Branded

NEW YORK — Pfizer is recruiting for a 1,200-patient actual use study to measure whether or not patients can appropriately self-select treating high cholesterol with the statin Lipitor, the Wall Street Journal reported on Sunday. 

The trial is recruiting patients through more than 35 pharmacies and is expected to be completed by year-end.  

WASHINGTON — The Generic Pharmaceutical Association on Friday hosted a Congressional briefing highlighting the economic impact the Food and Drug Administration’s proposed rule on prescription labeling that would allow for label changes without prior FDA approval.

JERUSALEM — Teva Pharmaceutical Industries announced the launch of Adasuve (loxapine) inhalation powder in a 10-mg dosage. The drug is the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults.

WASHINGTON — "The problem [of counterfeit medicines] is so big, disperse and complex that it requires a sweeping coordinated global response," wrote Scott LaGanga, executive director of the Partnership for Safe Medicines and SVP public affairs and advocacy for PhRMA in a blog published by The Hill on Saturday.

WASHINGTON — Last week, more than 30 organizations  — including the American Medical Association, Infectious Diseases Society of America and Pew Charitable Trusts — urged Congressional leaders to strengthen the labeling requirements for drugs approved under the proposed Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) limited population approval pathway, which will streamline regulatory approval for antibiotics. 

WILMINGTON, Del. — AstraZeneca received approval from the Food and Drug Administration for its Bydureon pen (exenatide extended-release for injectable suspension) 2-mg, which is to be used as an addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

The Bydureon pen is a pre-filled, single-use pen injector, which eliminates the need for the patient to transfer their medication between a vial and syringe during the process of self-injection. The pen contains the same formula and dose as the original Bydureon single-dose tray.

CAMBRIDGE, Mass. — An international team led by researchers at the Broad Institute and Massachusetts General Hospital has identified mutations in a gene that can reduce the risk of developing Type 2 diabetes, even in people who have such risk factors as obesity and old age, the group announced Sunday. The results focus the search for developing novel therapeutic strategies for Type 2 diabetes — if a drug can be developed that mimics the protective effect of these mutations, it could open up new ways of preventing this devastating disease.

WASHINGTON — The Pharmaceutical Research and Manufacturers of America on Tuesday announced the appointment of Charles “Chuck” Clapton to the position of SVP federal advocacy, effective March 17, 2014.  

In this capacity, Clapton will be responsible for leading PhRMA’s federal government affairs initiatives and advancing its legislative agenda, working with stakeholders to develop and advocate for health policies that foster innovation and ensure patient access to new medicines in the United States and around the world.