Category | News Wire

Allergan inks $600M off-label settlement

Posted on 03 September 2010

Pharma marketing got another black eye yesterday when the Department of Justice announced a $600 million settlement with Allergan. The drugmaker agreed to plead guilty to a misdemeanor and pay a $375 million fine and $225 million in civil penalties, all for pushing Botox for off-label uses such as headache, pain and cerebral palsy treatment.
It’s [...]

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Analysts: New FDA rules inspire tougher drug reviews

Posted on 03 September 2010

The analysts at Concept Capital did the math on this year’s decisions by FDA expert panels and reached the disturbing conclusion (for biotech execs, anyway) that the numbers clearly indicate that the panels are getting tougher.
On 23 tries related to new chemical entities and major new indications, developers won 12 votes in favor of recommendation–a [...]

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Lilly gets patent support from appeals court

Posted on 03 September 2010

Eli Lilly just saw two key franchises shored up in court–at least for now. An appeals court affirmed a lower court’s injunction against Teva Pharmaceutical Industries’ copycat form of Evista, Lilly’s blockbuster bone and cancer treatment. Judges also backed a temporary injunction against generic versions of the ADHD drug Strattera, giving Lilly time to appeal [...]

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Dendreon Shares Up on Provenge Medicare Coverage Meeting Scheduling

Posted on 02 September 2010

Shares in Dendreon rose more than 6% after Medicare authorities scheduled a Nov. 17 meeting to consider coverage of the company’s Provenge prostate-cancer treatment — and investors concluded the question of whether or not to pay for the therapy was not an issue.
As TheStreet.com reported last night, CMS said the meeting will “consider the currently [...]

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Termeer insists Genzyme is worth much more than $18.5B

Posted on 02 September 2010

Longtime Genzyme CEO Henri Termeer has taken a public stand on Sanofi’s low ball offer: “At $69 [a share, the current offer], the company is not for sale,” he tells the Wall Street Journal. In fact, he expects the board to open up the process and seek a White Knight, or at least some new [...]

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Judges offer AZ more time to settle Seroquel suits

Posted on 02 September 2010

U.S. judges are giving AstraZeneca more time to settle Seroquel litigation, rather than sending thousands of consolidated cases back to their home courts for trial. As Bloomberg reports, a judicial panel voted to let the cases stay in Florida for the time being, where U.S. District Judge Anne Conway has been overseeing pretrial work–and court-mandated [...]

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MS activity alters with seasons, US researchers say

Posted on 01 September 2010

The researchers compared MS brain lesions with weather patterns
The severity of multiple sclerosis (MS) may change with the seasons, say US researchers.
Brain scans of patients compared with weather patterns at the time showed higher levels of disease activity in the spring and summer.
The US researchers said the findings had implications for testing new medicines, which [...]

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Obama administration appeals stem cell injunction

Posted on 01 September 2010

The Obama administration asked a federal judge on Tuesday to lift an injunction halting human embryonic stem cell research, saying it would irreparably harm research and cost more than 1,300 jobs.
The Justice Department also appealed against the injunction by Judge Royce Lamberth in which he ruled National Institutes of Health funding of human embryonic stem [...]

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Endo looks for more acquisitions

Posted on 01 September 2010

Endo Pharmaceuticals’ CEO David Holveck, a Johnson & Johnson alum, is modeling his company after the Big Pharma. Gabelli & Co analyst Kevin Kedra notes that Lidoderm–a patch to treat post-shingles nerve pain–will account for 47 percent of Endo’s 2010 sales. Faced with the the loss of patent protection for it’s main drug in 2015, the pharma [...]

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FDA, Vaccine Manufacturers: No Worries of Salmonella From Flu Vaccines

Posted on 31 August 2010

This year’s flu vaccine has some consumers worried. While it might protect them against a potentially deadly virus, could they end up with salmonella instead?
The answer is no, according to the Food and Drug Administration and vaccine manufacturers.
Flu vaccine is manufactured by growing virus in chicken eggs, and eggs are the source of a salmonella [...]

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