Frontiers in Dermatology and Venereology - a Series of Theme Issues in Relation to the 100-Year Anniversary of Actadv
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WO 2015/063180 Al 7 May 2015 (07.05.2015) P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2015/063180 Al 7 May 2015 (07.05.2015) P O P C T (51) International Patent Classification: (74) Agent: WILLIAMS, Rachel; Novozymes Biopharma UK A61K 39/00 (2006.01) C07K 16/00 (2006.01) Ltd., Castle Court, 59 Castle Boulevard, Nottingham Not A61K 39/395 (2006.01) tinghamshire NG7 1FD (GB). (21) International Application Number: (81) Designated States (unless otherwise indicated, for every PCT/EP2014/073261 kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (22) International Filing Date: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, 29 October 2014 (29.10.2014) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (25) Filing Language: English HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (26) Publication Language: English MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, (30) Priority Data: PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 13 190750.3 29 October 2013 (29. 10.2013) EP SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 14166865.7 2 May 2014 (02.05.2014) EP TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (71) Applicant: NOVOZYMES BIOPHARMA DK A S (84) Designated States (unless otherwise indicated, for every [DK/DK]; Krogshoejvej 36, DK-2880 Bagsvaerd (DK). -
Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models. -
United States Atopic Dermatitis (AD) Market Report 2021
Source: Research and Markets July 28, 2021 04:08 ET United States Atopic Dermatitis (AD) Market Report 2021 Dublin, July 28, 2021 (GLOBE NEWSWIRE) -- The "Atopic Dermatitis (AD) - US Market Insight, Epidemiology and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering. This 'Atopic Dermatitis (AD) - Market Insights, Epidemiology and Market Forecast- 2030' report delivers an in- depth understanding of the Atopic Dermatitis (AD), historical and forecasted epidemiology as well as the Atopic Dermatitis (AD) market trends in the United States. Key Findings The total prevalent population of AD in the United States was estimated to be 32,197,083 in 2020. The total diagnosed prevalent population of AD in the United States was estimated to be 25,091,967 in 2020. The prevalent population of AD in the United States is expected to increase at a CAGR of 0.58% during the study period 2018-2030. In the United States, the total number of adult cases of AD comprised of 5,684,566 males and 9,421,907 females in 2020. The total number of cases of mild AD were 9,065,394 in the United States, in 2020, as compared to the cases of moderate and severe AD with 4,365,771 and 1,661,712 cases respectively, in adults. In children, the total number of cases of mild AD were 6,690,281, in 2020, as compared to the cases of moderate and severe AD with 2,596,228 and 698,985 cases respectively, in the United States. Report Highlights In the coming years, Atopic Dermatitis (AD) market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. -
Novartis R&D and Investor Update
Novartis AG Investor Relations Novartis R&D and investor update November 5, 2018 Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” “agreement to acquire,” or similar expressions, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this presentation, or regarding potential future revenues from such products, or regarding the proposed acquisition of Endocyte, Inc. (Endocyte) by Novartis including the potential outcome and expected timing for completion of the proposed acquisition, and the potential impact on Novartis of the proposed acquisition, including express or implied discussions regarding potential future sales or earnings of Novartis, and any potential strategic benefits, synergies or opportunities expected as a result of the proposed acquisition. 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 presentation 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. -
Newsletter of the Bromeliad Society of Central Florida Next Meeting Monday January 26 Puya Raimondii
