Annual Report 2019 to Our Shareholders
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28Th WHO Regulatory Update on COVID-19
28th WHO Regulatory Update on COVID-19 05 February 2021 Key Messages Vaccines are giving us a window of opportunity to bring the pandemic under control. The number of vaccinations globally has now overtaken the number of reported infections. But more than three quarters of those vaccinations are in just 10 countries while around 130 countries, with 2.5 billion people, are yet to start their first vaccination. WHO encourages COVID vaccine manufacturers to share their dossiers with WHO faster and more fully for assessment of emergency use listing. Highlights and main issues • WHO has been tracking virus variants since the beginning of the COVID-19 outbreak. With the emergence of new variants of concern, these efforts have been stepped-up to set up systems to quickly identify and study emerging variants. • WHO is working with relevant stakeholders on a common naming system for variants. The aim is to name variants that have potential impact on severity, on transmission and any that have any impact on diagnostics, therapeutics and vaccines. • On 3 February, COVAX has published an interim distribution forecast to provide information on early projected availability of doses of the Pfizer/BioNTech vaccine in Q1 2021 and the AstraZeneca/Oxford vaccine candidate in first half 2021 to COVAX Facility participants. • On 29 January 201, the EU granted a conditional marketing authorisation, based on a recommendation from the EMA, for the AstraZeneca COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. • The WHO Strategic Advisory Group of Experts (SAGE) on Immunization has issued interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19 in people aged 18 years and older. -
No. 33981 2 No
Pretoria, 4 February 2011 Februarle No. 33981 2 No. 33981 GOVERNMENT GAZETTE, 4 FEBRUARY 2011 IMPORTANT NOTICE The Government Printing Works will not be held responsible for faxed documents not received due to errors on the fax machine or faxes received which are unclear or incomplete. Please be advised that an "OK" slip, received from a fax machine, will not be accepted as proof that documents were received by the GPW for printing. If documents are faxed to the GPW it will be the sender's respon sibility to phone and confirm that the documents were received in good order. Furthermore the Government Printing Works will also not be held responsible for cancellations and amendments which have not been done on original documents received from clients. CONTENTS INHOUD Bladsy Koerant Page Gazette No. No. No. No. No. No. GENERAL NOTICE ALGEMENEKENNISGEWING Health, Department of Gesondheld, Departement van General Notice A/gemene Kennisgewing 58 Medicines and Related Substances Act 58 Wet op Beheer van Medisyne en (101/1965): Medicines Control Council: Verwante Stowwe (101/1965): Conditions of registration of a medicine Medisynebeheerraad: Voorwaardes vir in terms of the provisions of section die registrasie van 'n medisyne in terme 15 (7) ..................................................... .. 3 33981 van die bepalings van artikel 15 (7) ........ 4 33981 STAATSKOERANT, 4 FEBRUARIE 2011 No. 33981 3 GENERAL NOTICE ALGEMENE KENNISGEWING NOTICE 58 OF 2011 MEDICINES CONTROL COUNCIL CONDITIONS OF REGISTRATION OF A MEDICINE IN TERMS OF THE PROVISIONS OF SECTION 15(7) OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965) 1. The applicant shall ensure that the medicine is manufactured and controlled in terms of the current Good Manufacturing Practices as determined by Council 2. -
Update on Approved and Candidate COVID-19 Vaccines in the EU
