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FDA to Expand Opioid Medication-Assisted Treatment Use, Issue New Draft Guidance

  • Post author:Sam
  • Post published:February 26, 2018
  • Post category:Drug Industry Daily

HHS Secretary Alex Azar said the FDA plans to expand the use of medication-assisted treatments for opioid addiction and will soon issue two new guidances on the topic. Source: Drug…

Continue ReadingFDA to Expand Opioid Medication-Assisted Treatment Use, Issue New Draft Guidance

ObsEva Fertility Drug Shows Some Promise in Late-Stage Trial

  • Post author:Sam
  • Post published:February 25, 2018
  • Post category:BioPharma

ObsEva Sa highlighted a data point from a late-stage trial that showed its fertility treatment nolasiban was successful in improving the pregnancy rate of some women following in vitro fertilization.…

Continue ReadingObsEva Fertility Drug Shows Some Promise in Late-Stage Trial

European Regulators Make Decisions on Several Companies’ Drugs

  • Post author:Sam
  • Post published:February 25, 2018
  • Post category:BioPharma

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) announced a string of approvals, as well as a couple rejections. Source: BioSpace

Continue ReadingEuropean Regulators Make Decisions on Several Companies’ Drugs

Mylan Defeats Allergan's Maneuver to Rent Tribal Sovereign Immunity to Avoid Restasis® Patent Cha…

  • Post author:Sam
  • Post published:February 25, 2018
  • Post category:BioPharma

U.S. Patent Trial and Appeal Board denies St. Regis Mohawk Tribe's motion to terminate Restasis patent challenge. Source: BioSpace

Continue ReadingMylan Defeats Allergan's Maneuver to Rent Tribal Sovereign Immunity to Avoid Restasis® Patent Cha…

Price of Teva's Generic Drug to Treat Wilson’s Disease Sparks Outrage

  • Post author:Sam
  • Post published:February 25, 2018
  • Post category:BioPharma

Patients are discovering that Teva’s generic isn’t really that much cheaper than Valeant Pharmaceutical’s branded drug to treat Wilson's Disease. Source: BioSpace

Continue ReadingPrice of Teva's Generic Drug to Treat Wilson’s Disease Sparks Outrage

Vertex Pharmaceuticals Appoints Reshma Kewalramani as New CMO

  • Post author:Sam
  • Post published:February 25, 2018
  • Post category:BioPharma

Vertex Pharmaceuticals announced that Reshma Kewalramani will be the new chief medical officer and executive vice president, Global Medicines Development and Medical Affairs Source: BioSpace

Continue ReadingVertex Pharmaceuticals Appoints Reshma Kewalramani as New CMO

Diabetes Market Heats Up as Eli Lilly’s Trulicity Combo Shows Improved Blood Sugar Control

  • Post author:Sam
  • Post published:February 25, 2018
  • Post category:BioPharma

Eli Lilly and Company published results from a new Phase IIIb clinical trial of Trulicity (dulaglutide) in combination with a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, which has shown improved blood sugar…

Continue ReadingDiabetes Market Heats Up as Eli Lilly’s Trulicity Combo Shows Improved Blood Sugar Control

FDA Grants Yisheng Biopharma's Clinical Treatment its Second Orphan Drug Designation

  • Post author:Sam
  • Post published:February 25, 2018
  • Post category:BioPharma

Beijing-based Yisheng Biopharma Co. is celebrating this morning after its lead immunology treatment snagged a second Orphan Drug Designation from the U.S. Food and Drug Administration. Source: BioSpace

Continue ReadingFDA Grants Yisheng Biopharma's Clinical Treatment its Second Orphan Drug Designation

U.K. Could Seek Restitution from Pfizer if Legal Appeal Fails

  • Post author:Sam
  • Post published:February 25, 2018
  • Post category:BioPharma

Pfizer is fighting to preserve Lyrica’s use as the preferred physician’s treatment for nerve pain in the U.K. Source: BioSpace

Continue ReadingU.K. Could Seek Restitution from Pfizer if Legal Appeal Fails

TrueCare Biomedix Cited for Slew of Procedural Problems

  • Post author:Sam
  • Post published:February 23, 2018
  • Post category:Drug Industry Daily

The FDA slapped TrueCare Biomedix with a Form 483 for numerous procedural issues and violations observed during a November inspection of its facility in Gujarat, India. Source: Drug Industry Daily

Continue ReadingTrueCare Biomedix Cited for Slew of Procedural Problems
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