News

06/17/2010
Bayer Schering Pharma and OncoMed Pharmaceuticals Enter Strategic Alliance to Develop Anti-Cancer Stem Cell Therapeutics
Collaboration Focuses on the Discovery and Development of Multiple Antibody, Protein and Small Molecule Agents Targeting the Wnt Pathway more

05/18/2010
Bayer Presents New Riociguat Phase II Data
First Phase II study in patients with pulmonary hypertension owing to interstitial lung disease meets primary objectives / First long-term extension data of Phase II study in chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension show sustained improvement in exercise capacity. more

05/17/2010
Bayer Schering Pharma Enhances U.S. Research Strategy with New Innovation Center
Bayer Schering Pharma AG, Germany, will establish a U.S. Innovation Center in San Francisco, Calif. with the goal to expand its global research network and build its specialty pharmaceutical pipeline. The model introduces a newly formed “Science Hub” for innovation sourcing in the U.S. creating collaborations with academic research scientists and small biotech firms to realize product development and commercialization of new therapies through partnerships with Bayer. more

05/05/2010
Bayer Schering Pharma and EndoCeutics Enter into a Global Agreement for the Development and Commercialization of Vaginorm
Bayer Schering Pharma AG, Germany, announced that it has signed a global exclusive cooperation agreement with the Canadian company EndoCeutics, Inc. for the development and commercialization of Vaginorm, an intra-vaginal application of dehydroepiandrosterone (DHEA). more

02/18/2010
VEGF Trap-Eye Shows Positive Results in Phase II Study in Patients with Diabetic Macular Edema
Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that VEGF Trap-Eye showed positive results in a Phase II study in patients with Diabetic Macular Edema (DME). The primary endpoint of the study, a statistically significant improvement in visual acuity over 24 weeks compared to the standard of care in DME, macular laser treatment, was met. more

12/10/2009
Clinical Programs with Riociguat in Pulmonary Hypertension Well on Track
A first Phase II trial with Bayer Schering Pharma’s oral agent riociguat (BAY 63-2521) in pulmonary hypertension owing to interstitial lung disease (PH-ILD) has successfully been completed. PH-ILD is a form of pulmonary hypertension for which no approved treatment options are currently available. The primary objectives of the study – to investigate safety and tolerability of riociguat in this subgroup of PH-patients – were achieved. more

11/30/2009
Bayer Starts Phase III Trial with Florbetaben
Bayer Schering Pharma AG, Germany, is progressing with the development of florbetaben to support Alzheimer diagnosis. On the occasion of the 95th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), the company announced the enrollment of first patients in an international clinical Phase III trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid deposition in the brain. more

10/30/2009
Bayer and Onyx Initiate Phase III Trial of Nexavar® in Patients with Non-Responsive Thyroid Cancer
Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that the companies have begun enrolling patients in an international Phase III trial to evaluate Nexavar® (sorafenib) tablets for the treatment of patients with radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer. This Phase III trial was started based on the results from Phase II clinical trials evaluating Nexavar in patients with advanced thyroid cancer. more

10/08/2009
Bayer Schering Pharma collaborates with AC Immune in the field of Alzheimer´s disease
Bayer Schering Pharma AG, Germany, will provide its development candidate florbetaben, a so called PET (positron emission tomography) tracer, to the Swiss-based biopharmaceutical company AC Immune SA, to support a clinical trial in the field of Alzheimer´s disease (AD). This study is conducted to develop a therapy option for the treatment of AD. Bayer´s novel PET tracer florbetaben will be applied for imaging of beta-Amyloid deposition in the brain of patients undergoing the phase I clinical testing of AC Immune´s Alzheimer´s vaccine ACI-24. In this collaboration, florbetaben will be tested for the very first time in the development of a potential therapeutic for Alzheimer’s patients. more