Update on approved and candidate COVID-19 vaccines in the EU Dr. Marco Cavaleri Head of Biological Health Threats and Vaccines Strategy, EMA An agency of the European Union Outline 1 EMA response to COVID-19 pandemic - milestones 2 COVID-19 vaccines approved in the EU 3 Benefits and risks of COVID-19 vaccines 4 Real world evidence on effectiveness 5 Studies in children 6 Vaccines under review by EMA 7 Adapting COVID-19 vaccines to variants 8 Additional information Classified as public by the European Medicines Agency EMA RESPONSE TO COVID-19 PANDEMIC Milestones in the fight against the pandemic Scientific & regulatory Rapid development & Transparency & mobilisation evaluation outreach Approval: Comirnaty, COVID-19 vaccine Moderna, COVID-19 vaccine AstraZeneca, COVID-19 vaccine Janssen Accelerated development & evaluation procedures WHO declares pandemic COVID-19 Experts’ Task Force Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2020 2021 1 Classified as public by the European Medicines Agency COVID-19 vaccines approved in the EU 4 vaccines authorised in the EU • Comirnaty and Moderna vaccines contain a molecule called messenger RNA (mRNA) with instructions for producing the spike protein from SARS-CoV-2, the virus that causes COVID-19 • The AstraZeneca and Janssen vaccine uses a non-replicating adenovirus as a carrier that has been modified to produce the spike protein from SARS-CoV-2. • The vaccines do not contain the SARS-CoV-2 virus causing COVID-19 itself and cannot cause the disease. Comirnaty COVID-19 Vaccine COVID-19 Vaccine COVID-19 Vaccine (BioNTech/Pfizer) Moderna AstraZeneca Janssen 21 Dec 6 Jan 29 Jan 11 Mar 2 Classified as public by the European Medicines Agency BENEFITS AND RISKS Efficacy of COVID-19 vaccines in trials All COVID-19 vaccines approved in the EU have a positive benefit-risk balance in prevention of COVID-19 disease. -
IN the UNITED STATES DISTRICT COURT for the DISTRICT of DELAWARE ALZA CORPORATION and JANSSEN PHARMACEUTICALS, INC., Plaintiffs
Case 1:16-cv-00914-UNA Document 3 Filed 10/07/16 Page 1 of 20 PageID #: 24 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ALZA CORPORATION and ) JANSSEN PHARMACEUTICALS, INC., ) ) Plaintiffs, ) ) v. ) Civil Action No. ____________ ) REDACTED PUBLIC VERSION AMNEAL PHARMACEUTICALS OF ) NEW YORK, LLC and ) AMNEAL PHARMACEUTICALS LLC, ) ) Defendants. ) COMPLAINT In this patent infringement action, Plaintiffs ALZA Corporation ("ALZA") and Janssen Pharmaceuticals, Inc. (collectively "Plaintiffs"), for their complaint against Defendants Amneal Pharmaceuticals of New York, LLC ("Amneal Pharms. NY") and Amneal Pharmaceuticals LLC ("Amneal Pharms. LLC") (collectively, "Amneal"), allege as follows: NATURE OF THE ACTION 1. This is an action for patent infringement under the patent laws of the United States, Title 35, United States Code, in response to, inter alia, the submission by Amneal of Abbreviated New Drug Application ("ANDA") No. 207515, with the U.S. Food and Drug Administration ("FDA") seeking approval to manufacture and sell a generic version of CONCERTA® prior to the expiration of U.S. Patent No. 8,163,798 ("the '798 patent") and U.S. Patent No. 9,144,549 ("the '549 patent"). PARTIES 2. Plaintiff ALZA is a Delaware corporation, having its principal place of business at 700 Eubanks Drive, Vacaville, California 95688. Case 1:16-cv-00914-UNA Document 3 Filed 10/07/16 Page 2 of 20 PageID #: 25 REDACTED PUBLIC VERSION 3. Plaintiff Janssen Pharmaceuticals, Inc. ("Janssen") is a Pennsylvania corporation, having a place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey 08560. 4. On information and belief, Defendant Amneal Pharms. LLC is a limited liability company organized under the laws of the State of Delaware and has a place of business at 400 Crossing Boulevard, Bridgewater, NJ 08807. -
Management Team
