On International Day of Disabled Persons, TheHealthSite spoke to Dr. Sunil Bhat, Director and Clinical Lead, Pediatric Hematology, Oncology, and Blood & Marrow Transplantation, Mazumdar Shaw Cancer Centre, Narayana Health City, to discuss the condition and understand the ways one can manage it.

Written by Satata Karmakar | Updated : December 3, 2021 5:31 PM IST

3rd December every year is observed as UN-designated International Day for persons with disabilities. The observance of the Day aims to promote an understanding of disability issues and mobilize support for the dignity, rights, and well-being of persons with disabilities. This year's theme is "not all disabilities are visible" since some of the disabilities are non-visible but they cause significant challenges for people living with such conditions for day-to-day participation in society.

Such non-visible disabilities include some of the rare blood disorders such as Thalassemia, Aplastic Anemia, Sickle cell Anemia, Fanconi Anemia, Hemophilia, and so on. The Rights of People with Disability Bill passed by the Parliament of India in December 2016 included newer disabilities like blood disorders sickle cell anemia, thalassemia, and hemophilia. Today, on International Day of Disabled Persons, TheHealthSite spoke to Dr. Sunil Bhat, Director and Clinical Lead, Pediatric Hematology, Oncology, and Blood & Marrow Transplantation, Mazumdar Shaw Cancer Centre, Narayana Health City, to discuss the condition and understand the ways one can manage it.

In India, the burden of blood disorders and blood cancer is huge. India is even called as Thalassemia capital of the world with over 10,000 new cases every year. Thalassemia is a disabling condition not just because of chronic anemia but other co-morbidities like organ damage, bone damage, and cardiac complications.

People with thalassemia may need lifelong blood transfusions and other therapies (like iron removal medications). With the advances in the medical field, blood stem cell transplant plays an important role in the treatment of various blood disorders like thalassemia, aplastic anemia, and blood cancers as well. For a blood stem cell transplant to be deemed successful, the human leukocyte antigens (HLA) of the donor should match the antigens present in the cells of the patient. Only 30% of the patients find a matching donor in the family and the rest 70% depending on an unrelated donor. Such unrelated donors are being registered by stem cell registries like DKMS BMST Foundation India.

However, despite such a huge disease burden, Indian stem cell donors only form a tiny fraction, about 0.04% of the total listed unrelated donors globally. The main reason is the lack of awareness and prevailing myths around the stem cell donation process deny many patients a second chance at their lives in the country. It is high time that healthy people understand blood stem cell donation is a safe process and come forward to register as a donor. There is only a 1 in a million chance that someone comes as a match for a patient!

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Rare Blood Disorders In India: How It Can Lead To Disabilities In People Expert Explains | TheHealthSite. - TheHealthSite

BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that BESREMi (ropeginterferon alfa-2b-njft) is now commercially available in the U.S. to eligible patients with polycythemia vera (PV). BESREMi was approved by the FDA in November as the only interferon for adults with polycythemia vera. BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.

Today marks the beginning of a new chapter in the treatment of PV. Our team is delivering on our goal to bring an innovative solution that may help more people manage not only the symptoms of PV, but target the disease itself to gain durable control with potential to reduce progression over time, said Meredith Manning, U.S. General Manager. We look forward to working closely with U.S. providers to raise awareness of this therapy and help advance treatment goals.

PharmaEssentia SOURCE Now Available to Support People with PV in the U.S.

With the commercial availability of BESREMi, PharmaEssentia is also launching a comprehensive patient support program, which can be found at http://www.pharmaessentiaSOURCE.com.

The SOURCE program is available for patients prescribed BESREMi and offers a full suite of services designed to help patients start and stay on therapy. Services include insurance navigation support, titration and injection training, and ongoing adherence guidance. The program also includes physician resources, including guides to help patients get started on treatment and ordering processes.

As part of this program, PharmaEssentia will help patients with financial barriers to starting therapy. The company is offering co-pay and co-insurance programs to assist eligible patients who experience financial need. Programs include a $0 copay card for commercially insured patients, temporary product supply in case of insurance delays and/or gaps in coverage, free drug for the uninsured and under-insured as well as assistance identifying additional support as needed.

Weve designed SOURCE with active input from the PV community to simplify the process for appropriate patients to initiate and maintain access to BESREMi and to benefit from its effects over the long-term, added Manning. Our goal is to ensure that any appropriate person with PV who is prescribed BESREMi is able to receive the therapy.

