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Anika Therapeutics licenses U.S. rights to Monovisc to DePuy Mitek

Thursday, December 22 2011 | Comments
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Anika Therapeutics Inc. entered into an exclusive, multiyear U.S. licensing and supply agreement with DePuy Mitek Inc. for Monovisc (hyaluronic acid), Anika's investigational treatment for pain in patients with osteoarthritis of the knee. Under the terms of the agreement, Anika will receive an initial payment of $2.5 million and will be eligible to receive additional regulatory, clinical and sales milestone payments, pending a mutual decision by the two firms to launch the product. The...

Anika Therapeutics Inc. entered into an exclusive, multiyear U.S. licensing and supply agreement with DePuy Mitek Inc. for Monovisc (hyaluronic acid), Anika's investigational treatment for pain in patients with osteoarthritis of the knee.

Under the terms of the agreement, Anika will receive an initial payment of $2.5 million and will be eligible to receive additional regulatory, clinical and sales milestone payments, pending a mutual decision by the two firms to launch the product.

The Food and Drug Administration is reviewing Anika's approval application for Monovisc, a product that has been marketed in other countries since 2008.

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Researchers identify factors that appear to influence work interference in study of patients with chronic low back pain Verusmed

Monday, December 19 2011 | Comments
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Decreased physical function, daily pain and pain flare-ups all appear to interfere with the ability to work in individuals who have chronic low back pain, based on findings from a prospective study.

The study was conducted in urban family medicine clinics in Texas that provide care to mostly minority, low-income patients.

In all, 360 adults with a diagnosis of chronic low back pain that had persisted for more than three months completed a survey that assessed...

Kai Pharmaceuticals enters into license agreement with Ono Pharmaceutical Verusmed

Monday, December 19 2011 | Comments
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Kai Pharmaceuticals Inc. and Ono Pharmaceutical Co. Ltd. established an agreement regarding the development and commercialization of KAI-4169, Kai's lead product candidate, in Japan.

The agreement grants Ono exclusive rights to all indications for injectable formulations of KAI-4169 in Japan. Kai retains commercialization rights elsewhere....


Amgen's Prolia approved to increase bone mass in certain patients undergoing hormone ablation therapy for breast cancer, prostate cancer Verusmed

Monday, December 19 2011 | Comments
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The Food and Drug Administration approved two new indications for Amgen Inc.'s Prolia (denosumab).

The drug is now indicated as a treatment to increase bone mass in women at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer and as a treatment to increase bone mass in men at high risk for fracture who are receiving...

FDA approves label update for Ferring's Euflexxa OA therapy Verusmed

Monday, December 19 2011 | Comments
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The Food and Drug Administration approved a labeling supplement for Ferring Pharmaceuticals Inc.'s Euflexxa (sodium hyaluronate 1%), which is used to relieve knee pain resulting from osteoarthritis (OA) when other pain medications, exercise and physical therapy are inadequate.

The label supplement will contain efficacy data from the 26-week, randomized, double-blind FLEXX trial and...