Management Team Bruce C. Cozadd Executive Chairman Bruce Cozadd joined Jazz Pharmaceuticals at its inception. From 2001 until he joined Jazz Pharmaceuticals, Mr. Cozadd served as a consultant to companies in the biopharmaceutical industry. From 1991 until 2001, he held various positions with ALZA Corporation, a pharmaceutical company now owned by Johnson & Johnson, most recently as its Executive Vice President and Chief Operating Officer, with responsibility for research and development, manufacturing and sales and marketing. Previously at ALZA Corporation he held the roles of Chief Financial Officer and Vice President, Corporate Planning and Analysis. Mr. Cozadd received a B.S. from Yale University and an M.B.A. from the Stanford Graduate School of Business. Mr. Cozadd serves on the boards of Cerus Corporation, a biopharmaceutical company; Threshold Pharmaceuticals, a biotechnology company; and The Nueva School and Stanford Hospital and Clinics, both non-profit organizations. Samuel R. Saks, MD Chief Executive Officer Samuel Saks, M.D., joined Jazz Pharmaceuticals at its inception. From 2001 until he joined Jazz Pharmaceuticals, Dr. Saks was Company Group Chairman of ALZA Corporation and served as a member of the Johnson & Johnson Pharmaceutical Group Operating Committee. From 1992 until 2001, he held various positions with ALZA Corporation, most recently as its Chief Medical Officer and Group Vice President, where he was responsible for clinical and commercial activities. Dr. Saks received a B.S. and an M.D. from the University of Illinois. Dr. Saks serves on the board of Trubion Pharmaceuticals and Cougar Biotechnology. Robert M. Myers President Robert Myers joined Jazz Pharmaceuticals at its inception and was appointed as Jazz Pharmaceuticals’ President in March 2007. -
Notice Under S66 of the Commerce Act 1986 Application by Johnson & Johnson to Acquire the Stock, Assets and Business Of
PUBLIC COPY Notice under s66 of the Commerce Act 1986 Application by Johnson & Johnson to acquire the stock, assets and business of the Consumer Healthcare division of Pfizer Inc. COMMERCE ACT 1986: BUSINESS ACQUISITION SECTION 66: NOTICE SEEKING CLEARANCE 28 September 2006 The Registrar Business Acquisitions and Authorisations Commerce Commission PO Box 2351 Wellington Pursuant to s66(1) of the Commerce Act 1986 notice is hereby given seeking clearance of a proposed business acquisition. 518689_1.DOC 2 CONTENTS EXECUTIVE SUMMARY PART 1: TRANSACTION DETAILS 1 The business acquisition for which clearance is sought 2 The person giving this notice 3 Confidentiality 4 Participants 5 Interconnected and associated persons 6 Beneficial interests 7 Links between participants 8 Common directorships 9 Business activities of the participants 10 Reasons for the proposed acquisition PART II: IDENTIFICATION OF MARKETS AFFECTED 11 Horizontal aggregation 12 Differentiated product markets 13 Differentiated product markets 14 Vertical integration 15 Other business acquisitions PARTS III, IV AND V: CONSTRAINTS ON MARKET POWERS BY EXISTING AND POTENTIAL COMPETITION AND OTHER POTENTIAL CONSTRAINTS 16 Allergy medication 17 Products for the treatment of worms 18 Thrush treatment CERTIFICATE APPENDICES 1. Heartburn and indigestion remedies (MYLANTA and MOTILIUM) 2. Worm treatments (COMBANTRIN, VERMOX) 3. Cold, flu, nasal decongestant, cough relief and sort throat medications (CODRAL, SINUTAB, SUDAFED, BENADRYL, BRONDECON) 4. Allergy relief products (ACTIFED, SINUTAB, SUDAFED, VISINE, LIVOSTIN) 518689_1.DOC 3 5. Thrush treatments (DIFLUCAN ONE, DAKTARIN, DAKTAGOLD, NIZORAL, SPORANOX) 6. Shampoo (PREGAINE, ROGAINE, NEUTROGENA, JOHNSON’S BABY SHAMPOO) 7. Hand hygiene (PURELL and MICRO SHIELD) 8. Competitor worm treatment products 9. Multinational pharmaceutical businesses: GlaxoSmithKline, Douglas Pharmaceuticals, Alphapharm, Bayer Group 10. -
