A European pharmacoepidemiology study helped reassure advisory committee members about the constipation drug’s cardiovascular safety, but confounding factors limited interpretability of the results and information about the study population’s racial makeup was lacking; nevertheless, panelists urged a similar study be conducted to assess potential carcinogenic and psychiatric risks.

Approach offered as alternative to more disruptive changes to Part B's existing buy-and-bill system; more aggressive proposals include new iteration of  competitive acquisition program and moving Part B drug coverage to Part D.

Two highly anticipated proposed rules in Medicare Part D are scheduled for near-term release.

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.

GSK takes Theraflu brand from medicine cabinet to kitchen with launch of PowerPods of OTC ingredients delivered through single-serve coffee makers. Introduction of non-coffee pods also is growing, including lemonade, hot ciders, teas and Campbell's Soup pods.

Acorda's rise, fall, and attempt to rise again is a snapshot of the life of a biotech. The company reached the commercial-stage pinnacle with Ampyra, only to eventually see it fall away to patent challenges. Now, after big staff cuts, the company is hoping to prevail in the commercial market again, this time with Inbrija.

Leading off the third quarter earnings calls for biopharma, J&J offered mild support of a proposed HHS policy to require pricing information in direct-to-consumer advertising, but more enthusiastically backed a voluntary approach suggested by PhRMA.

Concerns that the US pharmaceutical industry will not have the necessary serialization systems in place to fully comply with DSCSA product package serialization requirement appear to be bearing fruit, according to a recent survey.

The key to pediatric approval for a flu vaccine: a manufacturing root cause investigation and subsequent process improvements.

A proposed revision of the EU GMP Guide’s Annex 1 calls for microbiologists to get out of the lab and more involved in risk assessments to ensure that sterile products are free from contamination, according to the annex’s rapporteur.

US FDA Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees meet in December to discuss proposed routes to make the opioid overdose reversal agent naloxone more available: both as an OTC product and one co-prescribed with opioids.

US FDA sends warning letters to online businesses operating a total of 465 websites selling unapproved Rx drugs for indications including breast cancer, chicken pox and pain relief. Warning letters were part of Interpol's annual Operation Pangea against online sales of illegal medical products; this year, US and 115 other countries made 859 arrests worldwide and seized $14m in potentially dangerous pharmaceuticals.

GSK takes Theraflu brand from medicine cabinet to kitchen with launch of PowerPods of OTC ingredients delivered through single-serve coffee makers. Introduction of non-coffee pods also is growing, including lemonade, hot ciders, teas and Campbell's Soup pods.