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FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adu – PharmiWeb.com

DGAP-News: MorphoSys AG / Key word(s): Regulatory Approval 01.08.2020 / 01:43 The issuer is solely responsible for the content of this announcement.

FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

- First FDA approval of a second-line treatment for adult patients with relapsed or refractory DLBCL, helping fill a high unmet medical need

- FDA granted Monjuvi Fast Track, Breakthrough Therapy and Priority Review designations

- MorphoSys and Incyte will co-commercialize Monjuvi in the United States

- Joint analyst and investor conference call and webcast scheduled for Monday, August 3, 2020 at 8:00 a.m. EDT / 2:00 p.m. CEST

PLANEGG/MUNICH, Germany - August 1, 2020 and WILMINGTON, Del. - July 31, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).1 Monjuvi, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, has been approved under accelerated approval by the U.S. FDA based on overall response rate (ORR). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide2, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter.3 In the United States each year approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for ASCT.4,5,6

"We are incredibly proud that the FDA has approved Monjuvi in combination with lenalidomide as the first treatment in second-line for patients with relapsed or refractory DLBCL, and we thank all the health care professionals, patients and families involved in our Monjuvi trials," said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys. "This approval marks an important step in MorphoSys' transformation into a fully integrated biopharmaceutical company. We remain committed to developing innovative treatments to improve the lives of patients with serious diseases."

"The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States," said Herv Hoppenot, Chief Executive Officer, Incyte. "At Incyte we are committed to advancing patient care and are proud to bring this new and much-needed targeted therapeutic option to appropriate patients and the clinical community."

"The FDA approval of Monjuvi brings a new treatment option to patients in dire need across the United States," said Professor Gilles Salles, M.D., Chair of the Clinical Hematology Department at the University of Lyon, France, and lead investigator of the L-MIND study. "Today's FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy."

The FDA approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter, single arm trial of Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL. Results from the study showed an overall response rate (ORR) of 55% (primary endpoint), including a complete response (CR) rate of 37% and a partial response rate (PR) of 18%. The median duration of response (mDOR) was 21.7 months (key secondary endpoint).1 Warnings and Precautions for Monjuvi included infusion-related reactions (6%), serious or severe myelosuppression (including neutropenia (50%), thrombocytopenia (18%), and anemia (7%)), infections (73%) and embryo-fetal toxicity. Neutropenia led to treatment discontinuation in 3.7% of patients. The most common adverse reactions (>= 20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.

The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL. FDA Breakthrough Therapy designation is intended to expedite development and review of drug candidates. It is granted if preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over existing therapies in the treatment of a serious or life-threatening disease. The Biologics License Application (BLA) for Monjuvi was granted Priority Review and approved under the FDA's Accelerated Approval program.

Monjuvi is expected to be commercially available in the United States shortly. MorphoSys and Incyte will co-commercialize Monjuvi in the United States. Incyte has exclusive commercialization rights outside the United States.

MorphoSys and Incyte are committed to supporting patients throughout their treatment journeys and are working together to help lower patient access barriers. As part of this commitment, the Companies have launched My Mission Support, a robust patient support program offering financial assistance, ongoing education and other resources to eligible patients who are prescribed Monjuvi in the United States. Program information will be available online at http://www.MyMissionSupport.com.

Conference Call Information MorphoSys and Incyte will host an analyst and investor conference call and webcast on Monday, August 3, 2020 at 8:00 a.m. EDT / 2:00 p.m. CEST. The live webcast and replay will be available via http://www.morphosys.com and investor.incyte.com.

To access the conference call, please dial 877-407-3042 for callers in the United States or +1 201-389-0864 for callers outside the United States. When prompted, provide the conference identification number 13706810.

If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is +1 201-612-7415. To access the replay, you will need the conference identification number 13706810.

About L-MIND The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant The study's primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion.

For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085.

About Monjuvi(R) (tafasitamab-cxix) Monjuvi is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize Monjuvi globally. Monjuvi will be co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG. XmAb(R) is a registered trademark of Xencor, Inc.

Important Safety Information What are the possible side effects of MONJUVI? MONJUVI may cause serious side effects, including:

- Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.

- Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or any bruising or bleeding.

- Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or develop any signs and symptoms of an infection.