Orlandiana Newsletter of the Bromeliad Society of Central Florida Volume No. 30 Issue No. 01 January 2004 Next Meeting Monday January 26 Puya raimondii Puya raimondii, one of the world’s most remarkable bromeliads, is the largest known bromeliad, forming a dense rosette of bayonette-like leaves six feet or more in diameter. Legend has it that a plant takes 150 years to flower. More recent estimates reduce the time for maturity to between 80 and 100 years. The plant flowers just once in its life, flowering usually takes place in the month of May, when a huge central stem (the largest inflorescence in the plant kingdom), is pushed up thirty feet or more into the sky, covered in some eight thousand individual blooming flowers. It is an unbelievable sight set against a spectacular snowy mountain backdrop, but is seldom seen because it grows in remote high altitude habitats rarely visited by travelers. Enormous energy is required to produce such a massive flower, a feat this plant can only accomplish once in a lifetime. After it blooms, it dies without forming offsets. Continued on page 6 President’s Message busy with the Mother’s Day Show. Steven Wagner has agreed to continue as newsletter editor, so send Happy New Year! I hope everyone had a safe him your ideas, recipes and items for the newsletter. and good holiday season. Sue Rhodes and Kathy Phinney are handling the refreshment table for us. Sudi and Phyllis are our We certainly finished 2003 with a great Holiday librarians. Party. Thank you, Betsy McCrory and Phyllis Baumer for coordinating the party, the food, the Join us this month for a program by George Aldrich decorations and the bromeliads – a big thanks to and be sure to bring those Show and Tell plants, for Paul DeRoose and Buddy McCrory for their bragging on blooms, identification or cultivation generous bromeliad donations. -
Meetei Mayek
Meetei Mayek http://arbornet.org/~prava/eeyek/ Meetei Mayek Meetei-Mayek is the script which was used to write Meeteilon (Manipuri) till the 18th century. The script nearly became extinct as a result of a mass burning of all books in Meeteilon ordered by Ningthau Pamheiba who ruled Manipur in the 18th century. The main person behind this atrocity was Shantidas Gosain who had come to Manipur to spread Vaishnavism, on whose instigation the king gave the order. The king embraced Vaishnavism, took the name Garibnawaz and made Vaishnavism the state religion. Subsequently, Bengali script was adopted to write the language and is being used till date. Recent research has resurrected this script, and it is now being given its due place. The Script History of Meetei Mayek We introduce the Meetei Mayek TrueType Font, which allows you to do everything you are used to doing in English, in the Meetei Mayek script! This means, you can Type documents in Meetei Mayek using MS-Word, or any Windows word processor of your choice Create WebPages in Meetei Mayek Send and Receive Emails in Meetei Mayek using any email software of your choice Do desktop publishing in Meetei Mayek and much more. This font is free! (because some of the best things in life are free) :-) The main idea behind creating this font is to make Meetei Mayek popular, by giving everybody a simple way to use it on the computer, without having to learn and use any new software. This font is also intended to introduce Meetei Mayek into the world of internet and World Wide Web, by paving a way for creating Web pages and exchanging emails in Meetei Mayek. -
PDCO Minutes of Meeting 18-21 May 2021
21 May 2021 EMA/PDCO/298607/2021 Human Medicines Division Paediatric Committee (PDCO) Minutes for the meeting on 18-21 May 2021 Chair: Koenraad Norga – Vice-Chair: Sabine Scherer Virtual Meeting Disclaimers Some of the information contained in this set of minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the PDCO Committee meeting reports (after the PDCO Opinion is adopted), and on the Opinions and decisions on paediatric investigation plans webpage (after the EMA Decision is issued). Of note, this set of minutes is a working document primarily designed for PDCO members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on-going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. -
Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products. -
Inflarx N.V. 2020 Dutch Board Report
InflaRx N.V. Dutch statutory board report and financial statements for the financial year ended December 31, 2020 - 1 - TABLE OF CONTENTS 1 Introduction ............................................................................................................................... 4 1.1 Preparation ................................................................................................................................. 4 1.2 Forward-looking statements ...................................................................................................... 4 2* Risk factors ................................................................................................................................ 7 2.1 Summary of key risk factors ...................................................................................................... 7 2.2 Risk factors ................................................................................................................................ 7 2.2.1 Risks related to our financial position and need for additional capital. ..................................... 7 2.2.2 Risks related to the discovery, development and commercialization of our product candidates. ................................................................................................................................................... 9 2.2.3 Risks related to our dependence on third parties ..................................................................... 20 2.2.4 Risks related to our intellectual property ................................................................................ -
