Moderna Joins the RNA Parade with Chunky Alexion Deal
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Uniqure N.V. Paasheuvelweg 25A 1105BP Amsterdam the Netherlands +1-339-970-7000
uniQure N.V. Paasheuvelweg 25a 1105BP Amsterdam The Netherlands +1-339-970-7000 NOTICE OF EXTRAORDINARY GENERAL MEETING OF SHAREHOLDERS To be held on September 14, 2017 To the Shareholders of uniQure N.V.: Notice is hereby given that an Extraordinary General Meeting of Shareholders (the “Extraordinary Meeting”) of uniQure N.V., a public company with limited liability ( naamloze vennootschap ) under the laws of the Netherlands (the “Company,” “uniQure,” and “we”), will be held on September 14, 2017, at 9:30 a.m., Central European Summer Time, at the Company’s principal executive offices located at Paasheuvelweg 25a, 1105BP Amsterdam, the Netherlands, for the following purposes: I. Opening and announcements; II. Appointment of Jeremy P. Springhorn, Ph.D. as a non-executive director (voting proposal no. 1); III. Appointment of Madhavan Balachandran as a non-executive director (voting proposal no. 2); IV Any other business that may properly come before the meeting or any adjournment of the meeting; and V. Closing of the meeting. Each person authorized to attend the Extraordinary Meeting may inspect the Agenda at the office of uniQure. Our Board of Directors (our “Board”) recommends that you vote “FOR” each of the voting proposals noted above. The record date is set at the close of business on August 17, 2017 EST and, therefore, only the Company’s shareholders of record at the close of business on August 17, 2017 EST are entitled to receive this notice (this “Notice”) and to vote at the Extraordinary Meeting and any adjournment thereof. Only shareholders who have given notice in writing to the Company by September 12, 2017 of their intention to attend the Extraordinary Meeting in person are entitled to attend the Extraordinary Meeting in person. -
Interim Recommendations for Use of the Moderna Mrna-1273 Vaccine Against COVID-19
Interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19 Interim guidance First issued 25 January 2021 Updated 15 June 2021 Background This interim guidance has been developed on the basis of the advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) at its extraordinary meeting on 21 January 2021 (1) and updated during its extraordinary meeting on 27 May 2021(2). Declarations of interests were collected from all external contributors and assessed for any conflicts of interest. Summaries of the reported interests can be found on the SAGE meeting website and SAGE Working Group website. The guidance is based on the evidence summarised in the Background document on the Moderna mRNA-1273 vaccine against COVID-19 (3) and the background paper on COVID-19 disease and vaccines (4). Annexes which include GRADE and evidence-to-recommendations (ETR) tables have also been updated to reflect the updated recommendations. All referenced documents are available on the SAGE COVID-19 webpage: https://www.who.int/groups/strategic- advisory-group-of-experts-on-immunization/covid-19-materials. These interim recommendations refer to the mRNA-1273 vaccine, manufactured by Moderna. The vaccine is also known as COVID-19 Vaccine Moderna. In the subsequent text the vaccine will be referred to as mRNA-1273. On 30 April 2021, mRNA-1273 was granted WHO’s Emergency Use Listing (EUL). Methods SAGE applies the principles of evidence-based medicine and has set in place a thorough methodological process for issuing and updating recommendations (5). A detailed description of the methodological processes as they apply to COVID-19 vaccines can be found in the SAGE evidence framework for COVID-19 vaccines (6). -
