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BAYER AG

1. LL 13 augustus 2021 13:58

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   Fears Nachawati Law Firm: Chorus Grows for Bayer CEO's Resignation as Juries Return Verdicts in Roundup Cancer Cases
   
   Victims call on Werner Baumann to step down over handling of claims against dangerous herbicide
   
   SAN FRANCISCO, Aug. 10, 2021 /PRNewswire/ -- Cancer victims are calling for Bayer AG CEO Werner Baumann to step down for his failed leadership amid multimillion-dollar jury verdicts against company subsidiary Monsanto for its Roundup weed killer.
   
   On Monday, a California appellate court affirmed an $87 million award for a couple diagnosed with non-Hodgkins lymphoma after exposure to the herbicide. Jurors in a 2019 trial awarded plaintiffs Alberta and Alva Pilliod $2 billion in punitive damages, finding that Roundup was likely a significant cause of their lymphoma. Alameda Superior Court Judge Winifred Smith later reduced the punitive damages to $87 million but called Bayer's efforts to impede scientific inquiry into the dangers of the chemical glyphosate in the weed killer "reprehensible."
   
   To date, three bellwether jury trials have produced multimillion-dollar verdicts against Bayer AG (OTCMKTS: BAYRY) subsidiary Monsanto, finding that Roundup exposure is linked to cancer. All three verdicts have now been affirmed on appeal. Also in May, U.S. District Court Judge Vince Chhabria, who is overseeing the Roundup multidistrict litigation (MDL), rejected terms of a proposed settlement and ordered the parties to return to negotiations.
   
   Bayer's mounting courtroom losses and inability to reach a fair resolution with cancer victims is a massive failure of leadership within the pharmaceutical giant, said trial lawyer Majed Nachawati, co-founder of Dallas-based Fears Nachawati Law Firm.
   
   "Three juries and three appellate courts have considered Bayer's claims and seen the scientific evidence," said Mr. Nachawati, whose firm represents thousands of individuals who developed cancer after exposure to Roundup. "Bayer continues to hide behind its corporate legal armies—it is time for Werner Baumann to show some leadership on this or step aside."
   
   The case is Pilliod et al. v. Monsanto Co., case number A158228, in the Court of Appeal of the State of California, First Appellate District.
   
   Fears Nachawati Law Firm represents individuals in mass-tort litigation, businesses and governmental entities in contingent litigation, and individual victims in complex personal injury litigation. The largest and most diverse products liability law firm in the nation, Fears Nachawati was ranked No. 1 nationally in products liability filings in federal court over the past three years. For more information visit www.fnlawfirm.com.
   
   Media Contact:
   Robert Tharp
   214-458-4007
   Robert@androvett.com
   
   
2. LL 17 augustus 2021 16:06

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   Bayer: to present detailed data from several studies
   
   (CercleFinance.com) - Bayer today announced that new cardiovascular data from its approved and investigational therapies will be presented in detail at the ESC 2021 congress at the end of the month (from 27 to 30 August).
   
   This will include detailed results from the Phase III efficacy and safety study of finerenone. This investigational drug, in combination with standard therapy, has been evaluated in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) and showed efficacy compared to placebo.
   
   In addition, new data on rivaroxaban (Xarelto) will also be presented, demonstrating Bayer's ongoing commitment to improving the lives of patients with kidney and cardiovascular disease, the company said.
3. LL 17 augustus 2021 16:07

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   Bayer: files petition in Roundup case
   
   (CercleFinance.com) - Through its subsidiary Monsanto, Bayer announced late on Monday that it has filed a motion for a writ of certiorari (i.e. an application for judicial review) with the United States Supreme Court, in connection with of the case between it and Edwin Hardeman, the only Roundup federal product liability case to have gone to trial.
   
   Monsanto urges the court to reconsider the Court of Appeal's decision by raising two arguments around the allegations of non-warning of the law by deeming that expert testimony deviated from federal standards.
   
   The company maintains 'consistent regulatory assessments in the U.S. and worldwide, and the overwhelming weight of scientific evidence, support the conclusion that glyphosate-based herbicides are safe and not carcinogenic.'
   
   In this situation, Bayer says that it has made additional provisions in Q2 2021 to take into account the future risks of litigation in the event of an unfavorable outcome to its claim. In the event of an unfavorable outcome the company says that it will implement a claims process to resolve claims over the next 15 years.
4. Shlomo 18 augustus 2021 11:31

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   Ik blijf positief over de afloop van de roundup-case.
   
