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Oct. 11, 2012

Vol. 9 No. 200

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Authorized Generic Deals Are ‘Pay for Delay,’ FTC Tells Courts … Again

The FTC is challenging a GlaxoSmithKline (GSK)-Teva patent settlement deal, filing an amicus brief that argues authorized generic agreements fall under the category of pay-for-delay deals and are anticompetitive. Read More

CMS Dodges Questions on Sunshine Timeline as Senators Turn Up Heat

Despite pressure from senators at a roundtable on the implementation of the Physician Payments Sunshine Act, a representative from the Centers for Medicare & Medicaid Services (CMS) simply said the agency hopes the rule will be released soon and that manufacturers’ data collection will begin in 2013. Read More

Daiichi, ArQule End Phase III Drug Combo Trial

Daiichi Sankyo and ArQule are discontinuing a Phase III trial of tivantinib in combination with erlotinib for patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC). Read More

Oxford Bio Abandons Prostate Cancer Vaccine Study

Britain’s Oxford BioMedica said it was closing a mid-stage clinical trial of its cancer vaccine TroVax in U.S. patients with prostate cancer, dealing a further blow to the troubled product. Read More

Merck Ordered to Turn Over Docs in Vioxx MDL

A New Jersey federal judge on Friday ordered Merck & Co. to hand over purportedly privileged documents produced for government investigations concerning Vioxx — a partial discovery win for multidistrict litigation plaintiffs accusing the company of inflating its stock through misrepresentations about the recalled arthritis medication. Read More

Raptor Pharmaceutical Obtains Tissue Fibrotic Disease Intellectual Property Related to Cysteamine

Raptor Pharmaceutical acquired exclusive worldwide rights to intellectual property related to cysteamine and related compounds in the potential treatment of tissue fibrosis from the Seattle Children’s Research Institute. Read More

Results of Lymphoseek Phase III Clinical Trials in Melanoma Published in Annals of Surgical Oncology

Navidea Biopharmaceuticals announced the peer-reviewed publication of results from two Phase III clinical trials of Lymphoseek (technetium 99m tilmanocept) in patients with melanoma of the skin. Read More

Teva Presents Positive Data on High Dosage Copaxone

Teva Pharmaceutical Industries announced positive data for the GALA Phase III clinical trial of high dosage Copaxone for the treatment of multiple sclerosis. Read More

QRxPharma Announces Strategic Collaboration With Paladin Labs

QRxPharma announced execution of a licensing agreement with Paladin Labs for the Canadian commercialization rights to MOXDUO, a patented, immediate release formulation of morphine and oxycodone. Read More