ALEXION PHARMACEUTICALS, INC. (Exact Name of Registrant As Specified in Its Charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 4, 2021 ALEXION PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 000-27756 13-3648318 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 121 Seaport Boulevard, Boston, Massachusetts 02210 (Address of principal executive offices, including zip code) (475) 230-2596 (Registrant’s telephone number, including area code) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☒ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Trading Name of each exchange Title of each class Symbol on which registered Common Stock, par value $0.0001 per share ALXN The Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). -
Moderna Vaccine Day Presentation
Zika Encoded VLP mRNA(s) RSV CMV + EBV SARS-CoV- RSV-ped 2 Flu hMPV/PIV3 H7N9 Encoded mRNA(s) Ribosome Protein chain(s) First Vaccines Day April 14, 2020 © 2020 M oderna Therapeutics Forward-looking statements and disclaimers This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not limited to, statements concerning; the impact of the SARS-CoV-2 pandemic on the Company’s clinical trials and operations; the timing and finalization of a dose-confirmation Phase 2 study and planning for a pivotal Phase 3 study for mRNA-1647; the status and outcome of the Phase 1 clinical trial for mRNA-1273 being conducted by NIH; the next steps and ultimate commercial plan for mRNA-1273; the size of the potential market opportunity for mRNA-1273; the size of the potential commercial market for novel vaccines produced by Moderna or others; the potential peak sales for the Company’s wholly-owned vaccines; the probability of success of the Company’s vaccines individually and as a portfolio; and the ability of the Company to accelerate the research and development timeline for any individual product or the platform as a whole. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. -
The Covid–19 Pandemic and Haemoglobin Disorders
THE COVID–19 PANDEMIC AND HAEMOGLOBIN DISORDERS VACCINATIONS & THERAPEUTIC DRUGS An Informational Guide from the Thalassaemia International Federation (TIF) Prepared by: Dr Androulla Eleftheriou, Executive Director, TIF Last Updated: 12 May 2020 VACCINATIONS & THERAPEUTIC DRUGS Introduction It is important to note that there are currently no FDA1 or EMA2-approved or even recommended agents for the treatment of the novel coronavirus (COVID-19), for which the World Health Organization (WHO) declared as pandemic on Wednesday 11th of March 2020. Any agent being used at this time is being administered in an experimental setting under controlled conditions. Thalassaemia International Federation (TIF) has made an effort to compile a list of studies/clinical trials for treatment and vaccines, which is by no means exhaustive as this situation is extremely labile and research in this area is dramatically intensified. New information is anticipated to be added to this guide which is prepared exclusively for TIF’s global thalassemia community. The viral genome was mapped very soon as rom early January 2020 and shared globally. In February 2020, the WHO published an overview of the potential therapeutic candidates for the treatment of COVID-19. The document outlines 76 regimens that have been proposed (as of February 17, 2020) for the treatment of patients infected with the virus. Thirty-eight of these candidates are in the preclinical state with minimal information available on their proposed mechanism, uses, doses routes, or planned trials. Sixteen of the remaining regimens contain an interferon-based product. The rest include a variety of antimicrobials, corticosteroids, convalescent plasma, and biologics. The Director-General of the WHO, Mr Tedros Adhanom, stated on the 10th of April 2020, that more than 70 countries have joined WHO’s trial to accelerate research on effective treatments and 20 Institutions and companies ‘are racing to develop a vaccine’. -