About Polycythemia Vera

Polycythemia Vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.1

About BESREMi

BESREMi is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients. After one year, patients with stable complete hematologic response (CHR) can be treated with BESREMi every four weeks.

BESREMi has orphan drug designation for treatment of PV in the United States. The product was approved by the European Medicines Agency (EMA) in 2019 and has received approval in Taiwan and South Korea. BESREMi was invented and is manufactured by PharmaEssentia.

Important Safety Information

IMPORTANT SAFETY INFORMATION AND INDICATIONS

WARNING: RISK OF SERIOUS DISORDERS

Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Other central nervous system effects, including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa products.

Closely monitor patients for any symptoms of psychiatric disorders and consider psychiatric consultation and treatment if such symptoms emerge. If psychiatric symptoms worsen, it is recommended to discontinue BESREMi therapy.

ADVERSE REACTIONS

The most common adverse reactions reported in > 40% of patients in the PEGINVERA study (n=51) were influenza-like illness, arthralgia, fatigue, pruritis, nasopharyngitis, and musculoskeletal pain. In the pooled safety population (n=178), the most common adverse reactions greater than 10%, were liver enzyme elevations (20%), leukopenia (20%), thrombocytopenia (19%), arthralgia (13%), fatigue (12%), myalgia (11%), and influenza-like illness (11%).

DRUG INTERACTIONS

Patients on BESREMi who are receiving concomitant drugs which are CYP450 substrates with a narrow therapeutic index should be monitored to inform the need for dosage modification for these concomitant drugs. Avoid use with myelosuppressive agents and monitor patients receiving the combination for effects of excessive myelosuppression. Avoid use with narcotics, hypnotics or sedatives and monitor patients receiving the combination for effects of excessive CNS toxicity.

USE IN SPECIFIC POPULATIONS

Please see accompanying full Prescribing Information, including Boxed Warning.

About PharmaEssentia

PharmaEssentia Corporation (TPEx: 6446), based in Taipei, Taiwan, is a rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, the company aims to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today the company is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung. For more information, visit our website or find us on LinkedIn and Twitter.

Forward Looking Statement

This press release contains forward looking statements, including statements regarding the timing of BESREMis availability in the United States, the commercialization plans and expectations for commercializing BESREMi in the United States, and the potential benefits or competitive position of BESREMi. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and similar legislation and regulations under Taiwanese law. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include PharmaEssentias ability to launch BESREMi in the United States, whether BESREMi is successfully commercialized and adopted by physicians and patients, the extent to which reimbursement is available for BESREMi, and the ability to receive FDA and other regulatory approvals for additional indications for BESREMi. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website, and the FDA website, is not incorporated by reference into this press release and is included for reference purposes only.

1 Cerquozzi S, Tefferi A. Blast Transformation and Fibrotic Progression in Polycythemia Vera and Essential Thrombocythemia: A Literature Review of Incidence and Risk Factors. Blood Cancer Journal (2015) 5, e366; doi:10.1038/bcj.2015.95.

2021 PharmaEssentia Corporation. All rights reserved. US-BSRM-2100225 11/21

BESREMi and PharmaEssentia are registered trademarks of PharmaEssentia Corporation, and the PharmaEssentia logo and PharmaEssentia SOURCE are trademarks of PharmaEssentia Corporation.

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PharmaEssentia's BESREMi (ropeginterferon alfa-2b-njft) Now Available for the Treatment of People With Polycythemia Vera in the United States -...

Shahid Akhter, editor, ETHealthworld, spoke to Ramesh Ramadurai, MD, 3M India, to know more 3M collaborations that can improve and impact cancer care, besides cutting down on the costs in a big way.

How has the technological and infrastructural facilities impacted Bone Marrow Transplantation in India ?Every year nearly 20,000 Indian patients, including many children, who suffer from blood and solid cancers require bone marrow transplantation (BMT). However, only 2,000 of these patients are fortunate enough to receive this therapy, as the cost of bone marrow transplantation can vary from INR 10 Lakhs to 30 Lakhs. It is imperative to reduce the cost of cancer treatment while maintaining a stringent focus on sterilization and quality. It is indeed the need of the hour for us to address this issue.

What are the various technological advancement required for the better functioning of the facilities?Despite the increasing demand for bone marrow transplantation, the number of bone marrow doners in India is astonishingly low. India conducts stem cell transplant procedure for approximately 2,000 every year, while around 80,000 to 100,000 annual transplants are required to tackle the burden of blood cancers and fatal blood disorders. Finding a matching donor is very difficult. This option is exercised only after the alternative options have failed.

