December 30, 2015

Lupin in late December received U.S. Food and Drug Administration approval for its Fyavolv (norethindrone acetate and ethinyl estradiol) tablets, the generic version of Warner Chilcott's Femhrt tablets.

December 28, 2015

Food and Drug Administration approved the company's famotidine tablets to treat gastroesophageal reflux diesease and active duodenal ulcer.

December 23, 2015

The Food and Drug Administration on Tuesday announced that it approved AstraZeneca's Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when combined with a xanthine oxidase inhibitor.

December 23, 2015

The Food and Drug Administration on Monday approved Actelion Pharmaceutivals' Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension.

December 17, 2015
The bill, of which there is a version in the Senate and House of Representatives, looks to make it possible for Medicare beneficiaries to use the pharmacy of their choice in a medically underserved area if it is willing to accept Medicare’s contract terms. 
December 17, 2015

The percent of teens abuse of over-the-counter cough medicine containing dextromethorphan to get high remains at 3%, according to the 2015 Monitoring the Future survey.

December 14, 2015

The dietary supplement industry stands in support of FDA taking enforcement action against misbranded and adulterated products. 

December 10, 2015

Raymond Kerins, Jr., who joined Bayer in 2013 after serving in senior executive positions at Pfizer and Merck, is a veteran communications and government relations professional. 

December 10, 2015

Newport Trial Group, a California law firm with a reputation for filing class action suits against dietary supplement companies, is being sued for "malicious prosecution and violations of federal racketeering laws" and for paying individuals to pose as injured parties, according to a report Wednesday from Nutra Ingredients USA. "On information and belief, defendants NTG have unlawfully obtained more than $300 million through their lawsuits, much of which can be linked to NTG's scheme to fabricate lawsuits identified in this complaint," the lawsuit reads. (Nutra Ingredients USA)

 

 

 

December 10, 2015

As the Senate investigates the impact of the rising costs of generics, organizations like the National Community Pharmacists Association are weighing in on the debate. The Generic Pharmaceutical Association commented Wednesday on the hearings and what proposed changes mean for the industry.

December 10, 2015

The NCPA pointed out that its recent survey of pharmacists found that from their perspective, generic price spikes have gotten worst since they last conducted a survey in 2013 and are affecting both pharmacists and patients. 

December 9, 2015

DSN examines chain pharmacy, including in-depth coverage of generics, technology, automation, prescription drug home delivery services and Web-based diabetes monitoring, in this multi-page report.

December 8, 2015

He joins GPhA at a time that president and CEO Chip Davis called one of “unprecedented opportunities and challenges for the generic drug industry.”

December 8, 2015

The bill’s passage gained its sponsor praise from CHPA for the bills sponsors and the timeline it lays out for removing synthetic microbeads from products. 

December 8, 2015

Steve Anderson, president and CEO of the National Association of Chain Drug Stores, as well as the president and CEO of the Arthritis Foundation, Anna Palmer, recently published an op-ed in Morning Consult about the value of Medication Therapy Management and the need to pass pending legislation that would improve access to MTM for Medicare beneficiaries. “Providing patients with better access to counseling when it comes to the safe and proper use of their medication should be a matter of commonsense,” they wrote. (Morning Consult)

December 7, 2015

A new, long-term pilot program from the U.S. Centers for Medicare and Medicaid Services’ Center for Medicare and Medicaid Innovation, set to launch in 11 states in January 2017, will gauge the effectiveness of an Enhanced Medication Therapy Management model.

December 7, 2015

Since 2005 generics have saved patients $1.68 trillion, a report released by the Generic Pharmaceutical Association showed.

December 7, 2015

The elevation of the Division of Dietary Supplement Programs to an 'office' would provide appropriate regulatory attention to the growing industry and increase FDA’s enforcement activities and priorities, the VMS industry argued. 

December 4, 2015

GPhA recommended wider use of generics among low-income Medicare beneficiaries, which it estimates could save $17.7 billion over the course of 10 years.

December 4, 2015

In the letter NACDS sent to all U.S. Senators earlier this week, the association cited the differences in active ingredients in drugs from other countries, as well as different shapes, sizes and colors, which can cause confusion for patients and healthcare professionals.

December 3, 2015

In 2014, national health care spending grew at a rate of 5.3% — a marked increase over the 2.9% growth seen in 2013, and an increase of the past five years, which averaged 3.7% growth.

December 3, 2015

The NACDS has filed an amicus brief with an appeals court in the District of Columbia opposing FCC orders restricting automated and pre-recorded calls and texts to cell phones. 

December 2, 2015

According to an Associated Press report published in the New York Times, a bipartisan Senate Finance committee report found that Gilead Sciences, maker of hepatitis C treatments Harvoni and Sovaldi, chose to price Sovaldi at $1,000 a pill ($84,000 for a course of treatment) despite evidence that a lower price would allow more people to take advantage of the treatment. Gilead rejected the committee’s conclusions, noting that it “responsibly and thoughtfully priced Sovaldi and Harvoni,” as lawmakers point to this case as a cautionary tale for other expensive treatments. (New York Times)

December 1, 2015

GPhA’s SVP sciences and regulatory affairs noted that GPhA and other industry associations have urged the FDA to avoid ambiguity in quality metrics and consider additional moves that would ensure that proposed changes won’t disrupt supply.