The most common side effects of MONJUVI include:

- Feeling tired or weak

- Diarrhea

- Cough

- Fever

- Swelling of lower legs or hands

- Respiratory tract infection

- Decreased appetite

These are not all the possible side effects of MONJUVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

- Have an active infection or have had one recently.

- Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

- You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.

- Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.

- Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, 27 of which are currently in clinical development. In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at http://www.morphosys.com.

Tremfya(R) is a registered trademark of Janssen Biotech.

About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

MorphoSys Forward-Looking Statements This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding tafasitamab's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab as well as the commercial performance of tafasitamab. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab as well as the commercial performance of tafasitamab, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: tafasitamab's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab, including ongoing confirmatory trials , additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab as well as the commercial performance of tafasitamab. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: obtaining regulatory approval for this planned collaboration; research and development efforts related to the collaboration programs; the possibility that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; other market or economic factors, including other scientific developments; unanticipated delays; the effects of market competition; risks associated with relationships between collaboration partners; the impact of governmental actions regarding pricing, importation and reimbursement for pharmaceuticals; and such other risks detailed from time to time in each company's reports filed with the U.S. Securities and Exchange Commission, including Incyte's annual report on Form 10-Q for the quarter ending March 31, 2020 and MorphoSys' Annual Report on Form 20-F for the fiscal year ended December 31, 2019. Each party disclaims any intent or obligation to update these forward-looking statements.

References

1. Monjuvi(R) (tafasitamab-cxix) Prescribing Information. Boston, MA, MorphoSys.

2. Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209-16. doi.org/10.1016/j.beha.2018.07.014.

3. Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253-265. doi.org/10.3747/co.26.5421.

4. DRG Epidemiology data.

5. Kantar Market Research (TPP testing 2018).

6. Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.

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01.08.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.

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FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adu - PharmiWeb.com

Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment Market 2020 Dynamics, Segments, Size, Share, Industry Demand and Growth Opportunities to 2026 -…

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Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment Market 2020 Dynamics, Segments, Size, Share, Industry Demand and Growth Opportunities to 2026 -...

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The report provides a 5-year forecast (2020-2025) assessed based on how the global Allogeneic Stem Cell Therapy market is predicted to grow in major regions like: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia), South America (Brazil, Argentina), MENA (Saudi Arabia, UAE, Turkey and South Africa)

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Global Allogeneic Stem Cell Therapy Market 2020 Research by Business Analysis, Growth Strategy and Industry Development to 2025 - Galus Australis

Global Stem Cell Assay Market 2020 Trends Analysis and Coronavirus (COVID-19) Effect Analysis | Key Players Market With COVID-19 Impact Analysis, In…

The globalStem Cell Assay marketreport has been updated by theMarket Data Analyticsowing to the changed market conditions because of COVID-19. Although, the world is still in hope that everything will come back to normal but the WHO finds no positive signs. The WHO has clearly mentioned that people will have to start living with this disease as there are very less chances that the coronavirus infection will go. The conditions in the global market have changed drastically and every single country is facing economic crunch owing to the slowing down of the business. Thus, it was necessary to update the Stem Cell Assay market report.

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The latest report consists of the following parts:

Part 1 In the first part of the Stem Cell Assay market report the market introduction or the market overview is included. In this part the target audience for the Stem Cell Assay market is also defined for better understanding the market and clients.

Part 2 In the second part the research methodologies and the market tools that were incorporated for studying the market is explained in detail. There are also details about the primary and secondary researches that were conducted by the research analysts.

Read Detailed Index of full Research Study at::https://www.marketdataanalytics.biz/worldwide-stem-cell-assay-market-report-2020-industry-analysis-37617.html

Part 3 In the third part the qualitative information about the Stem Cell Assay market is included. This information is mainly about the Stem Cell Assay market drivers, restraints, opportunities, and challenges.

Part 4 The fourth part of the report deals with the market segmentation. The Stem Cell Assay market includes the following segmentations:{Dermatology Stem Cell Assay, Cardiovascular Stem Cell Assay, Central Nervous System Stem Cell Assay, Oncology Stem Cell Assay, Other};{Regenerative Medicine & Therapy Development, Drug Discovery and Development, Clinical Research, Other}. A detailed analysis of every single category in the market segments has been included. The data includes both statistics and qualitative information which are depicted in the form of tables and figures in the report.