India has only about 400,000 donors registered on the bone marrow registry. Chances of finding a donor match are as low as 10% to 15% compared to the West where the chances of matching are as high as 60% to 70% due to higher rates of donations.

What are the major and significant developments in treating bone marrow cancer in the country?A bone marrow registry collects information on individuals willing and able to donate bone marrow and gathers the donor information into a database. In India, organisations like Datri are helping to create a pool of donors to help people who do not have blood-related donors by finding an unrelated match for life-saving treatment.

Infusion of a memory cell is another advancement. This involves taking out the cells, sorting the good cells and the memory cells or the fighting cells, which can fight infections, sorting them out, capturing them and putting them back into the body after giving the requisite chemotherapy. This is also called T-cell depletion with memory cell infusion. It is now available in India and is affordable.

Through this partnership with United Way Bengaluru and Sri Shankara Cancer Hospital and Research Centre (SSCHRC), how does 3M aim to foster accessibility for people from different sections of the society in treating cancer. 3M India was brought into the SSCHRC family through United Way of Bengaluru, and this is our second round of engagement with the hospital. Last year, 3M India had donated equipment for cancer research and diagnostics like the Sanger sequencer and QPCR, made enhancements to the childrens play area at the long-stay Lakshmi Childrens center with child-friendly wall graphics, and provided kitchen utensils and cooking counters for the resident families of paediatric cancer patients.

We have donated several critical equipments for the research labs which contribute to the successful treatment of the BMT patients. As on date the BMT unit at SSCHRC has treated and discharged 5 patients and currently 4 are undergoing treatment. This wing of the hospital is accessible by few staff nurses and specialists like Dr K N Nataraj who is the Chief of Adult and Paediatric Haematology at the hospital. For a successful bone marrow transplantation, there are several requisites, some of which include, successful donor matching, extremely technique-sensitive harvesting and transplantation processes and robust infection control. With this essential, life-saving equipment, the cost of the treatment will reduce to approximately 50% (between Rs 8-12 Lacs as against the actual cost of Rs 15- 30 lacs) and help the hospital treat many more cancer patients.

How do 3M India and Sri Shankara Hospital plan to take this initiative ahead in the future for the growth and enhancement of bone marrow transplantation in the facility? It is matter of pride for 3M India and United Way of Bengaluru that we are associated with SSCHRC, an institution at the forefront of providing comprehensive cancer treatment to the needy, through CSR interventions.

By complying with the Foundation for the Accreditation of Cellular Therapy (FACT) Guidelines, the BMT Centre will be a one-of-a-kind medical facility where people of all economic status can receive treatment. Being a growing facility, the hospital is committed to continuing its responsibility towards expansion of multiple hospital beds and medical care. We are inspired by the commitment of the doctors and Sri Shankara Board of Trustees, led by Dr. B.S. Srinath and other dedicated professionals who developed a multifaceted approach to establishment a state of the art, affordable cancer hospital that is accessible to all irrespective of caste, creed, religion, gender or socioeconomic status.

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It is imperative to reduce the cost of cancer treatment: Ramesh Ramadurai, MD, 3M India - ETHealthworld.com

Las Vegas, USAPolymyositis Pipeline to Progress with New and Emerging Drugs for Treatment, Analyzes , Dec. 08, 2021 (GLOBE NEWSWIRE) -- DelveInsights Polymyositis Pipeline Insight 2021 report offers exhaustive global coverage of available, marketed, and pipeline therapies in different phases of clinical development, major pharmaceutical companies working to advance the pipeline space, and future growth potential of the Polymyositis pipeline domain.

Some of the essential takeaways from thePolymyositis Pipelinereport:

Request a sample and discover more about the report offerings @ Polymyositis Emerging Therapies

The Polymyositis pipeline report lays down detailed profiles of the pipeline assets, comparative analysis of clinical and non-clinical stage Polymyositis products, inactive and dormant assets, comprehensive assessment of driving and restraining factors, as well as the opportunities and risks in the Polymyositis pipeline landscape.

Polymyositis Overview

Polymyositis is a type of inflammatory myopathy, which refers to a group of muscle diseases characterized by chronic muscle inflammation and weakness. Polymyositis (PM), an autoimmune disorder, develops due to abnormal activation of cytotoxic T lymphocytes (CD8 cells) and macrophages against muscular antigens as well as the strong extrafusal muscular expression of major histocompatibility complex 1 causing damage to the endomysium of skeletal muscles. Polymyositis develops gradually over time, and it rarely affects persons younger than age 18.

