Fearless Forecast Week 11: 279 Pass Yds, 2 Pass TD
Projected Points: 17.6
Fearless Forecast Week 11: 279 Pass Yds, 2 Pass TD
Projected Points: 17.6
Australia's star batsman has revealed the training breakthrough that should have India's cricketers worried.
Bitcoin investors, which include top hedge funds and money managers, are betting the virtual currency could more than quintuple to as high as $100,000 in a year. Bitcoin is within sight of its all-time peak of just under $20,000 hit in December 2017. Going from $18,000 to $100,000 in one year is not a stretch, Brian Estes, chief investment officer at hedge fund Off the Chain Capital, said.
Activist hedge fund Elliott Management Corp has invested at least $30 million in Cataleya Energy, a small firm focused on oil exploration in Guyana, the world's newest oil and gas hot spot, two people familiar with the matter said. The deal reflects rising interest in Guyana, a small South American country of 750,000 whose oil discoveries are set to transform an economy dependent on agriculture and mining. Five years ago, a consortium led by Exxon Mobil Corp struck oil off the Guyanese coast in the 6.6 million-acre (26,800 square kilometer) Stabroek block that has been shown to hold more than 8 billion barrels of recoverable oil and gas.
Down to world No. 226, Bernard Tomic has signalled his plans to continue his tennis career by making a competition return for the first time since March.
Melbourne Stars will play in their first WBBL finals with four ex-Perth players ready to continue the club's turnaround against the Scorchers.
For a long while, I felt the struggle for equality and social progress wasbeing squashed under the weight of Trumpism.
In the run up to Christmas, it's easy to focus on the one thing that we canenjoy, with or without a lockdown: food.
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LONDON, 24 Nov. 2020 (GLOBE NEWSWIRE) -- This is the Start of Day Message for GlobeNewswire.GlobeNewswire is operated by Intrado and is designated by the FCA as an approved primary information provider.DisclaimerThe content and accuracy of all information distributed through Intrado is wholly the responsibility of the originator. Intrado accepts no liability for any losses arising from reliance by any person upon the content of any announcement.If you have any questions about this message, please Contact Us.
* Novartis showcases unique profile with therapeutic area breadth and depth, exposure to cutting edge platforms and diversification of revenues in terms of assets and geographies * Key growth drivers now contributing to 48% of Innovative Medicines sales; upcoming launches expected to lay the foundation for future sales expansion * Advancing leading pipeline based on scale, innovation and value which will fuel growth in the mid- to long-term and help offset patent cliffs * Committed to driving consistent margin expansion, Innovative Medicines expected to reach high 30s in the mid-term. Target for Novartis Technical Operations productivity program starting in 2021 increased from USD 1.5bn to USD 2bn * Laying the foundations for sector leadership in the ESG space * Initiating share buyback of up to USD 2.5bn, highlighting confidence in growthBasel, November 24, 2020 — Novartis is hosting today its annual Meet Novartis Management event giving investors and industry analysts the opportunity to meet with key executives across the company. The virtual meeting provides a deeper view into the company's progress on its ongoing transformation and growth strategy focused on becoming the leading medicines company powered by data science and advanced therapy platforms. "Novartis offers a unique profile as a fully focused medicines company with diversification across therapeutic areas and geographies, while providing exposure to cutting-edge platforms. We have delivered strong operational performance, growing the top- and bottom- line and delivering on our commitment to margin expansion. Our rich pipeline continues to advance, and we highlight many assets that show significant promise. Reflecting our confidence in future growth and success of our pipeline, we are initiating a share buyback of up to USD 2.5 billion,” said Novartis CEO, Vas Narasimhan.Novartis has a leading pipeline based on scale, innovation and future value, including 116 assets in phase I or II, 49 in Phase III or undergoing registration and more than 65 new molecular entities. The pipeline is expected to fuel growth in the mid-to long-term, with around 90 percent potential first-in-class/first-in-indication medicines and about 80 percent of targets in areas of high unmet patient need. The company is strengthening its advanced therapy platforms along the value chain with 20 advanced platform therapies in clinical development alongside