Part 5 Geographical presence of the Stem Cell Assay market in the major regions such as North America, Europe, Latin America, Asia Pacific, and the Middle East and Africa is described in detail.

Part 6 The major market players in the Stem Cell Assay market includeGE Healthcare, Promega Corporation, Thermo Fisher Scientific, Merck KGaA, Bio-Rad Laboratories, Bio-Techne Corporation, Cellular Dynamics International, Cell Biolabs, Hemogenix, Stemcell Technologies. Along with these many other industry players are profiled in this section.

Part 7 The last part deals with the market conclusions. The conclusions mainly include the observations and the comments from the research analysts and the market experts.

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Cell Therapy Manufacturing Market is estimated to reach close to USD 11 Billion by 2030, predicts Roots Analysis – Market Research Posts

Manufacturing cell therapies is technically and financially demanding; as a result, despite therapy developers gradually strengthening their in-house expertise, they are also becoming increasingly reliant on contract service providers

Roots Analysis is pleased to announce the publication of its recent study, titled, Cell Therapy Manufacturing Market (3rd Edition), 2019 2030.

The report features an extensive study of the current market landscape and future opportunities associated with cell therapy manufacturing. It focuses on both contract manufacturers, as well as developers with in-house manufacturing facilities, offering in-depth analyses of the various business entities that are engaged in this domain, across different global regions. Amongst other elements, the report includes:

Read Detailed Analysis: https://www.rootsanalysis.com/reports/view_document/cell-therapy-manufacturing/285.html

A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Type of therapy

Source of cells

Scale of operation

Purpose of manufacturing

Key geographical regions

Key companies covered in the report

For more information, please click on the following link:

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Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If youd like help with your growing business needs, get in touch at [emailprotected]

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Cell Therapy Manufacturing Market is estimated to reach close to USD 11 Billion by 2030, predicts Roots Analysis - Market Research Posts

Trending Now: Retinal Dystrophy Treatment Market Size, Analytical Overview, Growth Factors, Demand, Trends and Forecast to 2026|, Spark Therapeutics…

LOS ANGELES, United States: QY Research has recently published a report, titled Global and China Retinal Dystrophy Treatment Market Size, Status and Forecast 2020-2026. The research report gives the potential headway openings that prevails in the global market. The report is amalgamated depending on research procured from primary and secondary information. The global Global and China Retinal Dystrophy Treatment market is relied upon to develop generously and succeed in volume and value during the predicted time period. Moreover, the report gives nitty gritty data on different manufacturers, region, and products which are important to totally understanding the market.

Key Companies/Manufacturers operating in the global Global and China Retinal Dystrophy Treatment market include: , Spark Therapeutics (Roche), Novartis AG, GlaxoSmithKline, Applied Genetic Technologies Corporation, Oxford BioMedica, Biogen, HORAMA S.A., MeiraGTx Limited, Novelion Therapeutics, IVERIC bio, Reflection Biotechnologies

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

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Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Global and China Retinal Dystrophy Treatment market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Global Global and China Retinal Dystrophy Treatment Market Segment By Type:

Gene Therapy Treatment Symptomatic Treatment Retinal Dystrophy Treatment

Global Global and China Retinal Dystrophy Treatment Market Segment By Application:

Hospitals Specialty Clinics Others Based on

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global Global and China Retinal Dystrophy Treatment market.

Key companies operating in the global Global and China Retinal Dystrophy Treatment market include , Spark Therapeutics (Roche), Novartis AG, GlaxoSmithKline, Applied Genetic Technologies Corporation, Oxford BioMedica, Biogen, HORAMA S.A., MeiraGTx Limited, Novelion Therapeutics, IVERIC bio, Reflection Biotechnologies

Key questions answered in the report:

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TOC

1 Report Overview 1.1 Study Scope 1.2 Market Analysis by Type 1.2.1 Global Retinal Dystrophy Treatment Market Size Growth Rate by Type: 2020 VS 2026 1.2.2 Gene Therapy Treatment 1.2.3 Symptomatic Treatment 1.3 Market by Application 1.3.1 Global Retinal Dystrophy Treatment Market Share by Application: 2020 VS 2026 1.3.2 Hospitals 1.3.3 Specialty Clinics 1.3.4 Others 1.4 Study Objectives 1.5 Years Considered 2 Global Growth Trends 2.1 Global Retinal Dystrophy Treatment Market Perspective (2015-2026) 2.2 Global Retinal Dystrophy Treatment Growth Trends by Regions 2.2.1 Retinal Dystrophy Treatment Market Size by Regions: 2015 VS 2020 VS 2026 2.2.2 Retinal Dystrophy Treatment Historic Market Share by Regions (2015-2020) 2.2.3 Retinal Dystrophy Treatment Forecasted Market Size by Regions (2021-2026) 2.3 Industry Trends and Growth Strategy 2.3.1 Market Trends 2.3.2 Market Drivers 2.3.3 Market Challenges 2.3.4 Market Restraints 3 Competition Landscape by Key Players 3.1 Global Top Retinal Dystrophy Treatment Players by Market Size 3.1.1 Global Top Retinal Dystrophy Treatment Players by Revenue (2015-2020) 3.1.2 Global Retinal Dystrophy Treatment Revenue Market Share by Players (2015-2020) 3.2 Global Retinal Dystrophy Treatment Market Share by Company Type (Tier 1, Tier 2 and Tier 3) 3.3 Players Covered: Ranking by Retinal Dystrophy Treatment Revenue 3.4 Global Retinal Dystrophy Treatment Market Concentration Ratio 3.4.1 Global Retinal Dystrophy Treatment Market Concentration Ratio (CR5 and HHI) 3.4.2 Global Top 10 and Top 5 Companies by Retinal Dystrophy Treatment Revenue in 2019 3.5 Key Players Retinal Dystrophy Treatment Area Served 3.6 Key Players Retinal Dystrophy Treatment Product Solution and Service 3.7 Date of Enter into Retinal Dystrophy Treatment Market 3.8 Mergers & Acquisitions, Expansion Plans 4 Retinal Dystrophy Treatment Breakdown Data by Type (2015-2026) 4.1 Global Retinal Dystrophy Treatment Historic Market Size by Type (2015-2020) 4.2 Global Retinal Dystrophy Treatment Forecasted Market Size by Type (2021-2026) 5 Retinal Dystrophy Treatment Breakdown Data by Application (2015-2026) 5.1 Global Retinal Dystrophy Treatment Historic Market Size by Application (2015-2020) 5.2 Global Retinal Dystrophy Treatment Forecasted Market Size by Application (2021-2026) 6 North America 6.1 North America Retinal Dystrophy Treatment Market Size (2015-2026) 6.2 North America Retinal Dystrophy Treatment Market Size by Type (2015-2020) 6.3 North America Retinal Dystrophy Treatment Market Size by Application (2015-2020) 6.4 North America Retinal Dystrophy Treatment Market Size by Country (2015-2020) 6.4.1 United States 6.4.2 Canada 7 Europe 7.1 Europe Retinal Dystrophy Treatment Market Size (2015-2026) 7.2 Europe Retinal Dystrophy Treatment Market Size by Type (2015-2020) 7.3 Europe Retinal Dystrophy Treatment Market Size by Application (2015-2020) 7.4 Europe Retinal Dystrophy Treatment Market Size by Country (2015-2020) 7.4.1 Germany 7.4.2 France 7.4.3 U.K. 7.4.4 Italy 7.4.5 Russia 7.4.6 Nordic 7.4.7 Rest of Europe 8 China 8.1 China Retinal Dystrophy Treatment Market Size (2015-2026) 8.2 China Retinal Dystrophy Treatment Market Size by Type (2015-2020) 8.3 China Retinal Dystrophy Treatment Market Size by Application (2015-2020) 8.4 China Retinal Dystrophy Treatment Market Size by Region (2015-2020) 8.4.1 China 8.4.2 Japan 8.4.3 South Korea 8.4.4 Southeast Asia 8.4.5 India 8.4.6 Australia 8.4.7 Rest of Asia-Pacific (2015-2020) (2015-2020) .4 Retinal Dystrophy Treatment Market Size by Country (2015-2020) 9.4.1 Mexico 9.4.2 Brazil .4 Retinal Dystrophy