   Bayer kondigt indiening van petitie aan bij het Amerikaanse Hooggerechtshof voor herziening van hardeman-beslissing
   Bedrijf betoogt fouten op federale voorrang en deskundige bewijsnormen vereisen herziening van uitspraken / beslissing kan duizenden Roundup™-zaken en andere rechtszaken beïnvloeden
   Leverkusen, 16 augustus 2021 – Vandaag heeft Bayer – via zijn dochteronderneming Monsanto – zijn petitie voor een dagvaarding van Certiorari ingediend bij het Amerikaanse Hooggerechtshof in Hardeman, de enige Roundup™ federale productaansprakelijkheidszaak die voor de rechter is gekomen. Het verzoekschrift dringt er bij het Hof op aan om de beslissing van het Ninth Circuit Court of Appeals op twee gronden te herzien. Ten eerste zijn de staatsrechtelijke niet-waarschuwende claims in het centrum van de zaak voorrang door de federale wet, zoals de Amerikaanse regering betoogde in haar amicus-indiening in het Negende Circuit. Ten tweede wijkt de toelating van getuigenissen van deskundigen af van de federale normen, waardoor de getuigen van de oorzakeloze verklaring van de eiser niet-ondersteunde getuigenissen kunnen afleggen over de belangrijkste kwestie in de zaak, het veiligheidsprofiel van Roundup™.
   De petitie gaat in op het belang van deze fouten en het belang van toetsing door het Hooggerechtshof, met als argument: "De fouten van het Negende Circuit betekenen dat een bedrijf zwaar kan worden gestraft voor het op de markt brengen van een product zonder kankerwaarschuwing wanneer de bijna universele wetenschappelijke en regelgevende consensus is dat het product geen kanker veroorzaakt, en het verantwoordelijke federale agentschap een dergelijke waarschuwing heeft
   verboden." Omdat, legt de Petitie uit, deze zaak het eerste proces was voor de Roundup™ zaken geconsolideerd in de multidistrict-rechtszaak in Noord-Californië, "zal de onderstaande beslissing duizenden andere federale rechtszaken beheersen en ongetwijfeld nog andere beïnvloeden die in het hele land aanhangig zijn."
   De petitie onderstreept dat consistente regelgevingsbeoordelingen in de VS en wereldwijd, en het overweldigende gewicht aan wetenschappelijk bewijs, de conclusie ondersteunen dat herbiciden op basis van glyfosaat veilig zijn en niet kankerverwekkend.
   In het licht van de goedkeuring door de EPA van het Roundup™ label zonder een kankerwaarschuwing, zou elke staatswet die claims niet waarschuwt die op een dergelijke waarschuwing zijn gebaseerd, duidelijk in strijd zijn met de federale wetgeving en dus voorrang hebben. Rechtbanken in de VS hebben verdeeld over deze fundamentele vraag wanneer de federale wet voorrang heeft op de staatswetgeving, wat toetsing door het Amerikaanse Hooggerechtshof zowel belangrijk als noodzakelijk maakt. Het is inderdaad 16 jaar geleden dat het Hooggerechtshof uitspraak deed over fifra-voorrang, en de eerdere zaak bevatte geen waarschuwing die EPA had afgewezen. Eerder dit jaar kondigde Bayer een vijfpuntenplan aan om toekomstige procesrisico's als gevolg van de Roundup™-rechtszaak te beheren en op te lossen.
   
   Toetsing en omkering van de gebrekkige uitspraak van het Negende Circuit is een belangrijke factor in dit plan en zal waarschijnlijk bepalen of de rechtszaak grotendeels zal eindigen (als de rechtbank een gunstige beslissing neemt over een horizontale kwestie zoals federale voorrang) of het bedrijf een claimproces implementeert om claims in de komende 15 jaar op te lossen (in het geval van een ongunstige uitkomst). Bayer heeft in het tweede kwartaal van 2021 een aanvullende bepaling genomen om in geval van een ongunstige uitkomst redelijkerwijs rekening te houden met toekomstige blootstelling aan geschillen. Bayer verwacht dat het Hooggerechtshof in de komende zes maanden zal beslissen of het de zaak Hardeman zal herzien.
   
   Belangrijkste argumenten
   Over federale voorrang betoogt Bayer dat staatsrechtelijke niet-waarschuwende claims moeten worden afgezwaveld op grond van zowel uitdrukkelijke voorrang (omdat ze worden voorrang krijgen door een specifieke wettelijke bepaling) als conflictvooruitval (omdat de staatsrechtelijke claims noodzakelijkerwijs in strijd zijn met federale vereisten).
   
