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Novo Nordisk Lays Off 185 Employees, Hiring 70 in Commercial Reorg

  • Post author:Sam
  • Post published:November 12, 2017
  • Post category:BioPharma

After falling short of analysts' expectations in its latest quarter, Novo Nordisk is restructuring its commercial operations as it looks to fend off challenges to its products. Source: BioSpace

Continue ReadingNovo Nordisk Lays Off 185 Employees, Hiring 70 in Commercial Reorg

Nektar Stock Blows Up on Encouraging Data to Treat Difficult Cancers

  • Post author:Sam
  • Post published:November 12, 2017
  • Post category:BioPharma

The initial results were presented at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Source: BioSpace

Continue ReadingNektar Stock Blows Up on Encouraging Data to Treat Difficult Cancers

Bay Area's Arcus Biosciences Scores $107M, Initiates Two Clinical Trials

  • Post author:Sam
  • Post published:November 12, 2017
  • Post category:BioPharma

Now totaling $227M, Arcus Biosciences announced it had closed a $107M Series C financing. Source: BioSpace

Continue ReadingBay Area's Arcus Biosciences Scores $107M, Initiates Two Clinical Trials

Lessons Learned: One-Time Leader Juno Uses Deaths to Create a Better CAR-T Formula

  • Post author:Sam
  • Post published:November 12, 2017
  • Post category:BioPharma

Neurotoxicity killed JCAR015 right along with 5 patients in the lead pivotal study, derailing Juno Therapeutics. Source: BioSpace

Continue ReadingLessons Learned: One-Time Leader Juno Uses Deaths to Create a Better CAR-T Formula

Argos Surges on Positive Phase III Kidney Cancer Data

  • Post author:Sam
  • Post published:November 12, 2017
  • Post category:BioPharma

Investors in beleaguered Argos are smiling this morning after the company announced some positive interim data for its Phase III kidney cancer drug, Rocapuldencel-T - a trial that some said…

Continue ReadingArgos Surges on Positive Phase III Kidney Cancer Data

ViGuard Health Petitions FDA to Classify IND as a Supplement

  • Post author:Sam
  • Post published:November 10, 2017
  • Post category:Drug Industry Daily

ViGuard Health called on the FDA to declare pyridoxamine to be a dietary supplement and no longer authorized for investigation as a new drug. Source: Drug Industry Daily

Continue ReadingViGuard Health Petitions FDA to Classify IND as a Supplement

FDA Raps Guangdong Firm Over Quality, Testing

  • Post author:Sam
  • Post published:November 10, 2017
  • Post category:Drug Industry Daily

The FDA issued a warning letter to Chinese drugmaker Guangdong Zhanjiang Jimin Pharmaceutical following a May inspection of its Guangdong Province facility. Source: Drug Industry Daily

Continue ReadingFDA Raps Guangdong Firm Over Quality, Testing

Appeals Court Rules Generic Label Would Direct Docs to Infringe Use Patent

  • Post author:Sam
  • Post published:November 10, 2017
  • Post category:Drug Industry Daily

The Federal Circuit upheld two Sanofi patents for its antiarrhythmic drug Multaq (dronedarone) — agreeing with Sanofi’s argument that the drug’s label, which is required to be similar for any…

Continue ReadingAppeals Court Rules Generic Label Would Direct Docs to Infringe Use Patent

CHMP Recommends Ten Medicines for Approval

  • Post author:Sam
  • Post published:November 10, 2017
  • Post category:Drug Industry Daily

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended ten medicines for approval, including two orphan medicines and a new treatment for multiple sclerosis. Source: Drug Industry…

Continue ReadingCHMP Recommends Ten Medicines for Approval

Senate Tax Plan Keeps, but Modifies Orphan Research Tax Credit

  • Post author:Sam
  • Post published:November 10, 2017
  • Post category:Drug Industry Daily

Senate Republicans released a competing tax reform plan that — in comparison to the House side’s proposed repeal — merely shrinks the size of the orphan drug research tax credit.…

Continue ReadingSenate Tax Plan Keeps, but Modifies Orphan Research Tax Credit
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