Regorafenib to be tested in brain cancer patients in multi-arm cooperation trial (for specialized target groups only)
GBM AGILE, an international platform trial sponsored by the Global Coalition for Adaptive Research (GCAR) to evaluate multiple therapies for patients with newly diagnosed and recurrent glioblastoma, is now open for enrollment in the US with regorafenib as the first treatment arm / Results from the Phase II REGOMA study (Lombardi G et al, Lancet Oncol, 2018) support further evaluation of regorafenib in patients with newly diagnosed and recurrent glioblastoma, the most aggressive form of brain cancer / Medical need remains high in glioblastoma as treatment options are limited and patient outcomes have remained largely unchan...
Source: Bayer Company News - June 19, 2019 Category: Pharmaceuticals Source Type: news

Bayer raises the bar in transparency, sustainability and engagement
With its solutions, the company aims to reduce environmental impact by 30 percent / Approximately 5 billion euros will be invested in additional methods to combat weeds over the next decade / Invitation to scientists, journalists and NGO representatives to participate in the scientific preparation for the upcoming EU glyphosate re-registration process / Crop protection products will only be sold in developing countries if they meet the standards of a majority of leading regulators on top of local regulations (Source: Bayer Company News)
Source: Bayer Company News - June 14, 2019 Category: Pharmaceuticals Source Type: news

New data on larotrectinib efficacy in patients with TRK fusion cancer and primary CNS tumors or brain metastases presented at ASCO 2019 (for specialized target groups only)
In five TRK fusion cancer patients with brain metastases across different tumor histologies, the overall response rate was 60%, with disease control achieved in all patients / In 14 adult and pediatric patients with TRK fusion cancer with primary central nervous system (CNS) tumors (including high grade gliomas), the overall response rate was 36% including two complete responses / 71% of evaluable patients with primary CNS tumors experienced disease control for 24 weeks or more / First prospective analysis of the activity of larotrectinib in patients with TRK fusion cancer and intracranial disease, including first data eve...
Source: Bayer Company News - June 3, 2019 Category: Pharmaceuticals Source Type: news

New data for larotrectinib show overall response rates of 94% in children and 76% in adults with TRK fusion cancer; clinical benefit demonstrated in patients with primary central nervous system tumors and brain metastases (for specialized target groups only)
In children with TRK fusion cancer (n=34), the overall response rate (ORR) was 94% and durable, with median duration of response (DOR) not reached / In adults with TRK fusion cancer (n=74), the ORR was 76% and durable, with median DOR not reached / In evaluable patients with brain metastases (n=5), ORR was 60% / Improvements in quality of life were shown with larotrectinib treatment in both children and adults / Majority of adverse events were grade 1 or 2, as reported in prior publications (Source: Bayer Company News)
Source: Bayer Company News - May 15, 2019 Category: Pharmaceuticals Source Type: news

Beiersdorf to acquire iconic Coppertone & #8482; brand from Bayer
Significant expansion of portfolio will advance Beiersdorf’s leading position as sun care expert / Beiersdorf delivers first major acquisition under its new C.A.R.E.+ strategy / Divestiture enables Bayer to focus on core OTC business (Source: Bayer Company News)
Source: Bayer Company News - May 13, 2019 Category: Pharmaceuticals Source Type: news

Bayer to present new data at ASCO 2019 highlighting commitment to evolve cancer treatment paradigm (for specialized target groups only)
Data from Bayer’s growing oncology portfolio include new analyses on the company’s precision oncology treatment larotrectinib, with two oral presentations in patients with solid tumors that harbor an NTRK gene fusion: one on expanded data in pediatric patients and the other one in patients with brain metastases or primary central nervous system tumors / First detailed presentation of quality of life data from the Phase III ARAMIS trial of the investigational androgen receptor antagonist darolutamide in patients with non-metastatic castration-resistant prostate cancer / Oral presentation on investigational ATR i...
Source: Bayer Company News - May 13, 2019 Category: Pharmaceuticals Source Type: news

Bayer commissions external law firm to investigate Monsanto's stakeholder mapping project and reaffirms its commitment to transparency and fair dealings with all stakeholders
(Source: Bayer Company News)
Source: Bayer Company News - May 12, 2019 Category: Pharmaceuticals Source Type: news

U.S. FDA accepts new drug application and grants priority review for darolutamide (for specialized target groups only)
(Source: Bayer Company News)
Source: Bayer Company News - April 29, 2019 Category: Pharmaceuticals Source Type: news

