Content about Pharmaceutical sciences

The Specialty Pharmacy Certification Board will begin certifying specialty pharmacists who pass a comprehensive exam in October. The exam is designed to cover the entire specialty pharmacy process, including intake, clinical management, fulfillment and outcomes. 

ALEXANDRIA, Va. — Bipartisan legislation that would let pharmacists devote more time to Medicare beneficiaries and less to adjudicating claims with pharmacy benefit management firms was introduced in the U.S. Senate and won the backing of the National Community Pharmacists Association earlier this week.

WASHINGTON — One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

WASHINGTON — The Council for Responsible Nutrition and the Natural Products Association on Wednesday announced they have met with the entire freshman class of the 113th Congress, including 83 offices in the House of Representatives and 14 offices in the Senate, as part of their educational efforts to ensure that newly elected members of Congress have accurate information about dietary supplements and their role in good health. 

WHITEHOUSE STATION, N.J. — Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

Merck said the Food and Drug Administration accepted a regulatory application for its ragweed pollen sublingual allergy immunotherapy tablet. Ragweed, also known as Ambrosia artemisiifolia, is a major cause of seasonal allergies in the United States. Merck also submitted an application for a similar drug, for Timothy grass pollen allergies, in March.

ALEXANDRIA, Va. — Federal prescription drug programs are more susceptible to waste, fraud and abuse because of the lack of transparency and oversight of mail-order pharmacy, proclaimed the Taxpayers Protection Alliance on Tuesday in a report called “The Expensive Truth Behind Taxpayer-Funded Mail Order Pharmaceuticals.” 

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

The study, by British market research firm Visiongain, forecast that the $2.445 billion market size marked more than 20% of growth from 2012 and would account for about 2% of the overall market for biologics. The market is expected to grow rapidly through 2023 as biosimilars hit the market in the United States and European Union.

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

Merck announced the approval of Liptruzet (ezetimibe and atorvastatin). The drug combines two preexisting cholesterol drugs: ezetimibe, which Merck markets under the brand name Zetia, and atorvastatin, which Pfizer markets under the name Lipitor. Both drugs are available as generics, but because Liptruzet is a novel combination of them, it required FDA approval as a new drug.

WASHINGTON — 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. 

SILVER SPRING, Md. — 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. 

PARSIPPANY, N.J. — Actavis' had $1.9 billion in sales in first quarter 2013, the drug maker said.

The latest figure represented a 24% increase from first quarter 2012's $1.52 billion. "The new Actavis is off to a strong start in 2013, and as a result, we are increasing our 2013 forecast based on the strong performance and execution against our objectives to date," president and CEO Paul Bisaro said.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday urged Hawaii Gov.