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Monthly Archives: June 2013

Raptor’s rare disease drug recommended in Europe

Four people who were on the ground the night of the Benghazi attacks last year are writing a book about their experience, and they’re getting a $3 million advance from Twelve Books to do it. The authors are unnamed, according to New York Post’s Keith J. Kelly, who describes them as “members of the elite security team from the annex of the US Embassy.” That annex, we now know, was the CIA annex, which makes this book deal really fascinating. …

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PTSD tied to raised heart disease risk

By Andrew M. Seaman

NEW YORK (Reuters Health) – People suffering from posttraumatic stress disorder (PTSD) may also be at increased risk of heart attacks and strokes, according to a new study of Vietnam War veterans.

After following nearly 300 pairs of male twins, all Vietnam vets, for more than a decade, researchers found that almost a quarter of the men diagnosed with PTSD also had heart disease, compared to less than a tenth of the men without the combat-related stress disorder.

“As time goes by, it’s become more and more clear that PTSD is not just something that impacts psychological health. It has broad repercussions throughout the body,” said Dr. Viola Vaccarino from the Emory University School of Public Health in Atlanta, the study’s lead author.

Behavioral symptoms of PTSD include reliving the traumatic event in memories or nightmares, avoiding situations that may trigger those memories and feelings of paranoia, fearfulness and guilt, according to the U.S. Department of Veterans Affairs.

The symptoms tend to start shortly after a person experiences a traumatic event, such as combat, terrorist attacks, serious accidents, natural disasters and personal violence or abuse.

Physically, Vaccarino‘s team notes, PTSD sufferers are known to often have raised levels of stress hormones and other chemicals signaling overactivation in the fight-or-flight pathways of the nervous system.

Previous research, including one study examining U.S. veterans from Iraq and Afghanistan, have found that people diagnosed with PTSD and other stress disorders are more likely to develop heart troubles (see Reuters Health story of August 5, 2009 here:).

Vaccarino said, however, that other studies found […]

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Raptor’s rare disease drug recommended in Europe

LONDON (Reuters) – European regulators have recommended approval of a drug from Raptor Pharmaceutical to treat a rare genetic disorder that can cause irreversible tissue damage, organ failure and premature death.

Friday’s green light for Procysbi from the European Medicines Agency (EMA) follows U.S. approval of the drug in April.

The medicine is designed to treat nephropathic cystinosis, the most common form of a disease known as cystinosis, in which toxic levels of cystine, a naturally occurring amino acid, build up in the body’s cells and organs.

The EMA also issued approvals for GlaxoSmithKline’s Tafinlar for metastatic melanoma and Sanofi’s multiple sclerosis medicine Lemtrada.

It also revised its previous opinion not to give Sanofi’s multiple sclerosis pill Aubagio ‘new active substance’ status in what it said was one of the busiest meetings of the CHMP in 2013 so far.

Recommendations for marketing approval by the agency’s Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

(Reporting by Rosalba O’Brien, Editing by Dasha Afanasieva)

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Sanofi wins diabetes drug approval in Japan

PARIS (Reuters) – French drugmaker Sanofi said it won approval from the Japanese government for its Lyxumia drug for the treatment of Type 2 diabetes in combination with basal insulin.

Lyxumia is part of a new class of diabetes treatments called GLP-1 analogues which prompt the body to release insulin when a diabetic’s blood sugar level climbs too high.

Lyxumia is now approved in Mexico, the European Union, Australia and Japan, Sanofi said in a statement on Friday. A new drug application for lixisenatide in the United States is currently being reviewed, it added.

(Reporting by James Regan; Editing by Dominique Vidalon)

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Small Trial Yields Promising Vaccine for Type 1 Diabetes

The Obama family is Africa this week, starting their three-country tour with a stop in the west coast nation of Senegal. There was an official presidential meeting and some talk of trade and democracy — and leaks, of course —  but Day One of the journey was mostly one for sightseeing. Some fun and some somber. In addition, the usual parade of local culture and a visit to a school, the President visited Goree Island, touted as one of the historic focal points of the African slave trade. …

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