a large number of pre-clinical projects. Novartis is also making significant progress on the manufacturing and commercialization of these advanced therapy platforms. The total value of estimated sales of products launched from 2020 to 2026 puts Novartis as number two for pipeline replacement power in the global pharmaceutical industry.The company is advancing sustained lifecycle management for many assets with five key programs highlighted at the meeting: * Entresto® (sacubitril/valsartan) is under review for the treatment of heart failure with preserved ejection fraction (HFpEF) with a US regulatory decision expected in the first quarter of 2021. Phase III results are expected in the first half of next year from the PARADISE MI trial studying Entresto in patients with acute myocardial infarction (AMI). * Cosentyx® (secukinumab) continues to show strength in dermatology and findings from a Phase III trial in hidradenitis suppurativa (HS) are expected in the second half of 2021. * Kisqali® (ribociclib) continues to grow in-market with overall survival (OS) data in aBC from the MONALEESA-2 trial anticipated in the second half of 2021. * Alpelisib (BYL719) is on track for a US submission in PIK3CA-Related Overgrowth Spectrum (PROS) in 2021. * Beovu® (brolucizumab) is progressing in Phase III development for diabetic macular edema (DME) with a potential submission planned in 2021.From the many assets in the Pharmaceuticals business unit, Novartis is also highlighting multiple mid- to late-stage assets with key milestones expected in 2021 and 2022: * Iptacopan (LNP023), a potential first-in-class oral factor B inhibitor in development for several rare renal diseases and a hematological disorder, is expected to begin Phase III development for IgA Nephropathy (IgAN) in the first half of 2021. The European Medicines Agency (EMA) has granted orphan drug designation to iptacopan for the treatment of IgAN and PRIME designation in C3G. * Iscalimab (CFZ533) is an anti-CD40 antibody in development across multiple indications including Sjögren’s syndrome, kidney and liver transplantation; with first results expected in 2022. * The Phase III clinical trials for the next-generation anti-IgE/FcεRI antibody ligelizumab (QGE031) in chronic spontaneous urticaria (CSU) are fully enrolled, with results expected in the second half of 2021 and regulatory submission in 2022. * In December 2019, Novartis initiated a Phase III outcomes study for pelacarsen (TQJ230), a potential first-in-class antisense oligonucleotide for secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a). Results are expected in 2024. * Inclisiran (Leqvio®) has received positive CHMP opinion for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, marking an important milestone towards it becoming potentially available in the EU. Currently under regulatory review with the FDA with an action date of December 2020. * The FDA granted orphan drug designation for the company’s orally administered, small molecule RNA splicing modulator branaplam (LMI070) for the treatment of Huntington’s disease (HD). A Phase IIb study in HD patients is planned to begin in the first half of 2021.From its broad portfolio in the Oncology business unit, Novartis is also highlighting five mid- to late-stage assets with key milestones expected in 2021: * The Phase III program for canakinumab (ACZ885) in non-small cell lung cancer (NSCLC) is progressing with final results expected from the CANOPY-1 and CANOPY-2 trials in the second and first half of 2021 respectively. * Results from the Phase III VISION trial for 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer (mCRPC 3L) are expected in the first half of 2021. * Sabatolimab (MBG453), an anti-TIM-3 monoclonal antibody, makes progress in a Phase III trial in high risk myelodysplastic syndrome (HR-MDS), and a potential first submission is anticipated in the second half of 2021. * TNO155, a SHP2 inhibitor, is advancing in early clinical trials with a broad combination strategy for KRAS G12C mutant NSCLC and other solid tumors. * LXH254, a selective B/C RAF inhibitor, is making progress in multiple combination studies in NRAS and BRAF mutant melanomas and in certain forms of lung cancers. For Sandoz, management provides an update on progress against its strategy. Recent successes include increasing biosimilar market share in Europe, expansion of gross margin, joint investment to drive sustainable production of antibiotics and strategic deals in the US and Japan. Sandoz is now the only generics company with a top three position in all major regions (US, Europe, ROW). The division continues to target sustained industry leadership, with growth driven primarily by biosimilars, based on a strong pipeline of more than 15 molecules, and a goal to achieve margins in the