Lymphatic system

Precision BioSciences Receives Favorable Type C Feedback from the FDA on the Company’s Chemistry, Manufacturing, and Controls (CMC) Strategies for Late-Stage Development of Azercabtagene Zapreleucel, its Lead Allogeneic CAR T Clinical Candidate

Retrieved on: 
Friday, January 6, 2023
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Research, Genetics, Science, Clinical Trials, CMC, Food, Gene editing, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NHL, Lymphatic system, CAR, Patient, Regulatory affairs, FDA, Lymphoma, Precision, Pharmaceutical industry

Azer-cel is Precision BioSciences lead allogeneic CAR T candidate being evaluated for relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) in subjects who have relapsed following autologous CAR T treatment.

Key Points: 
  • Azer-cel is Precision BioSciences lead allogeneic CAR T candidate being evaluated for relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) in subjects who have relapsed following autologous CAR T treatment.
  • “We are pleased with the FDA feedback on key components of our planned CMC package to support azer-cel ongoing development.
  • “There are currently no FDA-approved allogeneic CAR T products to address the high unmet need of the CAR T relapsed or refractory patient population.
  • An effective off-the-shelf allogeneic CAR T treatment has the potential to offer clinical benefit to this growing population of lymphoma patients.”

Graphite Bio Announces Voluntary Pause of Phase 1/2 CEDAR Study of nulabeglogene autogedtemcel (nula-cel) for Sickle Cell Disease

Retrieved on: 
Thursday, January 5, 2023
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Partnership, Bio, SCD, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Sickle cell disease, Pancytopenia, Risk, Lymphatic system, Microdeletion syndrome, Patient, Graphite, Thalassemia, FDA, Pharmaceutical industry

The decision by Graphite Bio to voluntarily pause the CEDAR study follows a serious and unexpected adverse event of prolonged low blood cell counts (pancytopenia) requiring ongoing transfusion and growth factor support in the first patient dosed with nula-cel.

Key Points: 
  • The decision by Graphite Bio to voluntarily pause the CEDAR study follows a serious and unexpected adverse event of prolonged low blood cell counts (pancytopenia) requiring ongoing transfusion and growth factor support in the first patient dosed with nula-cel.
  • While the event did not meet study stopping requirements, based on evolving clinical data, Graphite Bio decided to voluntarily pause the study.
  • Graphite Bio is comprehensively assessing the adverse event, risk factors and mitigation strategies, including potential modifications to the nula-cel manufacturing process.
  • Graphite Bio will provide a business update by the end of the first quarter of 2023.

Global CAR-T Cell Therapy Market Report 2023: Focus on Reducing Hospital Stays Driving Development - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 5, 2023
Health, General Health, Geography, Acquisition, Juno Therapeutics, Lymphatic system, BMS, Astellas Pharma, NMPA, Gilead, Kite Pharma, Ipos, Regenerative medicine, Clinical trial, Therapy, Bristol Myers Squibb, FDA, Pharmaceutical industry

These historic approvals demonstrate that the CAR-T market has arrived and is taking the biotech industry by storm.

Key Points: 
  • These historic approvals demonstrate that the CAR-T market has arrived and is taking the biotech industry by storm.
  • In total, there has been an astonishing $100 billion of market capitalization from CAR-T companies in recent years.
  • Financing rounds by CAR-T companies have approached $4 billion, while CAR-T industry partnerships have contributed an astounding $2 billion.
  • The billion-dollar CAR-T cell therapy market would not have been possible without the remarkable efficacy of the early CAR-T therapies in treating several types of blood cancers.

FDA Grants Priority Review to Genentech’s Bispecific Antibody Glofitamab for People With Relapsed or Refractory Large B-Cell Lymphoma

Retrieved on: 
Friday, January 6, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, The New England Journal of Medicine, Cancer, Hoffmann-La Roche, Priority review, Food, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Oxaliplatin, BLA, Lymphatic system, OR, Royal commission, Mantle cell lymphoma, DLBCL, NHL, HIV disease progression rates, Aggressive lymphoma, CAR, CRS, Patient, Cytokine release syndrome, ROG, RO, European Commission, FDA, Rituximab, Lymphoma, B-cell lymphoma, Phase, GemOx, Hematology, Incidence, Society, CR, Pharmaceutical industry, Genentech

The FDA is expected to make a decision on approval of this novel cancer immunotherapy by July 1, 2023.

