Health authorities in Europe have different approaches to evaluating the cost-effectiveness of new drugs, but in the case of the CAR-T therapies, they are likely to look favorably on factors such as their innovative nature, the small patient populations, and the dearth of effective treatments.

The latest drug development news and highlights from our FDA Performance Tracker.

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

Masters Speciality Pharma is in the process of registering sickle cell disease drug Siklos in Brazil. The company revealed how it would ensure the product gets to patients sooner rather than later.

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.

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.

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.

Supplement brand being marketed to compete with OTC drugs, including J&J's own brands, in cough and cold and other categories helped J&J overall consumer health sales grow 9.7% to $440m in Q3. Oral care brands showed 3.2% worldwide growth to $384m, benefiting from recent launch of chewable Listerine Ready! Tabs.