Treatment Market Size by Country (2015-2020) 10.4.1 Turkey 10.4.2 Saudi Arabia 10.4.3 UAE 10.4.4 Rest of Middle East & Africa 9 Key Players Profiles 9.1 Spark Therapeutics (Roche) 9.1.1 Spark Therapeutics (Roche) Company Details 9.1.2 Spark Therapeutics (Roche) Business Overview 9.1.3 Spark Therapeutics (Roche) Retinal Dystrophy Treatment Introduction 9.1.4 Spark Therapeutics (Roche) Revenue in Retinal Dystrophy Treatment Business (2015-2020)) 9.1.5 Spark Therapeutics (Roche) Recent Development 9.2 Novartis AG 9.2.1 Novartis AG Company Details 9.2.2 Novartis AG Business Overview 9.2.3 Novartis AG Retinal Dystrophy Treatment Introduction 9.2.4 Novartis AG Revenue in Retinal Dystrophy Treatment Business (2015-2020) 9.2.5 Novartis AG Recent Development 9.3 GlaxoSmithKline 9.3.1 GlaxoSmithKline Company Details 9.3.2 GlaxoSmithKline Business Overview 9.3.3 GlaxoSmithKline Retinal Dystrophy Treatment Introduction 9.3.4 GlaxoSmithKline Revenue in Retinal Dystrophy Treatment Business (2015-2020) 9.3.5 GlaxoSmithKline Recent Development 9.4 Applied Genetic Technologies Corporation 9.4.1 Applied Genetic Technologies Corporation Company Details 9.4.2 Applied Genetic Technologies Corporation Business Overview 9.4.3 Applied Genetic Technologies Corporation Retinal Dystrophy Treatment Introduction 9.4.4 Applied Genetic Technologies Corporation Revenue in Retinal Dystrophy Treatment Business (2015-2020) 9.4.5 Applied Genetic Technologies Corporation Recent Development 9.5 Oxford BioMedica 9.5.1 Oxford BioMedica Company Details 9.5.2 Oxford BioMedica Business Overview 9.5.3 Oxford BioMedica Retinal Dystrophy Treatment Introduction 9.5.4 Oxford BioMedica Revenue in Retinal Dystrophy Treatment Business (2015-2020) 9.5.5 Oxford BioMedica Recent Development 9.6 Biogen 9.6.1 Biogen Company Details 9.6.2 Biogen Business Overview 9.6.3 Biogen Retinal Dystrophy Treatment Introduction 9.6.4 Biogen Revenue in Retinal Dystrophy Treatment Business (2015-2020) 9.6.5 Biogen Recent Development 9.7 HORAMA S.A. 9.7.1 HORAMA S.A. Company Details 9.7.2 HORAMA S.A. Business Overview 9.7.3 HORAMA S.A. Retinal Dystrophy Treatment Introduction 9.7.4 HORAMA S.A. Revenue in Retinal Dystrophy Treatment Business (2015-2020) 9.7.5 HORAMA S.A. Recent Development 9.8 MeiraGTx Limited 9.8.1 MeiraGTx Limited Company Details 9.8.2 MeiraGTx Limited Business Overview 9.8.3 MeiraGTx Limited Retinal Dystrophy Treatment Introduction 9.8.4 MeiraGTx Limited Revenue in Retinal Dystrophy Treatment Business (2015-2020) 9.8.5 MeiraGTx Limited Recent Development 9.9 Novelion Therapeutics 9.9.1 Novelion Therapeutics Company Details 9.9.2 Novelion Therapeutics Business Overview 9.9.3 Novelion Therapeutics Retinal Dystrophy Treatment Introduction 9.9.4 Novelion Therapeutics Revenue in Retinal Dystrophy Treatment Business (2015-2020) 9.9.5 Novelion Therapeutics Recent Development 9.10 IVERIC bio 9.10.1 IVERIC bio Company Details 9.10.2 IVERIC bio Business Overview 9.10.3 IVERIC bio Retinal Dystrophy Treatment Introduction 9.10.4 IVERIC bio Revenue in Retinal Dystrophy Treatment Business (2015-2020) 9.10.5 IVERIC bio Recent Development 9.11 Reflection Biotechnologies 10.11.1 Reflection Biotechnologies Company Details 10.11.2 Reflection Biotechnologies Business Overview 10.11.3 Reflection Biotechnologies Retinal Dystrophy Treatment Introduction 10.11.4 Reflection Biotechnologies Revenue in Retinal Dystrophy Treatment Business (2015-2020) 10.11.5 Reflection Biotechnologies Recent Development 10 Analysts Viewpoints/Conclusions 11 Appendix 11.1 Research Methodology 11.1.1 Methodology/Research Approach 11.1.2 Data Source 11.2 Disclaimer 11.3 Author Details

