China officially issues regulation accepting clinical data obtained from overseas studies, with a priority on treatments for critical, rare and pediatric conditions.

With only one new proposal, brand industry association seems to banking on strength of past policy positions as Trump's drug pricing blueprint moves towards implementation stage.

Commissioner Scott Gottlieb says move could allow biosimilar sponsors to avoid anti-competitive efforts by brand sponsors in US.

Federal Circuit rules that material about Xyrem's REMS distribution system provided for advisory committee review constitutes prior art.

Focus should not be limited to rebates in Medicare Part D, manufacturers advise in comments on HHS drug pricing blueprint. Pharmacy benefit managers raise anti-trust issues with shift to upfront discounts.

Companies should introduce same drug under new NDC at lower list price to overcome difficulties of reducing list prices on existing brands, PBM says.

A French government/industry discussion forum has come up with concrete plans for accelerating access to innovative medicines by streamlining clinical trial approval and price negotiations.

Imbalance in deaths in study of novel cholesterol drug has been a concern, but Esperion made the case for safety during a July 10 investor day, which featured presentations by ex-FDA director John Jenkins and Cleveland Clinic cardiologist Steve Nissen.

Amazon's Basic Care OTC brand SKUs have doubled units since last year's launch and is putting great pricing pressure on private label competitors, says a Jefferies analyst. But a private label consultant says the e-commerce giant's threat to competitors in the consumer health market is over-hyped.

After a conversation with President Trump, CEO Ian Read agreed to cancel price increases on 40 drugs that took effect July 1, to give the administration time to work on its blueprint for improving the health care system.

President Trump called out Pfizer’s recent price increases on Twitter July 9. Pfizer was one of only four companies that took a second round of price increases in 2018, according to analysts at Morgan Stanley. CEO Read has long defended the industry's pricing practices, even as public criticism of the high drug prices has grown. 

FDA’s latest drug shortages task force aims to encourage investment in the reliable manufacture of generic sterile injectables that are fundamental to the practice of medicine. While the agency’s first task force continues to work with industry to avert shortages, the second will strike at underlying structural issues that cause persistent shortages of these critical medicines.

New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.

Sanofi is working on technical improvements after its Mourenx site in southwest France was found to be emitting illegally high levels of solvents. Production at the site is on hold.

Amazon's Basic Care OTC brand SKUs have doubled units since last year's launch and is putting great pricing pressure on private label competitors, says a Jefferies analyst. But a private label consultant says the e-commerce giant's threat to competitors in the consumer health market is over-hyped.

By setting up Pfizer Consumer Healthcare to have sales and earnings results reported separately, pharma giant could be making the division's assets more visible to potential buyers. Its sales pitch: "With a strong portfolio of global brands that span health and wellness, the company believes this business is well positioned to continue its growth."

Bristol-Myers Squibb weighs selling its UPSA French OTC business, conducting a strategic review to assess its growth potential. Milan-based Recordati, says it plans to grow its OTC business; the firm sold a 51.8% stake owned by the Recordati family to a consortium of private equity funds for $3.56bn.