Memorandum JUL 1 6 201D
Memorandum Subject Date Additional Quota Letters Received by July 15, 2010 (DFN: 630-08.2) JUL 1 6 201D To From Christine A. Sanncrud. Ph.D., Chief "Barbar• J.Illoockholdt, Chief Drug & Chemical Evaluation Section Regul• torn Section Office of Diverison Control Off cL rl Diversion Control On July 15. 2010, this section received your e-mail requesting a review of seventeen (17) quota applications from sixteen (16) registered manufacturers to determine if there arc any pending administrative/legal actions against these applicants and to advise ODE of the findings. ODOR conducted reviews (NADDIS, CSA, etc), as well as surveyed the responsible field offices for their input and recommendations. Provided below are the results and recommendations. QUOTA APPLICANTS wan NO ADVERSE OR DEROGATORY INFORMATIO N Novartis Consumer I lealth Lincoln (10345) (b)(4);(b)(7)(E) Baxter (10346) Generics Bidco li bda Vintage (10347) Noramco Delaware (10348) Pharmaceuticals International inc. (10349) Pharmedium (10351) Pharmedium (10352) Rhodes (10356) Bio-Pharm (10357) Patheon (10358) Patheon (10359) Watson (10361) B & B (10363) lospira. Inc. NC (10364) Epic Pharma (10366) Mallinckrodt I lobart (10367) Chemtos (10368) Vol. II Page 55 2 Per consultation with the field offices. DEA does not have sufficient grounds to limit, restrict. or deny quota requests from these registrants. Based on this information. ODG suggests that you proceed with the completion of the quota applications. If you have any questions pertaining to this information. please feel free to contact me (b)(6);(b)(7)( or SC C) (b)(6);(b)(7)(C) Vol. II Page 56 Memorandum Subject Date Additional Quota Letters Received as of July 19, 201() (DFN: 630-08.2) stir 2 8 2010,., To Fr ,./"./ Christine A. -
Management Liability Focus Johnson & Johnson 1
Insured Profile Report – Management Liability Focus Johnson_________________________________________________________________________ & Johnson Company Profile Credit Details Location 1 Johnson and Johnson Plz Overall Credit Risk High Risk New Brunswick, NJ www.jnj.com Number of Legal Derogatory 84 Company Type Public Items Liability Amount $322,285.00 Formerly Known As N/A Experian Intelliscore 2.57 SIC Code 2834 SIC Code Description Pharmaceutical Preparations Experian Intelliscore Percentile 2.00 % of companies score lower and have higher credit risk Established 1955 Experian Commercial IntelliscoreSM is an all-industry commercial model using business information to predict business risk. Its Sales (in millions) $65,030.00 predictiveness is among the best on the market today The objective of the Commercial Intelliscore Model is to predict seriously Employees 117,900 derogatory payment behavior. Possible score range from 0 to 100, where 0 is high risk and 100 is low risk Total OSHA Violations 18 -Liability Amount is the total dollar amount of debtor’s legal liability, OSHA is an arm of the Department of Labor that conducts inspections of company including accounts in collection, tax liens,judgments and/or bankruptcies facilities with the goal of preventing work-related injuries, illnesses and deaths. -The Number of Legal Derogatory items are the sum of Tax-Lien Worksites that do not meet health and/or safety standards at the time of inspection may Count, Bankruptcy,Judgment, Collection-Counter and UCC Derog receive an OSHA violation. Total FDA NDC Drugs 177 The total number of FDA Drugs filed in the FDA NDC Drug Database. Business Description Johnson & Johnson is engaged in the research and development, manufacture and sale of a range of products in the healthcare field. -
1851022002T Hydrocortisone Ointment 0.5% Mac's
