Monoclonal antibodies

SAB Biotherapeutics Doses First Participant in Phase 2a Trial of SAB-176 for the Treatment of Influenza

Retrieved on: 
Friday, July 2, 2021
Health, Infectious diseases, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Drugs, Monoclonal antibodies, Antibodies, Medical research, Neutralizing antibody, Placebo-controlled study, Health sciences, Health, Infectious diseases, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Drugs, Monoclonal antibodies, Antibodies, Medical research, Neutralizing antibody, Placebo-controlled study, Health sciences, SAB-176, Seasonal Influenza, SAB Biotherapeutics, Inc., SAB-176, SEASONAL INFLUENZA, SAB BIOTHERAPEUTICS, INC.

The Phase 2a trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza virus strain (pH1N1).

Key Points: 
  • The Phase 2a trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza virus strain (pH1N1).
  • SAB-176 is also being evaluated in an ascending dose, double-blind, randomized, placebo-controlled Phase 1 safety trial in healthy volunteers.
  • SAB-176 is a multivalent, broadly neutralizing fully-human polyclonal antibody therapeutic candidate in development for the treatment, or prevention, of severe influenza.
  • SAB Biotherapeutics, Inc. (SAB) is a clinical-stage biopharmaceutical company advancing a new class of immunotherapies based on its human polyclonal antibodies.

Baysient Launches Digital TDM App for Fast, Personalized Infliximab Dosing

Retrieved on: 
Tuesday, June 29, 2021
Medical specialties, Drugs, Clinical medicine, Monoclonal antibodies, Janssen Pharmaceutica, Biotechnology, Immune system, Immunology, Infliximab

FORT MYERS, Fla., June 29, 2021 /PRNewswire/ -- Baysient LLC announces the release of T 3 Time To Target ,a new web-based application specifically for simple precision dosing of Infliximab.

Key Points: 
  • FORT MYERS, Fla., June 29, 2021 /PRNewswire/ -- Baysient LLC announces the release of T 3 Time To Target ,a new web-based application specifically for simple precision dosing of Infliximab.
  • "This new app can be a game-changer for caregivers along the entire spectrum of IBD," noted Dr. Diane Mould, Founder and Chief Technical Officer of Baysient LLC.
  • And, it can be a nightmare in clinical trial settings when switching from Infliximab to another monoclonal antibody.
  • About Baysient: Built to provide individualized treatments for patients with improved outcomes, Baysient LLC develops SaaS, cloud-based software that provides medical providers with a full line of individual dosage-determination products.

Chugai’s Enspryng (Satralizumab) Approved by European Commission as First At-home Subcutaneous Treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD)

Retrieved on: 
Monday, June 28, 2021
Biotechnology, Health, Pharmaceutical, Optical, Clinical trials, Monoclonal antibodies, Orphan drugs, Autoimmune diseases, Rare diseases, Organ systems, Health, Neuromyelitis optica spectrum disorder, Satralizumab, Clinical medicine, T helper 17 cell, Inebilizumab

Enspryng is the first treatment approved in the EU for adolescents from 12 years of age with NMOSD.

Key Points: 
  • Enspryng is the first treatment approved in the EU for adolescents from 12 years of age with NMOSD.
  • We are confident that Enspryng will meaningfully contribute to improving the treatment of people with NMOSD, by fitting into their day-to-day lives.
  • Enspryng is designed to prevent NMOSD relapses by inhibiting IL-6 signal signaling, which is a key driver in NMOSD.
  • Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review.

Innovent Announces the China NMPA Approval of TYVYT® (sintilimab injection) in Combination with BYVASDA® (bevacizumab biosimilar injection) as First-Line Therapy for People with Hepatocellular Carcinoma

Retrieved on: 
Monday, June 28, 2021
Drugs, Health care, Clinical medicine, Orphan drugs, Specialty drugs, Angiogenesis inhibitors, Bevacizumab, Monoclonal antibodies, Biosimilar, Targeted therapy, Hepatocellular carcinoma, Adalimumab

BYVASDA (bevacizumab biosimilar injection)was previously approved for advanced non-small cell lung cancer, metastatic colorectal cancer, and adult recurrent glioblastoma.

Key Points: 
  • BYVASDA (bevacizumab biosimilar injection)was previously approved for advanced non-small cell lung cancer, metastatic colorectal cancer, and adult recurrent glioblastoma.
  • This new approval was based on the results of a randomized, open-label Phase 3 clinical trial (ORIENT-32) of TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) as first-line therapy for unresectable HCC.
  • Response of hepatocellular carcinoma to chemotherapy and targeted therapy is undesirable, while immunotherapy has emerged as breakthrough treatment for hepatocellular carcinoma.
  • BYVASDA (bevacizumab biosimilar injection), HALPRYZA (rituximab biosimilar injection), andSULINNO (adalimumab biosimilar injection) are not approved products in the United States.

Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Ranibizumab Biosimilar, BYOOVIZ™

Retrieved on: 
Friday, June 25, 2021
Life sciences, Health sciences, Health care, Biotechnology, Monoclonal antibodies, Specialty drugs, Biogen, Spinal muscular atrophy, Biosimilar, Samsung Biologics, Samsung, Biopharmaceutical

The CHMPs positive opinion will now be referred to the European Commission (EC), which will decide whether to grant a marketing authorization for BYOOVIZ.

Key Points: 
  • The CHMPs positive opinion will now be referred to the European Commission (EC), which will decide whether to grant a marketing authorization for BYOOVIZ.
  • We are very proud to see BYOOVIZ becoming the first biosimilar of ranibizumab to be recommended for approval in Europe.
  • This positive CHMP opinion on BYOOVIZ was based on a Phase 3 clinical study that demonstrated equivalence in efficacy for both primary endpoints.
  • Samsung Bioepis is a joint venture between Samsung Biologics and Biogen.

