Bayer HealthCare

Bayer's Stivarga receives FDA approval for GIST

Tuesday, February 26, 2013 12:27 PM

The FDA has approved Bayer's Stivarga (regorafenib) tablets to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

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Janssen, Bayer, Portola form clinical collaboration

Friday, February 8, 2013 11:17 AM

Janssen Pharmaceuticals has signed a clinical collaboration agreement with Portola Pharmaceuticals and Bayer HealthCare to evaluate the safety of PRT4445—an investigational-stage antidote for Factor Xa inhibitors—in healthy volunteers who have been administered the oral anticoagulant Xarelto (rivaroxaban). The study will evaluate several dosage strengths of PRT4445 and its ability to reverse the anticoagulant activity of Xarelto in emergency situations.

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Bayer submits NDA for radium Ra 223 dichloride for castration-resistant prostate cancer

Friday, December 14, 2012 12:07 PM

Bayer HealthCare has submitted a New Drug Application (NDA) to the FDA seeking approval for radium Ra 223 dichloride (radium-223), a fast tracked investigational compound for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases.

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Bayer HealthCare strengthens position in Russia

Friday, November 2, 2012 02:21 PM

Bayer HealthCare and Russian drug manufacturer Medsintez have entered into a strategic partnership to jointly manufacture and commercialize diagnostic imaging products as well as pharmaceuticals to treat infections and neural disorders.

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FDA grants Bayer’s Stivarga NDA priority review

Thursday, November 1, 2012 11:49 AM

Bayer HealthCare and Onyx Pharmaceuticals, a biopharmaceutical company based in South San Francisco, announced today that the FDA has granted priority review to the New Drug Application (NDA) for Stivarga (regorafenib) tablets.

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Bayer to acquire Schiff Nutrition International for $ 1.2B

Wednesday, October 31, 2012 09:15 AM

Bayer HealthCare has signed a merger agreement to acquire Schiff Nutrition International, a company offering vitamins and nutritional supplements in the U.S. and other countries, for $1.2 billion, representing a value of $34 per share in cash.

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Shire’s Angus Russell to retire in 2013, Ornskov to succeed as CEO

Friday, October 26, 2012 12:07 PM

The board of directors of Shire, a global specialty biopharmaceutical company based in Ireland, has announced the retirement in 2013 of chief executive Angus Russell after 13 years with the company and 32 years in the pharmaceutical industry.

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Bayer’s riociguat meets primary endpoint in phase III study in PAH

Tuesday, October 23, 2012 07:15 AM

Bayer HealthCare Pharmaceuticals, the U.S.-based pharmaceuticals business of Bayer HealthCare, issued data from the phase III PATENT-1 pulmonary arterial hypertension (PAH) trial evaluating its investigational drug riociguat in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid.

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Evotec, Bayer form multi-target alliance to fight endometriosis

Monday, October 1, 2012 02:57 PM

Evotec, a German drug discovery alliance and development partnership company, and Bayer have entered into a five-year, multi-target collaboration with the goal of developing three clinical candidates for the treatment of endometriosis.

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Bayer submits NDA for regorafenib for gastrointestinal stromal tumors

Friday, August 31, 2012 12:02 PM

Bayer HealthCare and Onyx Pharmaceuticals, a global biopharmaceutical company based in San Francisco, have submitted a New Drug Application (NDA) to the FDA for the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment.

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February 25

Analysts: With market anticipation of Quintiles IPO, other CROs could soon file to go public

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