Member companies’ direct-to-consumer TV ads will direct patients to information about drug costs – including list price, estimated out-of-pocket costs for the drug, and availability of financial assistance – under a voluntary program that takes effect in April 2019; initiative falls short of mandatory list price disclosures proposed by Trump Administration.

The pharmaceutical industry's renewed effort to find a pragmatic solution to managing adverse events from patient support programs has drawn the European Medicines Agency's attention.

A new joint procurement agreement between Norway and Denmark is a signal to drug companies that they will have to increasingly negotiate with more than one country in a new age of collaboration, says Amgros, the Danish medicines procurement agency.

Study analyzed follow-up data on 205,498 women from the Nurses’ Health Study started in 1976 and Nurses’ Health Study II opened in 1989; 1,054 of the women developed ovarian cancer.

Data from ASPREE trial with more than 19,000 subjects show five-year-use of low-dose aspirin did not prolong disability-free survival and is associated with a significantly higher rate of hemorrhage and somewhat higher rate of all-cause mortality. Findings in three reports in NEJM track with US FDA's guidance that OTC aspirin marketers include a statement referring to doctors when aspirin package labels include a heart or other image suggesting a CV indication.

CBER's Rachael Anatol says such a situation has happened "more than a few times"; instances appear to have been largely concentrated in earlier days of the RMAT program.

Member companies’ direct-to-consumer TV ads will direct patients to information about drug costs – including list price, estimated out-of-pocket costs for the drug, and availability of financial assistance – under a voluntary program that takes effect in April 2019; initiative falls short of mandatory list price disclosures proposed by Trump Administration.

Topical analgesic sales grew double digits in 2017 on innovation and adhesive patch launches, helping drive 2.1% growth of US manufacturers' OTC drug sales in 2017 to $21.2bn, Kline & Co. independent consultant Laura Mahecha says. But private label continues to outpace branded product sales growth.

OGD's Lionberger offers advice on when to request a pre-ANDA meeting instead of controlled correspondence – and on the pros and cons of waiting for the agency to update product-specific guidance with the latest approaches.

The large number of US FDA warning letters going to firms for data integrity failings is mirroring trends with EU regulatory authorities, who are flagging data integrity failings in almost half of their GMP non-compliance reports. The issue strikes close to home for one FDA official.

Mike Thompson, head of the Association of the British Pharmaceutical Industry, outlined his industry’s concerns over medicines stockpiling, batch testing, tariffs, regulatory collaboration and other issues at a parliamentary committee hearing on the implications of a no-deal Brexit.

Study analyzed follow-up data on 205,498 women from the Nurses’ Health Study started in 1976 and Nurses’ Health Study II opened in 1989; 1,054 of the women developed ovarian cancer.

Data from ASPREE trial with more than 19,000 subjects show five-year-use of low-dose aspirin did not prolong disability-free survival and is associated with a significantly higher rate of hemorrhage and somewhat higher rate of all-cause mortality. Findings in three reports in NEJM track with US FDA's guidance that OTC aspirin marketers include a statement referring to doctors when aspirin package labels include a heart or other image suggesting a CV indication.

Since Commissioner Gottlieb's appointment, US FDA has challenged END industry more aggressively to eliminate products and advertising targeting children and has said sales to minors could be a focal point of an FDA action to ban all e-cigarette sales. Finding pharmaceutical ingredients in liquid nicotine could make a general ban on e-cigarette sales more likely in addition to imperiling approval for a smoking cessation indication.