Key Points: 
  • The FDA is expected to make a decision on approval of this novel cancer immunotherapy by July 1, 2023.
  • If approved, glofitamab would be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with an aggressive lymphoma who have previously received multiple courses of treatment.
  • The FDA will review the glofitamab BLA under the granted Fast Track Designation.
  • Glofitamab is part of Genentech’s industry-leading CD20xCD3 T-cell engaging bispecific antibody clinical program, which is the broadest and most advanced in lymphoma.

Global T-Cell Therapy Market Report to 2035: Players Include Autolus, Bluebird Bio, Bristol Myers Squibb, Carsgen Therapeutics and Cellectis - ResearchAndMarkets.com

Retrieved on: 
Wednesday, January 4, 2023
Health, Pharmaceutical, Clinical trial, Partnership, Death, TILS, TCR, Immunocore, Research, Gilead Sciences, Lymphatic system, CMOS, Public sector, TIL, Novartis, Bristol Myers Squibb, D, Immune system, USFDA, WHO, Pharmaceutical industry, Fine chemical, Vaccine, Marketing, Cancer

In this context, immunotherapies, a relatively recent addition to the gamut of anticancer interventions, have demonstrated significant promise.

Key Points: 
  • In this context, immunotherapies, a relatively recent addition to the gamut of anticancer interventions, have demonstrated significant promise.
  • It is worth mentioning that, recently, KIMMTRAK (Immunocore) became the first T-cell receptor (TCR) therapy to receive approval from the USFDA.
  • Presently, more than 250 companies are engaged in the development of more than 1,200 early and late-stage T-cell therapies, worldwide.
  • How is the current and future market opportunity likely to be distributed across key market segments?

Thermo Fisher Scientific Completes Acquisition of The Binding Site Group

Retrieved on: 
Tuesday, January 3, 2023
Oncology, Health, Other Science, Research, Science, Pharmaceutical, Biotechnology, Thermo Fisher Scientific, Mindful Scientific Inc., Nordic Capital, Lymphatic system, Binding site, Disease, TMO, Acquisition, NYSE, Binding, Multiple myeloma, Diagnosis, Medical imaging

Thermo Fisher Scientific Inc. (NYSE: TMO) (“Thermo Fisher”), the world leader in serving science, today announced that it has completed its acquisition of The Binding Site Group (“The Binding Site”), a global leader in specialty diagnostics, from a shareholder group led by European private equity firm Nordic Capital, in an all-cash transaction valued at £2.3 billion, or $2.8 billion at current exchange rates.

Key Points: 
  • Thermo Fisher Scientific Inc. (NYSE: TMO) (“Thermo Fisher”), the world leader in serving science, today announced that it has completed its acquisition of The Binding Site Group (“The Binding Site”), a global leader in specialty diagnostics, from a shareholder group led by European private equity firm Nordic Capital, in an all-cash transaction valued at £2.3 billion, or $2.8 billion at current exchange rates.
  • Thermo Fisher announced the agreement to acquire The Binding Site on October 31, 2022 .
  • “We are very excited to welcome The Binding Site colleagues to Thermo Fisher Scientific,” said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher.
  • “The Binding Site expands our existing specialty diagnostics portfolio with the addition of pioneering innovation in diagnostics and monitoring for multiple myeloma.

Minimal Residual Disease Testing Global Market Report 2022: Industry to Reach $2.3 Billion by 2027 at a 14% CAGR - ResearchAndMarkets.com

Retrieved on: 
Friday, December 30, 2022
Health, Other Health, Government, Cancer, Region, Flow cytometry, NGS, Leukemia, USD, Neoplasm, Lymphatic system, Polymerase chain reaction, Hospital, Academic institution, Research, Growth, Patient, PCR, Pharmaceutical industry, Medical device, Lymphoma

The global minimal residual disease testing market is valued at an estimated USD 1.2 Billion in 2022 and is projected to reach USD 2.3 Billion by 2027, at a CAGR of 14.0% during the forecast period.

Key Points: 
  • The global minimal residual disease testing market is valued at an estimated USD 1.2 Billion in 2022 and is projected to reach USD 2.3 Billion by 2027, at a CAGR of 14.0% during the forecast period.
  • The PCR segment accounted for the highest growth rate in the minimal residual disease testing market, by technology, during the forecast period
    The minimal residual disease testing market is segmented into flow cytometry, polymerase chain reaction (PCR), next-generation sequencing (NGS).
  • In 2021, the PCR segment accounted for the highest growth rate in the minimal residual disease testing market.
  • The global minimal residual disease testing market is segmented into North America, Europe, the Asia Pacific, and the Rest of the World.

