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