FDA Sets Stage to Authorize Moderna's Covid-19 Vaccine
Total Page:16
File Type:pdf, Size:1020Kb

Load more
Recommended publications
-
Prostate Cancer in Focus
PROSTATE CANCER IN FOCUS Current Developments in the Management of Prostate Cancer Section Editor: Andrew J. Armstrong, MD Prostate Cancer Prostate PSMA-Targeted Therapy in Prostate Cancer Scott T. Tagawa, MD, MS Professor of Medicine and Urology Weill Cornell Medicine New York, New York H&O What is prostate-specific membrane agent such as a monoclonal antibody might be able to antigen (PSMA), and what makes it a good target target a tumor without binding to other PSMA-positive for the treatment of prostate cancer? sites owing to its large size and physical inability to reach luminal sites of expression that are separated from the ST PSMA is a cell surface antigen that is expressed to vasculature by tight junctions. a limited degree on certain normal cells in the body but generally is highly overexpressed in the setting of prostate H&O How is PSMA positivity established? cancer. Normal cells that express PSMA are located in the prostate, salivary, and lacrimal glands; the proximal part ST Imaging and biopsy are the main ways to establish of the small intestine; the proximal renal tubules; and PSMA positivity. Multiple imaging modalities are avail- some ganglia. In the setting of prostate cancer, PSMA able worldwide. The agent indium In 111 capromab expression generally increases along with the cancer grade, pendetide (ProstaScint) has been approved for years in and it also increases following hormonal therapy. In addi- the United States, and the US Food and Drug Adminis- tion, PSMA expression tends to be higher in metastatic tration (FDA) approved the use of gallium Ga 68 PSMA- sites than in primary tumors. -
Snippet Roundup: CETP Kaput and Biogen Buys Into Amyloid
October 27, 2017 Snippet roundup: CETP kaput and Biogen buys into amyloid Edwin Elmhirst Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items. This week, October 23 to 27, 2017, we had thoughts on the following: Amgen puts another CETP out of its misery; Stryker buys Vexim without waiting for US approval; How much is aducanumab worth? At least $8bn, Biogen reckons; Alcon delay puts dampener on Novartis; Soliris sitting pretty with complementary new indication; Smith & Nephew acquires, but divestments could follow; Global Blood drops IPF programme. These snippets were previously published daily via twitter. Amgen puts another CETP out of its misery October 26, 2017 If the once-promising CETP drug class lives on, it might only be in a rather restricted group of heart disease patients with a very specific mutation. Amgen became the last big biopharma group to cancel work on a drug in the HDL-raising class when it announced plans to seek a partner for AMG 899, following the lead of Merck & Co, which recently terminated its work with anacetrapib after disappointing results in the Reveal trial. Although big pharma groups obviously believe that it is unlikely for a CETP inhibitor to succeed commercially, it is not out of the realm of possibility that a partner could emerge for AMG 899 – Roche licensed its project, dalcetrapib, to the Canadian group Dalcor Pharmaceuticals, which has been researching its use in a genetic subtype, patients with an AA polymorphism at the rs1967309 location in the ADCY9 gene. Amgen will write off the $300m it paid for AMG 899’s originator, Dezima Pharma, in 2015, which at the time was seen as a cheap bet on the CETP sector. -
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. -
Abbvie Allergan Acquisition
Creating a New Diversified Biopharmaceutical Company The Combination of AbbVie and Allergan Investor Presentation June 25, 2019 NO OFFER OR SOLICITATION This presentation is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. In particular, this presentation is not an offer of securities for sale into the United States. No offer of securities shall be made in the United States absent registration under the U.S. Securities Act of 1933, as amended, or pursuant to an exemption from, or in a transaction not subject to, such registration requirements. Any securities issued in the acquisition are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S. Securities Act of 1933, as amended. The acquisition will be made solely by means of the Scheme Document (or, if applicable, the Takeover Offer document), which will contain the full terms and conditions of the acquisition, including details with respect to the AbbVie shareholder vote in respect of the acquisition. Any decision in respect of, or other response to, the acquisition, should be made only on the basis of the information contained in the Scheme Document. IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC In connection with the proposed Acquisition, Allergan will file with the Securities Exchange Commission (the “SEC”) a Proxy Statement, which will include the Scheme Document. -
