September 13, 2016

A pair of House and Senate bills currently under consideration would end DIR fees assessed by Medicare drug plans or pharmacy benefit manager corporations after prescriptions are filled.

September 9, 2016

The agency has reversed course on allowing the sale of vinpocetine, a supplement found in some mental alertness supplements, suggesting that the product is not a dietary ingredient.

September 9, 2016

HHS and Walgreens are distributing vouchers through a variety of outreach efforts, local events and community and faith-based organizations nationwide.

September 8, 2016

“The product registry is a potential game-changer for our industry ... some major retailers have expressed strong interest in how it might eventually help them decide what to put on their shelves," CRN stated.

September 8, 2016

NACDS' new SVP government affairs and public policy has served nearly three decades as a Congressional staff member and as a government affairs professional.

September 7, 2016

As critics of the Affordable Care Act continue to grumble about how the law has adversely affected much of the nation’s healthcare system, consultant and Foundation for Health Smart Consumers fellow Mike Tarino said that giving people more control over how their healthcare dollars are spent could help quiet the critics and put what many see as a failing reform plan back on track.

September 6, 2016

“Kratom is not an herbal supplement: it is addictive, harmful, and worse, it may be contributing to America’s opiate epidemic," stated Dan Fabricant, Natural Products Association CEO and executive director.

September 6, 2016
The expanded indication for Amgen's biologic was granted by the Food and Drug Administration under accelerated approval. 
 
August 31, 2016

The new version of GDUFA includes key improvements, metrics and resource provisions intended to streamline the review process for Abbreviated New Drug Applications

August 31, 2016

Among the changes, the FDA is requiring boxed warnings for nearly 400 products, as well as patient-focused Medication Guides for prescription opioids and benzodiazepines.

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.