Regulatory and Washington

05/07/2013 - 12:09pm
U.S. to contribute to 'rapid' biosimilar market growth through 2023, study finds

The global market for biosimilars will be worth nearly $2.5 billion this year, according to a new study.

05/06/2013 - 4:03pm
Florida legislature passes biosimilar substitution bill

Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

05/06/2013 - 3:18pm
CVS handles back-end functions as Pfizer sells Viagra online

Pfizer is attempting to stem the rise of counterfeit medicines by selling one of its most popular drugs — and one of the most popular targets for counterfeiters — online.

05/06/2013 - 3:07pm
Pregnant women shouldn't use valproate drugs to prevent migraines, FDA warns

Pregnant women should not use migraine-prevention medications containing valproate sodium due to a higher risk of decreased IQ scores in children, the Food and Drug Administration warned.

05/06/2013 - 1:41pm
Industry urges FDA to clarify new dietary ingredient notification regulations

The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient notifications, with a specific focus on the information to be included to identify the new dietary ingredient.

05/06/2013 - 1:24pm
FDA approves Merck cholesterol drug

The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

05/06/2013 - 1:15pm
FDA approves Bristol-Myers Squibb's Sustiva for HIV in infants, toddlers

The Food and Drug Administration has approved a drug for HIV in infants and toddlers.

05/06/2013 - 12:29pm
New Jersey attorney general's office releases anticrime best practices for pharmacy

Retail pharmacies, drug makers and law enforcement have a variety of methods used to fight organized crime, and the New Jersey Office of the Attorney General has drawn up a list of best practices that pharmacies can use to keep stores, drugs, staff and customers safe.

05/06/2013 - 11:14am
FDA gives breakthrough therapy designation to experimental hepatitis C regimen

An experimental drug regimen under development by AbbVie could change the way hepatitis C is treated, according to a special designation it received from the Food and Drug Administration.

05/06/2013 - 9:07am
FDA Law Blog: Recent Plan B One Step approval may reignite simultaneous Rx-OTC debate

The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.