COVID-19 Series
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Updated May 26, 2021 Cross-Border Industry Partnerships on COVID-19 Vaccines and Therapeutics Vaccines • Curevac O Celonic Wi
Updated May 26, 2021 Cross-Border Industry Partnerships on COVID-19 Vaccines and Therapeutics Vaccines • CureVac o Celonic will manufacture 100 million doses of CureVac’s vaccine at its plant in Heidelberg, Germany, providing bulk substance for 50 million doses by the end of 2021. (press release) o Novartis will manufacture CureVac’s vaccine. (press release) o GlaxoSmithKline plc and CureVac N.V. announced a new €150m collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. (press release) o Rentschler Biopharma SE will manufacture CureVac’s vaccine. (press release) o Bayer will support the further development, supply and key territory operations of CureVac’s vaccine candidate. (press release) o Fareva will dedicate a manufacturing plant in France to the fill and finish of CureVac’s vaccine. (press release) o Wacker Chemie AG will manufacture CureVac’s vaccine candidate at its Amsterdam site. (press release) o CureVac will collaborate with Tesla Grohmann Automation to develop an RNA printer that works like a mini-factory and can produce such drugs automatically. (press release) • Moderna o Samsung Biologics will provide large scale, commercial fill-finish manufacturing for Moderna’s vaccine in South Korea. (press release) o Baxter International will provide fill/finish services and supply packaging for Moderna. (press release) o Sanofi will manufacture 200 million doses of Moderna’s COVID-19 vaccine starting in September 2021. (press release) o Rovi will produce bulk substance for Moderna’s COVID-19 vaccine, expanding an agreement between the companies. -
FDA Covid-19 Response at a Glance Summary As of July 19, 2021
FDA COVID-19 Response At-A-Glance Summary as of July 19, 2021 The U.S. Food and Drug Administration, along with other federal, state, and local agencies and public health officials across the country, continues critical work to protect public health during the pandemic of COVID-19. Major focus areas of the FDA’s response include increasing the availability of tests, therapeutics, vaccines and devices such as ventilators and personal protective equipment, and many other important items necessary for the response. The FDA is also monitoring the human and animal food supply and taking swift action on fraudulent COVID-19 products. Highlights of FDA Activities Ensuring Timely Availability to Accurate • The agency has issued EUAs and policies to help increase and Reliable Tests the availability of personal protective equipment, such as • As of July 16, 396 tests and sample collection devices respirators, gowns, surgical masks, and more. are authorized by the FDA under Emergency Use • There are now more than 630 drug development Authorizations (EUAs); these include 281 molecular programs in planning stages and 11 EUAs for tests and sample collection devices, 85 antibody COVID-19 treatments are currently authorized for and other immune response tests and 30 antigen emergency use. One treatment is currently approved by tests. There are 52 molecular authorizations and one the FDA for use in COVID-19. antibody authorization that can be used with home- collected samples. There is one molecular prescription Facilitating the Development of at-home test, three antigen prescription at-home tests, COVID-19 Vaccines five antigen over-the-counter (OTC) at-home tests, and • There are three COVID-19 vaccines authorized for two molecular OTC at-home tests. -
Version 12.0, 01 Jun 2018 ANNEX I SUMMARY of PRODUCT
BioThrax® (Anthrax Vaccine Adsorbed) 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Version 12.0, 01 Jun 2018 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET Emergent BioSolutions, Inc. Confidential and Proprietary Page 1 of 25 BioThrax® (Anthrax Vaccine Adsorbed) 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet SUMMARY OF PRODUCT CHARACTERISTICS Emergent BioSolutions, Inc. Confidential and Proprietary Page 2 of 25 BioThrax® (Anthrax Vaccine Adsorbed) 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See Section 4.8 for how to report adverse reactions 1 NAME OF THE MEDICINAL PRODUCT BioThrax1 suspension for injection. Anthrax Vaccine Adsorbed (purified cell-free filtrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 mL) contains: Anthrax antigen filtrate: 50 micrograms (50 mcg) a, b For a full list of excipients, see Section 6.1. a Produced from cell-free filtrates of an avirulent strain of Bacillus anthracis b Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 3 PHARMACEUTICAL FORM Suspension for injection. Sterile, milky-white liquid suspension, when mixed. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications BioThrax is indicated for the prevention of disease caused by Bacillus anthracis, in adults at risk of exposure. BioThrax should be used in accordance with official recommendations, where available. 4.2 Posology and method of administration Posology: Primary Immunisation: 3-doses each of 0.5 mL, given at 0, 1 and 6 months. -
Report from Accountable.US