mid to high 20s range. Sandoz also continues to drive value for society, reaching well over 500 million patients annually, playing a leading role in generating generic savings for healthcare systems worldwide. The announced share buyback of up to USD 2.5 billion will be executed under the existing annual general meeting authority, starts immediately and will last into the first half of 2021. The program is supported by Novartis’ liquidity and strong balance sheet, in line with our capital structure reflecting AA- (S&P) / A1 (Moody’s) credit rating, and existing capital allocation priorities.Novartis is committed to driving constant margin expansion and is on track to deliver USD 2 billion cost savings by year-end across Novartis Technical Operations and Novartis Business Services. Novartis Technical Operations also has productivity programs in place that are set to further generate around USD 2 billion in cost reduction in the mid-term.In the Environment, Social, Governance (ESG) space, Novartis has taken significant steps to achieve its objective of becoming one of the leaders in the sector. Key developments in the last 12 months include the resolution of material legacy compliance issues and the launch of the Code of Ethics, expanded Diversity and Inclusions efforts across all operations, as well as the issuance of the first-of-its–kind sustainability bond in the pharmaceutical industry.Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “pipeline,” “potential,” “confidence,” “launch,” “launched,” “launches,” “will,” “driving,” “strategy,” “development,” “planned,” “continues,” “sustainable,” “on track,” “to deliver,” “future,” “milestones,” “focused,” “growing,” “advancing,” “committed,” “initiating,” “ongoing,” “commitment,” “advancing,” “progressing,” “expected,” “to achieve,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products; or regarding potential future sales or earnings of the Group or any of its divisions or potential shareholder returns; or regarding the potential impact of the share buyback plan; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the inherent uncertainties involved in predicting shareholder returns; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.About Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews For Novartis multimedia content, please visit https://www.novartis.com/news/media-library For questions about the site or required registration, please contact email@example.com Novartis Media Relations E-mail: firstname.lastname@example.orgAntonio Ligi Novartis External Communications +41 61 324 1374 (direct) email@example.com Eric Althoff Novartis US External Communications +1 646 438 4335 firstname.lastname@example.org Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: email@example.comCentral North America Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052 Thomas Hungerbuehler +41 61 324 8425 Isabella Zinck +41 61 324 7188
* Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person (post-exposure prophylaxis) * Roche also provides an update on the sNDA filing for Xofluza in the paediatric setting Basel, 24 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis. “With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We’re hopeful that reducing the burden of influenza may help to mitigate the strain on our healthcare system amid the COVID-19 pandemic.” Post-exposure prophylaxis with single-dose Xofluza was evaluated in the phase III BLOCKSTONE study, which was recently published in The New England Journal of Medicine.1 BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza. Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact. The proportion of household members 12 years of age and older who developed influenza was 1% in participants treated with Xofluza and 13% in the placebo-treated group. Xofluza was well tolerated in this study and no new safety signals were identified. “The flu is a serious illness that burdens households and sickens millions across the US every year,” said Serese Marotta, Chief Operating Officer at Families Fighting Flu. “As we are about to enter a flu season within a global COVID-19 pandemic, we welcome Xofluza as a single-dose flu medicine to be used preventively after exposure to flu.” The most frequently reported adverse events (occurring in at least 1% of adult and adolescent influenza patients treated with Xofluza) included diarrhoea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%). Additionally, Roche is determining a path forward with the FDA for a potential indication for Xofluza as a treatment for acute uncomplicated influenza in otherwise healthy children (one to 12 years of age) and for the prevention of influenza in the same age group who have been exposed to influenza. Xofluza is currently not approved for use in this