08/30/2016 - 3:29pm

Two recent unanimous approval recommendations from FDA advisory committees regarding biosimilars is a signal of growing scientific acceptance and understanding of the biosimilar regulatory pathway, suggested The National Law Review in a report Tuesday. The National Law Review has created a chart summarizing pending and approved BLAs for biosimilars using publicly available information, the publication noted, but there are still two barriers to entry. As biosimilars gain FDA approval, patent issues remain a barrier and the exorbitant R&D cost prevent significant price disparities. Accordingly, insurers may be slow to add biosimilars to the formulary, The National Law Review suggested. (The National Law Review)

08/30/2016 - 1:29pm

The steps Teva Pharmaceuticals  had to take to win antitrust approval for its $40.5 billion acquisition of Allergan's U.S. generics business are attention grabbing, TheStreet reported earlier this week - securing approval from the Federal Trade Commission took 12 months and required the divestiture of nearly 80 drugs. "Deal makers in the generics space should take note the FTC went beyond the traditional focus on head-to-head competition between drugs on the market and potential competitors in the R&D pipeline," TheStreet wrote. "The commission also considered three new theories of competitive harm, including whether buyers will gain pricing power by bundling drug portfolios, whether generic drug makers will have less incentive to challenge brand drug patents and whether the merger will reduce the number of players in hard-to-make complex generics." (TheStreet)

08/30/2016 - 10:09am

The National Bureau of Economic Research reads: “If a man has never smoked by age 18, the odds are three-to-one that he never will. By age 21, the odds are twenty-to-one.”

08/30/2016 - 9:05am

CRN speaker Charlie Cook has a longstanding reputation as a trustworthy and accurate voice on politics in Washington, spanning more than two decades.

08/12/2016 - 11:42am

The National Community Pharmacists Association’s Michael Rule outlines the ways that members of Congress are urging the Centers for Medicare and Medicaid service to finalize a guidance on DIR fees. 

08/11/2016 - 9:56am

The Council for Responsbile Nutrition will be hosting a webinar to share how the FDA's latest NDI draft guidance will impact industry.

08/03/2016 - 5:51pm

With generic drugs saving the healthcare system millions of dollars, Drug Store News caught up with Jim Cannon, Greenstone VP and general manager, to discuss authorized generics.

08/03/2016 - 1:43pm

A CDC study found that vaccinated people 50 years and older were 57% less likely to be hospitalized from flu than unvaccinated people.

08/02/2016 - 4:54pm

As some companies prepare to market their biosimilars, others are still in development. At the end of 2015, the IMS Institute noted that there were five biosimilars in the pre-registration phase of development.