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Association between race and treatment patterns and survival outcomes in multiple myeloma: A connect MM registry analysis – DocWire News

This article was originally published here

Cancer. 2020 Jul 24. doi: 10.1002/cncr.33089. Online ahead of print.

ABSTRACT

BACKGROUND: Studies have reported racial disparities in access to and use of multiple myeloma (MM) treatments between African American (AA) and White patients. Although AA patients demonstrate longer disease-specific survival, this has not uniformly translated into improved survival over time. The association between race and treatment patterns and survival outcomes was analyzed using data from the Connect MM Registry.

METHODS: The Connect MM Registry is a large US, multicenter, prospective observational cohort study of patients with newly diagnosed MM. Patients who received first-line (1L) stem cell transplantation (SCT) or who did not receive SCT (non-SCT or non-stem cell transplantation [NSCT]) were grouped by raceEffects of race and transplantation status on the use of triplet treatment were estimated using logistic regression.

RESULTS: Treatment patterns in 1L (types and duration of induction, posttransplantation maintenance) were similar between AA and White patients. SCT rates in 1L (32% vs 36%) and triplet treatment use (AA: 44% for NSCT patients and 72% for SCT patients; and White: 48% for NSCT patients and 72% for SCT patients) during first induction were similar. No significant effect of race or transplantation status on 1L triplet treatment use was observed. Race was not found to be associated with survival outcomes among patients who underwent NSCT; however, AA patients who received SCT had significantly longer overall survival compared with White patients who underwent SCT (not reached vs 88.2 months; hazard ratio, 0.56; 95% CI, 0.35-0.89 [P = .0141]).

CONCLUSIONS: AA and White patients were found to have similar treatment patterns in the Connect MM Registry, suggesting that both groups had equal access to health care. In this real-world setting, AA patients received standard-of-care treatment, which might have contributed to better MM-specific survival compared with White patients.

PMID:32706404 | DOI:10.1002/cncr.33089

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Association between race and treatment patterns and survival outcomes in multiple myeloma: A connect MM registry analysis - DocWire News

New Study Offers First Glimpse Into How Widespread COVID-19 Antibodies are in Canada’s Adult Population – Canada NewsWire

Initial results indicate fewer than 1 in 100 blood donations have antibodies to the novel coronavirus that causes COVID-19.

MONTREAL, OTTAWA, ON, and TORONTO, July 23, 2020 /CNW Telbec/ -Today, Canadian Blood Services and Canada's COVID-19 Immunity Task Force (CITF) are releasing initial results of the first 10,000 blood donor samples assessed for SARS-CoV-2 antibodies. This analysis reveals that over the period from May 9 through June 8, 2020, fewer than 1 per cent of the 10,000 samples from blood donors tested positive for antibodies to the novel coronavirus. Antibodies indicate past infection with SARS-CoV-2, and population studies like this one tell us how many people have likely been exposed to the virus.

These results offer a first, high-level glimpse into an ongoing Canadian Blood Services study assessing SARS-CoV-2 antibodies across nine provinces. They will be updated once Canadian Blood Services completes their analysis of the full sample of 37,800 donations made during the months of May and June 2020. In addition, Hma-Qubec will have results for Quebec in the near future, which will be important for a complete national picture, given the COVID-19 rates in that province.

While there will be adjustments to this initial figure once the full 10-province study is completed in the coming weeks, Professor Catherine Hankins, CITF Co-Chair, believes its implications bear public attention immediately, as reopening is causing a worrisome uptick in COVID-19 cases across Canada.

"What is clear is that only a small percentage of adult Canadians has been infected by SARS-CoV-2," Hankins says. "By far, the majority of us remain vulnerable to infection. We need to ramp up testing and tracing capacity across the country to interrupt any chains of transmission quickly to prevent unchecked spread."

CITF Co-Chair Professor David Naylor concurred: "These data suggest there are several undetected infections for every case confirmed with swabs and RNA tests. That lends weight to current public health advice. Please wear a mask in public indoor spaces, wash your hands often, and practice physical distancing if you're around people who aren't in your COVID-19 'bubble'."

Acknowledging that many more adult Canadians are infected than currently documented, Professor Timothy Evans, CITF Executive Director cautioned against over-interpreting the apparent reduction in risk. "Among adults, the death rate from being infected with SARS-CoV-2 is likely closer to one per cent, as compared to the eight per cent reported to date among those diagnosed with COVID-19. But this is a highly infective virus that could take a huge toll if we allow it to spread, and we are only now learning that many survivors have persistent symptoms."