population. Xofluza is already FDA-approved to treat acute uncomplicated influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.2 Although some of the symptoms of COVID-19 and influenza can look similar, the two illnesses are caused by completely different viruses. Xofluza is specifically designed to treat influenza viruses only and is not effective against SARS-CoV-2, the coronavirus causing COVID-19.3 About BLOCKSTONE 1, 3 BLOCKSTONE is a phase III, double-blind, multicentre, randomised, placebo-controlled, post-exposure prophylaxis study that evaluated a single dose of Xofluza® (baloxavir marboxil) compared with placebo in household members (adults and children) who were living with someone with influenza confirmed by a rapid influenza diagnostic test (the ‘index patient’). The study was conducted by Shionogi & Co., Ltd. in Japan during the 2018-2019 influenza season. Those diagnosed with influenza were required to have onset of symptoms for less than 48 hours and participants were required to have lived with those diagnosed for more than 48 hours. The participants were randomised to receive a single dose of Xofluza (dose according to body weight) or placebo as a preventive measure against developing influenza. Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact. The proportion of household members 12 years of age and older who developed influenza was 1% in participants treated with Xofluza and 13% in the placebo-treated group. Xofluza was well tolerated in this study and no new safety signals were identified. About Xofluza® (baloxavir marboxil) Xofluza is a first-in-class, single-dose oral medicine with an innovative proposed mechanism of action that has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.4 Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.4, 5 Xofluza is available in the US and in several other countries for the treatment of influenza types A and B. In the US, Xofluza is approved for the treatment of acute, uncomplicated influenza in people 12 years of age and older who are otherwise healthy or at high risk of developing serious complications from influenza, and who have been symptomatic for no more than 48 hours. Xofluza is also approved for post-exposure prophylaxis of influenza in people 12 years of age and older following contact with an individual who has influenza. Xofluza was the first new antiviral to be approved by the FDA in 20 years. Robust clinical evidence has demonstrated the benefit of Xofluza in several populations (otherwise-healthy, high-risk and post-exposure prophylaxis). Xofluza is being further studied in a phase III development program, including children under the age of one (NCT03653364) as well as to assess the potential to reduce transmission of influenza from an infected person to healthy people (NCT03969212). 6, 7 Xofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialised globally in collaboration with the Roche Group (which includes Genentech in the US) and Shionogi & Co., Ltd. Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd. About Roche in Influenza Influenza is one of the most common, yet serious, infectious diseases, representing a significant threat to public health. Globally, seasonal epidemics result in three to five million cases of severe disease, millions of hospitalisations and up to 650,000 deaths every year.8, 9, 10, 11 Roche has a long heritage in developing medicines that contribute to public health. We are committed to bringing innovation in the field of infectious diseases, including influenza. Tamiflu® (oseltamivir) has made a significant difference both to the treatment of seasonal influenza as well as in the management of recent pandemics, and we are proud to have brought this innovative medicine to patients. Although vaccines are an important first line of defence in preventing influenza, there is a need for new medical options for prevention (prophylaxis) and treatment. Other antiviral drugs have limitations with respect to efficacy, convenience of dosing, and resistance. Roche is committed to addressing the unmet need in this area through its agreement with Shionogi & Co., Ltd. to develop and commercialise Xofluza. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References  Ikematsu, H., et al. Baloxavir Marboxil for Prophylaxis against Influenza in Household Contacts. New England Journal of Medicine. 2020; 383:309-320.  Xofluza PI. [Internet; cited 2020 October]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210854s001lbl.pdf.  Roche. Data on file.  Noshi, T., et al. S-033447/S-033188, a Novel Small Molecule Inhibitor of Cap-dependent Endonuclease of Influenza A and B Virus: In Vitro Antiviral Activity against Laboratory Strains of Influenza A and B Virus in Madin-Darby Canine Kidney Cells. Poster presentation at OPTIONS IX, August 2016.  