DIA Biosimilars 2013

Bayer

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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Cenduit: Now with Patient Reminders

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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CRF Health – eCOA Forum

$262M Pan-European drug discovery platform launched

Friday, February 8, 2013 10:48 AM

The European Lead Factory, a novel platform for innovative drug discovery, was launched Feb. 7 by an international consortium of 30 partners. The partnership, the first of its kind, is supported by the Innovative Medicines Initiative (IMI) and creates opportunities for the discovery of new medicines by providing public partners with an “industry-like” discovery platform to translate cutting-edge academic research into high-quality drug lead molecules on a scale and speed that was not possible previously.

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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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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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