These initial results from Canadian Blood Services and CITF are a first step toward giving policymakers a deeper understanding of the COVID-19 infection rate across Canada. As further samples are analyzed by Canadian Blood Services and Hma-Qubec, the findings will offer new insights to help guide effective public health measures.

"I want to thank Canadians for the sacrifices made to flatten the curve in the first wave. While these first results reflect widespread adherence with public health measures, they also mean most Canadians remain susceptible to infection,"says the Honourable Patty Hajdu, Minister of Health."As we start to see case numbers rise again, we all need to follow public health advice and avoid crowded places, close-contact settings and confined spaces."

When the Government of Canada established CITF in late April 2020, Canadian Blood Services and Hma-Qubec reached out to offer their assistance. Canada's blood system became the first place the initiative looked for evidence of infection and immunity in the Canadian population.

The choice was obvious. Blood donation centres are a rapid and reliable resource for generating insights into the patterns of illness, such as COVID-19, in the broader population. Canadian Blood Services and Hma-Qubec routinely test blood donations, including tests for pathogens that can be transmitted through transfusion (SARS-CoV2 is not known to be transfusion-transmitted). Both organizations also regularly contribute to active, ethics-approved research programs like this one, some of which in the past have included seroprevalence work to guide policies.

"Canadian Blood Services is proud to support the CITF's mandate," says Dr. Graham Sher, Chief Executive Officer, Canadian Blood Services. "We are uniquely positioned to help by providing information on the presence of COVID-19 antibodies in a large number of people across Canada relatively quickly. This is a great opportunity and privilege for blood donors and staff at Canadian Blood Services to contribute to a national need in a novel way."

"Getting an early picture of the levels of population immunity is critical to inform the public health response," says Dr. Marc Germain, Vice-President, Medical Affairs and Innovation, Hma-Qubec. "We look forward in the coming days to sharing the results of the first study on antibodies to SARS-CoV-2 among blood donors in Quebec."

About the COVID-19 Immunity Task Force

The Government of Canada launched the COVID-19 Immunity Task Force in late April 2020 to measure the scope of coronavirus infection in Canada and rapidly provide information to manage the COVID-19 pandemic and safely get Canadians back to work. The Task Force has the mission of ensuring that at least one million Canadian blood samples are collected and tested over the next two years to track the spread of the virus in the general population and shed light on immune responses to it in a diversity of communities, settings, age brackets, and occupational groups across the nation. For more information visit: http://www.covid19immunitytaskforce.ca

About Canadian Blood Services

Canadian Blood Services is a not-for-profit charitable organization. Regulated by Health Canada as a biologics manufacturer and primarily funded by the provincial and territorial ministries of health, Canadian Blood Services operates with a national scope, infrastructure and governance that make it unique within Canadian healthcare. In the domain of blood, plasma, and stem cells, we provide services for patients on behalf of all provincial and territorial governments, except Quebec. The national transplant registry for interprovincial organ sharing and related programs reaches into all provinces and territories, as a biological lifeline for Canadians. For more information visit: blood.ca

SOURCE McGill University

For further information: Media contacts: COVID-19 Immunity Task Force, Katherine Gombay, [emailprotected] / [emailprotected], 514-717-2289; Canadian Blood Services, [emailprotected], 1-877-709-7773

http://www.mcgill.ca

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New Study Offers First Glimpse Into How Widespread COVID-19 Antibodies are in Canada's Adult Population - Canada NewsWire

COVID-19 Impacts: Cell Viability Assays Market will Accelerate at a CAGR of over 8% through 2020-2024 | Focus on Timely Diagnosis of Diseases to Boost…

LONDON--(BUSINESS WIRE)--Technavio has been monitoring the cell viability assays market and it is poised to grow by USD 1.40 billion during 2020-2024, progressing at a CAGR of over 8% during the forecast period. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment.

Technavio suggests three forecast scenarios (optimistic, probable, and pessimistic) considering the impact of COVID-19. Please Request the Latest Free Sample Report on COVID-19 Impact

Frequently Asked Questions-

The market is fragmented, and the degree of fragmentation will accelerate during the forecast period. Agilent Technologies Inc., Becton, Dickinson and Co., Bio-Rad Laboratories Inc., Biotium Inc., Danaher Corp., General Electric Co., Merck KGaA, PerkinElmer Inc., Promega Corp., and Thermo Fisher Scientific Inc. are some of the major market participants. To make the most of the opportunities, market vendors should focus more on the growth prospects in the fast-growing segments, while maintaining their positions in the slow-growing segments.