09/30/2009
Results Reported for Exploratory Phase II Trial of Nexavar in Combination with Chemotherapeutic Agent Paclitaxel for Treatment of Advanced Breast Can
Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced results from a randomized, placebo-controlled Phase II trial sponsored by Northwestern University. The study, which evaluated Nexavar® (sorafenib) tablets in combination with the chemotherapeutic agent paclitaxel in patients with locally advanced or metastatic HER-2 negative breast cancer, demonstrated a positive trend towards improvement of progression-free survival in the treatment group (p-value=0.09). more

09/23/2009
Nexavar® in Combination with Chemotherapy Demonstrates 74 Percent Improvement in Progression-Free Survival
Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced the full results from their first collaborative group-sponsored randomized, double-blind, placebo controlled Phase II trial showing that Nexavar® (sorafenib tablets) in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression-free survival in patients with advanced breast cancer by 74 percent. The data were presented at the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress in Berlin, Germany. more

09/17/2009
Bayer Announces New Data on Oncology Portfolio To Be Presented at the ECCO-ESMO Congress 2009
Bayer Schering Pharma today announced that data from more than 30 clinical trials evaluating three products in the company’s oncology portfolio – Nexavar® (sorafenib) tablets, regorafenib (BAY 73-4506) and Alpharadin™ – will be presented at the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress, September 20-24, 2009 in Berlin, Germany. more

09/03/2009
Bayer and Algeta Enter Global Agreement for Development and Commercialization of Treatment for Bone Metastases in Cancer Patients
Bayer Schering Pharma AG, Germany has entered into a global agreement with Algeta ASA, Oslo, Norway for the development and commercialization of Alpharadin™, a novel alpha-emitting radiopharmaceutical, based on radium-223. Alpharadin is currently being evaluated in a global Phase III trial for the treatment of bone metastases in symptomatic hormone-refractory prostate cancer (HRPC) patients. more

08/30/2009
Bayer Completes Enrollment into Major Phase III Study with Rivaroxaban (ROCKET AF)
ROCKET AF study compares rivaroxaban to warfarin in the prevention of stroke and non-CNS systemic embolism in patients with Atrial Fibrillation / Bayer Schering Pharma supports Thrombosis Research Institute’s launch of GARFIELD – a global patient Registry to evaluate ‘real life’ outcomes in the prevention of stroke in patients with Atrial Fibrillation / Fast Track designation for rivaroxaban development program in the secondary prevention of cardiovascular events in patients with Acute Coronary Syndrome recognizes high unmet medical need. more

07/22/2009
Nexavar® in Combination with Chemotherapy Shown To Extend Progression-Free Survival in Patients with Advanced Breast Cancer
Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that their first cooperative group-sponsored randomized Phase II trial in advanced metastatic breast cancer met its primary endpoint of progression-free survival. The study evaluated Nexavar® (sorafenib) tablets in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer. more

07/14/2009
Update on Status of Rivaroxaban Complete Response Letter From U.S. FDA
Bayer Schering Pharma AG, Germany, announced today that its partner, Ortho-McNeil, does not expect to submit its complete response to the U.S. Food and Drug Administration (FDA) until the fourth quarter of this year, at the earliest. more

07/13/2009
International Conference on Alzheimer's Disease (ICAD): Bayer presents positive Phase II data with florbetaben
Bayer Schering Pharma AG, Germany, has presented positive data on a global Phase II study with the novel positron emission tomography (PET) tracer florbetaben (BAY 94-9172) at the International Conference on Alzheimer's Disease (ICAD) in Vienna, Austria. This study showed that patients with a clinical diagnosis of Alzheimer´s disease could be differentiated from agematched healthy volunteers (HVs) on the basis of florbetaben uptake pattern in the brain. more

06/29/2009
Bayer Schering Pharma Extends Research Portfolio in the Field of Cancer-Related Targets
Bayer Schering Pharma AG, Germany, has entered into an exclusive license agreement with Celera Corporation, California, USA, providing Bayer Schering Pharma with access to five cancer-related targets for therapeutic development and in-vivo diagnostic imaging. These therapeutic targets were identified by Celera's proteomics discovery platform. more