[Docket No. FDA-2017-N-3203] Wyeth Pharmaceutical
This document is scheduled to be published in the Federal Register on 06/21/2017 and available online at https://federalregister.gov/d/2017-12908, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-3203] Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 121 new drug applications (NDAs) and 161 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: The withdrawal is effective on [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601. SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. 2 Table 1 Application No. -
Jabbercovid from the Jabberplex in Celebration of the Jabber Strategy Ensuring a Jab-For-All As a Global Panacea - /
Alternative view of segmented documents via Kairos 2 December 2020 | Draft Jabbercovid from the Jabberplex In celebration of the jabber strategy ensuring a jab-for-all as a global panacea - / - Institutional initiatives Unconscious strategic reliance on the "injection metaphor"? Jabberfear: indoctrination, fear-of-the-jab, and vaccination passports? Jabbercovid versus Jabberwocky? Sonification as a mnemonic aid to global sensemaking In quest of metabolic pathways of global governance? References Institutional initiatives The UN has convened a Special Session of the General Assembly in Response to the Coronavirus Disease (COVID-19) Pandemic at the level of Heads of State and Government on 3-4 December 2020 (General Assembly Decides to Hold High-level Special Session in Response to COVID-19 Pandemic, UN Press Release, 5 November 2020). This followed a year of discussions to overcome opposition to that possibility. The session provides an opportunity for Member States, the UN system and other :relevant stakeholders" to take stock of the current global situation and response efforts, identify policy and operational gaps and forge a path for joint collective action in combating the pandemic (WHO at the Special Session of the United Nations General Assembly in Response to the Coronavirus Disease (COVID-19) Pandemic, WHO News, 3 December 2020). The Session is seen as a unique opportunity to define and implement joint actions at the global level to fight the pandemic in order to ensure the right to life and health for all the inhabitants of the Earth (Riccardo Petrella, Global Health: will it become the first “res publica” of the humanity? Other News, 30 November 2020). -
Faculty Disclosure
Faculty Disclosure In accordance with the ACCME Standards for Commercial Support, course directors, planning committees, faculty and all others in control of the educational content of the CME activity must disclose all relevant financial relationships with any commercial interest that they or their spouse/partner may have had within the past 12 months. If an individual refuses to disclose relevant financial relationships, they will be disqualified from being a part of the planning and implementation of this CME activity. Owners and/or employees of a commercial interest with business lines or products relating to the content of the CME activity will not be permitted to participate in the planning or execution of any accredited activity. Nature of Relevant Financial Relationship Last Name Commercial Interest What Was Received For What Role AbbVie, Allergan/ Tobira Therapeutics Inc, Gilead Research Grant Research Balart Sciences Inc, Pfizer, Salix Pharmaceuticals AbbVie, Merck Honorarium Advisory Board Bau None N/A N/A Benz None N/A N/A AbbVie, Arbutus Biopharma, Dieterich Gilead Sciences, Inc., Bristol- Research Grant Consultant Myers Squibb, Merck Bayer HealthCare Pharmaceuticals, Gilead Sciences Honorarium Speaking, Consultant Inc. Bristol-Myers Squibb, Gilead Speaking, Advisory Sciences, Inc, Salix Honorarium Frenette Board Pharmaceuticals, Inc, Merck Intercept Pharmaceuticals Honorarium Advisor Conatus Pharmaceuticals Inc Honorarium Consulting Principle Investigator, Research Grant, Han Gilead Sciences, -
Q1 Pharma Sector Snapshot