Hayden F, et al. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med 2018; 379:913-923  ClinicalTrials.gov. Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms (NCT03653364). [Internet; cited 2020 October]. Available from: https://clinicaltrials.gov/ct2/show/NCT03653364.  ClinicalTrials.gov. Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households (NCT03969212). [Internet; cited 2020 October]. Available from: https://clinicaltrials.gov/ct2/show/NCT03969212.  WHO. Global Influenza Strategy 2019-2030. [Internet; cited 2020 October]. Available from: https://www.who.int/influenza/Global_Influenza_Strategy_2019_2030_Summary_English.pdf?ua=1.  CDC. How Well Flu Vaccines Work. [Internet; cited 2020 October]. Available from: https://www.cdc.gov/flu/about/qa/vaccineeffect.htm.  WHO. Influenza (Seasonal). [Internet; cited 2020 October]. Available from: https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal).  WHO. Up to 650 000 people die of respiratory diseases linked to seasonal flu each year. [Internet; cited 2020 October]. Available from: https://www.who.int/en/news-room/detail/14-12-2017-up-to-650-000-people-die-of-respiratory-diseases-linked-to-seasonal-flu-each-year Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: firstname.lastname@example.org Dr. Nicolas Dunant Phone: +41 61 687 05 17 Patrick Barth Phone: +41 61 688 44 86 Dr. Daniel Grotzky Phone: +41 61 688 31 10 Karsten Kleine Phone: +41 61 682 28 31 Nina Mählitz Phone: +41 79 327 54 74 Nathalie Meetz Phone: +41 61 687 43 05 Dr. Barbara von Schnurbein Phone: +41 61 687 89 67 Roche Investor Relations Dr. Karl Mahler Phone: +41 61 68-78503 e-mail: email@example.com Jon Kaspar Bayard Phone: +41 61 68-83894 e-mail: firstname.lastname@example.org Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: email@example.com Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: firstname.lastname@example.org Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: email@example.comDr. Gerard Tobin Phone: +41 61 68-72942 e-mail: firstname.lastname@example.org Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: email@example.comDr. Lisa Tuomi Phone: +1 650 467 8737 e-mail: firstname.lastname@example.org Attachment * 24112020_MR_ Xofluza US approval_ EN
Amsterdam, The Netherlands, November 24, 2020 – Kiadis Pharma N.V. ("Kiadis" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company developing innovative NK-cell-based medicines for the treatment of life-threatening diseases, today announces that Kiadis will participate in the 2020 Piper Sandler 32nd Annual Virtual Healthcare Conference. Arthur Lahr, the company’s chief executive officer, will participate in a fireside chat and host one-on-one meetings with investors on Thursday, December 3, 2020. A recording of the fireside chat may be accessed by visiting the "For Investors" section of the Company's website under the "Events and Presentations". A replay of the fireside chat will be available for 90 days.Dutch Translation/Nederlandse vertalingKiadis Pharma N.V. (‘Kiadis’), een biofarmaceutisch bedrijf in de klinische fase dat innovatieve op NK-cellen gebaseerde geneesmiddelen ontwikkelt voor de behandeling van levensbedreigende ziekten, maakt bekend dat het zal deelnemen aan de virtuele 32e Piper Sandler Health Conference. CEO Arthur Lahr zal op donderdag 3 december 2020 deelnemen aan een zogeheten ‘fireside chat’ en één-op-één meetings hebben met investeerders.Een video-opname van de chat kan worden bekeken door naar het gedeelte "For Investors" te gaan op de Kiadis-website onder het tabblad "Events and Presentations". Een replay van de fireside chat blijft 90 dagen beschikbaar.Dit persbericht vormt een samenvatting van het gepubliceerde Engelstalige persbericht. Bij eventuele verschillen is de tekst van het Engelstalige persbericht altijd leidend.ContactsKiadis: Maryann Cimino, Sr. Manager, Corporate Affairs Tel: +1 (617) 710-7305 email@example.com LifeSpring Life Sciences Communication: Leon Melens (Amsterdam) Tel: +31 538 16 427 firstname.lastname@example.org Optimum Strategic Communications: Mary Clark, Supriya Mathur Tel: +44 203 950 9144 email@example.com About Kiadis Founded in 1997, Kiadis is building a fully integrated biopharmaceutical company committed to developing innovative cell-based medicines for patients with life-threatening diseases. With headquarters in Amsterdam, The Netherlands, and offices and activities across the United States, Kiadis is reimagining medicine by leveraging the natural strengths of humanity and our collective immune system to source the best cells for life.Kiadis is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS. Learn more at www.kiadis.com.Forward Looking Statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis' or, as appropriate, Kiadis' officers' current expectations and projections about future events. By their nature, forward-looking statements involve a number of known and unknown risks, uncertainties and assumptions that could cause actual results, performance, achievements or events to differ materially from those expressed, anticipated or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, regulation, competition and technology, can cause actual events, performance, achievements or results to differ significantly from any anticipated or implied development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or projections, or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the anticipated or implied developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