1976 3M Medical Solutions Division 2019 Electrocore, Inc. 2019 Optinose 1985 Abbott Laboratories, Inc
CURRENT SUSTAINING MEMBER COMPANIES MEMBER FOR OVER: 10 Years 25 Years 50 Years Member Since (alphabetical order) 1976 3M Medical Solutions Division 2019 electroCore, Inc. 2019 Optinose 1985 Abbott Laboratories, Inc. 2010 Endo Pharmaceuticals 2018 Organogenesis 2013 AbbVie Inc. 2017 Exelixis 2004 Otsuka America Pharmaceutical, Inc. 2021 Adaptive Biotechnologies 2016 Express Scripts Federal Pharmacy 2018 Pacira BioSciences, Inc. 2017 ACADIA Pharmaceuticals, Inc. 2010 Federal Practitioner 2018 Paratek Pharmaceuticals 2020 AcelRx Pharmaceuticals, Inc. 2018 Foundation Medicine, Inc. 1990 Pfizer Pharmaceuticals 2020 Acorda Therapeutics 2021 Frontier Technology Inc. (FTI) 2017 Pharmacyclics, LLC 2019 Aimmune 2020 Fresenius Medical Care North America 2020 RedHill BioPharma 2003 Alcon Laboratories, Inc. 1989 Genentech Inc. 2019 Red One Medical 2019 Alexion Pharmaceuticals, Inc. 2006 Gilead Sciences 2020 Regeneron 2017 Alkermes, Inc. 1983 GLAXOSMITHKLINE 2009 Regenesis Biomedical, Inc. 2019 Alnylam Pharmaceuticals 2013 Golden State Medical Supply, Inc. 2011 Remund Group, LLC 2019 Altarum Institute 2020 GRAIL 2018 Rigel Pharmaceuticals 2020 Amarin Corporation 2019 Greenwich Biosciences 2000 Sanofi 1994 AmerisourceBergen 2013 Gulf Coast Pharmaceuticals Plus, LLC 2020 Seattle Genetics 1992 Amgen 2008 Heritage Health Solutions, Inc. 2004 Siemens Medical Solutions 2020 Amneal Pharmaceutical 2017 Hill-Rom Company 2019 SK Life Science, Inc. 2019 Aptive Resources LLC 2020 Immunomedics 2002 Smith & Nephew, Inc. 2020 The Arbinger Institute 2019 ImmunoVation, LLC 2019 Sobi Inc. 2011 Arbor Pharmaceuticals, LLC 2019 Incyte Corporation 2013 Stryker Orthopaedics 2010 Argentum Medical, LLC 2019 Indivior 2018 Sun Pharmaceutical 2019 ASM Research, LLC 2015 Intercept Pharmaceuticals 1999 Sunovion Pharmaceuticals, Inc. 1986 Astellas Pharma US, Inc. 2019 Ipsen Biopharmaceuticals, Inc. 2016 Taiho Oncology, Inc. 1995 AstraZeneca 2018 IT Cadre 2015 Takeda Oncology 2020 Baudax Bio, Inc. -
Biopharma R&D on Treatment and Vaccines
Biopharma R&D on Treatment and Vaccines Coronavirus: Gilead Readies For Remdesivir Ramp Up, Questions On Profit Motive Demand Could Be High For Antiviral Executive Summary “All of that is at risk in not knowing if the drug If clinical trials prove it effective against COVID-19, works or not – and that is really not with an eye to remdesivir could potentially help millions of commercial,” she added. patients - which raises big questions about funding and access. Mercier said the company was spending more time on considering issues of access to the drug once its safety and efficacy is established – especially in regions of the world with less As vaccines will take around 12 months to developed healthcare systems. develop, companies with antiviral treatments are now been pushed to the front line in the battle Nevertheless, Gilead is contemplating a possible against coronavirus, and Gilead Sciences Inc.’s commercial future for the drug. remdesivir is currently the biggest hope of a drug to treat infected patients. “I have to be honest, commercial opportunity might come if this becomes a seasonal disease The company had big news to talk about on 2 or if stockpiling comes into play, but that is much March at the Cowen Health Care conference, as it later down the line,” concluded Mercier. had announced earlier in the day the acquisition of oncology firm Forty Seven for $4.9bn. (Also see One precedent for a big commercial hit for an “Gilead Calls Forty Seven Buyout Complementary antiviral product is Roche’s Tamiflu (oseltamivir). To Kite, Other IO Efforts” - Scrip, 2 Mar, 2020.) The drug achieved peak revenues of $3bn in 2009, largely down to stockpiling in response to that Speaking at the investor conference, Gilead’s chief year’s H1N1 flu pandemic. -