   Op uitdrukkelijke voorrang, betoogt de Petitie het Negende Circuit vergist door te oordelen dat de staatsrechtelijke claims niet "naast of verschillend" waren van de vereisten van FIFRA, hoewel ze in strijd waren met de consistente bevinding van de EPA dat glyfosaat geen kanker bij mensen
   veroorzaakt. Dit resultaat wordt gedwongen door het precedent van het Hooggerechtshof, dat de Petitie uitlegt, stelt dat "wanneer EPA bepaalt dat een pesticide vergezeld moet gaan van één waarschuwing (zoals 'CAUTION'), maar een jury volgens de staatswetgeving concludeert dat het etiket een agressiever label moet bevatten (zoals 'GEVAAR'), de staatswetgeving voorrang heeft." De lezing van het Negende Circuit van de "naast of verschillende" taal splitst zich ook met hoe andere rechtbanken soortgelijke voorrangsbepalingen in andere federale statuten hebben begrepen.
   Over conflictvoorkeur oordeelde het Negende Circuit ten onrechte dat er geen conflict was tussen de staatsrechtelijke claims en de vereisten van FIFRA, hoewel EPA het soort label dat vereist is door het oordeel van de staatsjury niet zou goedkeuren en hoewel Monsanto zijn label niet eenzijdig kan wijzigen zonder goedkeuring van het
   agentschap. Ook deze uitspraak is in strijd met het precedent van het Hooggerechtshof, dat stelt dat beide scenario's impliciete voorrang vaststellen. Bovendien zou de uitspraak van het Negende Circuit, als het op zijn plaats zou blijven, tot een zeer ongewenst resultaat leiden: staten zouden van pesticidenfabrikanten kunnen eisen dat ze waarschuwingen op hun etiketten opnemen, zelfs als epa fabrikanten uitdrukkelijk heeft geïnformeerd dat dit onwettig zou zijn.
   Met betrekking tot deskundig bewijs legt de petitie uit dat het Negende Circuit ten onrechte de toelating van deskundige getuigenissen heeft gezegend over de vraag of glyfosaat de kanker van de heer Hardeman heeft veroorzaakt, hoewel die getuigenis "berustte op weinig meer dan subjectieve intuïties."
   Dit resultaat is in strijd met federal rule of evidence 702 en precedenten van het Hooggerechtshof, die vereisen dat "rechtbanken 'een poortwachtersrol' spelen om ervoor te zorgen dat deskundigenadviezen betrouwbaar zijn ... [en] het product van "betrouwbare beginselen en methoden", "betrouwbaar toegepaste ... de feiten van de zaak.".
   De petitie stelt dat de milde standaard van het Negende Circuit "[bestaande wet] onherkenbaar heeft vervormd", en "de grenzen tussen wetenschap en speculatie vervaagt met een derde categorie genaamd 'kunst', of niet-ondersteunde intuïties die zogenaamd geworteld zijn in klinische
   ervaring. De brief stelt dat "hoeveel klinische ervaring een expert ook heeft, intuïtie zonder wetenschappelijke validatie niet 'het product is van betrouwbare principes en methoden'" " Het argument concludeert: "Door te eisen dat rechtbanken van rechtsgeleerden deskundige conclusies toelaten die gebaseerd zijn op klinische ervaring – zelfs wanneer goed wetenschappelijk bewijs die conclusies weerlegt – heeft het Negende Circuit de misvatting gecodificeerd dat wanneer wetenschappers spreken, hun opvattingen noodzakelijkerwijs geworteld zijn in betrouwbare wetenschappelijke principes."
5. LL 19 augustus 2021 15:39

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   Thursday - August 19, 2021
   Leaps by Bayer Leads USD 45 Million Financing in Sound Agriculture to Accelerate Sustainability Solutions for Food and Agriculture
   Sound’s Dual-Technology Platform Uses Biochemistry to Tap into the Natural Capabilities of the Plant to Increase the Speed and Efficiency of Agriculture
   
   Leverkusen, Germany and Emeryville, CA, August 19, 2021 – Sound Agriculture, a company that is tackling sustainability through groundbreaking advancements in both food and agriculture, announced today that it has secured a USD 45 million investment led by Leaps by Bayer, the impact investment arm of Bayer. Northpond Ventures, a leading science and technology-driven venture capital firm also participated in the round, along with existing investors Cavallo Ventures, Fall Line Capital, S2G Ventures, and Syngenta Group Ventures.
   
   Sound is advancing two novel technology platforms that leverage plant and soil biology to radically improve food production. The first is Sound’s on-demand breeding platform that offers a paradigm shift in breeding by accelerating plant trait development ten times faster than current technologies without the use of genetically modified organisms (GMOs). The second is a nutrient efficiency platform poised to replace 30% of global nitrogen fertilizer use – the equivalent of removing 200 million cars from the road, with patented technology that allows crops to access more nutrients from the existing microbiome.
   
   The financing will be used to scale both platforms in order to address critical issues in the food and agriculture industry, which is responsible for 25% of greenhouse gas emissions, and contributes to declining water quality and soil health. With the potential for global supply shocks due to climate change and rapidly changing consumer preferences, the need for a more adaptable and resilient food system has never been more evident.
   
   “We are focused on progressing breakthrough solutions that are grounded in biotech science to provide long-term answers to today’s food production challenges,” said Jürgen Eckhardt, Head of Leaps by Bayer. “Sound Agriculture is a true pioneer in the industry, bringing not one, but two never before seen platform technologies to market that have tremendous potential to innovate and advance sustainability in our food system.”
   
   On-Demand Breeding is the first breeding technology that uses epigenetics to enable natural plant differentiation more rapidly and economically than any other option. By targeting improvements in taste, nutrition, sustainability, and appearance, on-demand breeding enables a more agile food system. Using this approach in agriculture allows for more biodiversity with a reduced need for chemical inputs, a greater and more reliable supply of nutritious and affordable food, and access to bespoke products for consumers to encourage more consumption of fruits and vegetables. Whereas today it typically takes 7 to 10 years to bring new crops to market, Sound’s technology can cut that timeline in half.
   
