August 30, 2016

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.”

August 30, 2016

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)

August 30, 2016

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)

August 30, 2016

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

August 12, 2016

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. 

August 11, 2016

The Council for Responsbile Nutrition will be hosting a webinar to share how the FDA's latest NDI draft guidance will impact industry.

August 3, 2016

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.

August 3, 2016

DSN associate editor David Salazar examines chain pharmacy, including in-depth coverage of pharmacy spending, telehealth, generics and technology, in this multi-page report.

August 3, 2016

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

August 2, 2016

Total spending on products whose patents expired between 2012 and 2015 declined by $14.2 billion last year, according to IMS Health’s Institute for Health Care informatics. And 2016 could bring about further cost reductions.

August 2, 2016

"In Brazil, the Ministry of Health recently issued a statement indicating pregnant women should use condoms specifically mentioning the female condom to prevent the transmission of Zika," Female Health Company noted.

August 2, 2016

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.

July 29, 2016

Low-risk general wellness products, including wearable fitness monitors and sleep monitors, will not be subject to pre- or post-market regulatory requirements, the Food and Drug Administration reported Thursday, according to a report from the Regulatory Affairs Professional Society. "FDA has kept in line with its previous guidance on other health and wellness products, such as mobile medical applications and exercise equipment, where depending on the product's intended use, it could fall under FDA regulations," RAPS reported. "FDA says manufacturers could say their product is intended 'to promote, track, and/or encourage choice(s), which as part of a healthy lifestyle, may help to reduce the risk of [or may help living well with] certain chronic diseases and conditions.'" (RAPS)
 

July 25, 2016

Walgreens is now more than halfway toward its goal, announced in February, of installing medication disposal kiosks at 500 locations around the country, the company announced Monday.

July 20, 2016

NPA worked closely with members of the House Natural Resources Committee, including Rep. Ryan Zinke, R-Mont., to  attach language to PROMESA requiring the Task Force to examine Puerto Rico’s AO 346.

July 20, 2016

The pilot program would allow the Department of Defense to access lower pricing for prescriptions dispensed at community pharmacies.

July 18, 2016

Amgen, Cardinal Health, Rite Aid and Walmart helped support American Pharmacists Association Academy of Student Pharmacists this past weekend.

July 18, 2016

Industry organizations have responded to the Food and Drug Administration’s issuing of a document with details on the reauthorization of the Prescription Drug User Fee agreement. 

July 13, 2016

Stansel has previously served as acting general counsel for the Dept. of Health and Human Services, working as the chief legal officer for it and several sub-agencies including the Food and Drug Administration. 

July 12, 2016

"CHPA strongly supports the OTC Monograph System, but we believe that policy reforms could make the system more flexible, responsive and accommodating to innovation," the association noted.

July 12, 2016

The agency has acted on 90% of the generic drug and prior approval supplement applications pending as of Oct. 1, 2012 — which puts it more than a year ahead of its final deadline of Sept. 30, 2017. 

July 11, 2016

The American Pharmacists Association has developed an overview of requirements and a more detailed summary that highlights key aspects of the rule and requirements relevant to pharmacists.

July 7, 2016

Walgreens will offer customers enrollment in the PMI Cohort Program at its stores, at Walgreens Healthcare Clinics, online through Walgreens.com and through the Walgreens mobile app.

July 6, 2016

CRN member companies will be required as a condition of membership to input all their product labels into the product registry by July 2017.