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Global Cytokine Market 2020 Top Countries Data Industry Size, Share, Business Growth, Revenue, Trends, Market Demand Penetration and Forecast to By…

Global Cytokine Market Report 2020offers Complete analysis of industry status and outlook of major regions based on of key players, countries, product types, and end industries. This report focuses on the Cytokine in Global market, especially inUnited States, Europe, China, Japan, South Korea, North America, India.Cytokine Market report categorizes the market based on manufacturers, regions, type and application. Cytokine Report 2020 (value and volume) by company, regions, product types, end industries, history data and estimate data.

Also, Report contains a comprehensive analysis of the important segments like market opportunities, import/export details, market dynamics, key manufacturers, growth rate, and key regions. Cytokine Market report categorizes the market based on manufacturers, regions, type, and application. Cytokine Market reports offer a detailed assessment of the Cytokine including enabling technologies, current market situation, market assumptions, restraining factors.

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List of Top Key-players in 2020 of Cytokine Market:-

The Global Cytokine market swot is provided for the international markets including progress trends, competitive landscape breakdown, and key in regions development status. Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed.

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The Cytokine Market is expected to witness a CAGR of 7.9% during the forecast period. North America dominate the global market due to the increasing prevalence of cancer in that region.

Increased Acceptance in Cancer Therapy

Cytokines are critical for tumor immune surveillance, and have demonstrated therapeutic anti-tumor activity in murine models and in the clinical treatment of several human cancers. To date, two cytokines have FDA approval as single agents for cancer treatment: high-dose, bolus IL-2 for metastatic melanoma and renal cell carcinoma and IFN- for the adjuvant therapy of Stage III melanoma. So, increased acceptance in cancer therapy is driving market of Global Cytokine Market. Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. Mesenchymal stem cells (MSCs) have emerged as major new cell technology, with a diverse spectrum of potential clinical applications. So, its potential contribution in stem cell therapy is also driving the Global Cytokine Market. Additionally, potential biomarker for neonatal sepsis is also contributing towards the growth of Global cytokine market.

Short Half-Lives of Drug

Cytokines have inherently short half-life, which necessitates prolonged administration of cytokine therapies. This is a major problem in maintaining an effective dose over a long period. This becomes an even greater issue when cytokine is administered systematically. The short half-life of cytokines, the production of cytokines by cells in peripheral blood preparations, and the potential degradation make the stability, treatment, and storage of biological samples important factors in circulating cytokine measurement, analysis, and interpretation. Additionally, lacks of specificity in cytokines is also restraining the growth of Global Cytokine Market.

North America is dominating the market

North America is dominating the cytokine market due to the rising prevalence of cancer in that region. Numerous animal tumor model studies have demonstrated that cytokines have broad anti-tumor activity and this has been translated into a number of cytokine-based approaches for cancer therapy. As per the Cancer Statistics in 2016, an estimated 1.6 million new cases of cancer were diagnosed in the United States, with prevalence expected to rise to almost 19 million by 2024. Augmenting growth in the R&D of cancer therapy, along with lesser side effects (as compared to chemotherapy) have predisposed cytokine therapy, which is a non-specific immunotherapy. This factor has increased the market share of cytokines, among cancer therapies in the United States.

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Functional Coil Coatings Market 2020 Industry Insights by Share, Emerging Trends, Regional Analysis, Segments, Prime Players, Drivers, Growth Factor and Foreseen till 2026

Functional Coil Coatings Market 2020 Industry Insights by Share, Emerging Trends, Regional Analysis, Segments, Prime Players, Drivers, Growth Factor and Foreseen till 2026

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Global Cytokine Market 2020 Top Countries Data Industry Size, Share, Business Growth, Revenue, Trends, Market Demand Penetration and Forecast to By...

What’s On The Ballot? A Summary Of The 12 State Propositions For November 2020 Election – KHTS Radio

When Santa Clarita residents cast their ballots in November during the 2020 election, they will have the opportunity to vote on a dozen state propositions ranging from cash bail to affirmative action.

At the beginning of July, the Office of the California Secretary of State posted the 12 statewide ballot measures that had qualified for the 2020 election on Nov. 3.