Bayer & #8217;s Supervisory Board unanimously stands behind Board of Management
(Source: Bayer Company News)
Source: Bayer Company News - April 27, 2019 Category: Pharmaceuticals Source Type: news

& #8220;We made great progress & #8211; both operationally and strategically & #8221;
Bayer now the leader in agriculture / Lawsuits and first verdicts concerning glyphosate weigh on company / Sales and earnings increased in 2018 / Proposed dividend of 2.80 euros marks record payout by Bayer / Successful start to fiscal 2019– outlook confirmed (Source: Bayer Company News)
Source: Bayer Company News - April 26, 2019 Category: Pharmaceuticals Source Type: news

Bayer: strong operational start to the year
Group sales increase 4.1 percent (Fx& portfolio adj.) to 13.015 billion euros / EBITDA before special items advances by 44.6 percent to 4.188 billion euros / Crop Science posts substantial sales and earnings gains following the acquisition / Pharmaceuticals shows encouraging sales and earnings growth / Consumer Health below the prior-year quarter, full-year outlook confirmed / Net income declines as expected by 36.5 percent to 1.241 billion euros, held back by special items related to the acquisition and restructuring / Core earnings per share increase 13.8 percent to 2.55 euros / Business outlook for 2019 confirmed (S...
Source: Bayer Company News - April 25, 2019 Category: Pharmaceuticals Source Type: news

More than 100 Bayer-owned glyphosate safety study reports accessible as Monsanto integration continues
(Source: Bayer Company News)
Source: Bayer Company News - April 8, 2019 Category: Pharmaceuticals Source Type: news

Bayer submits European marketing authorization application for darolutamide (for specialized target groups only)
Third submission for darolutamide in two weeks underscores Bayer’s commitment to fill an unmet need for men with nmCRPC worldwide / Regulatory submission based on positive data from Phase III study ARAMIS (Source: Bayer Company News)
Source: Bayer Company News - March 8, 2019 Category: Pharmaceuticals Source Type: news

Bayer submits darolutamide for marketing authorization in Japan (for specialized target groups only)
Regulatory submission based on positive data from Phase III ARAMIS study (Source: Bayer Company News)
Source: Bayer Company News - March 5, 2019 Category: Pharmaceuticals Source Type: news

Bayer increases sales and earnings & #8211; leader in agriculture after acquisition
Group sales advance 4.5 percent (Fx& portfolio adj.) to 39.586 billion euros / EBITDA before special items increases by 2.8 percent to 9.547 billion euros, held back by currency effects of 457 million euros / Pharmaceuticals posts higher sales (Fx& portfolio adj.) and slightly lower earnings / Consumer Health: sales level with prior year (Fx& portfolio adj.), earnings decline / Crop Science reports sales gains, substantially higher earnings due to the acquisition, integration off to a strong start / Positive safety profile of glyphosate unchanged– Bayer vigorously defending itself against lawsuits/ Net in...
Source: Bayer Company News - February 27, 2019 Category: Pharmaceuticals Source Type: news

Bayer completes rolling submission for darolutamide in U.S. (for specialized target groups only)
(Source: Bayer Company News)
Source: Bayer Company News - February 27, 2019 Category: Pharmaceuticals Source Type: news

Bayer proposes dividend for 2018 of 2.80 euros per share
Total dividend payment: record high of 2.611 billion euros (Source: Bayer Company News)
Source: Bayer Company News - February 26, 2019 Category: Pharmaceuticals Source Type: news

Bayer exercised option to obtain full licensing rights for larotrectinib and BAY 2731954 (LOXO-195) (for specialized target groups only)
Bayer exercised option under change-in-control clause in it’s agreement with Loxo Oncology to obtain full licensing rights for the two TRK inhibitor agents / Bayer to be solely responsible for the global development and commercialization of both larotrectinib and BAY 2731954 (LOXO-195) / Co-Promotion in the U.S. to be converted into exclusive commercialization by Bayer / Larotrectinib was approved in November 2018 in the U.S. under the brand name VITRAKVI ® as the first TRK inhibitor for patients with advanced solid tumors harboring an NTRK gene fusion; filings in Europe and other regions underway (Source: Bayer Company News)
Source: Bayer Company News - February 15, 2019 Category: Pharmaceuticals Source Type: news