Awilco Drilling PLC reported contract revenue of USD 10.6 million (USD 6.4 million Q2), EBITDA USD 1.7 million (USD 1.5 million loss in Q2) and a net loss of USD 1.0 million (USD 4.6 million loss in Q2).Revenue efficiency was 100% during the standard day rate work in the quarter (Q2 fixed price work only).Operational uptime was 100% during the quarter during the standard day rate work in the quarter (Q2 fixed price work only).Contract backlog at the end of Q3 was approximately USD 15.2 million (USD 19.4 million Q2).Please see attached for the Q3 2020 report.A digital presentation will be held today, on 24 November 2020 at 12:00 UK time (13:00pm CET / 07:00 EST). The presentation will be available for download on the Investor Relations section (go to "Press Releases") at www.awilcodrilling.com prior to the meeting. There will be a Q&A session after the presentation.To join the digital meeting, please click this link or copy and paste the following address into your browser: https://bit.ly/AWDR-Q3-2020A replay of the presentation will be made available on the Company website after the event.Aberdeen, 24 November 2020For further information please contact:Jens Berge, CEO Phone: +44 1224 737900Cathrine Haavind, IR Manager Phone: +47 93 42 84 64 Email: firstname.lastname@example.orgThis information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. Attachment * AWDR Q3 2020 report
PRESS RELEASE - REGULATED INFORMATION24 November 2020, 07:00 CETDisclosure of a transparency notificationMechelen, Belgium, 24 November 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), announces today, in accordance with Article 14, paragraph 1 of the Belgian Act of 2 May 2007 on the disclosure of major shareholdings in issuers whose shares are admitted to trading on a regulated market (the ‘Belgian Transparency Act’), that on 19 November 2020 it received a transparency notification dated 19 November 2020 (the ‘Notification’), indicating that on that date the shareholding of Debiopharm Innovation Fund S.A. decreased below the 3% notification threshold. Debiopharm Innovation Fund S.A. now holds 2.95% of the voting rights in Biocartis.The Notification contains the following information: * Reason for the Notification: Acquisition or disposal of voting securities or voting rights, and downward crossing of the lowest threshold. * Notification by: A parent undertaking or a controlling person. * Person subject to the notification requirement: Debiopharm Innovation Fund S.A., Chemin Messidor 5-7, 1006 Lausanne, Switzerland; Après-Demain S.A. (formerly Après-Demain Holding S.A.), Chemin Messidor 5-7, 1006 Lausanne, Switzerland; Thierry Mauvernay, Chemin du Praz-Buchilly 113, 1000 Lausanne 25, Switzerland. * Transaction date: 19 November 2020. * Threshold that is crossed: 3%. * Denominator: 56,382,088. * Details of the Notification: Debiopharm Innovation Fund S.A. now holds 1,662,963 voting securities. * Chain of controlled undertakings through which the holding is effectively being held: Debiopharm Innovation Fund S.A. is controlled by Après-Demain S.A. (formerly Après-Demain Holding S.A.), which is controlled by Mr. Thierry Mauvernay.For further information, reference is made to the Notification which is available here on the Biocartis website.Pursuant to the Belgian Transparency Act and the articles of association of the Company, a notification to the Company and the Belgian Financial Services and Markets Authority (‘FSMA’) is required by all natural and legal persons in each case where the percentage of voting rights in the Company held by such persons reaches, exceeds or falls below the threshold of 3%, 5%, 10%, and every subsequent multiple of 5%, of the total number of voting rights in the Company.\--- END --- More information: Renate Degrave Head of Corporate Communications & Investor Relations Biocartis e-mail email@example.com tel +32 15 631 729 mobile +32 471 53 60 64 About BiocartisBiocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis is developing and marketing a continuously expanding test menu addressing key unmet clinical needs, with a focus in oncology, which represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as for SARS-CoV-2 and sepsis. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_.Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.Forward-looking statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations and projections concerning future events such as the Company's results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Attachment * 20201119 DPIF tr-1be-ENG_FINAL