Out of the dozen state propositions set to be voted on in November, eight were placed on the ballot by citizens and special interests, while four were put on by state legislators.

With issues ranging from lifting the decades-old ban on affirmative action to the fate of the cash bail system in California, here are the 12 state propositions Santa Clarita residents are set to vote on in November.

Bonds

Only one state bond measure made it onto the ballot this year, with this one going towards the funding of stem cell research.

Prop 14: Authorize Bonds to Continue Funding Stem Cell and Other Medical Research

This proposition would authorize $5.5 billion in state general obligation bonds to fund grants from the California Institute of Regenerative Medicine to educational, non-profit, and private entities for three things:

As part of this, $1.5 billion would also go towards funding research and therapy for Alzheimers, Parkinsons, stroke, epilepsy and other brain and central nervous system diseases and conditions, according to the propositions text.

See Related: COC Measure E Committee, COC Foundation Fined $14,500 For Campaign Violations

The California Institute for Regenerative Medicine was initially created after California voters passed Proposition 71 in 2004, which allowed the state to borrow roughly $3 billion to create the institute.

While payments on the bond would be postponed for an initial five years, money from the states General Fund would be used to pay back the estimated $7.8 billion cost of the bond (principal of $5.5 billion, interest of $2.3 billion).

Housing/Real Estate

There are three measures on the 2020 ballot that pertain to housing and real estate, including the controversial issues of rent control and the split roll tax.

Prop 15: Increases Funding for Public Schools, Community Colleges, and Local Government Services by Changing Tax Assessment of Commercial and Industrial Property

More commonly known as the split roll tax, this proposition would require certain commercial and industrial properties to be taxed based on their current market value, as opposed to the market value when the property was originally purchased.

Proposition 15 would overturn a portion of Proposition 13, a measure passed by California voters in 1978 that capped property taxes from increasing as the market value of a piece of property increased.

Residential and agricultural properties would be exempt from the measure, as well as commercial and industrial properties with a combined value of $3 million or less.

State officials say that an estimated $7.5 billion to $12 billion would be generated each year, the majority of which would go towards public schools and local governments.

Prop 19: ACA 11: The Home Protection for Seniors, Severely Disabled, Families, and Victims of Wildfire or Natural Disasters Act

This measure would allow eligible homeowners to transfer their tax assessments anywhere within the state and allow tax assessments to be transferred to a more expensive home with an upward adjustment

Additionally, it would increase the number of times that a person over the age of 55 or an individual with severe disabilities can transfer their tax assessments from one to three.

The measure also requires that any homes that a person inherits and does not use as a principal residence to be reassessed using the market value at the time of the transfer.

The majority of funds raised by this measure would go towards combating wildfires, as well as local counties.

Prop 21: Expands Local Governments Authority to Enact Rent Control on Residential Property

This proposition would amend state law to allow local governments to establish rent control on residential properties over 15 years old.

State legislators had previously passed a law in 2019 that set a seven percent ceiling on how much landlords can raise their rents each year.

The measure exempts single-family homes owned by landlords with no more than two properties.

If the measure is passed, state officials estimated a potential reduction in state and local revenues of tens of millions of dollars per year in the long term, depending on the actions that local communities take.

Civil Rights

The largest section of the 2020 ballot is dedicated to various civil rights issues ranging from affirmative action to lifting some voting restrictions.

Prop 16: ACA 5: Government Preferences

Proposition 16 would repeal an amendment to the state constitution that bans the practice of affirmative action within state institutions.

Passed in 1996, Proposition 209 amended the California Constitution to prohibit any public agency from discriminating against, or granting preferential treatment to, any individual or group on the basis of race, sex, color, ethnicity or national origin.

See Related: Senator Scott Wilk Votes To Put Repeal Of State Affirmative Action Ban On November Ballot

Republican State Senator Scott Willk, who represents Santa Clarita Valley as part of the 21st Senate District, crossed the aisle and voted to put this measure on the ballot, stating at the time that with the conversations many citizens have been having around their dinner tables the past few weeks, it is reasonable to let voters revisit this issue.

The measure was introduced by Democratic Assemblywoman Shirley Weber of San Diego.

Prop 17: ACA 6: Elections: Disqualification of Electors

If passed, Proposition 17 would allow individuals who were out of prison on parole for a felony conviction to vote.

Under the California Constitution, felons are disqualified from voting until both their imprisonment and parole are completed.