Bayer & #8217;s darolutamide plus androgen deprivation therapy (ADT) significantly extends metastasis-free survival with a favorable safety profile compared to placebo plus ADT in non-metastatic castration-resistant prostate cancer (for specialized target groups only)
Statistically significant improvement in metastasis-free survival (MFS), with a median MFS of 40.4 months with darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT (18.4 months) / Positive trend in overall survival with a 29% reduction in risk of death at interim analysis (P=0.045) / Incidence of treatment-emergent adverse events was similar for darolutamide plus ADT and placebo plus ADT / Health-related quality of life was maintained / First results from the Phase III ARAMIS trial with the androgen receptor antagonist darolutamide were presented in an oral presentation at American Society of Clinic...
Source: Bayer Company News - February 14, 2019 Category: Pharmaceuticals Source Type: news

Bayer expands digital innovation pipeline at The Climate Corporation to bring breakthrough digital tools to more farmers
(Source: Bayer Company News)
Source: Bayer Company News - January 8, 2019 Category: Pharmaceuticals Source Type: news

Bayer to drive value creation as company pursues ambitious growth targets through 2022
Company strongly positioned to benefit from key megatrends / Through 2022, Bayer aims to grow sales by 4 percent, EBITDA before special items by 9 percent and free cash flow by 18 percent annually on average / Adjusted EBITDA margin targets for 2022: Crop Science to exceed 30 percent, Pharmaceuticals to hit more than 35 percent, and Consumer Health to reach approximately 24 percent (Source: Bayer Company News)
Source: Bayer Company News - December 5, 2018 Category: Pharmaceuticals Source Type: news

FDA grants breakthrough device designation to artificial intelligence software for CTEPH pattern recognition from Bayer and MSD
The software in development intends to support clinical decision-making of chronic thromboembolic pulmonary hypertension– a progressive and life-threatening condition (Source: Bayer Company News)
Source: Bayer Company News - December 3, 2018 Category: Pharmaceuticals Source Type: news

Bayer to strengthen core life science businesses while significantly enhancing productivity and profitability
Group plans to exit Animal Health business, the Consumer Health brands Coppertone™ and Dr. Scholl’s™, and sell its 60-percent interest in Currenta, a site services provider in Germany / Efficiency and structural measures set to enhance competitiveness and generate annual contributions of 2.6 billion euros as of 2022 including the expected synergies from the Monsanto acquisition / A portion of the contributions to be reinvested in core businesses / Total one-time costs expected at a factor of 1.7 times annual contributions / Core earnings per share expected to increase by around 1 euro to 6.80 euros in 201...
Source: Bayer Company News - November 29, 2018 Category: Pharmaceuticals Source Type: news

Bayer receives EU approval for its hemophilia A treatment Jivi ® (for specialized target groups only)
The safety and efficacy profile of Jivi has been demonstrated in more than five years of clinical studies / Prophylaxis with Jivi enables sustained factor VIII concentrations in the blood over time (Source: Bayer Company News)
Source: Bayer Company News - November 27, 2018 Category: Pharmaceuticals Source Type: news

U.S. FDA approves Larotrectinib, the first TRK inhibitor, for patients with advanced solid tumors harboring an NTRK gene fusion (for specialized target groups only)
First treatment with a tumor-agnostic indication at the time of initial FDA approval / Larotrectinib approved under the brand name Vitrakvi ® / 75% overall response rate (ORR) (95% CI, 61%, 85%) [22% complete response (CR) and 53% partial response (PR)] across various solid tumors in adults and children / Adverse events (AEs) of any grade observed in more than 20 percent of patients, regardless of attribution, included increased ALT (4 5%), increased AST (45%), anemia (42%), fatigue (37%), nausea (29%), dizziness (28%), cough (26%), vomiting (26%), constipation (23%), and diarrhea (22%) (Source: Bayer Company News)
Source: Bayer Company News - November 27, 2018 Category: Pharmaceuticals Source Type: news

Bayer: Good performance in a challenging environment, Group outlook confirmed
Group sales increase by 1.9 percent (Fx& portfolio adj.) to 9.905 billion euros / EBITDA before special items level year on year at 2.202 billion euros / Business performance at Pharmaceuticals remains strong / Consumer Health with increase in sales (Fx& portfolio adj.), while currency effects weigh on earnings / Crop Science posts substantial rise in sales and earnings due to acquisition– successful start to integration process / Sales and earnings of Animal Health decline following a strong second quarter / One-time gain (before taxes) of roughly 3.9 billion euros from divestments / Net income 2.886 billion...
Source: Bayer Company News - November 13, 2018 Category: Pharmaceuticals Source Type: news

Phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer meets primary endpoint (for specialized target groups only)
The safety and tolerability observed in the trial were consistent with previously published data on darolutamide (Source: Bayer Company News)
Source: Bayer Company News - October 24, 2018 Category: Pharmaceuticals Source Type: news

Expanded larotrectinib data confirm findings on efficacy and safety in adult and pediatric patients with TRK fusion cancer across various tumor types (for specialized target groups only)
Data presented across 122 adult and pediatric patients (55 patients from primary dataset plus supplementary dataset with 67 additional patients) with TRK fusion cancer across various tumor types / Integrated dataset on larotrectinib demonstrated high overall response rate of 81 percent (63 percent partial responses and 17 percent complete responses), per investigator assessment / For the initial 55 patients, ongoing responses at 12 months improved to 75 percent with longer follow-up; ongoing responses in the supplementary dataset were 81 percent at 12 months; median duration of response not reached at a respective follow-u...
Source: Bayer Company News - October 21, 2018 Category: Pharmaceuticals Source Type: news

U.S. FDA approves Bayer & #8217;s Xarelto ® for patients with coronary or peripheral artery disease (for specialized target groups only)
Xarelto, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease / Xarelto, in combination with aspirin, is the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated for this patient group / Approval in the U.S. follows regulatory clearance in both Europe and Canada (Source: Bayer Company News)
Source: Bayer Company News - October 12, 2018 Category: Pharmaceuticals Source Type: news

Bayer receives positive CHMP opinion for its hemophilia A treatment BAY94-9027 (for specialized target groups only)
The safety and efficacy profile of BAY94-9027 has been demonstrated in more than five years of clinical studies / Prophylaxis with BAY94-9027 enables sustained factor VIII concentrations in the blood over time (Source: Bayer Company News)
Source: Bayer Company News - September 21, 2018 Category: Pharmaceuticals Source Type: news

Bayer & #8217;s Jivi ® approved in Japan for hemophilia A (for specialized target groups only)
(Source: Bayer Company News)
Source: Bayer Company News - September 21, 2018 Category: Pharmaceuticals Source Type: news

Stefan Oelrich to join Bayer Board of Management and head Pharmaceuticals Division
Dieter Weinand leaving the company as of November 1, 2018 / Contract extensions for Board of Management members Liam Condon and Dr. Hartmut Klusik (Source: Bayer Company News)
Source: Bayer Company News - September 13, 2018 Category: Pharmaceuticals Source Type: news

Bayer completes biggest acquisition in its history
Monsanto business included on prorated basis from June 7 / Group sales advance by 8.5 percent (Fx& portfolio adj.) to 9.481 billion euros / EBITDA before special items increases by 3.9 percent to 2.335 billion euros despite unfavorable currency effects / Pharmaceuticals registers higher sales (Fx& portfolio adj.) but lower earnings– substantial increase in R&D investment / Consumer Health business weak again / Crop Science achieves strong increase in sales and earnings after weak prior-year quarter / Animal Health improves sales (Fx& portfolio adj.) and earnings / Net income amounts to 799 million eur...
Source: Bayer Company News - September 5, 2018 Category: Pharmaceuticals Source Type: news

Brazilian court rules that growers will continue to have access to glyphosate
(Source: Bayer Company News)
Source: Bayer Company News - September 3, 2018 Category: Pharmaceuticals Source Type: news

Bayer receives US approval for modern hemophilia A treatment Jivi ® with a step-wise prophylaxis dosing regimen (for specialized target groups only)
Jivi’s extended half-life allows for twice-weekly initial dosing / May be adjusted to every five days and further individually adjusted to less or more frequent dosing (Source: Bayer Company News)
Source: Bayer Company News - August 30, 2018 Category: Pharmaceuticals Source Type: news

Bayer submits European marketing authorization application for larotrectinib for the treatment of TRK fusion cancer (for specialized target groups only)
(Source: Bayer Company News)
Source: Bayer Company News - August 27, 2018 Category: Pharmaceuticals Source Type: news

Bayer secures approval in the EU for Xarelto ® (rivaroxaban) for patients with coronary or peripheral artery disease (for specialized target groups only)
Xarelto is the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated in combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in patients with coronary artery disease or symptomatic peripheral artery disease at high risk for ischemic events / Launch first expected in Germany (Source: Bayer Company News)
Source: Bayer Company News - August 24, 2018 Category: Pharmaceuticals Source Type: news