federal right-to-try legislation gathers steam on Capitol Hill, the FDA rolled out measures to streamline its expanded access process — including loosening institutional review board requirements — and issued…

Continue ReadingFDA Loosens Expanded Access Requirements as Gottlieb Testifies on Right-to-Try Bills

Amgen Brings Suit Against Yet Another Neulasta Biosimilar Maker: Mylan

  • Post author:Sam
  • Post published:October 2, 2017
  • Post category:Drug Industry Daily

Amgen leveled new biosimilar patent infringement litigation against Mylan, after the generics manufacturer submitted an FDA application for its version of the company’s Neulasta (pegfilgrastim) therapy earlier this year. Source:…

Continue ReadingAmgen Brings Suit Against Yet Another Neulasta Biosimilar Maker: Mylan

Judge Refuses Request for Injunction Against Maryland’s Generic Price-Gouging Law

  • Post author:Sam
  • Post published:October 2, 2017
  • Post category:Drug Industry Daily

A federal judge declined to block Maryland’s new law on generic drug price-gouging that went into effect Oct. 1, but said a challenge based on the law’s vagueness can proceed.…

Continue ReadingJudge Refuses Request for Injunction Against Maryland’s Generic Price-Gouging Law

Class Action Suit Claims Celgene Gamed the System to Guard Thalomid, Revlimid Monopolies

  • Post author:Sam
  • Post published:October 2, 2017
  • Post category:Drug Industry Daily

A health plan for a carpenters’ union filed a class action lawsuit against Celgene, claiming the drugmaker engaged in anti-competitive practices to maintain its monopoly on Thalomid and Revlimid. Source:…

Continue ReadingClass Action Suit Claims Celgene Gamed the System to Guard Thalomid, Revlimid Monopolies

FDA Guidance Steps Up Push to Speed Generics to Market

  • Post author:Sam
  • Post published:October 2, 2017
  • Post category:Drug Industry Daily

As part of a broad effort to increase competition and lower drug prices, the FDA spelled out what it expects from sponsors of abbreviated new generic drug applications who are…

Continue ReadingFDA Guidance Steps Up Push to Speed Generics to Market

Senators Seek Investigation Into Allergan’s Mohawk Tribe Patent Deal

  • Post author:Sam
  • Post published:September 29, 2017
  • Post category:Drug Industry Daily

Four Democratic senators are calling for an investigation into a Native American tribe’s acquisition of four patents from Allergan, saying the deal is a “blatantly anti-competitive” scheme to avoid review…

Continue ReadingSenators Seek Investigation Into Allergan’s Mohawk Tribe Patent Deal

Amgen to Delay Humira Biosimilar Until 2023 in Deal With AbbVie

  • Post author:Sam
  • Post published:September 29, 2017
  • Post category:Drug Industry Daily

Amgen has agreed to delay U.S. sales of its cheaper biosimilar to AbbVie’s Humira for the next six years under a settlement with AbbVie. Source: Drug Industry Daily

Continue ReadingAmgen to Delay Humira Biosimilar Until 2023 in Deal With AbbVie

Amerisourcebergen Pleads Guilty in Cancer Drug Ploy

  • Post author:Sam
  • Post published:September 29, 2017
  • Post category:Drug Industry Daily

Drug wholesaler Amerisourcebergen agreed in federal court to pay $260 million and plead guilty to violating federal drug law via a criminal scheme to sell cancer drugs illegally repackaged in…

Continue ReadingAmerisourcebergen Pleads Guilty in Cancer Drug Ploy
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