ZURICH, Switzerland, Nov. 24, 2020 (GLOBE NEWSWIRE) -- Systemorph, a leader in data management solutions for insurance and banking, today announced that it signed a contract with Baloise Group to implement and run its IFRS 17 solution for Baloise Group to comply with the new international reporting standard.The Systemorph IFRS 17 solution includes all group-wide calculation functions required to comply with the accounting standard and will be used by Baloise Group for its IFRS 17 reporting.Baloise Group chose the Systemorph solution because it delivers an important part in the overall auditable end-to-end reporting process. This easy, transparent, consistent and custom-built solution to meet the specific Baloise Group requirements enhances the collaboration between actuarial, finance and IT departments.After the implementation phase Systemorph will provide the IFRS 17 solution as Software-as-a-Service (SaaS) for Baloise Group.About Systemorph: Founded in Zurich in 2011 the Swiss-based Systemorph AG is a privately held technology company specialized in building data-driven software solutions for the financial services market. The company streamlines and simplifies management of data-centric functions by providing custom focused solutions with short implementation times and ongoing application management and support during the entire solution lifecycle at unmatched cost in a very customer friendly way.Contact: Andreas Grigull 49 177 268 1771 firstname.lastname@example.org
* If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options for the management of uterine fibroids: * 100 mg once daily for women with a contraindication to or who prefer to avoid hormonal add-back therapy (ABT) * 200 mg once daily with concomitant ABT for long-term use (beyond 6 months) * 200 mg once daily for short-term use, in particular when rapid reduction in fibroid volume is desired * ObsEva expects to submit a new drug application to U.S. Food and Drug Administration in 1H:21 GENEVA, Switzerland and BOSTON, MA (November 24, 2020) – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for YSELTY® (linzagolix 100mg and linzagolix 200mg) for the management of heavy menstrual bleeding (HMB) associated with uterine fibroids.“The MAA submission is a major milestone for the company as it represents more than 5 years of drug development work by ObsEva team. I want to thanks all those who in the company or as subcontractors, as well as the more than 2,000 patients who contributed to this milestone. In developing multiple dose options, our long-term strategy has always been to meet the needs of the diverse population of women with uterine fibroids,” said Dr. Ernest Loumaye, founder and CEO of ObsEva. “Successful submission of the MAA brings us a step closer toward commercialization of Yselty, which will provide more women a potential best-in-class treatment for uterine fibroids.”The Phase 3 clinical program in uterine fibroids comprises two pivotal trials, PRIMROSE 1 and PRIMROSE 2, that were designed to demonstrate the effectiveness and safety to support the claimed indication: management of HMB associated with uterine fibroids. The application is being submitted at this time as both Phase 3 studies have met their success criteria: both low and high doses of linzagolix with and without ABT are effective in the treatment of HMB associated with uterine fibroids and have an acceptable benefit risk profile.The EMA is expected to notify ObsEva in December 2020 regarding the outcome of its validation of the MAA to ensure all essential regulatory elements required for a scientific assessment are included in the application prior to the start of the procedure.About LinzagolixLinzagolix (previously known as OBE2109) is a novel, oral, once daily, GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product.About PRIMROSE 1 AND 2PRIMROSE 1 (conducted in the United States, which enrolled 574 women with uterine fibroids) and the PRIMROSE 2 (conducted in Europe and in the United States, which enrolled 535 women with uterine fibroids) clinical trials are two Phase 3 clinical trials of linzagolix in patients with HMB associated with uterine fibroids. In both trials, patients were administered linzagolix doses of 100 mg or 200mg, both with and without hormonal ABT, or placebo. The primary endpoint of both trials was reduction in