   The company’s first product, SOURCE™, which sold out in 2020 and 2021, is a bio-inspired alternative to synthetic fertilizer for corn and soybeans, with more crops currently being trialed. By activating the existing soil microbiome, SOURCE gives plants access to more nitrogen and phosphorus, increasing corn yields an average of 7.5 bushels per acre and giving growers a reliable option to reduce nitrogen fertilizer application by up to 50 lbs per acre. While there are an increasing number of microbial solutions being introduced, SOURCE is the only solution that stimulates the microbes already in the soil. The data collected from trials and usage is providing insights that allow for precision application based on soil type through a tool called the Performance Optimizer, providing a sustainable environmental solution as well as a stronger return on investment for growers.
   
   “Northpond is committed to advancing environmental sciences and sustainability,” said Andrew Lee, Ph.D., Senior Associate at Northpond Ventures. “Sound Agriculture’s on-demand breeding and unique dual-technology platform represent an extensible approach to build a more sustainable, healthier food system.”
   
   “The backing of Leaps by Bayer and Northpond Ventures, in addition to our current list of investors, further validates the hard work and creative approach of our team to rethink the way we grow food and align it with the outcomes that our planet needs,” said Adam Litle, CEO of Sound Agriculture. “Given the speed of climate change, it’s critical to find reliable solutions like ours that have the ability to scale quickly.”
   
   About Bayer and Leaps by Bayer
   Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.
   
   Leaps by Bayer, a unit of Bayer AG, leads impact investments into solutions to some of today’s biggest challenges in health and agriculture. The investment portfolio includes more than 35 companies. They are all working on potentially breakthrough technologies to overcome some specific challenges such as, e.g. Provide sustainable organ & tissue replacement, reducing the environmental impact of agriculture, preventing or curing cancer, and others. For more information, go to leaps.bayer.com.
   
   About Sound Agriculture
   Sound Agriculture unlocks the natural power of plants to meet the demands for more diverse and nutritious food. Innovative, on-demand crop solutions allow agriculture to adapt faster to climate change and evolving consumer preferences, creating healthier food that is better for the planet. Products are designed to improve on-farm efficiency and create healthier, tastier, more sustainable food. SOURCE activates the microbiome to give crops access to more of the nitrogen and phosphorus that exists in the field, improving yield and reducing synthetic fertilizer by up to 50 lbs per acre. Learn more at www.sound.ag and follow @sound_ag on Twitter.
   
   Find more information at www.bayer.com.
   
   Forward-Looking Statements
   This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
   
   bron:
   media.bayer.com/baynews/baynews.nsf/i...
6. LL 24 augustus 2021 15:30

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   Tuesday - August 24, 2021
   Not intended for U.S. and UK Media
   U.S. FDA approves expansion of the peripheral artery disease (PAD) indication for Xarelto™ plus aspirin
   Patients after recent lower-extremity revascularization due to symptomatic PAD now included in the label in the US / Xarelto plus aspirin is the first treatment approach indicated in the US for both coronary artery disease (CAD) and PAD, now including patients post recent lower-extremity revascularization (LER) due to symptomatic PAD
   download
   Human blood cells
   
   Berlin, August 24, 2021 – The U.S. Food and Drug Administration (FDA) has approved an expansion of the peripheral artery disease (PAD) indication for the Xarelto™ (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD.
   
   “This FDA approval is an important advance for patients with PAD,” said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG's Pharmaceuticals Division and Chief Medical Officer at Bayer. “Xarelto is the only anticoagulant in more than 20 years to show a significant benefit in patients with PAD who remain at high risk for major thrombotic events post lower extremity revascularization. They are suffering from a disease which often goes undiagnosed and undertreated.”
   
   “These data provide a new mechanism of treatment using an evidenced-based strategy for this vulnerable population,” said Marc P. Bonaca, M.D., MPH, Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado. “The approval sets the stage to evolve the current standard of care for patients with PAD.”
   
   The approval by the FDA is based on data from the Phase 3 VOYAGER PAD trial. In the EU, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to include the data from the Phase 3 study in the label of Xarelto in July 2021. The treatment of patients with symptomatic PAD at high risk for ischemic events with Xarelto plus aspirin has already been approved in the EU based on the COMPASS study. The VOYAGER PAD study demonstrates a positive benefit-risk profile of starting Xarelto in patients with symptomatic PAD after recent lower-extremity revascularization and supports continued treatment.
   
   PAD is caused by atherosclerosis, a chronic progressive disease, which is characterized by a build-up of plaque in the arteries limiting blood flow to the limbs. It is a serious underlying health crisis that impacts an estimated 20 million Americans with only 8.5 million diagnosed. PAD increases the risk for major CV events and is the leading cause of amputation in the US which can double a patient’s risk of death.
   
   Xarelto plus aspirin is the first therapy in the US indicated to help reduce both the risks of major cardiovascular (CV) events (CV death, myocardial infarction, and stroke) in patients with coronary artery disease (CAD), and of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in patients with PAD, who have recently undergone LER due to symptomatic PAD.
   
