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News archive


Bayer HealthCare initiates discussion regarding public awareness of benefits and risks of modern contraception

Bayer HealthCare has invited international experts to debate approaches how to increase awareness on the benefits and potential risks of modern contraception. This topic was recently subject to a number of controversial media reports and European regulatory actions.   » more


Bayer to Present New Data on Advancing Oncology Portfolio #

Bayer HealthCare (Bayer) will present latest preclinical and clinical data on promising early-stage compounds with new mechanism of action at the American Association for Cancer Research (AACR) 105th Annual Meeting, April 5-9, 2014, in San Diego, CA.   » more


Bayer Initiates Phase III Trial of Radium-223 Dichloride in Combination with Abiraterone Acetate for Patients with Metastatic Castration-Resistant Prostate Cancer #

Bayer HealthCare today announced that the company has begun to enroll patients in a new Phase III trial with radium-223 dichloride (radium-223, Xofigo®). The study evaluates radium-223 in combination with abiraterone acetate and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone predominant metastatic castration-resistant prostate cancer (CRPC).   » more


Bayer Initiates Two New Phase III Trials to Evaluate Rivaroxaban in Medically-ill Patients and Children at High Risk of Blood Clots #

The MARINER trial will evaluate the safety and efficacy of rivaroxaban to reduce the risk of post-hospital discharge symptomatic venous thromboembolism (VTE) in patients hospitalized for acute medical illness. The EINSTEIN JUNIOR trial will assess the efficacy and safety of rivaroxaban for the treatment and secondary prevention of venous thromboembolism (VTE) in children.   » more


Bayer’s Adempas® (riociguat) Approved for the Treatment of Two Life-Threatening Forms of Pulmonary Hypertension in the EU #

Adempas is indicated for the treatment of adult patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgical treatment, and for the treatment of adult patients with pulmonary arterial hypertension (PAH) as a monotherapy or in combination with endothelin receptor antagonists.   » more


Bayer HealthCare to significantly increase production capacity in China

Bayer is the fourth-largest multinational pharmaceutical company in China, with more than 7,000 employees and production sites in Beijing, Guangzhou, Chengdu and Qidong. The company has already established a center for research and development in Beijing with investments of around EUR 100 million.   » more


Start of Phase IIIb Study with Bayer’s Riociguat in PAH Patients Who Demonstrate an Insufficient Response to PDE-5 Inhibitors #

Bayer HealthCare announced today the enrolment of the first patient in an open-label, multicentre, multinational Phase IIIb pilot study, RESPITE (Riociguat clinical Effects Studied in Patients with Insufficient Treatment response to PDE-5 inhibitors).   » more


Bayer to invest more than 500 million Euros for the manufacturing of hemophilia A products currently in development #

With an investment of more than 500 million Euros at its sites in Wuppertal and Leverkusen, Germany, Bayer will establish additional capacities for the manufacturing of the recombinant factor VIII (rFVIII) hemophilia products that are currently in development.   » more


Phase III Trial of Sorafenib as Adjuvant Therapy for Liver Cancer Did Not Meet Primary Endpoint #

Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc., an Amgen subsidiary, today announced that a Phase III trial evaluating sorafenib (Nexavar®) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC, a form of liver cancer) who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival.   » more


Bayer to Sell Back Rights to ATX-101 to KYTHERA

Bayer HealthCare and KYTHERA today announced that Bayer will sell back to KYTHERA commercial rights to ATX-101 outside of the U.S. and Canada.   » more


Regulatory update on Kogenate® Bayer

This final European Commission decision, dated 20 February 2014, supports the company’s point of view that current evidence in previously untreated patients with the bleeding disorder, haemophilia A did not indicate an increased risk of developing antibodies (factor VIII inhibitors) against Kogenate Bayer when compared with other recombinant or plasma-derived factor VIII products.   » more


Bayer Submits VEGF Trap-Eye (aflibercept solution for injection) for Treatment of Diabetic Macular Edema in Japan #

Bayer HealthCare today announced that Bayer Yakuhin, Ltd., Osaka, Japan, has submitted an application for marketing authorization for VEGF Trap-Eye (aflibercept solution for injection) for the treatment of patients with diabetic macular edema (DME) to the Ministry of Health, Labour and Welfare (MHLW) in Japan.   » more

Bayer continues successful course in anniversary year

Bayer continues successful course in anniversary year

The Bayer Group continued its successful course in 2013. “We met important business objectives in our anniversary year,” said Management Board Chairman Dr. Marijn Dekkers on Friday at the Financial News Conference in Leverkusen.   » more


Bayer to acquire Dihon Pharmaceutical Group Co., Ltd. in China

Transaction strengthens Consumer Care business and moves Bayer HealthCare to a leading OTC position in key growth country   » more


Bayer Initiates Phase III Trial of Regorafenib in Patients with Colorectal Cancer after Resection of Liver Metastases #

Bayer HealthCare today announced that the company has begun to enroll patients in the COAST trial studying regorafenib (Stivarga®) tablets in colorectal cancer (CRC) patients with resected liver metastases.   » more


Bayer’s Long-Acting Recombinant Factor VIII Demonstrated Effective Prophylaxis with Less Frequent Infusions in Hemophilia A in Phase III Trial #

