February 26, 2015

Sanofi expands its portfolio of insulin therapy products with the introduction of the once-daily, long-acting Toujeo. 

February 24, 2015

The Food and Drug Administration is looking into enabling holders of abbreviated new drug applications to unilaterally update their generic drug product labels prior to any branded drug change. 

February 24, 2015

NPA  renewed its call to the New York Attorney General to produce the scientific evidence behind that office's recall request of herbal supplements.

February 23, 2015

Combined Distributors reported that its medicine disposal product was found to exceed U.S. FDA and EPA guidelines. 

February 20, 2015

FDA makes direct-to-consumer genetic testing easier to bring to market. 

February 17, 2015

The Food and Drug Administration has approved Lenvima (lenvatinib) for the treatment of differentiated thyroid cancer. 

February 17, 2015

The Food and Drug Administration last week issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions.

February 13, 2015

In response to the New York Attorney General’s recent recall of herbal supplements from four major retailers, the Council for Responsible Nutrition has assembled a microsite for consumers.

February 10, 2015

GNC on Monday announced that it refuted the claims made by the New York State Attorney General in his Feb. 2 letter.

February 6, 2015

The pharma industry praised outgoing Food and Drug Administration commissioner Margaret Hamburg and welcomed Stephen Ostroff, who will assume the role of acting commissioner.

February 5, 2015

In this issue, DSN looks at another three hot spot issues identified by PwC’s HRI that will help define how health care is provided in 2015.

February 5, 2015

Food and Drug Commissioner Margaret Hamburg will resign from her post in March.

 

February 5, 2015

Generic drug prices are going up. Spurred by market opportunities, short-term market exclusivity for some newly launched single-source generics and rising costs for manufacturing, quality control and raw materials, me-too drug manufacturers have escalated a series of price hikes, some of them significant.

February 4, 2015

DSN examines chain pharmacy, including in-depth coverage of telehealth, generic drug prices, and the GPhA CEO to step down, as well as Uhl appointed director of OGD, in this multi-page report.

February 3, 2015

Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Co. on Monday announced that the Food and Drug Administration has approved Glyxambi (empagliflozin/linagliptin) tablets. 

 

February 3, 2015

New York Attorney General Eric Schneiderman on Monday called on four major retailers to stop selling store-brand herbal supplement products in New York that could not be verified to contain the labeled substance by using what the industry describes as a questionable testing method — DNA barcoding.

February 2, 2015

The Food and Drug Administration announced that it has expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults, making it the first FDA-approved medicine to treat this condition.

 

January 30, 2015

Diplomat Pharmacy announced Thursday that the Food and Drug Administration has approved an expanded indication of Imbruvica (ibrutinib) for the treatment of Waldenström’s macroglobulinemia (WM).

January 30, 2015

Janssen Therapeutics on Thursday announced that the Food and Drug Administration has approved its Prezcobix (darunavir 800 mg/cobicistat 150 mg) tablets. The drug is used to treat human immunodeficiency virus in combination with other antiretovirals for treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions, according to the company.

 

January 27, 2015

Rep. Jason Chaffetz, R-Utah, last week introduced a bill that would extend to new combination drugs containing molecules already approved by the Food and Drug Administration the same five-year market exclusivity as a drug product containing an entirely new set of active ingredients.

January 27, 2015

The Food and Drug Administration on Monday announced approval for the first generic version of Nexium (esomeprazole magnesium delayed-release capsules), which are used to treat gastroesophageal reflux disease in adults and children ages 1 year and older.

January 26, 2015

The Food and Drug Administration last week approved Natpara (parathyroid horomone), which is indicated to control low blood calcium levels in patients who have hypoparathyroidism.

 

January 26, 2015

The Food and Drug Administration last week announced approval for Bexsero, a vaccine intended to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 years through 25 years of age.

 

January 21, 2015

Eisai on Tuesday announced the launch of a new savings card for Belviq (lorcaserin HCl) CIV, the most-prescribed branded FDA-approved prescription drug therapy for chronic weight management.