May 21, 2014

Citing the need for a one-year transition period for states to implement the July average manufacturer price-based federal upper limits, or FULs, nine Senators are urging Department of Health and Human Services Secretary Kathleen Sebelius to consider the challenges that states will face when the final Medicaid AMP-based FULs are published.

May 21, 2014

Takeda Pharmaceutical on Tuesday announced that the Food and Drug Administration simultaneously approved a new biologic therapy, Entyvio (vedolizumab), for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.

May 20, 2014

The Centers for Medicare & Medicaid Services on Monday issued final regulations for the Medicare Advantage and prescription drug benefit (Part D) programs.

May 19, 2014

Responding to recent comments by Attorney General Eric Holder that "opiate addiction is an urgent — and growing — public health crisis," the National Community Pharmacists Association wrote to the Attorney General to offer recommendations on effectively combating the scourge of prescription drug abuse without forcing patients with legitimate medical issues to endure chronic pain, NCPA has announced.

May 16, 2014

The Food and Drug Administration on Thursday announced it required Sunovion Pharmaceuticals, manufacturer of the sleep drug Lunesta (eszopiclone), to change the drug label and lower the current recommended starting dose.

May 16, 2014

The National Association of Chain Drug Stores announced that Ben Bernanke, chairman of the Federal Reserve System from 2006 to 2014, will address the NACDS Total Store Expo during the morning Business Program on Aug. 24 at the Boston Convention and Exhibition Center in Boston.

May 16, 2014

Pfizer announced plans to submit a new drug application with the Food and Drug Administration for palbociclib, which is used for the first-line systemic treatment of post-menopausal women with advanced or metastatic breast cancer.

May 15, 2014

The Centers for Disease Control and Prevention on Wednesday released guidance advising practitioners to offer an HIV prevention pill to healthy individuals who are at high risk for an HIV infection, according to published reports.

May 15, 2014

The Generic Pharmaceutical Association lobbied for greater access to generics at this week’s meeting of the chief negotiators of the Trans-Pacific Partnership in Ho Chi Minh City, Vietnam, the association announced Wednesday.

May 15, 2014

The Retail Industry Leaders Association, along with several of America's most recognized retail brands, on Wednesday launched the Retail Cyber Intelligence Sharing Center.

May 15, 2014

Teva Pharmaceutical was denied in its suit to block approval of Mylan's and Sandoz' generic Copaxone, a multiple sclerosis, drug 10 days before the patent on the medication expires, according to a Bloomberg report published Thursday morning.

May 14, 2014

Actavis on Tuesday announced that it has received final approval from the Food and Drug Administration on its abbreviated new drug application for a generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride extended-release tablets 8 mg, 12 mg and 16 mg).

May 14, 2014

About half of all Americans reported taking one or more prescription drugs in the past 30 days during 2007-2010, and 1-in-10 took five or more, according to "Health, United States, 2013," the government’s annual, comprehensive report on the nation’s health that was released Wednesday.

May 14, 2014

The Food and Drug Administration moved one step closer to establishing a biosimilar pathway with a new guidance document explaining how to use clinical pharmacology data to show similarity to a reference product, according to a report published by Regulatory Focus on Tuesday.

May 14, 2014

The U.S. Department of Health and Human Services and the European Commission on Tuesday released the first progress report of the Transatlantic Taskforce on Antimicrobial Resistance.

May 13, 2014

Teva Pharmaeceuticals on Tuesday announced that the Food and Drug Administration accepted the company's supplemental new drug application for a lower dose QNASL (beclomethasone dipropionate) nasal aerosol, which is used for the treatment of seasonal and perennial allergic rhinitis in children ages 4 years to 11 years.

May 12, 2014

The Consumer Healthcare Products Association on Friday filed comments to the Food and Drug Administration in response to the agency’s Notice of Public Hearing and Request for Comments on the Over-the-Counter Drug Monograph System, also referred to as the OTC Drug Review.

May 12, 2014

A new study from the Centers for Disease Control and Prevention found that flu vaccines prevent flu-associated hospitalizations in people 65 years and older, even during seasons when vaccine effectiveness is low, the agency stated Friday.

May 9, 2014

Working-age adults with disabilities who do not get any aerobic physical activity are 50% more likely than their active peers to have a chronic disease — such as cancer, diabetes, stroke or heart disease — according to a Vital Signs report released earlier this week by the Centers for Disease Control and Prevention.

May 9, 2014

Propeller Health, the FDA-cleared digital health solution for chronic respiratory disease, earlier this week announced that the Food and Drug Administration granted 510(k) clearance to market its latest generation of the Propeller platform, including a new sensor.

May 8, 2014

The National Association of Chain Drug Stores and a national coalition working to achieve “provider status” for pharmacists under Medicare Part B have asked the Federal Trade Commission to back legislation to this effect, as well as other policies that would help pharmacists practice at the top of their education level, NACDS reported Thursday.

May 8, 2014

Walgreens' new store format encouraging pharmacists to practice at the top of their license has passed muster with the Department of health and Human Services, The Wall Street Journal reported Wednesday.

May 6, 2014

The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted 11-4 opposed to switching Merck's allergy remedy Singulair from Rx-to-OTC, according to an Associated Press report.

May 6, 2014

The Generic Pharmaceutical Association applauded the launch of the bipartisan Affordable Medicines Caucus, co-chaired by Reps. Peter Welch, D-Vt., and Keith Rothfus, R-Pa.