Focus on the timely diagnosis of diseases has been instrumental in driving the growth of the market. However, limitations associated with cell viability assays might hamper market growth.

Cell Viability Assays Market 2020-2024: Segmentation

Cell Viability Assays Market is segmented as below:

To learn more about the global trends impacting the future of market research, download a free sample: https://www.technavio.com/talk-to-us?report=IRTNTR40302

Cell Viability Assays Market 2020-2024: Scope

Technavio presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources. Our cell viability assays market report covers the following areas:

This study identifies the growing focus on stem cell research as one of the prime reasons driving the cell viability assays market growth during the next few years.

Cell Viability Assays Market 2020-2024: Vendor Analysis

We provide a detailed analysis of around 25 vendors operating in the cell viability assays market, including some of the vendors such as Agilent Technologies Inc., Becton, Dickinson and Co., Bio-Rad Laboratories Inc., Biotium Inc., Danaher Corp., General Electric Co., Merck KGaA, PerkinElmer Inc., Promega Corp., and Thermo Fisher Scientific Inc. Backed with competitive intelligence and benchmarking, our research reports on the Cell Viability Assays Market are designed to provide entry support, customer profile and M&As as well as go-to-market strategy support.

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Cell Viability Assays Market 2020-2024: Key Highlights

Table of Contents:

PART 01: EXECUTIVE SUMMARY

PART 02: SCOPE OF THE REPORT

PART 03: MARKET LANDSCAPE

PART 04: MARKET SIZING

PART 05: FIVE FORCES ANALYSIS

PART 06: MARKET SEGMENTATION BY PRODUCT

PART 07: CUSTOMER LANDSCAPE

PART 08: GEOGRAPHIC LANDSCAPE

PART 09: DECISION FRAMEWORK

PART 10: DRIVERS AND CHALLENGES

PART 11: MARKET TRENDS

PART 12: VENDOR LANDSCAPE

PART 13: VENDOR ANALYSIS

PART 14: APPENDIX

PART 15: EXPLORE TECHNAVIO

About Us

Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavios report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

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COVID-19 Impacts: Cell Viability Assays Market will Accelerate at a CAGR of over 8% through 2020-2024 | Focus on Timely Diagnosis of Diseases to Boost...

Stem Cell Manufacturing Market Segmentation By Qualitative And Quantitative Research Incorporating Impact Of Economic and Non-Economic Aspects By 2027…

New Jersey, United States,- The recent report on Stem Cell Manufacturing Market offered by Verified Market Research, comprises of a comprehensive investigation into the geographical landscape, industry size along with the revenue estimation of the business. Additionally, the report also highlights the challenges impeding market growth and expansion strategies employed by leading companies in the Stem Cell Manufacturing market.

This is the most recent report inclusive of the COVID-19 effects on the functioning of the market. It is well known that some changes, for the worse, were administered by the pandemic on all industries. The current scenario of the business sector and pandemics impact on the past and future of the industry are covered in this report.

In market segmentation by manufacturers, the report covers the following companies-

Exploring the growth rate over a period

Business owners looking to scale up their business can refer this report that contains data regarding the rise in sales within a given consumer base for the forecast period, 2020 to 2027. Product owners can use this information along with the driving factors such as demographics and revenue generated from other products discussed in the report to get a better analysis of their products and services. Besides, the research analysts have compared the market growth rate with product sales to enable business owners to determine the success or failure of a specific product or service.

By Type

Type 1

Type 2

By Application

Application1

Application 2

Global Stem Cell Manufacturing Market Report 2020 Market Size, Share, Price, Trend and Forecast is a professional and in-depth study on the current state of the global Stem Cell Manufacturing industry.

The report at a glance

The Stem Cell Manufacturing market report focuses on economic developments and consumer spending trends across different countries for the forecast period 2019 to 2026. The research further reveals which countries and regions will have a better standing in the years to come. Apart from this, the study talks about the growth rate, market share as well as the recent developments in the Stem Cell Manufacturing industry worldwide. Besides, the special mention of major market players adds importance to the overall market study.