Investor Presentation
Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Q1 2021 Results Investor presentation 1 Investor Relations │ Q1 2021 Results Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the impact of the COVID-19 pandemic on certain therapeutic areas including dermatology, ophthalmology, our breast cancer portfolio, some newly launched brands and the Sandoz retail and anti-infectives business, and on drug development operations; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings of the Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions; or regarding the Group’s liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our collaboration with Molecular Partners to develop, manufacture and commercialize potential medicines for the prevention and treatment of COVID- 19 and our joining of the industry-wide efforts to meet global demand for COVID-19 vaccines and therapeutics by leveraging our manufacturing capacity and capabilities to support the production of the Pfizer-BioNTech vaccine and to manufacture the mRNA and bulk drug product for the vaccine candidate CVnCoV from CureVac. -
Conference Reportpeer-Reviewed
Medicom International Conference Series in Dermatology 28th EADV Congress European Academy of Dermatology and Venereology 9-13 october 2019 • Madrid • Spain EVIEWED R PEER- CONFERENCE CONFERENCE REPORT Late-Breaking News Emerging Therapies Spotlight on Psoriasis JAK inhibitors are a fascinating The IL-4/IL-13 blocker dupilumab Ten-year data from the ESPRIT novel drug class entering the der- leads to rapid itch reduction in registry shows the importance of matologic arena. The JAK1 and adolescents. The safety profile is achieving good control of moderate- JAK2 inhibitor baricitinib showed similar to that in adults. to-severe psoriasis. to be effective in patients with moderate-to-severe atopic derma- titis in a phase 3 trial. read more on PAGE 5 read more on PAGE 10 read more on PAGE 13 Editor Peter van de Kerkhof, Radboud University Medical Center, the Netherlands MEDIC AL PUBLISHERS Contents Letter from the Editor 3 Late-Breaking News 3 IL-17A blocker effective in paediatric psoriasis patients 3 Rituximab beats mycophenolate mofetil in pemphigus vulgaris COLOPHON 4 Novel JAK1/2 inhibitor shows remarkable efficacy in alopecia areata Editor Prof. Peter van de Kerkhof Radboud University Medical Center, 5 Acne highly influenced by climate, pollutants, and unhealthy diet the Netherlands 5 JAK inhibition plus TCS lead to high clearance rates in AD Advisory Board Prof. Margarida Gonçalo 6 No cancer risk with long-term use of calcineurin inhibitor in Coimbra University Hospital, Portugal children with AD Dr Tom Hillary UZ Leuven, Belgium 7 Green -
Historical Evaluation of Puya Meithaba: a Contemporary Re
Imphal Times Supplementary issue 22 Editorial Historical Evaluation of Puya Meithaba: Friday, July, 13, 2018 A Contemporary Re-interpretation Recreation- a By- Dr. Lokendra Arambam binary dimensions of the divide. unprecedented. During the process, of the people was moving forward Some are of the positive character the rough outlines and the cultural into a period of great vitality and The indigenous civilization the of Manipur civilization in the light and ethnic structuring of the future conflictual dynamism, which were Serious Business Manipuris developed throughout of the synthesis between Indian nation-states were imperceptibly met with deep grandeur, grace and The enigmatic cycle of our modern world has everyone its history had a cataclysmic rupture and Manipur cultures while others settled. capability of sacrifice! The martial in it’s grip- people devoting increasingly longer time in the early eighteenth century are of deep distrust for the The pre-occupation of both race reached its zenith of splendour, and efforts in their work for higher financial returns when the emerging world religion hegemonizing, cultural imperialistic indigenous and colonial authorities and new demands were met on the of Hinduism was enforced unto the hegemony of the Indian civilization (European empire builders in aspirations for greatness, power which will be utilized for amassing more goods and unwilling Meitei population over the Manipur people thereby Southeast Asia) was primarily with and exuberance by the collective services pushing up demands and subsequently the through the use of state power and blaming Indian culture for the the procurement of security and the labour of the people. Why did the prices thus forcing people to work even harder to violence.