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Valeant Files Patent Lawsuit Over Zydus’ Cardizem Generic

  • Post author:Sam
  • Post published:January 25, 2017
  • Post category:Drug Industry Daily

Valeant has sued Zydus over the alleged infringement of a patent covering the company’s extended-release hypertension drug, Cardizem LA. Source: Drug Industry Daily

Continue ReadingValeant Files Patent Lawsuit Over Zydus’ Cardizem Generic

FDA: Porton Failed to Follow Contamination Procedures, Notify Agency of Product Changes

  • Post author:Sam
  • Post published:January 25, 2017
  • Post category:Drug Industry Daily

FDA served Porton Biopharma a warning letter after an inspection revealed failures to notify the agency of changes affecting drugs, and failing to follow procedures to prevent microbiological contamination. Source:…

Continue ReadingFDA: Porton Failed to Follow Contamination Procedures, Notify Agency of Product Changes

Mezzion Sues Dr. Reddy’s for Concealing GMP Deficiencies That Resulted in An NDA Rejection

  • Post author:Sam
  • Post published:January 25, 2017
  • Post category:Drug Industry Daily

Mezzion filed a lawsuit accusing its former manufacturer Dr. Reddy of fraud for concealing significant GMP deficiencies that resulted in the FDA’s refusal to approve an NDA for udenafil, an…

Continue ReadingMezzion Sues Dr. Reddy’s for Concealing GMP Deficiencies That Resulted in An NDA Rejection

Shredded Documents and Dirty Equipment Net Hetero Labs a Form 483

  • Post author:Sam
  • Post published:January 25, 2017
  • Post category:Drug Industry Daily

Hetero Labs has been handed a Form 483 after an inspection revealed employees shredding documents, in addition to sanitation and GMP issues. Investigators listed eight observations after inspecting the firm’s…

Continue ReadingShredded Documents and Dirty Equipment Net Hetero Labs a Form 483

Pharma Industry to Fight Drug Pricing Criticism With Ad Campaign

  • Post author:Sam
  • Post published:January 24, 2017
  • Post category:Drug Industry Daily

The drug industry is launching a new ad campaign to push back against the negative media attention over increasing drug prices.  Source: Drug Industry Daily

Continue ReadingPharma Industry to Fight Drug Pricing Criticism With Ad Campaign

Pfizer Reasserts Claims Against Texas for Disclosing Medicaid Rebates to Lawmakers

  • Post author:Sam
  • Post published:January 24, 2017
  • Post category:Drug Industry Daily

Pfizer is standing firm on its allegations that Texas violated federal laws when it disclosed the company’s Medicaid rebate information to local lawmakers. The company is challenging the state’s argument…

Continue ReadingPfizer Reasserts Claims Against Texas for Disclosing Medicaid Rebates to Lawmakers

Compounding Pharmacy Draws Warning Letter for Misbranded, Unapproved Drugs

  • Post author:Sam
  • Post published:January 24, 2017
  • Post category:Drug Industry Daily

The FDA Philadelphia district office has issued a warning letter to a compounding pharmacy in Allentown, PA over misbranded drugs and sterility issues. Source: Drug Industry Daily

Continue ReadingCompounding Pharmacy Draws Warning Letter for Misbranded, Unapproved Drugs

UK Looks Toward Investing in Life Sciences Industry

  • Post author:Sam
  • Post published:January 24, 2017
  • Post category:Drug Industry Daily

British Prime Minister Theresa May is working toward a deal with the UK’s life sciences industry to increase the sector’s productivity and maximize the country’s investment in research and development.…

Continue ReadingUK Looks Toward Investing in Life Sciences Industry

Trump’s Pick to Lead HHS Says He’s Open to Better Ways to Lower Drug Prices

  • Post author:Sam
  • Post published:January 24, 2017
  • Post category:Drug Industry Daily

Pressed for details by a Senate committee Tuesday, Rep. Tom Price (R-Ga.) — President Donald Trump’s pick to lead HHS — refused to confirm whether or not he would push…

Continue ReadingTrump’s Pick to Lead HHS Says He’s Open to Better Ways to Lower Drug Prices

EMA: 30 Drugs Granted Conditional Market Authorization in the Past Decade

  • Post author:Sam
  • Post published:January 24, 2017
  • Post category:Drug Industry Daily

The European Medicines Agency said 30 drugs across four therapeutic classes have received conditional marketing authorization in the EU since the expedited approval pathway became available a decade ago. Source:…

Continue ReadingEMA: 30 Drugs Granted Conditional Market Authorization in the Past Decade
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