Proposition 17 would amend the state constitution to allow felons out on parole to vote, restoring the right to vote to an estimated 40,000 Californians.

The measure was introduced by Democratic Assemblyman Kevin McCarty of Sacramento.

Prop 18: ACA 4: Elections: Voting Age

This measure would allow 17-year-olds to vote in primary and special elections, provided that they will be 18 at the time of the subsequent general election.

This is the first time that such a measure has made it onto the ballot, despite lawmakers pushing similar efforts several times in the past.Similar measures have already been approved in at least 18 other states, as well as Washington D.C.

The proposition was introduced by Democratic Assemblyman Kevin Mullin of San Mateo

Prop 24: Amends Consumer Privacy Laws

Proposition 24 would expand consumer data privacy laws in the state of California, which are already considered the strongest in the nation.

Under this measure, consumers would be allowed to:

In addition to prohibiting businesses from retaining personal information for longer than reasonably necessary, the measure also triples maximum penalties for certain violations concerning consumers under the age of 16.

The proposition would also establish the California Privacy Protection Agency in order to enforce and implement consumer privacy laws, and impose administrative fines.

Criminal Justice

Two measures pertaining to criminal justice are on the ballot this year, with one addressing the future of the cash bail system within the state of California.

Prop 20: Restricts Parole for Non-Violent Offenders. Authorizes Felony Sentences For Certain Offenses Currently Treated Only as Misdemeanors

If passed, Proposition 20 would add crimes to the list of violent felonies for which early parole is restricted, allow prosecutors to charge certain misdemeanor crimes with felony charges, and require people convicted of specified misdemeanors to submit to collection of DNA samples for a state database.

Under the measure, those who are convicted of domestic violence, as well as other crimes that are currently categorized as nonviolent, would no longer be considered for early parole.

See Related: Dozens Of Residents Protest Against Human Trafficking In Valencia

Additionally, the passage of the proposition would make specific types of theft and fraud crimes such as firearm theft, vehicle theft, and unlawful use of a credit card chargeable as misdemeanors or felonies, rather than just misdemeanors.

The ballot initiative also establishes two new types of crimes in state code (serial crime and organized retail crime), which could be charged as either a misdemeanor or a felony.

Prop 25: Referendum to Overturn a 2018 Law That Replaced Money Bail System with a System Based on Public Safety Risk

This measure looks to uphold contested legislation that replaces Californias cash bail system with risk assessments for detained suspects awaiting trials.

In 2018, state legislators passed Senate Bill 10, which eliminated the cash bail system, and instead gave judges the role in determining whether or not an arrested individual should be held in jail or not leading up to their trial based on the risk that they pose to others or themself.

The law also restricts pretrial detentions for many misdemeanor charges.

Voting yes on Proposition 25 would uphold the 2018 law, while voting no would overturn it and bring back cash bail to California.

Labor

The final two ballot initiatives on this years ballot involve labor regulations, including a vote on whether or not to reclassify ride-share drivers as independent contractors.

Prop 22: Changes Employment Classification Rules for App-Based Transportation and Delivery Drivers

Proposition 22 would reclassify drivers for ride-share apps or food delivery services as independent contractors, essentially overturning a significant portion of Assembly Bill 5 (AB 5), which was passed in September of 2019.

This would exempt companies such as Uber and Lyft from standard wage and hour restrictions.

In exchange, companies with independent-contractor drivers would be required to provide specified alternative benefits, such as minimum compensation and healthcare subsidies, vehicle insurance, and sexual harassment policies.

The ballot initiative was largely funded by Uber, DoorDash and Lyft.

Prop 23: Authorizes State Regulation of Kidney Dialysis Clinics. Establishes Minimum Staffing and Other Requirements

This ballot initiative would require at least one licensed physician on site during treatment at outpatient kidney dialysis clinics.

Clinics would also be required to report data on dialysis-related infections to the state health department, as well as obtain consent from the same department before closing.

Additionally, Proposition 23 would prohibit clinics from discriminating against patients based on the source of payment for care.

State officials estimate that the measure would likely increase dialysis costs, resulting in increased state and local health care costs by tens of millions of dollars each year.

Ed. Note: The full text for all of the ballot measures can be read here.

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What's On The Ballot? A Summary Of The 12 State Propositions For November 2020 Election - KHTS Radio