August 21, 2014

Restricting access to samples of generic biological drugs would lead to nearly $140 million in lost savings for every $1 billion in biologics sales, Matrix Global Advisors said.

August 21, 2014

GlaxoSmithKline announced FDA approval for Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid medicine for the treatment of asthma in patients 12 years of age and older.

August 20, 2014

Pharmacists aren’t the only professionals grappling with the uncertainties of health reform, shifting patient-care delivery models and changing reimbursement standards.

August 20, 2014

Despite creating a detailed plan to speed up the rate at which generic drug applications are reviewed, experts say a backlog has developed at the Food and Drug Administration’s Office of Generic Drugs.

August 20, 2014

Despite a rocky start, the full rollout of health reform under the Affordable Care Act has already brought major benefits to the nation’s troubled health system and affordable coverage to millions of formerly uninsured or underinsured Americans, one of the Obama administration’s top health officials asserted recently.

August 20, 2014

The Food and Drug Administration has approved Cerdelga (eliglustat) for the treatment of adult patients with the Type 1 form of Gaucher disease.

August 20, 2014

“All providers in the healthcare system should practice to the fullest extent allowed by their license.”

August 20, 2014

“We have a system that needs fixing.” That comment on the state of the nation’s healthcare system, shared by physician and New York Times correspondent and senior writer Elisabeth Rosenthal, served as the springboard for a high-level summit on the future of health care in the United States. The event drew a who’s who of nationally known health experts, scientists and government officials.

August 19, 2014

Advertising claims for weight loss supplement products feed the Federal Trade Commission with the highest settlement costs within the dietary supplement and functional food category, according to a new web-based, members-only tool from the Council for Responsible Nutrition. 

August 19, 2014

CVS Caremark on Monday announced that its Accordant Health Services division has received full NCQA Patient and Practitioner Oriented Disease Management accreditation.

 

August 19, 2014

The Food and Drug Administration has approved Mylan Institutional’s application for its dexmedetomidine hydrochloride injection, the company announced Tuesday. 

August 19, 2014

PharmaJet, the developer of a needle-free injection technology to administer medications and vaccines to patients, and bioCSL, the maker of Afluria (influenza vaccine) on Tuesday announced the Food and Drug Administration has approved the PharmaJet Stratis 0.5mL Needle-Free Jet Injector for delivery of Afluria in individuals ages 18 years to 64 years.

August 19, 2014

The Food and Drug Administration has granted tentative approval for Basaglar (insulin glargine injection), which is used to improve glycemic control in adults with Type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with Type 1 diabetes.

August 19, 2014

A coalition of retail groups on Monday filed a joint-merchant petition with the Supreme Court seeking its review of the March 2014 swipe fee decision by the U.S. Court of Appeals for the D.C. Circuit.

August 18, 2014

The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities. 

August 15, 2014

Pfizer’s Prevnar 13 vaccine for pneumonia has been recommended for use by patients 65 years old and up by the Centers for Disease Control and Prevention’s immunization practices advisory committee. 

August 15, 2014

The Food and Drug Administration announced approval of a new use for Avastin (bevacizumab), to treat patients with persistent, recurrent or late-stage cervical cancer.

August 14, 2014

The Food and Drug Administration has announced approval for Belsomra (suvorexant) tablets, which are used to treat insomnia.

August 11, 2014

Janssen Pharmaceuticals received approval from the Food and Drug Administration for Invokamet, a fixed-dose therapy that combines canagliflozin and metformin hydrochloride in a single tablet.

August 11, 2014

The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.

August 8, 2014

The Food and Drug Administration earlier this week announced approval for Orbactiv (oritavancin), an antibacterial drug used to treat patients with acute bacterial skin and skin structure infections.

August 7, 2014

Following Walgreens' decision to acquire the rest of the Alliance Boots business — and to keep its headquarters based in the greater Chicago area — Sen. Dick Durbin, D-Ill., weighs in on the decision in a brief video.

August 6, 2014

Michael Taylor, who currently serves as the Food and Drug Administration's deputy commissioner for foods and veterinary medicine, outlined the importance for companies to adhere to gluten-free guidelines in a post on FDA Voice.