Regulatory
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Family Wins Fight Linking MMR Vaccine To Epilepsy

Friday, September 3rd, 2010

In what is being described as the first judgment of its kind in the UK, a family was awarded nearly $140,000 after a medical assessment panel consisting of two doctors and an attorney concluded that the MMR vaccine was to blame for the brain damage suffered by Robert Fletcher. He was vaccinated at 13 months and is now 18 years old, confined to a wheelchair and requires round-the-clock care. His parents applied for compensation under the UK government’s Vaccine Damage Payment Scheme, but were rejected in 1997 on the grounds that it was impossible to prove beyond reasonable doubt what had caused their son’s illness, The Daily Mail reports

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Dissident Elan Shareholder To Propose New Board

Friday, September 3rd, 2010

Danish investor Ib Sonderby is stepping up the pressure on Elan. The dissident shareholder, who recently launched a web site called Save Elan in which he has launched tirades against Elan ceo Kelly Martin, will hold a conference call next Wed., Sept. 8, to introduce four people he would like to install on the board.

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Half Of Americans Are Taking Prescription Meds

Friday, September 3rd, 2010

More than 48 percent of all Americans took at least one prescription drug each month in 2008, which amounts to a 10 percent increase over the previous decade, according to a new report from the US Centers for Disease Control and Prevention. And the use of multiple prescription meds rose by 20 percent, while the use of five of more drugs increased by 70 percent. In fact, one out of every five Americans was using five or more drugs by 2008, and one out of every five children used at least one prescription med compared with nine out of 10 adults aged 60 and over

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Yes, Roche Is Planning Those Job Cuts

Friday, September 3rd, 2010

The speculation earlier this week that Roche was planning a round of cutbacks is, in fact, on the money.

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Pharmalot… Pharmalittle… A Holiday Weekend

Friday, September 3rd, 2010

Good morning, everyone.

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American Heart Association, Avandia & Ghostwriting

Thursday, September 2nd, 2010

Did the American Heart Association’s Circulation journal publish a ghostwritten article about Avandia? There has been disagreement about this ever since the US Senate Finance Committee released a report in July about the controversy concerning the GlaxoSmithKline diabetes pill. Glaxo, you may recall, once ran a program aptly named Cassper, or Case Study Publications for Peer Review, which was designed to assist researchers with their articles.

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Another Japanese Drugmaker Buys Into Diet Pills

Thursday, September 2nd, 2010

For the second time this summer, a Japanese drugmaker has agreed to pay $50 million upfront for the rights to a forthcoming diet pill. This time, Takeda Pharmaceuticals is giving Orexigen Therapeutics $50 million for exclusive North American marketing rights (but co-promotion in the US) for Contrave and another $1 billion for meeting regulatory and sales milestones, along with double-digit royalties (see statement ). Just a few weeks ago, Eisai paid $50 million for the rights to sell Arena Pharmaceuticals’ lorcaserin in the US; another $160 million based on development and approval milestones, and a $1.16 billion, one-time payment that may follow based on annual sales.

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Should The FDA Have Moved Faster On Meridia?

Thursday, September 2nd, 2010

After months of waiting, the final and complete results from a study about the Meridia diet pill are now available in The New England Journal of Medicine and the findings are as bad as what was suggested by the preliminary data released last November. The SCOUT study, which was financed by Abbott Labs, the company that sells the pill, shows Meridia raised heart attack and stroke risk in patients with pre-existing heart disease ( read the abstract ). The study examined nearly 10,000 people 55 and older with pre-existing cardiovascular disease, type 2 diabetes or both, who were given Meridia or a placebo.

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JAMA Editor Catherine DeAngelis Is Leaving

Wednesday, September 1st, 2010

After a decade of running one of the world’s most prestigious medical journals, Catherine DeAngelis is leaving her job as editor-in-chief of the Journal of the American Medical Association next year to join Johns Hopkins University School of Medicine, Baltimore, where she will develop a Center for Professionalism in Medicine and the Related Professions, including nursing, public health, business and law.

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Merck Manager Charged With Insider Trading

Wednesday, September 1st, 2010

In a lawsuit filed in federal court in Philadelphia, the US Securities and Exchange Commission has charged Jim Self, a pharmaceutical executive, and Stephen Goldfield, a hedge fund manager, with insider trading in connection with the 2007 acquisiton of MedImmune by AstraZeneca. Ultimately, Goldfield made nearly $14 million on his trades, according to the lawsuit

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