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Senate Committee Explores Value-Based Drug Pricing to Help Stem Increases

  • Post author:Sam
  • Post published:December 12, 2017
  • Post category:Drug Industry Daily

The Senate’s health committee held its final hearing in a set of three this year on the rising costs of prescription drugs — this time exploring how value-based pricing could…

Continue ReadingSenate Committee Explores Value-Based Drug Pricing to Help Stem Increases

FDA Hits Glenmark for Quality Controls, Complaint Handling

  • Post author:Sam
  • Post published:December 11, 2017
  • Post category:Drug Industry Daily

The FDA cited a Glenmark Pharmaceuticals facility in Solan, India for failing to investigate discrepancies, inadequate complaint records and improper maintenance of quality data. Source: Drug Industry Daily

Continue ReadingFDA Hits Glenmark for Quality Controls, Complaint Handling

FDA’s Complete Responses to Generic Drugmakers Continue to Outpace Fiscal 2017

  • Post author:Sam
  • Post published:December 11, 2017
  • Post category:Drug Industry Daily

The FDA continued to issue a larger number of complete response letters to generics manufacturers last month — dropping from a spike in October, but still higher than any single…

Continue ReadingFDA’s Complete Responses to Generic Drugmakers Continue to Outpace Fiscal 2017

PhRMA Sues California to Block Law Requiring Advanced Notice of Price Hikes

  • Post author:Sam
  • Post published:December 11, 2017
  • Post category:Drug Industry Daily

PhRMA filed a lawsuit against the state of California challenging its newly signed law meant to stem rising prescription drug prices. Source: Drug Industry Daily

Continue ReadingPhRMA Sues California to Block Law Requiring Advanced Notice of Price Hikes

FDA Finalizes Guidance on Product Name Placement in Advertisements

  • Post author:Sam
  • Post published:December 11, 2017
  • Post category:Drug Industry Daily

The FDA finalized its guidance on drug advertisements, clarifying the legal requirements for companies in the placement of the product’s name — as well as its size, prominence and frequency…

Continue ReadingFDA Finalizes Guidance on Product Name Placement in Advertisements

Payers, Providers Want More Data From Biopharma Companies

  • Post author:Sam
  • Post published:December 8, 2017
  • Post category:Drug Industry Daily

Two PhRMA-funded surveys found that payers and providers would like more information from biopharmaceutical companies about approved and unapproved uses of medicines, including products undergoing clinical trials. Source: Drug Industry…

Continue ReadingPayers, Providers Want More Data From Biopharma Companies

Mylan Urges FDA Not to Approve Advair Generics Based on Multi-Batch Studies

  • Post author:Sam
  • Post published:December 8, 2017
  • Post category:Drug Industry Daily

The FDA should not approve generics of Glaxo Smith Kline’s asthma drug Advair Diskus that depend on multiple-batch studies to show pharmacokinetic bioequivalence, according to Mylan. Source: Drug Industry Daily

Continue ReadingMylan Urges FDA Not to Approve Advair Generics Based on Multi-Batch Studies

FDA: Most Sponsors’ PMRs on Time, But Reporting Lags Behind

  • Post author:Sam
  • Post published:December 8, 2017
  • Post category:Drug Industry Daily

Most drugmakers are fulfilling their postmarketing study commitments, but many are not meeting their deadlines for annual status reports, the FDA said. Source: Drug Industry Daily

Continue ReadingFDA: Most Sponsors’ PMRs on Time, But Reporting Lags Behind

CMS: Prescription Drug Spending Growth Plummeted to 1.3 Percent in 2016

  • Post author:Sam
  • Post published:December 8, 2017
  • Post category:Drug Industry Daily

U.S. healthcare spending growth slowed in 2016, including a steep drop in spending on retail prescription drugs — decelerating after two years of faster growth associated with coverage expansions under…

Continue ReadingCMS: Prescription Drug Spending Growth Plummeted to 1.3 Percent in 2016

FDA Committee Votes to Combine Bladder Pain, Interstitial Cystitis Patients in Trials

  • Post author:Sam
  • Post published:December 7, 2017
  • Post category:Drug Industry Daily

An FDA advisory committee voted unanimously in favor of combining patients with bladder pain syndrome and interstitial cystitis in clinical trials citing the minimal differences in symptoms between the two…

Continue ReadingFDA Committee Votes to Combine Bladder Pain, Interstitial Cystitis Patients in Trials
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