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2014-07-30

Bayer continues positive business development

The Bayer Group was again successful in the second quarter of 2014. "Our Life Science businesses, in particular, saw unabated growth momentum, with very encouraging sales gains for our recently launched pharmaceutical products and our North and Latin American CropScience business," said Management Board Chairman Dr. Marijn Dekkers when the interim report was published on Wednesday.   » more

2014-07-30
Stivarga® (regorafenib) from Bayer Approved in the European Union for the Treatment of Gastrointestinal Stromal Tumors

Stivarga® (regorafenib) from Bayer Approved in the European Union for the Treatment of Gastrointestinal Stromal Tumors #

Approval in the second indication for Stivarga in the EU within one year / Decision based on positive results from Phase III GRID trial in which regorafenib significantly extended progression-free survival   » more

2014-07-30
Aflibercept Solution for Injection into the Eye Receives FDA Approval for the Treatment of Diabetic Macular Edema (DME)

Aflibercept Solution for Injection into the Eye Receives FDA Approval for the Treatment of Diabetic Macular Edema (DME) #

The approval of aflibercept solution for injection in DME was based on the one year data from the Phase 3 VISTA-DME and VIVID-DME trials of 862 patients, which compared aflibercept solution for injection 2 milligrams (mg) given monthly, 2 mg given every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed).   » more

2014-07-25

Phase III Trial of Sorafenib in Combination with Capecitabine Does Not Meet Primary Endpoint in Patients with Advanced Breast Cancer #

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc., an Amgen subsidiary, today announced that an investigational Phase III trial of sorafenib (Nexavar®) tablets plus capecitabine in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).   » more

2014-07-18
Two-Year Results From Phase 3 Trial Show Sustained Improvement in Vision for People with Diabetic Macular Edema

Two-Year Results From Phase 3 Trial Show Sustained Improvement in Vision for People with Diabetic Macular Edema #

Full two-year data from the VIVID-DME trial will be presented at upcoming medical conferences. Both the VIVID-DME and the VISTA-DME trials will continue as planned up to 148 weeks.   » more

2014-07-03
Bayer and University of Oxford to Develop Novel Gynecological Therapies

Bayer and University of Oxford to Develop Novel Gynecological Therapies

Under the terms of the agreement both parties will contribute innovative drug targets and high quality technology infrastructures. Furthermore, Bayer and the University of Oxford will share responsibilities from basic research to early clinical trials in these two diseases.   » more

2014-06-27
Regorafenib from Bayer Recommended for Approval in the European Union for the Treatment of Gastrointestinal Stromal Tumors

Regorafenib from Bayer Recommended for Approval in the European Union for the Treatment of Gastrointestinal Stromal Tumors #

The oncology compound regorafenib (Stivarga®) from Bayer has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.   » more

2014-06-27
Bayer Receives positive CHMP Opinion for the Treatment of Visual Impairment due to Diabetic Macular Edema in EU

Bayer Receives positive CHMP Opinion for the Treatment of Visual Impairment due to Diabetic Macular Edema in EU #

The final decision of the European Commission is expected in the coming months.   » more

2014-06-23
Bayer HealthCare and Dimension Therapeutics to Develop Novel Gene Therapy for Hemophilia A

Bayer HealthCare and Dimension Therapeutics to Develop Novel Gene Therapy for Hemophilia A

Depending on the results of the Phase I/IIa clinical trial, Bayer will conduct the confirmatory Phase III trial, make all regulatory submissions, and will have worldwide rights to commercialize the potential future product for the treatment of hemophilia A. Dimension Therapeutics is eligible to receive tiered royalties based on product sales.   » more

2014-06-20
Bayer Receives Approval for Nexavar® (sorafenib) in Japan for Treatment of Differentiated Thyroid Cancer

Bayer Receives Approval for Nexavar® (sorafenib) in Japan for Treatment of Differentiated Thyroid Cancer #

Nexavar was approved for the treatment of progressive, locally advanced or metastatic differentiated thyroid cancer that is refractory to radioactive iodine in the United States in November 2013 and in May 2014 in the European Union.   » more

2014-06-12
FDA approves Bayer’s Gadavist (gadobutrol) Injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the United States

FDA approves Bayer’s Gadavist (gadobutrol) Injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the United States #

Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Gadavist® (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast disease.   » more

2014-06-11
Bayer Submits Aflibercept Solution for Injection Into the Eye for Fourth Indication in EU

Bayer Submits Aflibercept Solution for Injection Into the Eye for Fourth Indication in EU #

Bayer HealthCare has applied for marketing authorization of aflibercept solution for injection for the treatment of patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) to the European Medicines Agency (EMA).   » more

2014-06-05
Dieter Weinand to become President of Bayer HealthCare Pharmaceuticals

Dieter Weinand to become President of Bayer HealthCare Pharmaceuticals

Dieter Weinand has more than 25 years of experience in various commercial operative and strategic executive roles in the pharmaceutical industry.   » more

2014-06-04
Bayer’s Erica Mann Chairs World Self-Medication Industry

Bayer’s Erica Mann Chairs World Self-Medication Industry

In one of her first acts as WSMI-Chair, Mann proposed a reform plan designed to strengthen WSMI’s capabilities and to position the industry group to meet the challenges and opportunities present today and in the future.   » more

2014-06-03

Bayer to Evaluate Riociguat in New Indication #

Pulmonary hypertension is a co-morbidity seen in 30%-85% of patients with idiopathic interstitial pneumonia (IIP) and is associated with increased mortality. Once diagnosed, the median survival time in PH-IIP patients is estimated to be 2.5 to 3.5 years.   » more

