Researchers read drug patterns in European sewage

"The Antwerp city hall. Drug testers sifting through raw sewage in 19 European cities found the highest cocaine use in Antwerp, a Nordic preference for methamphetamines and Amsterdam unsurprisingly leading in cannabis use. (AFP Photo/Herwig Vergult)" title

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European rabbis fear circumcision row could spread

A group of Orthodox rabbis warned Wednesday that the ancient Jewish practice of infant male circumcision could face further restrictions in Europe after some hospitals in Austria and Switzerland suspended the procedure by citing a German court ruling that it could amount to criminal bodily harm.

Last month's verdict by a regional court in Cologne didn't ban circumcision. But it prompted angry protests from Jewish and Muslims groups, especially after the German Medical Association advised doctors not to perform unnecessary circumcisions until the legal situation is clarified

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European regulator: Gene therapy treatment OK

The European Medicines Agency is recommending the first-ever approval of a gene therapy treatment in the EU, in a significant move for a type of treatment that has so far failed to deliver on its promise to cure diseases.

In a statement on Friday, the EMA said Glybera, made by Dutch company uniQure, should be approved across Europe for the treatment of an extremely rare disorder that leaves people unable to digest fat. The treatment consists of a gene that makes a protein to break down fat.

Gene therapy is an experimental technique that tries to cure diseases by replacing genes that don't work. It has never been approved in the U.S. and most trials over the past two decades have failed. China was the first country to approve a gene therapy treatment in 2003 for cancer.

Scientists have struggled to find ways to deliver the genes safely, often by using a harmless virus. There are also concerns that inserting a gene at the wrong spot could cause cancer or that the body's immune system might attack the new gene and the virus used to deliver it.

The EMA previously rejected Glybera three times but it was reconsidered at the request of the European Commission. The agency recommended approval under tough restrictions and will require the company to set up a registry to closely track patients. Previous trials of the treatment only tested it in 27 patients.

"It is only meant for patients with the greatest need," said Monika Benstetter, an EMA spokeswoman, explaining the gene therapy is intended for people with no other treatment options. She said only a handful of gene therapy treatments had been considered before

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SkyePharma asthma drug wins European backing

Reuters – 1 hr 41 mins ago LONDON (Reuters) - SkyePharma said on Friday its lead product, asthma therapy Flutiform, had been recommended for approval by European regulators, doubling the value of the group's shares.

Flutiform was referred to the European Medicines Agency (EMA) last year after member states could not reach unanimous agreement on the drug, which will compete with GlaxoSmithKline's Advair and AstraZeneca's Symbicort in the multi-billion dollar respiratory drugs market

A positive opinion from the EMA is usually rubber stamped by the European Commission in a matter of months.

Shares in SkyePharma, which has partnered Mundipharma in developing the drug, more than doubled to 85.5 pence, valuing the group at about 22 million pounds.

"This is the end of a long struggle for the company," said Singer analyst Shawn Manning. "It's highly unlikely that it will get this stamp of approval and not get approved."

He said Flutiform could have sales in Europe of $200 million within five years, assuming it won "a modest" 7 percent share of combination therapy patients.

"We estimate 10 percent will go to SkyePharma, so it's a good solid contributor," he said, adding that the positive opinion also opened the door to markets in Latin America and Canada.

Flutiform is a combination of two commonly prescribed drugs to treat asthma, the corticosteroid fluticasone propionate and the beta-agonist formoterol fumarate, in a metered dose inhaler.

SkyePharma's chief executive Peter Grant said the decision was a strong endorsement of the group's capabilities in developing complex respiratory products.

"It is also good news that we are now on track for a new treatment option to be available for many patients suffering from asthma across Europe," he said.

Earlier on Friday, SkyePharma received a $10 million payment from Pacira Pharmaceuticals following the launch of post-surgical pain drug Exparel in the United States.

(Editing by Hans-Juergen Peters)

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