Bayer HealthCare today announced positive results from the PROTECT VIII trial evaluating the company’s investigational site-specific PEGylated recombinant human factor VIII compound BAY94-9027. The study met its primary objective of protection from bleeds with fewer infusions.   » more


Bayer Initiates Rivaroxaban Phase III Study to Support Dose Selection According to Individual Benefit-Risk Profile in Long-Term VTE Prevention #

Bayer HealthCare announced today the initiation of EINSTEIN CHOICE, a Phase III clinical trial that will evaluate two doses of its once-daily novel oral anticoagulant rivaroxaban (Xarelto®) against acetylsalicylic acid (ASA) for the long-term, secondary prevention of symptomatic venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE).   » more


U.S. FDA Issues Complete Response Letters for Bayer’s Xarelto® (Rivaroxaban) to Reduce the Risk of Thrombotic Cardiovascular Events and Stent Thrombosis in Patients with ACS #

Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) issued complete response letters (CRLs) regarding the supplemental New Drug Applications for the oral anticoagulant Xarelto® (rivaroxaban) 2.5 mg twice daily (BID) in combination with standard antiplatelet therapy to reduce the risk of thrombotic cardiovascular events and stent thrombosis in patients with Acute Coronary Syndrome (ACS).   » more


Bayer: Takeover offer for Algeta expires at 9:00 a.m. CET on February 24,2014

Through its wholly owned subsidiary Aviator Acquisition AS, Bayer is offering NOK 362 in cash for each Algeta share. The German antitrust authorities (Bundeskartellamt) issued the necessary approval on January 6, 2014.   » more


“Green light” for Bayer’s new transparent low dose contraceptive patch in the EU #

The contraceptive transdermal patch is small, round and transparent and contains 2.1 mg gestodene and 550 micrograms ethinylestradiol. Each transdermal patch releases 60 micrograms gestodene per 24 hours and 13 micrograms ethinylestradiol per 24 hours.   » more


Two-Year Results From Phase III Trial of VEGF Trap-Eye (aflibercept solution for injection) for the Treatment of Diabetic Macular Edema Show Sustained Improvement in Vision #

Trial results show that after 100 weeks, patients receiving VEGF Trap-Eye 2 mg dosed monthly had a mean change from baseline in BCVA of 11.5 letters (12.5 letters at 52 weeks).   » more


Bayer and German Cancer Research Center (DKFZ) in Strategic Alliance Against Cancer

Over a period of another five years, the DKFZ and Bayer have agreed to further invest up to 6 million Euros per year, which would lead to an investment of up to 30 million Euros in collaborative oncology research projects.   » more


Bayer’s Riociguat Recommended for Approval in the EU in Two Forms of Pulmonary Hypertension #

The European Committee for Medicinal Products for Human Use (CHMP) today recommended approval for riociguat tablets for use in two forms of pulmonary hypertension, a group of life-threatening and progressive diseases: The treatment of adult patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgical treatment to improve exercise capacity, and the treatment of adult patients with pulmonary arterial hypertension (PAH) to improve exercise capacity.   » more


Bayer Regulatory update on various combined hormonal contraceptives

The final European Commission decision in the EU referral procedure regarding combined hormonal contraceptives, dated January 16, 2014, supports our point of view that no new scientific evidence has emerged that would change the positive benefit-risk assessment of combined hormonal contraceptives.   » more


Bayer commences takeover offer for all the shares of Algeta ASA

Aviator Acquisition AS, a subsidiary established by Bayer Nordic SE, Espoo, Finland, for the purpose of the acquisition, today commenced a public takeover offer for all the shares of Algeta at a price of NOK 362 per share in cash.   » more


Bayer Receives Approval for Riociguat in Japan for the Treatment of Chronic-Thromboembolic Pulmonary Hypertension #

Bayer HealthCare has received approval for riociguat under the name Adempas® for the treatment of adults with inoperable chronic-thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgical treatment by the Ministry of Health, Labour and Welfare (MHLW) in Japan.   » more


U.S. FDA Advisory Committee Recommends Against Approval of Bayer’s Xarelto® (Rivaroxaban) in Patients with ACS #

Recommendations from the Advisory Committee will now be considered by the FDA in its review of the supplemental New Drug Application (sNDA) for rivaroxaban in this indication, although the FDA is not bound to follow them.   » more


Bayer reintroduces Diane-35 onto the French market

Following the confirmation of the positive benefit-risk profile by the European Medicines Agency (EMA), Bayer is reintroducing Diane-35 onto the French market in agreement with the French health authority (ANSM).   » more


Bayer and Regeneron to Develop New Treatment Option for Wet Age-Related Macular Degeneration #

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced an agreement to jointly develop an innovative antibody to Platelet Derived Growth Factor Receptor Beta (PDGFR-?) as a potential combination therapy with EYLEA® (aflibercept) for the treatment of wet age-related macular degeneration (wet AMD).   » more


Bayer Leads Unique Effort to Support Global Public Health by Fighting Vector-Borne Diseases

Nearly half of the world’s population is infected with at least one type of vector-borne disease. These diseases are transmitted from parasites to animals and humans, and have a significant impact on public health and our global economy.   » more

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