NEW ANALYSIS REVEALS $250M IN INSIDER PROFITEERING AT GOVERNMENT-BACKED DRUG COMPANIES, INCLUDING $105M IN NEW TRADES IN LESS THAN 3 MONTHS’ TIME In Six Months Since Launch Of Operation Warp Speed, Execs At Five Drug Companies Made Net Profit Of More Than $250 Million Dumping Their Companies’ Stocks. An earlier report from Accountable.US compiled executive trading data from the launch of Operation Warp Speed on May 15 through August 31, 2020 and found they made stock transactions valued at a net profit of more than $145 million. New analysis of insider transactions at those companies over the six months between May 15 and November 15, 2020, show more than $250 million in net profit. Company Net Profit Emergent BioSolutions $23,906,515.14 Johnson & Johnson $4,276,630.00 Moderna $165,889,439.69 Novavax $46,372,082.90 Pfizer $10,490,165.85 Total $250,934,833.57 From September To Mid-November, Execs At Four Drug Companies Involved In Operation Warp Speed Have Made Net Profit Of More Than $105M Dumping Their Companies’ Stock. According to SEC filings, from the beginning of September through November 15, 2020, executives and directors at four of the companies receiving COVID vaccine funding through Operation Warp Speed have made stock transactions valued at a net profit of more than $105 million. NOTE: Johnson & Johnson did not report any new individual insider transactions during this period. Company Net Profit Emergent BioSolutions $18,860,527.37 Moderna $50,406,146.77 Novavax $29,037,668.05 Pfizer $7,388,569.80 Total $105,692,911.99 • The net profit of these transactions from May 15-November 15, 2020 was $250.9 million; the total profit of these trades was $292.1 million. -
Johnson and Johnson Vaccine in Use Is Safe, Says US Regulator
NEWS New York BMJ: first published as 10.1136/bmj.n897 on 6 April 2021. Downloaded from Cite this as: BMJ 2021;373:n897 Covid-19: All Johnson and Johnson vaccine in use is safe, says US http://dx.doi.org/10.1136/bmj.n897 regulator Published: 6 April 2021 Janice Hopkins Tanne The acting head of the US Centers for Medicare and Medicaid Services gave reassurances on 5 April that the Johnson & Johnson vaccine was safe, after a mix-up at a production plant in Maryland ruined 15 million potential doses of the vaccine.1 Andy Slavitt said at a press briefing, “All of the Johnson & Johnson vaccine that’s available in the US has been authorised by the FDA [Food and Drug Administration]. None of it came out of this plant . No vaccine will leave any factory unless authorised by the FDA . “The Johnson & Johnson vaccine [will be] the only vaccine made in this plant, to eliminate any potential for cross contamination.” The Emergent BioSolutions pharmaceutical plant in Baltimore, Maryland, was a partner with Johnson & Johnson in producing a single dose vaccine approved by the FDA for use in the US, as well as with AstraZeneca, whose vaccine has not yet been authorised in the US. Workers at the Emergent plant accidentally mixed ingredients for the two vaccines several weeks ago. The problem was detected in quality control checks before the manufacture of any vaccines was completed.2 3 Johnson & Johnson took control of production of its vaccine at the plant and said that it was “providing additional experts in manufacturing, technical operations, and quality to be on site at Emergent to supervise, direct, and support all manufacturing of the Johnson & Johnson covid-19 vaccine. -
Catalent, Inc. Annual Report 2019
Catalent, Inc. Annual Report 2019 Form 10-K (NYSE:CTLT) Published: August 27th, 2019 PDF generated by stocklight.com UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________ FORM 10-K ______________________________ x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2019 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36587 ___________________________ CATALENT, INC. (Exact name of registrant as specified in its charter) ______________________________ Delaware 20-8737688 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 14 Schoolhouse Road 08873 Somerset, New Jersey (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (732) 537-6200 ______________________________ Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.01 par value per share CTLT New York Stock Exchange Securities registered pursuant to Section 12(g) of the Act: None ______________________________ Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No o Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No x Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. -
Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing
04/04/2021 Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing | Johnson & Johnson OUR COMPANY Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing New Brunswick, NJ (March 31, 2021) – Since January of 2020, Johnson & Johnson has been working directly with governments, health authorities and other companies to help end the global pandemic. We continue to expect to deliver our COVID-19 vaccine at a rate of more than one billion doses by the end of 2021. We are pleased we have met our commitment to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States. This is part of our plan to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021, aiming to deliver those doses by the end of May. As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards. This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality. This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process. This is an example of the rigorous quality control applied to each batch of drug substance. -