Market segment by Region/Country including:

North America (United States, Canada and Mexico) Europe (Germany, UK, France, Italy, Russia and Spain etc.) Asia-Pacific (China, Japan, Korea, India, Australia and Southeast Asia etc.) South America (Brazil, Argentina, Colombia and Chile etc.) Middle East & Africa (South Africa, Egypt, Nigeria and Saudi Arabia etc.)

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What are the market trends business owners can rely upon in the coming years?

What are the threats and challenges expected to restrict the progress of the industry across different countries?

What are the key opportunities that business owners can bank on for the forecast period, 20202027?

Why Choose Verified Market Research?

To summarize, the global Stem Cell Manufacturing market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

About us:

Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

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Stem Cell Manufacturing Market Segmentation By Qualitative And Quantitative Research Incorporating Impact Of Economic and Non-Economic Aspects By 2027...

Stem Cell Banking Market 2019 | How The Industry Will Witness Substantial Growth In The Upcoming Years | Exclusive Report By DataIntelo – Owned

The Global Stem Cell Banking Market analysis report published on Dataintelo.com is a detailed study of market size, share and dynamics covered in XX pages and is an illustrative sample demonstrating market trends. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. It covers the entire market with an in-depth study on revenue growth and profitability. The report also delivers on key players along with strategic standpoint pertaining to price and promotion.

Get FREE Exclusive PDF Sample Copy of This Report: https://dataintelo.com/request-sample/?reportId=109977

The Global Stem Cell Banking Market report entails a comprehensive database on future market estimation based on historical data analysis. It enables the clients with quantified data for current market perusal. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and regional analysis. Listed out are key players, major collaborations, merger & acquisitions along with upcoming and trending innovation. Business policies are reviewed from the techno-commercial perspective demonstrating better results. The report contains granular information & analysis pertaining to the Global Stem Cell Banking Market size, share, growth, trends, segment and forecasts from 2020-2026.

With an all-round approach for data accumulation, the market scenarios comprise major players, cost and pricing operating in the specific geography/ies. Statistical surveying used are SWOT analysis, PESTLE analysis, predictive analysis, and real-time analytics. Graphs are clearly used to support the data format for clear understanding of facts and figures.

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The report segments the Global Stem Cell Banking Market as: Global Stem Cell Banking Market Size & Share, by Regions

Global Stem Cell Banking Market Size & Share, by Products Umbilical Cord Blood Stem Cell Embryonic Stem Cell Adult Stem Cell Other

Global Stem Cell Banking Market Size & Share, Applications Diseases Therapy Healthcare

Key Players CCBC CBR ViaCord Esperite Vcanbio Boyalife LifeCell Crioestaminal RMS Regrow Cordlife Group PBKM FamiCord cells4life Beikebiotech StemCyte Cryo-cell Cellsafe Biotech Group PacifiCord Americord Krio Familycord Cryo Stemcell Stemade Biotech

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About DataIntelo: DATAINTELO has set its benchmark in the market research industry by providing syndicated and customized research report to the clients. The database of the company is updated on a daily basis to prompt the clients with the latest trends and in-depth analysis of the industry. Our pool of database contains various industry verticals that include: IT & Telecom, Food Beverage, Automotive, Healthcare, Chemicals and Energy, Consumer foods, Food and beverages, and many more. Each and every report goes through the proper research methodology, validated from the professionals and analysts to ensure the eminent quality reports.

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R3 International Offering New Stem Cell Therapy for Neuropathy Program in Mexico – Benzinga

SCOTTSDALE, Ariz., July 23, 2020 /PRNewswire-PRWeb/ -- R3 International is now offering a new stem cell therapy for neuropathy program in Mexico. The regenerative treatments involve up to 200 million stem cells and have been very effective at relieving neuropathic pain.

Peripheral neuropathy affects many millions of Individuals worldwide, and often leads to chronic, debilitating pain. It may occur as a result of diabetes, alcoholism, radiation, chemo or many other potential causes.

Stem cell and exosome therapy for neuropathy has achieved tremendous results at R3 International. Stem cells and exosomes are excellent at promoting nerve regeneration and new blood vessel formation.

According to R3 CEO David Greene, MD, MBA, "Patients lament the traditional pain medications they are offered for relief, which may lead to addiction or an overdose. The stem cell and exosome therapy offered at R3 International is safe and very effective for relief and helping patients be able to walk farther."