2014-06-02

Bayer and Orion Corporation to develop and commercialize novel prostate cancer treatment #

Bayer has entered into a global agreement with Orion Corporation, a pharmaceutical company based in Espoo, Finland, (Nasdaq OMX Helsinki: ORNAV and ORNBV) for the development and commercialization of the compound ODM-201, an investigational novel oral androgen receptor inhibitor.   » more

2014-05-30
Bayer Receives EU Approval for Nexavar® (sorafenib) for the Treatment of Differentiated Thyroid Cancer

Bayer Receives EU Approval for Nexavar® (sorafenib) for the Treatment of Differentiated Thyroid Cancer #

Bayer HealthCare and Onyx Pharmaceuticals, Inc., an Amgen subsidiary, announced today that the European Commission (EC) has granted marketing authorization for the oral multi-kinase inhibitor Nexavar® (sorafenib) for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).   » more

2014-05-28

Andreas Fibig to leave Bayer HealthCare Pharmaceuticals

Andreas Fibig (52), President of Bayer HealthCare Pharmaceuticals and a member of the Bayer HealthCare Executive Committee, will leave Bayer HealthCare to become Chief Executive Officer of International Flavors & Fragrances Inc., New York, NY, USA, effective September 1, 2014.   » more

2014-05-28
Xarelto™ from Bayer Submitted in Japan for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism as well as for the Prevention of Recurrent Venous Thromboembolism

Xarelto™ from Bayer Submitted in Japan for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism as well as for the Prevention of Recurrent Venous Thromboembolism #

Bayer HealthCare’s oral anticoagulant Xarelto™ (rivaroxaban) has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for marketing authorization to treat patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as to prevent recurrent venous thromboembolism (VTE).   » more

2014-05-23
Bayer Introduces First Bluetooth-enabled Injection Management System for Multiple Sclerosis Patients

Bayer Introduces First Bluetooth-enabled Injection Management System for Multiple Sclerosis Patients #

Bayer has developed a new system for administering and monitoring Betaferon® injection, named BETACONNECT™.   » more

2014-05-15

Bayer to divest Interventional device business to Boston Scientific for $415 million

Bayer HealthCare has entered into a definitive agreement to sell its Interventional device business to Boston Scientific. The total consideration for the transaction, including fees for transitional services, is $415 million (about EUR 300 million).   » more

2014-05-14
Bayer HealthCare to unveil 'CoLaborator' in Berlin

Bayer HealthCare to unveil 'CoLaborator' in Berlin

Bayer HealthCare (Bayer) has officially inaugurated its second research incubator for young life sciences companies at its Berlin location, dubbed 'CoLaborator'. The opening ceremony took place in the presence of Berlin's Governing Mayor Klaus Wowereit.   » more

2014-05-13
Bayer HealthCare extends access to clinical trial data

Bayer HealthCare extends access to clinical trial data

Secured data access will be granted after approval of the research proposal by an independent scientific review panel. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 1, 2014.   » more

2014-05-06
Bayer to acquire consumer care business of US-based Merck & Co., Inc. and to engage in strategic pharma cooperation in the field of sGC modulators

Bayer to acquire consumer care business of US-based Merck & Co., Inc. and to engage in strategic pharma cooperation in the field of sGC modulators

Bayer has agreed to acquire the consumer care business of U.S. pharmaceutical company Merck & Co., Inc., Whitehouse Station, NJ, USA, for a purchase price of USD 14.2 billion (EUR 10.4 billion). “This acquisition marks a major milestone on our path towards global leadership in the attractive non-prescription medicines business," explained Bayer CEO Dr. Marijn Dekkers.   » more

2014-04-28

Bayer: Very successful start to 2014

The Bayer Group started the year 2014 with encouraging growth in sales and earnings. "Our Life Science businesses continued their dynamic development and achieved slight earnings increases despite significant negative currency effects," Bayer CEO Dr. Marijn Dekkers said on Monday when the interim report was published.   » more

2014-04-25

Sorafenib Recommended for Approval in the European Union for the Treatment of Differentiated Thyroid Cancer #

Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc., an Amgen subsidiary, announced today that the European Committee for Medicinal Products for Human Use (CHMP) recommended the oral multi-kinase inhibitor sorafenib (Nexavar®) for approval for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.   » more

2014-04-24

Positive Results from Phase III DECISION Study of Sorafenib in RAI-Refractory Differentiated Thyroid Cancer Published in The Lancet #

These data supported U.S. Food and Drug Administration approval of Nexavar for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine (RAI) treatment in November 2013.   » more

2014-04-23

Bayer Submits Riociguat for the Treatment of Pulmonary Arterial Hypertension in Japan #

Bayer HealthCare has filed riociguat for the treatment of pulmonary arterial hypertension (PAH) for regulatory approval in Japan. PAH is a progressive and life-threatening form of pulmonary hypertension in which the blood pressure in the pulmonary arteries is significantly increased due to vasoconstriction and which can lead to heart failure and death.   » more

2014-04-22

FDA Grants Orphan Drug Designation for Bayer’s Investigational Ciprofloxacin Dry Powder for Inhalation for Treatment of NCFB #

Bayer HealthCare today announced that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development has granted an orphan drug designation for its investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).   » more

2014-04-19

Response to article in German news magazine "Der Spiegel" from April 19, 2014

In its printed edition of April 19, 2014 the German news magazine “Der Spiegel” has published an article under the headline “Control is better” that references a number of anticoagulants, including Xarelto from Bayer.   » more

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