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Statement By Merck & Co., Inc. Regarding FOSAMAX® (alendronate Sodium) And Rare Cases Of Osteonecrosis Of The Jaw
Merck is committed to putting patients first and providing accurate information regarding the efficacy, safety and tolerability of our medicines. Merck offers the following statement concerning the osteoporosis medication FOSAMAX® (alendronate sodium) and reports of jaw problems associated with delayed healing and infection of the jaw often following tooth extraction. The condition is known as osteonecrosis of the jaw (ONJ).

Placenta Harmed By Cocaine And Heroin
Cocaine and heroin increase permeability of the placenta. Researchers writing in BioMed Central"s open access journal Reproductive Biology and Endocrinology have shown that exposure to the drugs causes an increase in the passage of some chemicals into the fetus.
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Industry Lobby Wars Heighten As Reform Efforts Progress
"Healthcare companies are spending millions of dollars and marshaling armies of lobbyists to influence a landmark debate in the U.S. Congress that could dramatically change the way they do business," Reuters reports. "Drugmakers, doctors, insurers and hospitals have opened their wallets, spending more than $1 million a day to buy a voice in the escalating political battle over what could be the broadest revamp of healthcare laws in decades." And "as the debate has unfolded, key lawmakers have seen a surge in campaign donations, and hundreds of lobbyists have jammed Capitol hallways and lined the reception room outside the Senate chamber to talk to lawmakers." Sheila Krumholz, executive director of the Center for Responsive Politics, says "there is a frenzy going on to get in your two cents worth before the legislation reaches the next stage."
Diagnostics

Embera NeuroTherapeutics Announces Expansion Of Management Team After Successful Completion Of Pilot Study Of Cocaine Addiction Treatment

Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for drug addiction and obesity, announced today that the company has recently expanded its management team to prepare for its next stage of development, following the successful completion of the company"s pilot study of cocaine addiction treatment. Bob Linke was named President and CEO earlier this year, bringing over twenty-four years of healthcare experience to the company that includes building two life science companies. Mr. Linke has also held senior management positions at Baxter International and Caremark. Dr. Bruce McCarthy recently joined as Embera"s consultant Chief Medical Officer and Vice President of Clinical Development. Dr. McCarthy, a neurologist, has extensive experience in neurology and psychiatry drug development and previously led neuroscience clinical development at Pfizer. Dr. Carol Gloff has also joined the company as a pharmaceutical regulatory consultant. Dr. Gloff has over twenty-five years experience in drug development and regulatory affairs, from preparation of INDs through FDA product approval. Prior to establishing her consulting practice, Dr. Gloff was Vice President of Regulatory Affairs for Alkermes and ImmunoGen. At the end of 2008, the company completed a forty-five subject pilot study of its lead combination drug product, EMB-001, in cocaine dependent subjects at the Louisiana State University Health Sciences Center"s Psychopharmacology Research Clinic. This was the first placebo-controlled investigation in humans with EMB-001, the combination drug approach developed by Embera"s Chief Scientific Officer, Dr. Nicholas Goeders. The company believes its treatment approach, which targets the neurological mechanisms of addiction, may also prove useful in other addiction disorders such as smoking and alcohol dependence. Mr. Linke commented: "I am very excited to serve as the new President and CEO of Embera as the company prepares for its next phase of development. The positive findings in the company"s pilot clinical study of craving in cocaine dependent subjects, along with the preclinical studies conducted at Louisiana State University Health Sciences Center by Embera"s Chief Scientific Officer, Dr. Nicholas Goeders, laid the foundation for the company"s plans to move EMB-001 forward in clinical development. There is a significant unmet need for new treatments for individuals who suffer from addictions or eating disorders in obesity. Embera"s novel approach to addressing these disorders offers the potential of new treatment options for these populations." Embera is currently raising capital to advance the clinical development of its lead combination drug product, EMB-001, in a financing round led by its current investors, Louisiana Ventures and Louisiana Fund I. Ross Barrett, Chairman of Embera NeuroTherapeutics and Managing Partner of Louisiana Ventures, LP commented: "The Board is enthused about our expanded management team that includes new CEO Bob Linke, as well as Dr. McCarthy and Dr. Gloff. Their commitment speaks volumes regarding the potential value EMB-001 can bring to addiction and obesity-related therapeutics." Embera NeuroTherapeutics, Inc.


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