Pharma: Strategic Realignment for a 112/113 Better Future Prism / 2 / 2020
Pharma: Strategic realignment for a 112/113 better future Prism / 2 / 2020 Pharma: Strategic realignment for a better future ... and how the industry will be forced to overcome its hesitation to innovate in operations Ben van der Schaaf, Aurelien Guichard The life sciences sector faces significant impact from Amid the search for COVID-19 – and although the race for treatments and vaccines effective COVID-19 treatments and vaccines, is dominating the headlines, the effect on the industry will the pandemic will have not solely be positive. long-term side effects for the global pharmaceutical In the short term, some companies industry. As our article explains, companies are laying people off and reducing will need to focus on operations, whereas others are change in three areas reallocating resources to focus on (portfolio reprioritization, COVID-19, or even ramping up accelerated R&D and technology efforts in other areas. Stock-market transformation) if they performance has been as diverse are to position (Figure 1). themselves successfully for the future. Organizations need to consider major strategic questions now, to ensure their success in the longer term. The industry is clearly in the middle of the efforts to combat COVID-19: - More than 20 companies are trying to find a treatment with either new or approved drugs1. - More than 15 companies globally are mobilizing resources to develop new vaccines2. - Globally, by the end of May, more than 1,300 clinical trials related to COVID-19 were recruiting patients3. 1. Marketwatch.com, 6 May 2020 2. Drugtargetreview.com, 9 April 2020 3. clintrials.gov, 31 May 2020 Pharma: Strategic realignment for a 114/115 better future Prism / 2 / 2020 2. -
Effectiveness of Pfizer-Biontech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021
Morbidity and Mortality Weekly Report Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021 Mark W. Tenforde, MD, PhD1; Samantha M. Olson, MPH1; Wesley H. Self, MD2; H. Keipp Talbot, MD2; Christopher J. Lindsell, PhD2; Jay S. Steingrub, MD3; Nathan I. Shapiro, MD4; Adit A. Ginde, MD5; David J. Douin, MD5; Matthew E. Prekker, MD6; Samuel M. Brown, MD7; Ithan D. Peltan, MD7; Michelle N. Gong, MD8; Amira Mohamed, MD8; Akram Khan, MD9; Matthew C. Exline, MD10; D. Clark Files, MD11; Kevin W. Gibbs, MD11; William B. Stubblefield, MD2; Jonathan D. Casey, MD2; Todd W. Rice, MD2; Carlos G. Grijalva, MD2; David N. Hager, MD, PhD12; Arber Shehu, MD12; Nida Qadir, MD13; Steven Y. Chang, MD, PhD13; Jennifer G. Wilson, MD14; Manjusha Gaglani, MBBS15,16; Kempapura Murthy, MPH15; Nicole Calhoun, LMSW, MPA15; Arnold S. Monto, MD17; Emily T. Martin, PhD17; Anurag Malani, MD18; Richard K. Zimmerman, MD19; Fernanda P. Silveira, MD19; Donald B. Middleton, MD19; Yuwei Zhu, MD2; Dayna Wyatt2; Meagan Stephenson, MPH1; Adrienne Baughman2; Kelsey N. Womack, PhD2; Kimberly W. Hart2; Miwako Kobayashi, MD1; Jennifer R. Verani, MD1; Manish M. Patel, MD1; IVY Network; HAIVEN Investigators On April 28, 2021, this report was posted as an MMWR Early ≥65 years. Vaccination is a critical tool for reducing severe Release on the MMWR website (https://www.cdc.gov/mmwr). COVID-19 in groups at high risk. Adults aged ≥65 years are at increased risk for severe outcomes Randomized clinical trials of vaccines that have received an from COVID-19 and were identified as a priority group to EUA in the United States showed efficacy of 94%–95% in receive the first COVID-19 vaccines approved for use under preventing COVID-19–associated illness (4,5).§ However, an Emergency Use Authorization (EUA) in the United States hospitalization is a rare outcome among patients with (1–3). -
Comparing Three Covid-19 Vaccines: Pfizer, Moderna, J&J
