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Medtech Petitions FDA for Permission to Change Dosage in ANDA for Generic Excedrin

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

Medtech petitioned the FDA to allow the company to submit an ANDA for generic Excedrin in which the proposed product is in a dosage form different from the reference drug.…

Continue ReadingMedtech Petitions FDA for Permission to Change Dosage in ANDA for Generic Excedrin

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

Merck Chemist Arrested for Stealing Deadly Chemical

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:BioPharma

A 60-year-old chemist has been charged with stealing 219.79 grams of potassium cyanide, a deadly poison, from a Merck facility in Pennsylvania. Source: BioSpace

Continue ReadingMerck Chemist Arrested for Stealing Deadly Chemical

3 Biotechs Facing Stiff Headwinds in 2018

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:BioPharma

The stock market has been rocky recently, but overall the biotech market appears to have been comparatively stable. Source: BioSpace

Continue Reading3 Biotechs Facing Stiff Headwinds in 2018

“An Unrelenting Disaster Zone”: Merck’s Alzheimer’s Drug Fails in Phase III

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:BioPharma

Alzheimer's drug development took another hit. Source: BioSpace

Continue Reading“An Unrelenting Disaster Zone”: Merck’s Alzheimer’s Drug Fails in Phase III

Meet the Little-Known Chinese CAR-T Biotech Up More Than 500% Since June 2017

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:BioPharma

The company reported positive results from early studies in 35 patients with a type of blood cancer last year. Source: BioSpace

Continue ReadingMeet the Little-Known Chinese CAR-T Biotech Up More Than 500% Since June 2017

Jobs Affected as ImmunoGen Winds Down Ops at Massachusetts Facility

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:BioPharma

ImmunoGen gave a pipeline progress report and 2017 operating results last week. Source: BioSpace

Continue ReadingJobs Affected as ImmunoGen Winds Down Ops at Massachusetts Facility

FDA Berates Bayer for Inadequate Cleaning, QC Questions at HQ

  • Post author:Sam
  • Post published:February 13, 2018
  • Post category:BioPharma

The company is addressing the FDA’s complaints regarding manufacturing practices, which stem from a routine inspection in January, Source: BioSpace

Continue ReadingFDA Berates Bayer for Inadequate Cleaning, QC Questions at HQ
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