HMB at 24 weeks; responders were defined as patients with menstrual blood loss (MBL) of ≤ 80 mL and a ≥ 50 percent reduction from baseline in MBL, measured using the alkaline hematin method. Secondary endpoints included amenorrhea, time to reduced MBL, hemoglobin (Hb), pain, and quality of life (QoL). Safety endpoints included bone mineral density (BMD), and adverse events (AEs). Calcium/vitamin D were not provided. BMD was measured centrally via Dual Energy X-ray Absorptiometry (DEXA) scan at baseline and 24, 52, and 76 weeks (6-month post treatment assessment).Both PRIMROSE trials successfully met the primary endpoint, with all doses showing statistically significant and clinically relevant reductions in HMB compared to placebo. There was a clear efficacy dose response, with the highest responder rates for the primary endpoint observed in women who received the 200 mg with ABT dose. Substantial improvements were also observed in all doses for the secondary endpoints of amenorrhea, time to reduced MBL and amenorrhea, hemoglobin levels in anemic subjects, pain, and quality of life. The 200 mg dose alone showed rapid and substantial reduction in uterine and fibroid volume.In PRIMROSE 1, the responder rate was 75.5% (p < 0.001) for patients receiving 200 mg with ABT and 56.4% for patients receiving 100 mg without ABT (p =0.003), compared to 35.0% in the placebo group. The overall safety profile was in line with expectations. The most frequently observed adverse events (occurring in > 5% of patients) were headache and hot flushes. Mean percentage changes from baseline in BMD were minimal, as expected with any GnRH antagonist treatment.In PRIMROSE 2, the responder rate was 93.9% (p < 0.001) for patients receiving 200 mg with ABT and 56.7% for patients receiving 100 mg without ABT (p < 0.001), compared to 29.4% in the placebo group. The overall safety profile was in line with expectations. The most frequently observed adverse events (occurring in > 5% of patients) were headache, hot flushes, and anemia. Mean percentage changes from baseline in BMD were minimal and consistent with previous clinical data. 52-week results demonstrated that continued treatment with linzagolix provided sustained efficacy in the reduction of HMB; responder rates of 91.6% and 53.2% were observed in women receiving 200 mg with ABT and 100 mg without ABT, respectively. In addition, small incremental changes in BMD were observed at week 52 compared to week 24, suggesting the onset of plateauing BMD loss.Additional follow-up data to be collected include PRIMROSE 1 52-week treatment results and 6-month post treatment assessment from both studies.About ObsEvaObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor, and improving embryo transfer outcomes following in vitro fertilization. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.obseva.com.About KisseiKissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney-dialysis and Unmet Medical Needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. KLH-2109/OBE2109 is a new chemical entity discovered by Kissei R&D.Cautionary Note Regarding Forward Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the timing, advancement, best-in-class efficacy and potential therapeutic benefits of linzagolix, the potential for linzagolix to be a commercially competitive product, expectations regarding regulatory and development milestones, including the potential timing of regulatory submissions to the FDA, and the results of interactions with regulatory authorities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that the results of earlier clinical trials may not be predictive of the results of later stage clinical trials, related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, the impact of the novel coronavirus outbreak, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2019, the Risk Factors disclosed in ObsEva’s Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on November 5, 2020 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.ObsEva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. For further information, please contact: CEO Office contact Shauna Dillon Shauna.email@example.com +41 22 552 1550 Attachment * Press Release in Pdf
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Hundreds of flights at one of China's busiest airports were cancelled Tuesday as Shanghai raced to bring a local coronavirus outbreak under control.
Jared Goff passed for three touchdowns and 376 yards as the Los Angeles Rams showed their offensive versatility on Monday with a 27-24 victory over Tom Brady's Tampa Bay Buccaneers.
France is expected to loosen its coronavirus restrictions on Tuesday as the boss of a major airline said proof of vaccination will likely become the only way people can fly in a post-pandemic world.