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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

2014-04-09

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

Today, various contraceptive methods offer solutions tailored to women’s needs and their individual life situations. While it is clear that modern contraception is the primary method for family planning and prevention of unintended pregnancy, reoccurring discussions on the benefit/risk profile of combined hormonal contraceptives among healthcare experts as well as in the public could lead to uncertainty for women regarding which method individually is the right one for them.   » more

2014-04-04

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

2014-04-02

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

2014-03-31

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

2014-03-31

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

2014-03-28

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

2014-03-13

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

2014-03-11

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

2014-03-11

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

2014-03-10

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

2014-03-05

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

2014-03-03

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

2014-02-28
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

2014-02-27

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

2014-02-20

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

2014-02-18

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

2014-02-17

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

2014-02-14

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

2014-02-14

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

2014-02-12

“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

2014-02-10

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

2014-02-04

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

2014-01-24

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

2014-01-23

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

2014-01-20

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

2014-01-17

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

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