Whether Sloan Pharma's irritable bowel constipation drug tegaserod should be indicated only for women at low cardiovascular risk, women who are severely symptomatic, or women who fall into both categories is a question for FDA's Gastrointestinal Drugs Advisory Committee; panel also is asked to discuss risk of psychiatric adverse events with the 5-HT4 receptor agonist.

“Vested interests” are pressuring EU policymakers to water down further European Commission plans for an exemption intended to allow generic and biosimilar firms to manufacture their versions of products for export while SPCs are still in effect, claims the industry sector body Medicines for Europe.

Remicade, Procrit, Aranesp and biosimilars will be subject to step therapy in limited number of Medicare Advantage plans in 2019.

Agreement with New York attorney general resolves allegations Pfizer deceptively advertised that consumers would "pay no more" than $15 or $20 for drugs even though they were often far more expensive.

The drug value assessment organization said it is considering whether or not to move forward with a program to consult pharmaceutical manufacturers on early research, a move that could raise questions about the group's independence.

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.

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.

Sandoz joins list of companies that opt to settle rather than challenge AbbVie's hefty patent portfolio; staggered launches offer model for future deals.

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.

The European Medicines Agency is continuing to work on revising Annex 1 of the EU GMP guideline even as the agency focuses more on core tasks like responding to urgent public health threats amid greater-than-expected staff departures in advance of its Brexit-driven move from London to Amsterdam.

“Vested interests” are pressuring EU policymakers to water down further European Commission plans for an exemption intended to allow generic and biosimilar firms to manufacture their versions of products for export while SPCs are still in effect, claims the industry sector body Medicines for Europe.

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.

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.