   About the VOYAGER PAD study
   The Phase 3 VOYAGER PAD study included 6,564 patients from 542 sites across 34 countries worldwide. In the study, patients were randomized to receive either Xarelto 2.5 mg twice daily plus aspirin 100 mg once daily or aspirin 100 mg once daily alone. The primary efficacy endpoint was a composite of acute limb ischemia, major amputation of a vascular etiology, heart attack (myocardial infarction, MI), ischemic stroke or cardiovascular death. The primary safety outcome was major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) classification.
   
   About Rivaroxaban (Xarelto™)
   Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide and is marketed under the brand name Xarelto. Worldwide Xarelto is approved for more venous and arterial thromboembolic (VAT) conditions than any other NOAC:
   
   • The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors
   • The treatment of pulmonary embolism (PE) in adults
   • The treatment of deep vein thrombosis (DVT) in adults
   • The prevention of recurrent PE and/or DVT in adults
   • The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery
   • The prevention of VTE in adult patients undergoing elective knee replacement surgery
   • The prevention of atherothrombotic events after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine
   • The prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischaemic events when co-administered with acetylsalicylic acid (ASA)
   • Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment
   
   Xarelto is approved in more than 130 countries, although the approved labelling, including the number of indications may differ from country to country. Since launch in 2008, more than 86 million patients have been treated.
   
   Rivaroxaban was discovered by Bayer, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer and in the U.S. by Janssen Pharmaceuticals, Inc. (Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson).
   
   Anticoagulant medicines are therapies used to prevent or treat serious illnesses and potentially life-threatening conditions. Before initiating treatment with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.
   
   Responsible use of Xarelto is a very high priority for Bayer, and the company has developed a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practice.
   
   To learn more about thrombosis, please visit www.thrombosisadviser.com and www.vascularadviser.com
   
   To learn more about Xarelto, please visit www.xarelto.com
   
   About Bayer
   Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.
   
   Find more information at pharma.bayer.com
   Follow us on Facebook: www.facebook.com/bayer
   Follow us on Twitter: @BayerPharma
   
7. stockholder 26 augustus 2021 18:14

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   LL)
   dank voor jouw (vele) posts. Duimpie
8. LL 26 augustus 2021 20:06

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   quote:

   stockholder schreef op 26 augustus 2021 18:14:

   LL)
   dank voor jouw (vele) posts. Duimpie
   

   Graag gedaan! Hopelijk kunnen op termijn onze inleg verdubbelen :)
9. [verwijderd] 26 augustus 2021 20:23

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   Ik heb ook Bayer, ik ben wel een beetje geschrokken van enkele websites in de US waar advocaten iedereen oproept die schade heeft ondervonden van glyfosaat om zich aan te melden om Bayer aan te klagen.
   Zag er zeer professioneel uit en verwees naar allerlei informatie (oa studies) die destijds ook gedeeld was met Bayer en er behoorlijk betrouwbaar en ongunstig voor Bayer uitzag.
   Nu zegt dat niet alles en wellicht cherry picking, maar aangezien ze keer op keer door jury rechtspraak in het ongelijk zijn gesteld vraag ik me af of ze wel zo'n overtuigend verweer hebben. Als je het gelijk aan je zijde hebt maar een jury niet kan overtuigen mankeert er sowieso iets aan je juridische team.
10. Shlomo 27 augustus 2021 11:15

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    Bayer treft in mijn optiek geen enkele blaam. Het probleem is de Amerikaanse regelgeving zelf die de goedkeuring geeft tot het op de markt brengen van een bepaald product. En daar heeft Bayer (Montosanto) m.i. aan voldaan. Ik ben dan ook de mening toegedaan dat de consument zich moet wenden tot de Amerikaanse staats organen die deze goedkeuringen getoetst en goedgekeurd hebben.
11. [verwijderd] 27 augustus 2021 19:07

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    quote:

    Shlomo schreef op 27 augustus 2021 11:15:

    Bayer treft in mijn optiek geen enkele blaam. Het probleem is de Amerikaanse regelgeving zelf die de goedkeuring geeft tot het op de markt brengen van een bepaald product. En daar heeft Bayer (Montosanto) m.i. aan voldaan. Ik ben dan ook de mening toegedaan dat de consument zich moet wenden tot de Amerikaanse staats organen die deze goedkeuringen getoetst en goedgekeurd hebben.
    

    Klinkt als juridische trucjes, schuld afschuiven en geen verantwoording willen nemen (ik zeg niet dat het zo is, maar komt zo over)
    Ik heb zelf Bayer dus ik hoop dat je gelijk krijgt, maar ik heb er geen goed gevoel over.
    
    Vraag me ook af wat een worst case scenario doet met het bedrijf. Als het probleem met Montosanto overwaait is Bayer veel te laag gewaardeerd. Kan iedere zieke die ooit met Roundup heeft gewerkt echter miljoenen ophalen kan het hard gaan.
12. Shlomo 28 augustus 2021 10:11

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    quote:

    Brt_van_H schreef op 27 augustus 2021 19:07:

    [...]
    
