Enasidenib, which last year became the first US-approved treatment for relapsed or refractory acute myeloid leukemia with an IDH2 mutation, is among a new crop of products being reviewed for marketing approval in the EU.

Vertex is staunchly defending its cystic fibrosis portfolio-based reimbursement deal rejected by NHS England and has called on the UK’s prime minister to intervene. The company says similar deals have worked well in Ireland and Sweden.

Energy & Commerce Health Subcommittee releases several discussion drafts at hearing on 340B drug discount program reform as the debate seems poised to move into the next phase.

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. 

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.

Medicine shortages are under scrutiny at national and EU level. In France, a newly established Senate task force is hearing evidence from a range of stakeholders including industry and regulators.

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.