US health reforms will raise prices of breakthrough drugs (PharmaTimes)
Curetech gets FDA nod for liver cancer trial (Globes)
Acadia and Biovail’s pimavanserin fails in Phase III trial (PharmaTimes)
Genzyme’s bid to extend Clolar hits stumbling block (PharmaTimes)
Latin American Rx markets to grow 10% a year to 2013 (PharmaTimes)
New cancer cases will grow 30% by 2020 (PharmaTimes)
Protein–telomere Interactions Could Be Key In Treating Cancer (ScienceDaily)
Fine-tuning An Anti-cancer Drug (ScienceDaily)
What’s The Price For Marketing A DESI Drug? Solvay Settles Estratest Class Action for $30 Million (The Pink Sheet)
Five months after discontinuing its hormone replacement therapy Estratest and Estratest H.S. , Solvay Pharmaceuticals has agreed to pay $30 million to settle a California class action alleging the company falsely marketed the drug without FDA approval.
Solvay will put the money into a settlement fund to reimburse consumers and third party payers who paid for Estratest purchases in California. Los Angeles Superior Court granted preliminary approval of the settlement agreement in Alexander v. Solvay on Aug. 11 and the plaintiffs’ attorneys issued an announcement on Aug. 31.
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CHPA Seeks Enforcement Discretion, Clarifications On OTC Analgesic Rule (The Tan Sheet)
The Consumer Healthcare Products Association says the liver damage warning for acetaminophen-containing products in the OTC analgesics final rule potentially is inaccurate for combination products and asks FDA to allow firms to use alternate language.
In two Aug. 26 letters to the Office of Nonprescription Products in FDA’s drug center, the trade group outlines how the required labeling language would confuse consumers and asks FDA to exercise enforcement discretion for combination products.
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Otamixaban For Anticoagulation In Non-STEMI ACS (Elsevier Global Medical News)
Otamixaban, an intravenous anticoagulant, compared well with standard anticoagulant therapy in treating high-risk, non-ST-segment elevation acute coronary syndromes in a phase II study.
Otamixaban was associated with a 40 percent decrease in the composite outcome of all-cause mortality, MI, severe recurrent ischemia requiring urgent revascularization, and “bailout” use of a glycoprotein IIb/IIIa inhibitor for recurrent ischemia or a thrombotic complication during PCI. There was no accompanying increase in bleeding events with the drug up to seven days, study investigators reported online Aug. 31 in the Lancet.
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PTC Therapeutics Announces Drug Discovery Collaboration With Roche (NewsBlaze)
Document Details Plan to Promote Costly Drug (New York Times)
Taking Risk for Profit, Industry Seeks Cancer Drugs (New York Times)
Pfizer to pay $2.3 billion to settle marketing charges (Reuters)
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