Lori Clapper

Eisai launched its epilepsy treatment Fycompa (perampanel) in Belgium last week. The drug is the first in a new class of treatment for partial onset seizures, the most common form of epilepsy.  Continue Reading..

Pharmaceutical manufacturing facilities located outside of the U.S. are now required to pay 12 to 15 percent more in annual facility fees following the release of new rates by the U.S. Food and Drug Administration (FDA), the Economic Times says. The newly released rates affect user fees for certain applications and supplements for human generic drug products. The fees go into effect on October 1st, 2014 and will be enforced through September...  Continue Reading..

The National Institute for Health and Care Excellence (NICE) announced new quality standards aimed at the preventing hepatitis B transmission and improving the lives of those living with the condition.  Continue Reading..

Reckitt Benckiser (RB), the consumer goods company most known for manufacturing Clearasil, announced last Monday that it wants to spin off its pharmaceutical business to existing shareholders within the next year, after failed attempts to appeal to any public takers.  Continue Reading..

U.S. biopharmaceutical research companies currently have 92 innovative new medicines either in clinical trials or under review by the U.S. Food and Drug Administration (FDA), according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA). The new meds in development include 55 for rheumatoid arthritis, 15 for musculoskeletal pain, 10 for osteoarthritis, and 7 for psoriatic arthritis.  Continue Reading..

In order to cut national healthcare bills, cash-strapped European governments want to reimburse patients who use drugs that aren’t approved for their particular conditions. However, pharmaceutical companies aren’t too keen about this, arguing that prescribing medicines for so-called off-label use could not only harm patients, but also break EU law.  Continue Reading..

The National Association of Pharmaceutical Manufacturers (NAPM) is pushing for a zero Value Added Tax (VAT) rating on medicines in South Africa to make drugs more affordable for those in need of treatment. Indeed, according to NAPM’s press release, levied taxes, which account for 20 -30 percent of the price consumers pay for the drug, both heighten overall drug costs and often limit patient access.  Continue Reading..

Médecins Sans Frontières (MSF) reports that skyrocketing costs of HIV medicines and subsequent care prevents people in developing countries from having affordable access to vital care. The organization had called for scaled-up efforts to reach more people in need and to ensure successful treatments.  Continue Reading..

Consumers in Ireland will soon have access to a broader range of pharmaceutical products, following the Health Products Regulatory Authority’s (HPRA) decision to change up to 34 prescription-only meds to over-the-counter (OTC) status. The drug regulator published 12 of the initial products that will make the switch on Wednesday.  Continue Reading..

The U.S. Food and Drug Administration (FDA) has penned a five-year, $10 million contract with the Pan American Health Organization (PAHO) to strengthen medical product regulatory monitoring systems in South American regions. By working more closely with global regulators, the FDA hopes to ultimately protect U.S. citizens.  Continue Reading..