The Worldwide Laboratory Freezers Industry is Expected to Reach $7.2 Billion by 2030: Rising Demand for Lab Freezers Due to its Proper Temperature-Controlled Storage of COVID-19 Vaccines Drives Growth - ResearchAndMarkets.com

Retrieved on: 
Wednesday, December 28, 2022
COVID-19, Research, Medical Supplies, Infectious Diseases, Hospitals, Biotechnology, Pharmaceutical, Health, Science, Other Science, Refrigeration, Degenerative disease, Blood, CDC, Infection, Korea Disease Control and Prevention Agency, COVID-19, Temperature, Laboratory, Anti-transglutaminase antibodies, Person, Growth, Lymphatic system, Patient, Severe acute respiratory syndrome coronavirus 2, Transplant, Haemophilia, Vaccine, Prevalence, Diagnosis, Pharmaceutical industry

The key factors responsible for the market growth include the rapidly rising demand for lab freezers due to its proper temperature-controlled storage of COVID-19 vaccines.

Key Points: 
  • The key factors responsible for the market growth include the rapidly rising demand for lab freezers due to its proper temperature-controlled storage of COVID-19 vaccines.
  • As a result, the need for laboratory refrigerators, freezers, and low-temperature freezers has risen to aid pattern processing, checking out, and vaccine improvement laboratories.
  • The rising vaccine development for the emerging infectious disease and rising cases of organ transplantations is driving the laboratory freezers industry during the forecast period.
  • The publisher has segmented the laboratory freezers market report on the basis of product, end-use, and region.

FDA Approves Genentech’s Lunsumio, a First-in-Class Bispecific Antibody, to Treat People With Relapsed or Refractory Follicular Lymphoma

Retrieved on: 
Friday, December 23, 2022
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Cancer, Rash, Hoffmann-La Roche, Blood, AE, Fever, Haematopoietic system, Food, Leukemia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Hospital, City, Skin, News, HIV disease progression rates, Immunotherapy, AES, Disease, CRS, Patient, Cytokine release syndrome, Lymphatic system, ROG, RO, The Hope Division, Physician, FDA, Follicular lymphoma, Fatigue, Headache, Hematology, CR, Pharmaceutical industry, Vaccine, Genentech, Lymphoma, Phase

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available, so that patients do not have to wait to start treatment.
  • Lunsumio will be available in the United States in the coming weeks.
  • “This bispecific antibody is an off-the-shelf, accessible treatment option that has the potential to help those with relapsed or refractory follicular lymphoma achieve remission.”
    Lunsumio was developed based on Genentech’s broad expertise in creating bispecific antibodies.

City of Hope-led trial leads to U.S. Food and Drug Administration's approval of a first of its kind bispecific antibody

Retrieved on: 
Thursday, January 5, 2023
Yee, Cancer, Budde, Rash, Hoffmann-La Roche, B-cell lymphoma, Fever, Haematopoietic system, Follicular lymphoma, Food, National Cancer Institute, Genentech, City, Science, HIV disease progression rates, Non-Hodgkin lymphoma, Immunotherapy, LOS, Disease, CAR, CD3, Patient, Cytokine release syndrome, Lymphatic system, The Hope Division, Weight loss, FDA, Therapy, Fatigue, Prognosis, Headache, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CD20, Hematology, Diagnosis, Pharmaceutical industry, Vaccine, Health insurance, Lymphoma, Hope

LOS ANGELES, Jan. 5, 2023 /PRNewswire/ -- A trial led by City of Hope, one of the largest cancer research and treatment organizations in the nation, contributed to the U.S. Food and Drug Administration's approval of mosunetuzumab (commercial name: Lunsumio), the first bispecific antibody to treat people with relapsed or difficult to treat follicular lymphoma (FL), a type of non-Hodgkin lymphoma, after they have received two or more standard therapies.

Key Points: 
  • Instead of concentrating on a singular target, bispecific antibodies are therapeutics that act on two cellular targets simultaneously.
  • "At City of Hope, the integration of scientific research and clinical trials allows us to deliver groundbreaking science and treatments from laboratory to patient.
  • Mosunetuzumab is a first in class T cell engaging bispecific antibody and could change the way advanced follicular lymphoma is treated."
  • Ninety patients with follicular lymphoma, who ranged in age from 29 to 90 years old, were enrolled in the multicenter international trial.