Comparing three Covid-19 vaccines: Pfizer, Moderna, J&J 3/1/21, 2:09 PM Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson By Helen Branswell Feb. 2, 2021 CVS registered pharmacist Ken Ramey prepares to give a Covid-19 vaccine at the Isles of Vero Beach assisted and independent senior living community in Vero Beach, Fla. Wilfredo Lee/AP In an ideal world, a pandemic vaccine could be delivered in a single shot, so supplies could be stretched to cover a lot of people. It would trigger no side effect more significant than a sore arm. And it would be easy to ship and store. https://www.statnews.com/2021/02/02/comparing-the-covid-19-vaccines-developed-by-pfizer-moderna-and-johnson-johnson/ Page 1 of 10 Comparing three Covid-19 vaccines: Pfizer, Moderna, J&J 3/1/21, 2:09 PM We now have one such vaccine. On Feb. 27, the Food and Drug Administration announced it had issued an emergency use authorization for Johnson & Johnson’s one-dose Covid vaccine. Developed by J&J’s vaccines division, Janssen Pharmaceuticals, it was shown to be 66% protective against moderate to severe Covid infection in a multi-country study. Importantly, it was 85% effective in protecting against severe disease. And there were no hospitalizations or deaths among people in the vaccine arm of a large clinical trial. Overall efficacy varied a bit geographically, especially in South Africa, where a new variant appears to evade to some degree the immunity induced both by infection and by Covid vaccines, which were designed to target earlier strains of the SARS-CoV-2 virus. -
ASN Kidney Week 2020 Reimagined: Disclosures Page 1
10/14/2020 ASN Kidney Week 2020 Reimagined: Disclosures Page 1 Last Name First Name Nothing Employer Consultancy Ownership Interest Research Funding Honoraria Patents or Inventions Scientific Advisor or Membership Speakers Bureau Other Interests or Relationships to Disclose Abdel-Kader Khaled Vanderbilt University Medical Center BMC Nephrology; CJASN NKF Education committee; NIDDK Health IT work group Abudayyeh Ala University of Texas MD Anderson Cancer Center Adler Sharon Retrophin; Bristol Myers Squibb; Bayer; Retrophin; Bayer; ChemoCentryx; Omeros; Zyversa Bayer; Zyversa; Retrophin; AstraZeneca; Morphosys Retrophin; Bayer Pharmaceuticals; Zyversa; KDIGO; KRN; NephCure Kidney International AstraZeneca; ChemoCentryx; Omeros; Zyversa; Therapeutics; Calliditas; Morphosys AstraZeneca; Morphosys Foundation; Karger Publishers Morphosys; Karger Afkarian Maryam University of California, Davis Afrouzian Marjan University of Texas Medical Branch Alexion Pharmaceuticals; Banff Foundation Afshinnia Farsad Agarwal Anupam University of Alabama at Birmingham Dynamed - review content related to AKI for Goldilocks Therapeutics Genzyme/Sanofi Fabry Fellowship Award Univ Southern California, Vanderbilt, Emory, Akebia Editorial Board of AJP Renal, Kidney Int and My wife, Lisa Curtis, will be President-elect Dynamed and review updated materials prepared by Lab Investigation; invited to serve on for Women in Nephrology (2018-2019). Dynamed editorial team for AKI topics. Akebia - Advisory board of Goldilocks Therapeutics, Expert Panel to review new therapeutics -
Biopharma Leaders Unite to Stand with Science
Biopharma Leaders Unite to Stand with Science • Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines NEW YORK, September 8, 2020 (GLOBE NEWSWIRE) – The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech SE (NASDAQ: BNTX), GlaxoSmithKline plc (LSE/NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Merck (NYSE: MRK), known as MSD outside the United States and Canada, Moderna, Inc. (Nasdaq: MRNA), Novavax, Inc. (Nasdaq: NVAX), Pfizer Inc. (NYSE: PFE), and Sanofi (NASDAQ: SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. All nine CEOs signed the following pledge: We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles. The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer- blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.