SPECIALTY & GENERIC PHARMA Q1 2021 Report Market Commentary – Debt Capital Markets Debt Markets ▪ 2020 saw increased amounts of debt used in buyouts across the board, resulting in the highest debt / EBITDA Median US Buyout Multiples levels since 2014 − The increased use of debt was driven by 2H20 back- end loaded lending activity (primarily 4Q20) as 16.0x 12.7x 14.1x 12.2x 12.0x 11.6x 11.5x certainty around the U.S. election and vaccination 11.1x 10.0x 9.8x 12.0x 9.7x expectations increased 9.4x 8.6x 8.3x 8.2x 7.5x 7.8x 5.2x 6.7x 5.7x 5.6x ▪ 8.0x 5.9x As the effects of COVID now begin to diminish, debt 5.4x 4.4x 4.1x 3.7x 4.6x 4.3x 3.8x markets have seemingly recovered, signaling that 3.6x lenders have become increasingly comfortable with 4.0x 4.3x 6.9x 6.5x 6.3x 6.0x 5.9x 5.7x 5.7x 5.7x 5.7x 5.6x 5.3x 4.5x 4.4x macroeconomic and company-specific fundamentals 4.3x 0.0x 3.2x − With increased confidence, lenders are currently looking to provide strong leverage for high-quality assets, particularly ones that have proven their Debt/EBITDA Equity/EBITDA EV/EBITDA stability through the recent market downturn Source: PitchBook ▪ The spread on U.S. high-yield debt has returned to pre- Historical US High Yield Debt Effective Yield COVID levels − 4.22% current effective yield compared with a 12.0% 11.4% 11.38% effective yield on March 23, 2020 (peak of the pandemic) 9.0% ▪ We expect increased activity by lenders in 2021 due to: 6.0% 4.2% − Pent-up demand in M&A activity driven by the impact of COVID 3.0% − Limited Partner agreements and investor -
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). -
Speaker Biographies
Speaker Biographies Gary Claxton Gary Claxton is a Senior Vice President, the Director of the Program on the Health Care Marketplace at the Kaiser Family Foundation. The Health Care Marketplace Project provides information, research, and analysis about trends in the health care market and about policy proposals that relate to health insurance reform and our changing health care system. The Program for the Study of Health Reform and Private Insurance examines changes in the private insurance market under the Affordable Care Act as federal and state policymakers implement provisions of the health reform law. Prior to joining KFF, Mr. Claxton worked as a senior researcher at the Institute for Health Care Research and Policy at Georgetown University, where his research focused on health insurance and health care financing. From March 1997 until January 2001, Mr. Claxton served as the Deputy Assistant Secretary for Health Policy at the U.S. Department of Health and Human Services, where he advised the Secretary on health policy issues including: improving access to health insurance, Medicare reform, administration of Medicaid, financing of prescription drugs, expanding patient rights, and health care privacy. Other previous positions include serving as a consultant for the Lewin Group, a special assistant to the Deputy Assistant Secretary for Health Policy in the Office of the Assistant Secretary for Planning and Evaluation, an insurance analyst for the National Association of Insurance Commissioners, and a health policy analyst for the American Association of Retired Persons. Brian Webb Brian Webb is Assistant Director of Life & Health Policy and Legislation for the National Association of Insurance Commissioners (NAIC). -
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. -
Refreshing the Biologic Pipeline 2020
news feature Credit: Science Lab / Alamy Stock Photo Refreshing the biologic pipeline 2020 In the absence of face-to-face meetings, FDA and industry implemented regulatory workarounds to maintain drug and biologics approvals. These could be here to stay. John Hodgson OVID-19 might have been expected since 1996) — a small miracle in itself “COVID-19 confronted us with the need to severely impair drug approvals (Fig. 1 and Table 1). to better triage sponsors’ questions,” says Cin 2020. In the event, however, To the usual crop of rare disease and Peter Marks, the director of the Center for industry and regulators delivered a small genetic-niche cancer treatments, 2020 Biologics Evaluation and Research (CBER) miracle. They found workarounds and also added a chimeric antigen receptor at the FDA. “That was perhaps the single surrogate methods of engagement. Starting (CAR)-T cell therapy with a cleaner biggest takeaway from the pandemic related in January 2020, when the outbreak veered manufacturing process and the first to product applications.” Marks says that it westward, the number of face-to face approved blockbuster indication for a became very apparent with some COVID- meetings declined rapidly; by March, small-interfering RNA (siRNA) — the 19-related files that resolving a single they were replaced by Webex and Teams. European Medicines Agency’s (EMA) issue can help a sponsor enormously and (Secure Zoom meeting are to be added registration of the RNA interference accelerate the development cycle. Before this year.) And remarkably, by 31 December, (RNAi) therapy Leqvio (inclisiran) for COVID-19, it was conceivable that a small the US Food and Drug Administration cardiovascular disease.