Treatments at the clinic are outpatient, and involve anywhere from 30 million stem cells up to 200 million. The treatment starts at only $2975, with escorted transportation included from San Diego to the clinic and back. The patient concierge representative goes with the patient to the treatment as well.

The process starts with a free phone consultation with the R3 licensed, experienced stem cell doctor. Once treatment is scheduled, the R3 patient concierge assists with travel logistics.

In addition to the neuropathy stem cell program, R3 International also provides stem cell treatment in Mexico for COPD, kidney failure, autism, arthritis, diabetes, hepatitis, Lyme disease, MS, ALS, Alzheimers and more.

Call (888) 988-0515 to schedule the free phone consultation.

SOURCE R3 Stem Cell International

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R3 International Offering New Stem Cell Therapy for Neuropathy Program in Mexico - Benzinga

Two people receive helping hand from Centre to get their advanced treatment in Delhi amid COVID-19 lockdown – Yahoo India News

New Delhi [India], July 25 (ANI): As India faced a complete lockdown till May due to the COVID-19 pandemic, the government lent a helping hand to two people -- one Indian and a Nepali national from Australia -- to get their advanced treatment in Delhi.

Fifteen-year-old Nitya Singh (name changed) from Punjab, who was diagnosed with very severe aplastic anemia, was granted special permission to reach a Delhi hospital for advanced treatment.

Similarly, Arjun Prasad Timilsina, a 31-year-old Nepali national, was airlifted from Australia by an Air India flight (AI-301) to Delhi to get the bone marrow transplant which is a lifesaving treatment.

According to Nitya's doctors, her condition started to deteriorate due to her medical condition and suggested a bone marrow transplant for her.

On the other hand, Timilsina was living in Australia. He was diagnosed with acute myeloid leukaemia early this year. Timilsina underwent few cycles of chemotherapy in Australia, but the induction therapy failed twice following which he was given a high dose of chemotherapy.

Timilsina's family connected with doctors at the BLK Super Speciality Hospital in Delhi through e-mails and video conferencing. After going through his reports, medical experts suggested him a bone marrow transplant as the only treatment. In May, Timilsina decided to come to India for the treatment.

Dr Dharma Choudhary, Senior Director and HoD, Centre for Hemato-oncology and bone marrow transplant, BLK Super Speciality Hospital, and his team performed the bone marrow transplant on both the patients during the lockdown.

"Her (Nitya) parents took special permission from the state government authorities as the lockdown was prevailing in the entire country due to the ongoing coronavirus pandemic. In the utmost emergency, we decided to take Nitya's mother as a donor. All the requisite tests were done and her mother was fit to be a donor for the half match allogeneic bone marrow transplant. The procedure performed on June 2," Dr Choudhary told ANI.

Nitya accepted the graft well and got discharged in the third week of June. Presently, the patient is well and is doing a regular follow-up with us, he said.

Dr Choudhary said that Timilsina contacted the Indian and Nepali embassies in Australia and the Union Health Ministry.

"His efforts worked and finally he was airlifted from Australia to India through Vande Bharat Mission flight along with his brother who was a complete match for the bone marrow transplant. After thorough investigations, he underwent successful allogeneic stem cell transplant from full match sibling donor (brother) on June 11. We kept him under close observation for several days and currently he is in good condition. He has been discharged," he added.

"Delay in these treatments could result in severe consequences. But thanks to the Punjab government, Ministry of Health, Indian and Nepali embassies who helped these patients reach the hospital on time to get the required treatment," Dr Choudhary further said. (ANI)

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Two people receive helping hand from Centre to get their advanced treatment in Delhi amid COVID-19 lockdown - Yahoo India News

Trending News on Targeted Oncology, Week of July 24, 2020 – Targeted Oncology

In oncology news this week, the FDA accepted a supplemental New Drug Application for selinexor(Xpovio) as treatment of patients with relapsed or refractory multiple myeloma who had received at least 1 prior line of therapy. Meanwhile, theFDA granted clearance for the cancer drug abivertinib to be investigated in a phase 2 study as treatment of hospitalized patients with coronavirus disease 2019 (COVID-19).

This week Targeted Oncology hosted a tweet chat with Alexander N. Shoushtari, MD, of Memorial Sloan Kettering Cancer Center, to discussion the case of a 52-year-old woman withBRAF-mutant metastatic melanoma. Following the tweet chat, Shoushtari continued the discussion in an interview.