Find out more about the disease and recent developments @Polymyositis Pipeline Assessment

Polymyositis Pipeline Drugs

Learn more about the novel and emerging Polymyositis pipeline therapies @ Polymyositis Pipeline Analysis

Polymyositis Therapeutics Assessment

ThePolymyositis Pipelinereport proffers an integral view of the Polymyositis emerging novel therapies segmented by Stage, Product Type, Molecule Type, Mechanism of Action and Route of Administration.

By Product Type

By Stage

By Route of Administration

By Molecule Type

By Mechanism of Action

Scope of the Polymyositis Pipeline Report

Dive deep into rich insights for emerging therapies and assessment, visit @ Polymyositis Emerging Therapies

Table of Contents

For further information on the Polymyositis current pipeline therapeutics, reach out @ Polymyositis Ongoing Clinical Trials

Track and assess a candidates clinical development journey through Actionable Intelligence and Comparative Therapeutic Assessment

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BOSTON, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced the upcoming departure of Pat Horn, M.D., Ph.D., Chief Medical Officer, who will be leaving at the end of the year after almost three and a half years with the Company. Jan Mattsson, Ph.D., Chief Scientific Officer and co-founder of Albireo, will be taking over as the interim head of R&D, leading research and development of early and late-stage assets and programs. As one of the co-founders of the Company with deep experience in drug development and approvals, Dr. Mattsson is primed to lead the R&D organization with his institutional knowledge, vision for the pipeline and products, and ability to deliver against corporate objectives.

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Data suggests in triple negative breast cancer that MUC4 predicts survival and resistance to immunotherapy and that INB03 reverses resistance by decreasing immunosuppression in the TME

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BUDAPEST, Hungary, Dec. 09, 2021 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP) today announced the conclusion of high-level meetings in Hungary that are expected to lead to utilization of ZYESAMI® (aviptadil) in that country and the pivotal clinical trial of the BriLife COVID-19 vaccine (BriLife).

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TryptageniX, a majority-owned joint venture with CB Therapeutics, employs bioprospecting to develop new chemical entities with potential applications in mental health.

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atai Life Sciences launches TryptageniX to further expand atai’s robust intellectual property portfolio and strengthen atai's supply chain

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Publication of Phase 1/2 MM1636 Trial Results Follows FDA Breakthrough Therapy Designation for IO102-IO103 in combination with an anti-PD-1 monoclonal antibody Publication of Phase 1/2 MM1636 Trial Results Follows FDA Breakthrough Therapy Designation for IO102-IO103 in combination with an anti-PD-1 monoclonal antibody

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IO Biotech Announces Publication of Phase 1/2 Melanoma Clinical Trial Results in Nature Medicine

CARSON CITY, NV, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Pharmagreen Biotech, Inc., (OTC PINK: PHBI), today released a second management update form CEO Peter Wojcik.  Today’s update provides further information on the company’s strategy to convert the revenue potential of its proprietary intellectual property into realized revenue.  The first update can be reviewed and the following link:

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NEW YORK and MAINZ, Germany, December 9, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 16 years of age and older. The booster dose is to be administered at least six months after completion of the primary series and is the same formulation and dosage strength as the doses in the primary series.

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TryptageniX will research and develop new sustainable methods of manufacturing therapeutic compounds commercially with increased reproducibility and reliability for clinical use. This partnership will also leverage CB Therapeutics’ versatile platform to propel the development of new chemical entities for next-generation mental health treatments. TryptageniX will research and develop new sustainable methods of manufacturing therapeutic compounds commercially with increased reproducibility and reliability for clinical use. This partnership will also leverage CB Therapeutics’ versatile platform to propel the development of new chemical entities for next-generation mental health treatments

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CB Therapeutics and atai Life Sciences launch TryptageniX to sustainably supply and develop clinically relevant compounds to tackle the growing mental...

CAMBRIDGE, Mass. and GOSSELIES, Belgium, Dec. 09, 2021 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, today announced the presentation of new preclinical data for its anti-TIGIT monoclonal antibody, EOS-448, at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition and the TIGIT Therapies Digital Summit 2021.

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iTeos Announces New Data for its Anti-TIGIT Antibody, EOS-448, at the American Society of Hematology Annual Meeting and TIGIT Therapies Digital Summit...

-- Angion to host a conference call today at 4:30 p.m. EST

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NEW YORK, Dec. 09, 2021 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its proprietary DeltEx platform, today announced the promotion of Kate Rochlin, Ph.D. to Chief Operating Officer (COO). Dr. Rochlin previously served as Vice President, Operations and Innovation.

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