    Klinkt als juridische trucjes, schuld afschuiven en geen verantwoording willen nemen (ik zeg niet dat het zo is, maar komt zo over)
    Ik heb zelf Bayer dus ik hoop dat je gelijk krijgt, maar ik heb er geen goed gevoel over.
    
    Vraag me ook af wat een worst case scenario doet met het bedrijf. Als het probleem met Montosanto overwaait is Bayer veel te laag gewaardeerd. Kan iedere zieke die ooit met Roundup heeft gewerkt echter miljoenen ophalen kan het hard gaan.
    

    Hoezo juridische trucjes, als een medicijn op de markt wordt gebracht gaat dat toch ook met de goedkeuring van de daarvoor verantwoordelijke instanties. Recent voorbeeld hiervan zijn de medicijnen ter vaccinatie van Covid 19.
13. LL 30 augustus 2021 08:19

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    Berlin, August 28, 2021 – Detailed results from the Phase III FIGARO-DKD study demonstrate that compared to placebo in addition to standard of care, the investigational drug finerenone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, reduced the risk of cardiovascular (CV) outcomes in a broad population of patients with stages 1-4 chronic kidney disease (CKD) and type 2 diabetes (T2D).
    
    Finerenone significantly reduced the risk of the composite primary endpoint of time to first occurrence of CV death or non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization by 13% (relative risk reduction, HR 0.87 [95% CI: 0.76-0.98]; p=0.0264) over a median duration of follow-up of 3.4 years versus placebo when added to maximum tolerated dose of guideline-directed therapy. In the FIGARO-DKD study, finerenone was well-tolerated, which is consistent with the safety profile seen in previous studies. The FIGARO-DKD study adds significant evidence of the CV benefits of finerenone across a broader patient population, building on the FIDELIO-DKD study which demonstrated that finerenone improved the primary composite kidney endpoint and the key secondary composite CV endpoint in patients with predominantly stages 3-4 CKD and severely elevated albuminuria.
    
    The findings from the FIGARO-DKD study were presented today during a Hot Line session at ESC Congress 2021, and simultaneously published in the New England Journal of Medicine.
    
    “The unfortunate reality is that patients living with chronic kidney disease and type 2 diabetes are three times more likely to die from a cardiovascular event than those with type 2 diabetes alone, so early diagnosis and treatment is important to reduce the high cardiovascular and heart failure burden in these patients,” said Professor Bertram Pitt, Professor of Medicine Emeritus at the University of Michigan School of Medicine in Ann Arbor, and co-principal investigator of the FIGARO-DKD clinical trial. “The FIGARO-DKD study demonstrated cardiovascular benefits of finerenone across a wide range of patients, including those with earlier stages of chronic kidney disease.”
    
    The study showed that the effects of finerenone on the primary outcome were generally consistent across pre-specified subgroups, including baseline estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR) categories. Patients in both groups received standard of care, including blood glucose lowering therapies and a maximum tolerated dose of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).
    
    Also presented during the Hotline session at ESC were data from FIDELITY, a prespecified meta-analysis of more than 13,000 patients from the Phase III studies FIGARO-DKD and FIDELIO-DKD. The results demonstrated cardiovascular and renal benefits of finerenone in patients with CKD and T2D. In the FIDELITY analysis, finerenone reduced the risk of the composite CV outcome of time to CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure by 14% compared to placebo (HR:0.86 [95% CI: 0.78–0.95]; p=0.0018). The risk of the composite kidney outcome of time to first onset of kidney failure, sustained =57% decrease in eGFR from baseline over =4 weeks, or renal death was 23% lower with finerenone versus placebo (HR: 0.77 [95% CI: 0.67–0.88]; p=0.0002). A kidney outcome event occurred in 360 (5.5%) patients receiving finerenone and 465 (7.1%) receiving placebo.
    
    “Despite current treatment options, patients remain at high risk of progression to kidney failure and cardiovascular events,” said Professor Gerasimos Filippatos, M.D., Professor of Cardiology at the National and Kapodistrian University of Athens, Greece, and co-principal investigator of the FIDELIO-DKD and FIGARO-DKD Phase III clinical trials. “The data from the meta-analysis also highlight the importance of detecting kidney damage early to slow CKD progression and prevent poor patient outcomes. This can only be achieved through regular monitoring of albuminuria to spot earliest signs of kidney damage.”
    
    “The new data presented today provide further insights into the potential of finerenone to delay chronic kidney disease progression and reduce the risk of cardiovascular events in these vulnerable patients,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development.
    
    In July, finerenone was approved under the brand name Kerendia® by the United States (U.S.) Food and Drug Administration (FDA) based on the positive results of the FIDELIO-DKD Phase III study. Finerenone has also been submitted for marketing authorization in the European Union (EU) and China, as well as multiple other countries worldwide and these applications are currently under review.
    
    het gehele bericht is te lezen op:
    media.bayer.de/baynews/baynews.nsf/id...
14. Putschrijvert 30 augustus 2021 08:33

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    Dat is goed nieuws, LL. Ben nog altijd blij met mijn portie Bayer, ook al is de koers omlaag.
15. LL 1 september 2021 10:14

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    Bayer starts Phase III clinical development program OASIS with Elinzanetant
    Elinzanetant is an innovative non-hormonal development compound investigated for the treatment of vasomotor symptoms during menopause
    
    Berlin, August 31, 2021 – Bayer, a global leader in women’s healthcare, announced today that it started the Phase III clinical development program OASIS, which aims to evaluate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms during menopause. Elinzanetant is a first in class, non-hormonal, once-daily, oral, dual neurokinin-1,3 receptor antagonist under investigation.
    