Johnson & Johnson Statement on US COVID-19 Vaccine Manufacturing
04/04/2021 Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing (Updated) | Johnson & Johnson OUR COMPANY Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing (Updated) New Brunswick, NJ (April 3, 2021) – Johnson & Johnson is assuming full responsibility regarding the manufacturing of drug substance for its COVID-19 vaccine at the Emergent BioSolutions Inc. Bayview facility. Specifically, the Company is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the Company specialists already at Emergent. Additional information: All Johnson & Johnson COVID-19 vaccine doses distributed to date have met rigorous Company and regulatory quality standards. The Company continues to work closely with the U.S. Food and Drug Administration toward the Emergency Use Authorization (EUA) of the Emergent Bayview facility. The Company expects to deliver nearly 100 million single-shot doses of its COVID-19 vaccine to the U.S. Government by the end of May. The Company is committed to continuing its extensive collaborations and partnerships with governments, health authorities and other companies to help end this pandemic. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward- looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company, any of the other Janssen Pharmaceutical Companies, and/or Johnson & Johnson. -
GAO-21-443, COVID-19: Efforts to Increase Vaccine Availability And
United States Government Accountability Office Report to Congressional Addressees April 2021 COVID-19 Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation GAO-21-443 April 2021 COVID-19 Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation Highlights of GAO-21-443, a report to congressional addressees Why GAO Did This Study What GAO Found Providing the public with safe and The federal government has taken several actions to increase the availability of effective vaccines to prevent COVID- COVID-19 vaccine doses and indicated it expects to have enough doses 19 is crucial to mitigating the public available for all adults in the United States by the end of May. As of April 1, 2021, health and economic impacts of the the government had purchased 1.2 billion doses of one- and two-dose regimen disease. The U.S. had almost 30 vaccines. Also, vaccine companies reported making additional manufacturing million reported cases and over sites operational, among other actions to expand capacity and mitigate 545,000 reported deaths as of March challenges. 27, 2021. The federal government took a critical step in December 2020 in Federal officials said projecting future availability of vaccine doses can be authorizing the first two COVID-19 difficult, in part because of uncertainty surrounding complex manufacturing vaccines and beginning distribution of processes. Given this uncertainty, coupled with the significant manufacturing and doses across the nation. The distribution increases needed to have enough vaccine doses available for all government had distributed about adults, managing public expectations is critical. GAO’s prior work has found that 180.6 million vaccine doses, and about timely, clear, and consistent communication about vaccine availability is essential 147.8 million doses had been to ensure public confidence and trust, especially as initial vaccine implementation administered, as of March 27, 2021, did not match expectations. -
Vaccine Manufacturing Collaborations
WORKING TOGETHER TO FIGHT COVID-19: VACCINE MANUFACTURING COLLABORATIONS Across the industry, biopharmaceutical companies are working around the clock to meet the demands of COVID-19 vaccine manufacturing. Companies are working to source needed raw materials and other supplies and increasing manufacturing capacity to get COVID-19 vaccine shots in as many arms as possible. Even prior to knowing the efficacy of particular vaccine candidates, companies have proactively been increasing their own manufacturing capabilities as well as partnering with other manufacturers who are sharing available capacity to support production. These partnerships have been key to manufacturing ramp-up following vaccine authorization. MANUFACTURING PROCESS Manufacturing vaccines on a global scale is a highly specialized and intensive bioprocess given that COVID-19 vaccines are complex biologic products. At a high level, the manufacturing process falls into six critical phases and biopharmaceutical companies are lending a hand at every step: Raw Material Active Coupling & Packaging & Shipment & Filling Reception Ingredient Formulation Lot Releases Distribution RECENT EXAMPLES OF PhRMA MEMBER Bayer COMPANY VACCINE MANUFACTURING Bayer and CureVac are partnering to manufacture CureVac’s COLLABORATIONS INCLUDE: mRNA-based COVID-19 vaccine. Bayer will contribute its expertise and established infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information and AstraZeneca supply chain performance as well as support in selected -
Getting Rich on Uncle Sucker Should the Federal Government Strengthen Efforts to Fight Profiteering?