Sorafenib Maintenance May Prevent Recurrence After Transplant in FLT3-ITD+ AML

The risk of relapse or death was reduced by 61% with the use of sorafenib maintenance therapy compared with placebo following allogeneic hematopoietic stem cell transplantation in patients withFLT3-ITDpositive acute myeloid leukemia, according to the results of the phase 2 SORMAIN trial.

Ruxolitinib Reduces Spleen Size in Patients With Myelofibrosis and Low-Platelet Counts

Ruxolitinib, the JAK1/2 inhibitor, induced significant spleen responses in patients with myelofibrosis, both with general disease and in patients with low platelet counts, according to results from the phase 3b JUMP study.

Pivotal Phase 3 Trial Initiated to Study Promising Cabozantinib/Atezolizumab Combo in Advanced RCC

A pivotal phase 3 trial has been initiated to explore the combination of cabozantinib and atezolizumab for the treatment of patients with inoperable, locally advanced or metastatic renal cell carcinoma who progressed during or after treatment with an immune checkpoint inhibitor immediately following initial therapy.

CLR 131 Induces Encouraging Responses in Relapsed/Refractory LPL and WM

CLR 131 induced an objective response rate of 100% as treatment of patients with relapsed/refractory lymphoplasmacytic lymphoma and Waldenstrms macroglobulinemia in the ongoing phase 2 CLOVER-1 study.

Avelumab Plus TG4001 Shows Promising Efficacy in HPV16-Positive Metastatic Cancers

Avelumab in combination with a novel HPV16-targeted vaccine, demonstrated clinical activity as treatment of patients with HPV16-positive recurrent and/or metastatic malignancies, a phase 1b/2 clinical trial showed.

A 79-Year-Old Man With Relapsed Chronic Lymphocytic Leukemia

Jeff Sharman, MD, reviews a case of a 79-year-old man with relapsed chronic lymphocytic leukemia in this episode of Targeted Oncology Case Based Peer Perspectives series.

Analyzing the Importance of Biomarker Testing and MSI Status in mCRC

Heinz-Josef Lenz, MD, discusses the significance of conducting biomarker testing in patients with metastatic colorectal cancer in accordance with the results of the phase 2 CheckMate 142 trial.

Limited Toxicity Seen With Leronlimab in Mild to Moderate COVID-19

Treatment with leronlimab in patients with mild to moderate symptoms of respiratory illness from COVID-19 caused fewer serious adverse events when compared with placebo, according to safety results from a phase 2 clinical trial.

Study Shows Disparities, Effects of Treatment for Patients With Cancer and COVID-19

Data from a treatment utilization study revealed racial disparities in treatments for COVID-19 as well as the effects and clinical outcomes of treatments such as remdesivir and dexamethasone in patients with cancer who were diagnosed with COVID-19.

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Trending News on Targeted Oncology, Week of July 24, 2020 - Targeted Oncology

US regulations for regenerative medicine advanced therapies – Regulatory Focus

This article examines US regulations and guidance documents for regenerative medicine advanced therapies (RMATs). The author describes the field of regenerative medicine, noting that it is expanding at an accelerated pace, and outlines some of the common terms associated with it. He also addresses the application process for these therapies, accelerated regulatory pathways, market access, and the outlook for RMATs. The author cautions that, as exciting as these therapies are, they require a rigorous and carefully planned approach to ensure a seamless progression to regulatory approval and commercial success. Introduction Regenerative medicine is a rapidly expanding field, offering the potential to treat serious and life-threatening conditions by replacing, or regenerating, human cells, tissues, or organs that have been damaged by disease, trauma, or congenital defects.1 With more than 200 investigational new drug (IND) applications anticipated by the US Food and Drug Administration (FDA) in 2020,2 regenerative medicine should yield many new therapies with enormous benefits to patients, especially those with unmet medical needs. Navigating the complex regulatory environment of regenerative medicine requires companies to engage with the FDA early and often throughout the drug development process to identify and overcome potential obstacles to approval. Many of these therapies are developed by scientific institutions and medical research groups with limited inhouse regulatory resources, so it is advisable to seek external regulatory support early in the planning process. Regenerative medicines defined Regenerative medicines, as defined by the FDA, include cell therapies (non- and genetically modified), therapeutic tissue-engineering products, human cell and tissue products, and combination products using these biologic components, which lead to a sustained effect on cells and tissues. In addition, a combination product (biologic device, biologic drug, or biologic device-drug) can be eligible for regenerative medicine advanced therapy (RMAT) designation when the biological product constituent part is a regenerative medicine therapy and provides the greatest contribution to the overall intended therapeutic effects of the combination product (i.e., the primary mode of action of the combination product is conveyed by the biological product constituent part). In January 2020, the FDA released six final guidances on gene therapy manufacturing and clinical development of products and a draft guidance.3 The FDAs policy to advance the development of safe and effective cell and gene therapies can be found here.4 This article explains some of the terminology and covers the key US regulations and guidance documents. Discussions of a select number of these documents will be published in separate articles in Regulatory Focus. Terminology Cellular & gene therapy products5 Cellular therapy products include cellular immunotherapies, cancer vaccines, and other types of autologous and allogeneic cells, including hematopoietic stem cells and adult and embryonic stem cells, for certain therapeutic indications. Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use. The FDAs Center for Biologics Evaluation and Research (CBER) has approved both cellular and gene therapy products.5 Gene therapy6 Gene therapy is a technique that modifies a persons faulty genes treat or cure disease and is most often applied to cancer, genetic diseases and infectious diseases. Gene therapies can work by several mechanisms:

The following figureshows CBERs organisation for pre and postmarket regulation35

Market access and outlook As of May 2019, the FDA had granted 34 products FDA regenerative medicine advanced therapy designations.36 In all, 68 of the 100 designation applications were cell therapy products, 20 of the 34 RMAT granted products have orphan product designation, and 11 of the 34 have fast track designation. While the promise of regenerative medicines to cure disease is driving the field forward at an accelerated pace, developing these therapies require a rigorous and carefully planned approach to ensure a seamless progression to regulatory approval and commercial success. Abbreviations ANDA, abbreviated new drug application; CBER, Center for Biologics Evaluation and Research; FDA, Food and Drug Administration; HCT/P, human cell, tissue, and cellular and tissue-based product; IND, investigational new drug; PDUFA, Prescription Drug User Fee Act; rDNA, ribosomal DNA; RMAT, regenerative medicine advanced therapy. References All references were accessed 23 July 2020.

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US regulations for regenerative medicine advanced therapies - Regulatory Focus

This is What He and His Family Are Working Towards- Former Ferrari Head Todt Reveals He Saw Michael Schumacher Last Week – Essentially Sports

Gauging the progress made by Formula 1 legend, Michael Schumacher, as far as his health is concerned, often seems like a losing battle. The Schumacher family has mostly been very private about the 7-time world champions condition and health ever since he suffered a horrific skiing accident, about 6 and a half years ago.

Last month, reports indicated that the F1 legends stem cell surgery was put on hold due to the pandemic. Since then, there has been no update about Schumis health. Until now.

Former Ferrari CEO Jean Todt, who is a rather close acquaintance to Schumacher, gives fans some reason for optimism.

According to Dailymail, the former CEO of Ferrari said, I saw Michael last week. He is fighting. I hope that the world will be able to see him again. This is what he and his family are working towards.

It may not be a lot in terms of an update, but well savor whatever information we can get about the F1 legend. We wish him a speedy recovery and hope to see him soon enough.

Todt obviously shares a very special connection with Schumi. Todt occupied the role of the Team Principal at Scuderia Ferrari, and he was responsible for bringing Michael in to Ferrari in 1996.

Schumacher, at the time, had won back-to-back world titles with Benetton.

The duo of Todt and Schumacher saw the Maranello-based outfit through their most successful years in the sport of Formula 1.

For five consecutive seasons, Schumacher dominated F1 and won back-to-back world titles. His brilliance also led The Prancing Horse to win 5 back-to-back Constructors championship titles as well.

Thereafter, Todt was promoted to the role of CEO of the Ferrari brand for four years (2004-08). Now he is part of the UN Secretary-Generals special envoy for road safety.

As for Michael, he continued at Ferrari for two more seasons, finishing 3rd and 2nd respectively. After that, the German driver retired from F1 for 3 years.

But the love for the sport couldnt keep him out for long, and he was back for a second stint with Mercedes.

However, that move didnt go to plan and Schumi retired for a second time after the 2013 season. This time for good.

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This is What He and His Family Are Working Towards- Former Ferrari Head Todt Reveals He Saw Michael Schumacher Last Week - Essentially Sports