    Vasomotor symptoms (hot flashes) are reported by up to 80% of women at some point during the menopausal transition and the leading cause for seeking medical attention during this particular phase of a woman’s life. Over 1/3 of women report severe symptoms, which can last 10 years or more after the last menstrual period. Vasomotor symptoms may have a negative impact on sleep, mood and quality of life.
    
    “Based on the positive Phase II data, we are very pleased to now start the Phase III program with elinzanetant targeting the most frequent and bothersome menopausal symptoms”, said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “With our OASIS clinical development program, we are addressing an important unmet medical need in women’s health as currently a vast majority of women is not receiving treatment for their menopausal symptoms. Our clear goal therefore is to develop a non-hormonal treatment option that will improve women’s quality of life during menopause.“
    
    The OASIS Phase III clinical development program is investigating the efficacy and safety of elinzanetant 120mg once daily in menopausal women with vasomotor symptoms. The program intends to enroll approximately 1,300 patients at more than 200 centers in over 20 countries.
    
    The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1) demonstrating good efficacy for elinzanetant with a favorable safety profile. RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study, which investigated the efficacy and safety of four different doses of elinzanetant compared to placebo in patients with vasomotor symptoms. Results have been presented at the 2020 virtual annual meeting of the North American Menopause Society (NAMS).
    
    In September 2020, Bayer completed the acquisition of KaNDy Therapeutics Ltd., a UK clinical-stage biotech company, and fully integrated elinzanetant into its women’s healthcare development pipeline.
    
    bron:
    media.bayer.de/baynews/baynews.nsf/id...
16. LL 6 september 2021 12:45

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    Bayer’s Eliapixant significantly decreased cough frequency in Phase IIb trial in patients with refractory chronic cough
    Significant improvement in 24-hour cough counts over placebo after 12 weeks of treatment and with a favorable safety and tolerability profile / Results from PAGANINI Phase IIb dose-finding study presented at the virtual European Respiratory Society (ERS) International Congress 2021 / Currently no treatment approved for refractory chronic cough, a condition affecting one to five percent of people wordwide
    
    Berlin, Germany, September 6, 2021 – Bayer today announced the results from PAGANINI, the Phase IIb dose-finding study evaluating the efficacy and safety of its investigational orally administered, potent and selective P2X3 receptor antagonist eliapixant (BAY1817080) in patients with refractory chronic cough (RCC). The primary efficacy outcome was met showing a statistically significant reduction in the 24-hour cough count (average hourly cough frequency based on 24-hour sound recordings) of up to 27% for eliapixant 75 mg twice daily over placebo after 12 weeks of treatment. In the study, eliapixant demonstrated a positive benefit-risk profile, with the vast majority of adverse events considered mild or moderate. Discontinuation of the study due to adverse events occurred in 8% of patients treated with eliapixant. Taste-related adverse events were reported in 24% of patients treated with the highest dose of eliapixant 150 mg twice daily and markedly less in patients receiving lower doses. Most were described as “a little” and “somewhat” bothersome, none described as “extremely” bothersome. The favourable tolerability of eliapixant in this trial is consistent with earlier clinical findings. As a result, eliapixant may have the potential for safe and effective long-term use.
    
    RCC affects one to five percent of people worldwide and often has a debilitating effect on the quality of patients’ lives. Currently, no treatment is approved for the therapy of RCC, and the medical need for new effective treatments is high.
    
    “Given the high unmet medical need, we are very encouraged with the positive outcome of eliapixant in the chronic cough indication regarding efficacy and safety,” said Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. “The selective mechanism of action of eliapixant appears to be translating into improved tolerability in clinical trials. These results will guide us to advance our clinical development strategy of eliapixant.”
    
    “Chronic cough is a common clinical condition with significant impact on quality of life and for which effective therapy remains an unmet clinical need. Over the past decade, there has been a major shift in how we approach this problem, driven by better appreciation of the clinical manifestation of chronic cough and an improved understanding of the associated neurobiology,” said Dr. Lorcan McGarvey, Professor of Respiratory Medicine, Wellcome-Wolfson Institute of Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast. “The findings from the PAGANINI trial with eliapixant are very encouraging, showing a promising outcome to address this unmet need. Such advancements are needed to offer new treatment options to patients with refractory chronic cough who are often suffering for many years without a relief.”
    