List of Drugs Registered in Accordance with the provisions of the Food and Drugs Act and Regulations Chapter 30:01 Year 2002 DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF OF SALE ORIGIN 1851022002T Hydrocortisone Ointment Mac’s Pharmaceuticals Jamaica Third Schedule 0.5% 1852022002T Hydrocortisone Ointment Mac’s Pharmaceuticals Jamaica Third Schedule 1% 1853022002T Hydrocortisone Cream Mac’s Pharmaceuticals Jamaica Third Schedule 0.5% 1854022002T Hydrocortisone Cream Mac’s Pharmaceuticals Jamaica Third Schedule 1% 1855022002 New-Glow Antifungal Mac’s Pharmaceuticals Jamaica Freely Solution 1856022002 Paradmol Tablets Mac’s Pharmaceuticals Jamaica Freely 1857022002 Paradmol Elixir Mac’s Pharmaceuticals & Jamaica Freely Cosmetics 1858022002 Paradmol Elixir - Alcohol Mac’s Pharmaceuticals & Jamaica Freely Free Cosmetics 1859022002T Cifran Injection Ranbaxy Laboratories India Third Schedule 200mg/100ml Limited 1739022002 Bell’s Antiseptic Cream Adams Healthcare England Freely England for Bell, Sons & Co (Druggists) Ltd. 1740022002 Menthodex Lozenges Bell, Sons & Co England Freely (Druggists) Ltd. 1741022002 Proactin Syrup Meyer Organics Ltd. India Freely 1742022002T Intaxel Injection Dabur India Ltd. India Third Schedule 100mg/17ml (Pharmaceutical Division) 1743022002T Topotel Injection Dabur India Ltd. India Third Schedule Concentrate 4mg (Pharmaceutical Division) DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF OF SALE ORIGIN 1744022002T Cytarine Injection 100mg Dabur India Ltd. India Third Schedule (Pharmaceutical Division) 1745022002 HbRich Syrup Naxpar Lab. Pvt. Ltd. India Freely 1746022002 HbRich-300 Composite Wockhardt Limited India Freely Pack 1747022002 Juvelon Capsules Wockhardt Limited India Freely 1748022002T Aerobon Inhaler Wockhardt Limited India Third Schedule 100mcg/dose 1749022002 Ehrlich Balsam Joint Ehrlich Pharma Allgauer Germany Freely +Muscle Balsam Heilmoor Ehrlich GmbH 1750022002T FluaRIX Junior SSW Dresden a branch Germany Third Schedule Inactivated Split Influenza of SB Pharma GmbH & Vaccine - Suspension for Co. -
Current State and Challenges in Developing Respiratory Syncytial Virus Vaccines
Review Current State and Challenges in Developing Respiratory Syncytial Virus Vaccines Carlotta Biagi 1, Arianna Dondi 1,* , Sara Scarpini 1 , Alessandro Rocca 1, Silvia Vandini 2, Giulia Poletti 1 and Marcello Lanari 1 1 Pediatric Emergency Unit, Department of Medical and Surgical Sciences (DIMEC), Sant’Orsola University Hospital, 40138 Bologna, Italy; [email protected] (C.B.); [email protected] (S.S.); [email protected] (A.R.); [email protected] (G.P.); [email protected] (M.L.) 2 Pediatric and Neonatology Unit, Imola Hospital, 40026 Imola (Bologna), Italy; [email protected] * Correspondence: [email protected]; Tel.: +39-051-2144635; Fax: +39-051-2144440 Received: 14 October 2020; Accepted: 10 November 2020; Published: 11 November 2020 Abstract: Respiratory syncytial virus (RSV) is the main cause of acute respiratory tract infections in infants and it also induces significant disease in the elderly. The clinical course may be severe, especially in high-risk populations (infants and elderly), with a large number of deaths in developing countries and of intensive care hospitalizations worldwide. To date, prevention strategies against RSV infection is based on hygienic measures and passive immunization with humanized monoclonal antibodies, limited to selected high-risk children due to their high costs. The development of a safe and effective vaccine is a global health need and an important objective of research in this field. A growing number of RSV vaccine candidates in different formats (particle-based vaccines, vector-based vaccines, subunit vaccines and live-attenuated vaccines) are being developed and are now at different stages, many of them already being in the clinical stage. -
