Biogen, the first company to win a positive reimbursement decision from the BeNeLuxA groups, says the process was “constructive and collaborative.” However, differences in local laws mean there will initially be some differences in coverage.

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Biogen, the first company to win a positive reimbursement decision from the BeNeLuxA groups, says the process was “constructive and collaborative.” However, differences in local laws mean there will initially be some differences in coverage.

Regeneron challenges Federal Circuit finding that withholding information in discovery constitutes inequitable conduct; district judge orders firm to pay Merus $10.5m in attorneys' fees and costs.

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. 

European authorities are examining how a manufacturing process change six years ago may have introduced a probable carcinogen into Zhejiang Huahai’s valsartan API that was only recently detected. They hope to learn how the firm could reduce or eliminate the impurity.

Capacity shortages are looming for manufacturers wanting to develop and commercialize cell and gene therapy products over the next five years, an industry survey shows. The key finding: these firms should quickly build and staff the manufacturing facilities they will need.

Next step for OTC monograph reform legislation is Senate consideration; market exclusivity periods are likely focus of House/Senate conference. Separate bill to allow consumers to use health savings accounts to buy OTC drugs without a doctor's prescription clears House Ways and Means panel.

Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been switched from Rx to OTC. Draft guidance on innovative switch applications to be followed by rule-making in near future.