FLICKR.COM/KEVIN H. FLICKR.COM/KEVIN Getting Rich on Uncle Sucker Should the Federal Government Strengthen Efforts to Fight Profiteering? Scott Lilly October 2010 WWW.AMERICANPROGRESS.ORG Doing What Works Advisory Board Andres Alonso John Koskinen CEO, Baltimore Public School System Non-Executive Chairman, Freddie Mac Yigal Arens Richard Leone Professor, USC School of Engineering President, The Century Foundation Ian Ayres Ellen Miller Professor, Yale Law School Executive Director, Sunlight Foundation Gary D. Bass Claire O’Connor Executive Director, OMB Watch Former Director of Performance Management, City of Los Angeles Larisa Benson Washington State Director of Performance Tim O’Reilly Audit and Review Founder and CEO, O’Reilly Media Anna Burger Ali Partovi Secretary-Treasurer, SEIU Senior Vice President of Business Development, MySpace Jack Dangermond President, ESRI Tony Scott Chief Information Officer, Microsoft Dan C. Esty Professor, Yale Law School Richard H. Thaler Professor, University of Chicago School Beverly Hall of Business Superintendent, Atlanta Public Schools Eric Toder Elaine Kamarck Fellow, Urban Institute Lecturer in Public Policy, Harvard University Margery Austin Turner Sally Katzen Vice President for Research, Urban Institute Executive Managing Director, The Podesta Group Laura D. Tyson Edward Kleinbard Professor, University of California-Berkeley Professor, USC School of Law School of Business Members of the advisory board do not necessarily share all the views expressed in this document. Getting Rich on Uncle Sucker Should the Federal Government Strengthen Efforts to Fight Profiteering? Scott Lilly October 2010 CAP’s Doing What Works project promotes government reform to efficiently allocate scarce resources and achieve greater results for the American people. -
GCSG 2020 Global Virtual Conference Registrant List
GCSG 2020 Global Virtual Conference Registrant List First Name Last Name Attendee company Attendee country Beth Adams Takeda United States Robert Adriaansen Berlinger & Co. AG Netherlands Christopher Allaire Clovis Oncology United States Deb Allwine Global Clinical Connections United States Alexi Anderson Regeneron United States David Antieau Zymeworks United States Kingsley Asam-Dankwah Bristol-Myers Squibb United States Andrew Atchley Arena Pharmaceuticals United States Steven Awad Johnson & Johnson United States Natalie Balanovsky Almac Group United States Jennifer Banh MyoKardia United States Jim Bannister Clinigen Group United States Lindsay Belcher Cryoport United States Melanie Bell SciLucent Inc. United States Harry Berlanga Thermofisher United Kingdom Sashin Bhuta Bristol-Myers Squibb United States Katie Bielat Apellis Pharmaceuticals United States William Birecree Bausch Health Companies United States Marcel Bizien VA Cooperative Studies Program United States Michelle Blandin Molecular Templates United States Alena Bolazeva Bristol Myers-Squibb Belgium Allen Bolden BDO USA, LLP (BPTG) United States Richard Bolnick Citation Healthcare Labels United States Bruce Bowman Marken Clinical Trial Logistics United States Caitlin Bowne Alkermes United States Ted Bradley Pfizer United States Tom Brady Xerimis United States Fadoua Braz Eli Lilly United States George Brennan ThermoFisher Scientific United States Lorna Briddick Brizzey United States William Brocious Eli Lilly United States Chris Brown QED Therapeutics United States Gerard Brown 4G Clinical United States Lisa Brown Mylan Pharmaceuticals United States Kimberly Buchanan Merck United States Andrew Buckley Takeda United States Jennifer Bulthuis Pfizer United States Cristine Burfeind United Therapeutics United States Kristi Byrnes Agios Pharmaceuticals United States Carolyn Cammarano Agios Pharmaceuticals United States Ana-Zeralda Canals Debiopharm International S.A.