Pharma News

EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines available in Europe safe and effective.
As of today, EMA will start sharing a series of info-cards on its Twitter and LinkedIn accounts.

Primary health care is key to solving the health challenges facing countries in Asia and the Pacific, according to the World Health Organization (WHO).

WHO says that investment in primary health care is essential to provide access for the most vulnerable, build more equitable societies and help economies grow.

U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable on a milligram to milligram basis and their recommended doses differ.

The U.S. Food and Drug Administration  approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. The only other treatment approved for LEMS is only approved for use in adults.

Pre-exposure prophylaxis (PrEP), a combination drug used to prevent HIV infection, has already gained significant traction in the U.S. and Europe. The once-a-day pill, when taken consistently, can reduce the risk of HIV acquisition by over 85 percent. A new study published in Clinical Infectious Diseases by an international research team suggests that making PrEP available to men who have sex with men (MSM) and people who inject drugs (PWID) in India may be a cost-effective way of curbing the epidemic there.

The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.

There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s an issue that has been a priority for us at the U.S. Food and Drug Administration since 2011 when we warned women that the available information at the time indicated that there is a risk for women with breast implants, especially those with textured implants, for developing this disease.

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Sixmo (buprenorphine) as a substitution treatment for opioid dependence.

The U.S. Food and Drug Administration  approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant. The device allows the transplant team to perform a more careful assessment of lung function to get a better sense of how the organs are working when they are perfused with a solution outside the body to better determine whether the lungs can then be viable for transplant.