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Cellectis’ T-Cell Gene Editing Technology Granted Patents

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:Drug Industry Daily

The U.S. Patent and Trademark Office issued two patents to French cell therapy group Cellectis for use of CRISPR technologies in T-cells. Source: Drug Industry Daily

Continue ReadingCellectis’ T-Cell Gene Editing Technology Granted Patents

FDA Finalizes Guidance on Co-Crystals in NDAs and ANDAs

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:Drug Industry Daily

The FDA finalized new guidance establishing co-crystals as a drug product intermediate. Source: Drug Industry Daily

Continue ReadingFDA Finalizes Guidance on Co-Crystals in NDAs and ANDAs

Azar Defends FY 2019 Budget Request at Congressional Hearing

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:Drug Industry Daily

In his first appearance as HHS Secretary on Capitol Hill, Alex Azar fielded questions Wednesday about the Trump administration’s plans to address the opioid crisis and drug prices. Source: Drug…

Continue ReadingAzar Defends FY 2019 Budget Request at Congressional Hearing

Bayer Facility Warned for GMP Noncompliance

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:Drug Industry Daily

The FDA issued a warning letter to Bayer arising from an inspection at a Bayer Pharma facility in North Rhine-Westphalia, Germany. Source: Drug Industry Daily

Continue ReadingBayer Facility Warned for GMP Noncompliance

Allergan Agrees to Settle Botox Antitrust Case for $13.45 Million

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:Drug Industry Daily

Allergan agreed to pay a class of doctors $13.45 million over claims the company artificially maintained the price of Botox through a deal with a potential competitor. Source: Drug Industry…

Continue ReadingAllergan Agrees to Settle Botox Antitrust Case for $13.45 Million

Drugmaker Payments to Advocacy Groups May Have Fueled Opioid Epidemic, Senator Asserts

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:Drug Industry Daily

Leading U.S. opioid manufacturers donated millions of dollars to organizations that doubled as advocacy groups, potentially fueling the opioid epidemic, according to the latest report to emerge from the opioids…

Continue ReadingDrugmaker Payments to Advocacy Groups May Have Fueled Opioid Epidemic, Senator Asserts

Sens. McCain, Baldwin Ask Trump to Support Bill on Drug Price Increases

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:Drug Industry Daily

Two senators called on the Trump administration to back a bill requiring drugmakers to justify any proposed price increases — invoking the president’s commitment in the State of the Union…

Continue ReadingSens. McCain, Baldwin Ask Trump to Support Bill on Drug Price Increases

Industry Groups Welcome Administration’s FDA Budget Request, With Some Reservations

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:Drug Industry Daily

The White House’s proposed budget for fiscal 2019 drew mixed reviews from pharma industry groups, who praised steps they say will improve access but warned the proposal does not properly…

Continue ReadingIndustry Groups Welcome Administration’s FDA Budget Request, With Some Reservations

Gottlieb Summarizes New Initiatives Under Administration’s Proposed Budget Increase

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:Drug Industry Daily

FDA Commissioner Scott Gottlieb issued a statement Tuesday highlighting what the agency would do with the increased funds provided in the administration’s proposed budget for FY 2019. Source: Drug Industry…

Continue ReadingGottlieb Summarizes New Initiatives Under Administration’s Proposed Budget Increase

Administration Requests Huge Hike in FDA Budget for FY2019 — Increased User Fees

  • Post author:Sam
  • Post published:February 12, 2018
  • Post category:Drug Industry Daily

President Trump’s proposed budget for FY 2019 calls for a major increase in budget authority for the FDA along with a significant increase in user fees. Source: Drug Industry Daily

Continue ReadingAdministration Requests Huge Hike in FDA Budget for FY2019 — Increased User Fees
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