    The results of the eliapixant PAGANINI study were presented at the virtual European Respiratory Society (ERS) International Congress 2021 (Abstract #BA23231).
    
    het hele verhaal is te vinden op de onderstaande url:
    media.bayer.com/baynews/baynews.nsf/i...
17. Stephanus1987 21 september 2021 19:18

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    Beste mede bayerbeleggers. even benieuwd, ik zit al een geruime tijd >1jr. in Bayer (GAK 55,96). De koers wil maar niet vlotten, benieuwd naar jullie strategie. Ik zit opzich Long maar vraag mij af of er nog iets hoopvols inzit komend jaar. Heb mijn aandacht tijdje los gelaten sinds glyphosate litigation werd afgeketst. Op zich prima dividend en niet duur, alleen zal het ooit nog goedkomen met de koers.
18. LL 21 september 2021 20:05

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    Stephanus1987 schreef op 21 september 2021 19:18:

    Beste mede bayerbeleggers. even benieuwd, ik zit al een geruime tijd >1jr. in Bayer (GAK 55,96). De koers wil maar niet vlotten, benieuwd naar jullie strategie. Ik zit opzich Long maar vraag mij af of er nog iets hoopvols inzit komend jaar. Heb mijn aandacht tijdje los gelaten sinds glyphosate litigation werd afgeketst. Op zich prima dividend en niet duur, alleen zal het ooit nog goedkomen met de koers.
    

    Stephanus1987 de Roundup rechtzaak blijft de gemoederen bezighouden. Het wachten is op een uitspraak van de U.S. Supreme Court inzake Edwin Hardeman. Ik heb geen enkel idee wanneer de uitspraak komt. Mocht iemand een dit weten please let us know.
    
    Tot die tijd is het gewoon geduld hebben en profiteren van de +/- 4% bruto dividend.
    
    
19. 4finance 22 september 2021 09:21

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    quote:

    LL schreef op 21 september 2021 20:05:

    [...]
    
    Stephanus1987 de Roundup rechtzaak blijft de gemoederen bezighouden. Het wachten is op een uitspraak van de U.S. Supreme Court inzake Edwin Hardeman. Ik heb geen enkel idee wanneer de uitspraak komt. Mocht iemand een dit weten please let us know.
    
    Tot die tijd is het gewoon geduld hebben en profiteren van de +/- 4% bruto dividend.
    
    

    Heel veel geduld hier. Gaat "uiteindelijk" wel weer richting de €60 - €80 range. De daling lijkt er wel uit.
    
    
20. LL 22 september 2021 10:06

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    Bayer extends clinical development program for finerenone with Phase III study in patients with non-diabetic chronic kidney disease
    
    There are limited treatment options available for chronic kidney disease (CKD), and patients often still progress to kidney failure or premature death / The Phase III study FIND-CKD will investigate the effect of finerenone on kidney and cardiovascular outcomes in patients with non-diabetic chronic kidney disease
    
    Berlin, September 20, 2021 – Bayer announced today the initiation of the FIND-CKD study, a multicenter, randomized, double-blind, placebo-controlled Phase III study to investigate the efficacy and safety of finerenone in addition to guideline-directed therapy, on the progression of chronic kidney disease (CKD) in patients with non-diabetic CKD. The primary objective of the study is to demonstrate superiority of finerenone over placebo in delaying the progression of kidney disease in these patients. The primary outcome measure is the mean rate of change in kidney function over time (estimated glomerular filtration rate, eGFR slope) from baseline to month 32.
    
    “In 2017, an alarming 1.2 million people died from chronic kidney disease worldwide. Although diabetes is well-recognized as a leading cause of chronic kidney disease globally, a substantial proportion of the global burden is non-diabetic in origin and attributable to other causes, such as hypertension. To improve outcomes, new treatments that can target kidney-specific disease mechanisms are highly desired,” said Hiddo L. Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University Medical Center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “If successful, this study could be of great significance to those living with chronic kidney disease globally.”
    
    Finerenone is an investigational, non-steroidal, selective mineralocorticoid (MR) antagonist that has been shown in preclinical studies to block harmful effects of MR overactivation. MR overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors. Finerenone has already demonstrated benefits on kidney and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes in two completed Phase III studies, FIDELIO-DKD and FIGARO-DKD.
    
    “Finerenone has been studied so far in more than 13,000 patients through the comprehensive Phase III clinical trial program in chronic kidney disease and type 2 diabetes, which demonstrated positive kidney and cardiovascular outcomes for finerenone versus placebo on top of standard of care,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “The new FIND-CKD study extends our clinical research for finerenone to a non-diabetic population where the unmet need is high for new treatments to delay disease progression.”
    
    The planned Phase III FIND-CKD study will investigate finerenone compared to placebo in addition to standard of care in more than 1,500 patients with non-diabetic chronic kidney disease etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys). Patients will be randomized to receive either finerenone 10mg or 20mg or placebo on top of individually tolerated maximum labeled doses of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).
    
    In July, finerenone was approved under the brand name Kerendia® by the United States (U.S.) Food and Drug Administration (FDA) based on the positive results of the FIDELIO-DKD Phase III study for patients with CKD and T2D. Finerenone has also been submitted for marketing authorization in the European Union (EU) and China, as well as multiple other countries worldwide and these applications are currently under review.
    
    meer info:
    media.bayer.com/baynews/baynews.nsf/i...