BioMarin Receives Positive CHMP Opinion in Europe for Vosoritide for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close

Retrieved on: 
Friday, June 25, 2021
Drugs, Rare diseases, Clinical medicine, Achondroplasia, Medical specialties, Immunosuppressants, Monoclonal antibodies

Vosoritide is potentially the first medicine to be approved to treat children with achondroplasia in Europe and would be marketed under the brand name VOXZOGO (vosoritide).

Key Points: 
  • Vosoritide is potentially the first medicine to be approved to treat children with achondroplasia in Europe and would be marketed under the brand name VOXZOGO (vosoritide).
  • "The positive opinion from the CHMP represents a significant step towards making vosoritide available as a treatment choice for families.
  • The CHMP opinion reinforces the strength of the data and the clinical benefit to children as young as two years old.
  • "This positive CHMP opinion represents a significant step toward delivering on the promise of the first pharmacological treatment option for children and families affected by achondroplasia.

Tiziana Life Sciences plc (the "Company") Result of Annual General Meeting

Retrieved on: 
Friday, June 25, 2021
Monoclonal antibodies, Corporate governance, Shareholders, Meetings, Anti-CD3 monoclonal antibody, Proxy voting, Annual general meeting, Foralumab, Articles, Group decision-making, Political philosophy

LONDON, June 25, 2021 (GLOBE NEWSWIRE) -- At the Annual General Meeting of the Company held at 10.00 a.m. on 25June 2021, all of the resolutions were duly passed.

Key Points: 
  • LONDON, June 25, 2021 (GLOBE NEWSWIRE) -- At the Annual General Meeting of the Company held at 10.00 a.m. on 25June 2021, all of the resolutions were duly passed.
  • The results of the proxy voting will be available shortly on the Company's website, https://ir.tizianalifesciences.com/shareholder-services/annual-general-m... .
  • The Company also confirms that it has re-activated its strategic plan to redomicile to Bermuda; shareholders will receive further information in due course.
  • Foralumab is the only second generation fully human anti-CD3 monoclonal antibody in clinical development in the world.

SELLAS Reports Encouraging Updated Clinical Data from Ongoing Mesothelioma Study of Galinpepimut-S (GPS) Combined with Opdivo

Retrieved on: 
Thursday, June 24, 2021
Drugs, Health sciences, Health care, Bristol-Myers Squibb, Antineoplastic drugs, Breakthrough therapy, Orphan drugs, Monoclonal antibodies, Nivolumab, Bristol Myers Squibb

The study details are as follows:

Key Points: 
  • The study details are as follows:
    Four evaluable male patients, aged approximately 67.3 + 4.1 (standard deviation), received GPS plus nivolumab for at least one month.
  • About SELLAS Life Sciences Group, Inc.
    SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapeutics for a broad range of indications.
  • Opdivo is a registered trademark of Bristol Myers Squibb, and is not a trademark of SELLAS.
  • The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

FDA issues Emergency Use Authorization for CovAb™ SARS-CoV-2 Ab Test, the oral fluid rapid test for SARS-CoV-2 antibodies

Retrieved on: 
Thursday, June 24, 2021
Medicine, Health sciences, Medical specialties, Antiviral drugs, COVID-19 drug development, Monoclonal antibodies, COVID-19, Public health, Zoonoses, Emergency Use Authorization, Development of COVID-19 tests, Viral disease testing

CovAb, the only oral fluid rapid, Pan Ig antibody test for Covid-19 gets FDA Emergency Use Authorization

Key Points: 
  • CovAb, the only oral fluid rapid, Pan Ig antibody test for Covid-19 gets FDA Emergency Use Authorization
    CovAb is the first and only rapid, oral fluid-based, point-of-care antibody test authorized by the FDA for use under an EUA.
  • In addition to being rapid and noninvasive, the CovAb test has sensitivity of 97.6% and specificity of 98.8%.
  • The CovAb test was developed based on Diabetomics' expertise in oral fluid and autoantibody diagnostics developed for its core service areas of diabetes and fetal-maternal disease.
  • The CovAb test is available for sale through Diabetomics' subsidiary COVYDx, Inc.
    View original content to download multimedia: http://www.prnewswire.com/news-releases/fda-issues-emergency-use-authori...

Teva Announces Ministry of Health, Labour and Welfare Approves AJOVY® (fremanezumab) Injection in Japan for the Preventive Treatment of Migraine in Adults

Retrieved on: 
Wednesday, June 23, 2021
Health, Other Science, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Hormones, Monoclonal antibodies, Branches of biology, Calcitonin gene-related peptide receptor antagonists, Endocrine system, Calcitonin gene-related peptide, Neuropeptides, Migraine, Teva Pharmaceuticals, Fremanezumab, Calcitonin, AJOVY (fremanezumab-vfrm) injection, Teva, AJOVY (FREMANEZUMAB-VFRM) INJECTION, TEVA

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Ministry of Health, Labour and Welfare (MHLW) has approved the use of AJOVY (fremanezumab) injection for the preventive treatment of migraine in adults in Japan.

Key Points: 
  • Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Ministry of Health, Labour and Welfare (MHLW) has approved the use of AJOVY (fremanezumab) injection for the preventive treatment of migraine in adults in Japan.
  • Driven by our global mission to improve patients lives, we are pleased to offer this new treatment option to people living with migraine in Japan.
  • In 2020, the two companies announced outcomes from two pivotal studies of AJOVY in people living with episodic and chronic migraine in Japan.
  • AJOVY is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.