06/12/2009
Bayer completes Phase II Study on BAY 94-9172 in Alzheimer’s Disease Imaging
Bayer Schering Pharma AG, Germany, has completed its first global Phase II study analyzing the sensitivity and specificity of BAY 94-9172 (AV1/ZK) using positron emission tomography (PET) in patients with probable Alzheimer’s disease compared to healthy volunteers. BAY 94-9172 binds to the beta amyloid protein in the brain, a pathological hallmark of Alzheimer’s disease. The data is being analyzed and results will be presented at this years International Conference on Alzheimer's Disease (ICAD) in Vienna. more

06/02/2009
Bayer HealthCare and Genzyme Finalize Strategic Alliance Agreement
Bayer HealthCare and Genzyme Corporation said today that they have received regulatory approvals for the strategic alliance announced on March 31, 2009. With these approvals, the legal closing of the transaction was completed on May 29, 2009. more

06/01/2009
Bayer and Onyx Initiate Phase III Trial of Nexavar® in Non-small Cell Lung Cancer
Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that the companies have begun enrolling patients in an international Phase III trial to evaluate Nexavar® (sorafenib) tablets in patients with non-squamous non-small cell lung cancer (NSCLC) who have failed two or three previous treatments. more

05/30/2009
Bayer Schering Pharma Announces New Data on Novel Anti-cancer Compound BAY 73-4506
Bayer Schering Pharma AG today announced results from Phase I and II trials of BAY 73-4506, a potent oral multi-kinase inhibitor currently being studied in multiple tumor types. These data were presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO). more

05/28/2009
U.S. FDA Issues Complete Response Letter for Rivaroxaban
The U.S. Food and Drug Administration (FDA) has issued a complete response letter for the new drug application (NDA) for Bayer’s rivaroxaban, a novel, oral anticoagulant taken as one tablet, once-daily. The NDA, filed in July 2008 by Bayer’s development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD), seeks approval to market rivaroxaban, a first-in-class direct Factor Xa inhibitor, in the United States for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery. more

05/28/2009
Phase III Trial Started to Evaluate Combination Therapy of Nexavar® and Tarceva® in Patients with Liver Cancer
Bayer HealthCare AG, Onyx Pharmaceuticals, Inc., OSI Pharmaceuticals, Inc. and Roche today announced the initiation of a Phase III trial examining Nexavar® (sorafenib) tablets in combination with Tarceva® (erlotinib) tablets as a potential new treatment option for patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer. more

05/19/2009
Bayer Schering Pharma presents positive results of phase II study with Riociguat
Positive data from a phase II trial with Bayer Schering Pharma’s oral agent riociguat (BAY 63-2521) in chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) were presented today at the American Thoracic Society (ATS) international conference in San Diego, USA. Riociguat is the first member of a new class of vasodilating agents called soluble guanylate cyclase (sGC) stimulators and is being investigated as a new approach for the treatment of different forms of pulmonary hypertension (PH). more

05/15/2009
Bayer and Onyx Announce Nexavar® Data Presentations at 45th American Society of Clinical Oncology (ASCO) Annual Meeting
Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that more than 65 studies evaluating the use of Nexavar® (sorafenib) tablets will be presented at the 2009 American Society of Clinical Oncology (ASCO) annual meeting. more

05/05/2009
Bayer Schering Pharma is starting Phase III studies with an innovative low-dose contraceptive patch
Bayer Schering Pharma AG, Germany is starting Phase III with an innovative patch for female contraception that combines low dosed ethinylestradiol and gestodene. Approximately 3300 women will be enrolled into two global studies to evaluate the contraceptive reliability of the patch starting in May 2009. It is planned to submit the new patch for registration worldwide. First filing is expected in 2012. more