INTERNATIONAL STUDENT COVID VACCINE LIST and COMMUNICATION Dear International Student
INTERNATIONAL STUDENT COVID VACCINE LIST and COMMUNICATION Dear International Student We have provided a list of Selected Countries to help you find the COVID-19 vaccine you may have already received. Please see the “WHO” list below to find your COVID-19 vaccine, and if it has been APPROVED. And please upload your record following these directions: https://youtu.be/wvBGeRqIMHc If you see that your vaccine HAS NOT yet been approved by “WHO”, you may be required to receive an approved COVID-19 vaccine and upload those records to meet UC campus policy and requirements. Many US Airports are now providing COVID-19 vaccine on-site. Here is a list of several California Airports that you may arriving where you may receive a vaccine IMMEDIATELY upon your entry into the U.S. LAX – Los Angeles https://www.flylax.com/TravelSafely SNA – Orange County https://hoagurgentcare.com/airport/ SFO – San Francisco https://www.flysfo.com/travel-well/vaccination-site-sfo If you have any additional questions or concerns, please call (949)824-2300 for support. THANK YOU for helping to ensure UCI continues to be a SAFE and HEALTHY Campus! Dr Chang INDIA SOUTH KOREA TAIWAN INDONESIA VIETNAM JAPAN Vaccine Vaccine Vaccine Vaccine Vaccine Vaccine Oxford–AstraZeneca Oxford-AstraZeneca Sinovac Sputnik V Pfizer–BioNTech Covishield Pfizer–BioNTech Oxford–AstraZeneca Oxford–AstraZeneca Sinopharm Janssen Sinopharm Moderna Pfizer–BioNTech Moderna Pfizer–BioNTech Moderna Moderna Covaxin Novavax Moderna Johnson & Johnson Oxford–AstraZeneca Sputnik V Novavax Nanocovax Johnson & Johnson Sputnik V COVIVAC Sputnik V CanSino Vabiotech MVC-COV1901 ZyCoV-D Corbevax Covovax . -
Annual Report
ANNUAL REPORT 2019 MARCH 2020 To Our Shareholders Alex Gorsky Chairman and Chief Executive Officer By just about every measure, Johnson & These are some of the many financial and Johnson’s 133rd year was extraordinary. strategic achievements that were made possible by the commitment of our more than • We delivered strong operational revenue and 132,000 Johnson & Johnson colleagues, who adjusted operational earnings growth* that passionately lead the way in improving the health exceeded the financial performance goals we and well-being of people around the world. set for the Company at the start of 2019. • We again made record investments in research and development (R&D)—more than $11 billion across our Pharmaceutical, Medical Devices Propelled by our people, products, and and Consumer businesses—as we maintained a purpose, we look forward to the future relentless pursuit of innovation to develop vital with great confidence and optimism scientific breakthroughs. as we remain committed to leading • We proudly launched new transformational across the spectrum of healthcare. medicines for untreated and treatment-resistant diseases, while gaining approvals for new uses of many of our medicines already in the market. Through proactive leadership across our enterprise, we navigated a constant surge • We deployed approximately $7 billion, of unique and complex challenges, spanning primarily in transactions that fortify our dynamic global issues, shifting political commitment to digital surgery for a more climates, industry and competitive headwinds, personalized and elevated standard of and an ongoing litigious environment. healthcare, and that enhance our position in consumer skin health. As we have experienced for 133 years, we • And our teams around the world continued can be sure that 2020 will present a new set of working to address pressing public health opportunities and challenges.