04/30/2009
Bayer and Regeneron extend development program for VEGF Trap-Eye
Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. today announced that the companies will extend their development program for VEGF Trap-Eye, an investigational new substance for the treatment of certain eye diseases, to include Central Retinal Vein Occlusion (CRVO). The companies plan to initiate a Phase III program evaluating the efficacy and safety of VEGF Trap-Eye in the treatment of this disease in the second half of this year. more

04/28/2009
Bayer and Ardea Biosciences Enter Global Agreement Focused on the Development of MEK Inhibitors for the Treatment of Cancer
Bayer HealthCare AG, Germany has entered into a global agreement with Ardea Biosciences, Inc., San Diego California, USA (Nasdaq: RDEA) focused on the development of small molecule mitogen-activated ERK kinase (MEK) inhibitors for the treatment of solid tumors. These kinases are believed to play an important role in cancer cell proliferation, apoptosis and metastasis, as well as inflammation. more

04/27/2009
Phase III Trial of Nexavar® in Chemotherapy-Naive Patients with Advanced Melanoma Does Not Meet Primary Endpoint
Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that a Phase III trial evaluating Nexavar® (sorafenib) tablets in patients with unresectable stage III or stage IV melanoma was stopped early following a planned interim analysis by an independent Data Monitoring Committee (DMC). The trial was sponsored by the National Cancer Institute and led by the Eastern Cooperative Oncology Group (ECOG) under a Clinical Trials Agreement between NCI and Bayer and Onyx. more

03/18/2009
Bayer and Tsinghua University (Institute of Biomedicine) establish joint research center in China
Bayer HealthCare AG, Germany, and Tsinghua University in Beijing, China have signed a comprehensive collaboration agreement to enter into a strategic partnership. The two partners will establish a joint research center at Tsinghua University, the Bayer-Tsinghua (Institute of Biomedicine) Research Center of Innovative Drug Discovery. more

02/12/2009
Bayer Schering Pharma to invest 100 million Euro in China to build a global R&D center
Bayer Schering Pharma AG, the pharmaceutical division of Bayer HealthCare (BHC), announced today that it will be strengthening its global Research and Development (R&D) capabillities through the foundation of a global R&D center in Beijing, China. The company will invest some 100 million Euro over the next five years to establish the center. With the establishment of the R&D center in China, especially Asian patients will benefit from considering their clinical profile and medical needs early-on. more

02/09/2009
Bayer Schering Pharma Starts Phase III Program of New Drug Against Pulmonary Hypertension
Based on the positive findings from the clinical development phase II trial, Bayer Schering Pharma has begun a phase III program with its oral agent riociguat. Two phase III trials will investigate the application in patients with both chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH). Riociguat is the first member of a new class of therapeutics stimulating the enzyme soluble guanylate cyclase (sGC). Riociguat showed promising phase II results by significantly improving exercise capacity and hemodynamic parameters, such as pulmonary vascular resistance, cardiac output and pulmonary arterial pressure, compared to baseline values. more

01/12/2009
Exclusive licensing option for solid tumor antibody
Bayer Schering Pharma AG, Germany, has acquired an exclusive option for a collaboration and licensing agreement with Micromet, Inc., a biopharmaceutical company developing antibodies for the treatment of cancer, inflammation and autoimmune diseases. Bayer Schering Pharma will pay Micromet a 4.5 million Euro fee to secure a one-year option on a specific BiTE antibody. more

01/08/2009
Bayer Schering Pharma enhances research in cancer imaging
Bayer Schering Pharma AG and Hamamatsu Photonics K.K., Japan have signed a licensing agreement for the use of novel substances in the field of molecular imaging for cancer. Within the agreement, Bayer Schering Pharma acquires the worldwide exclusive rights for research, development and commercialization of a group of molecules that specifically bind to malignant tumor cells. In combination with positron emission tomography (PET), these tracers could potentially improve the diagnosis of a variety of cancers. more

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