Immunosuppressants

Biogen Announces Results from Phase 3b NOVA Study Evaluating Every Six-Week Dosing with Natalizumab in Relapsing-Remitting Multiple Sclerosis

Retrieved on: 
Monday, August 2, 2021
Monoclonal antibodies, Medical specialties, Immunosuppressants, Life sciences, Natalizumab, Immunology, Multiple sclerosis, Biogen, Autoimmune diseases

The NOVA study provides the first prospective, randomized efficacy data of every six-week dosing with natalizumab, building on its well-established clinical profile and the real-world findings1,2,3, said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen.

Key Points: 
  • The NOVA study provides the first prospective, randomized efficacy data of every six-week dosing with natalizumab, building on its well-established clinical profile and the real-world findings1,2,3, said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen.
  • A complete analysis of the study data is ongoing and detailed results will be shared in a future scientific forum.
  • Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis.
  • No Difference in Radiologic Outcomes for Natalizumab Patients on Extended Interval Dosing Compared with Standard Interval Dosing in MS PATHS.

HUMIRA (Adalimumab) Biosimilars Report 2021: Focus on Approved & Launched, Investigational & Research Use, Inactive/Terminated/Withdrawn, Industry/Non-Industry Partnerships - ResearchAndMarkets.com

Retrieved on: 
Friday, July 30, 2021
Biotechnology, Pharmaceutical, Health, Drugs, Life sciences, Articles, Biotechnology, Immunosuppressants, TNF inhibitors, Biosimilar, Monoclonal antibodies, Adalimumab

The "HUMIRA (Adalimumab) Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive/Terminated/Withdrawn Biosimilars, Industry/Non-Industry Partnerships" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "HUMIRA (Adalimumab) Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive/Terminated/Withdrawn Biosimilars, Industry/Non-Industry Partnerships" report has been added to ResearchAndMarkets.com's offering.
  • The "Adalimumab Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive/Terminated/Withdrawn Biosimilars, Industry/Non-Industry Partnerships" report features an extensive study of the current developer landscape and clinical research scenario related to all the follow-on products of the blockbuster biologic drug, HUMIRA, which are either available or under development.
  • An analysis of the various partnerships related to adalimumab biosimilars, based on parameters, such as year of partnership, type of partnership, and geographical locations of partnering entities.
  • A detailed assessment of the various marketing and distribution agreements inked in relation to HUMIRA biosimilars, highlighting the key players involved.

China's Infliximab Market Investigation Report 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 29, 2021
Biotechnology, Genetics, Health, Oncology, Drugs, Monoclonal antibodies, Immunosuppressants, TNF inhibitors, Janssen Pharmaceutica, Infliximab, Janssen Biotech, Economy of China, China

The "Investigation Report on China's Infliximab Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Investigation Report on China's Infliximab Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.
  • By 2020, Janssen Biologics BV is the only manufacturer in the Chinese Infliximab market.
  • According to the market research, since Infliximab entered the Chinese market in 2007, its sales have had an increasing trend.
  • 2 Sales of Infliximab in China, 2016-2020
    2.3 Sales of Infliximab by Dosage Form in China, 2016-2020
    3 Analysis of Major Infliximab Manufacturers in China, 2016-2020
    4 Prices of Infliximab for Different Manufacturers in China, 2020-2021
    5 Prospect of Chinese Infliximab drug Market, 2021-2025
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210729005802/en/

Regulatory update from US Food and Drug Administration

Retrieved on: 
Wednesday, July 28, 2021
Drugs, Health care, Medicine, Orphan drugs, Immunosuppressants, Antineoplastic drugs, Aromatic amines, Multiple myeloma, Lenalidomide, Food and Drug Administration, Daratumumab

The Company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes available.

Key Points: 
  • The Company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes available.
  • The Company plans to submit complete data from the OCEAN-study to the International Myeloma Workshop meeting in Vienna on September 8-11, 2021.
  • The information was submitted for publication, through the agency of the contact persons above, on July 28, 2021, at 16:30 (CET).
  • They have all developed resistance to their last line of therapy, and within 18 months from the study start to lenalidomide, the most used drug in multiple myeloma.

Regulatory update from US Food and Drug Administration

Retrieved on: 
Wednesday, July 28, 2021
Drugs, Health care, Medicine, Orphan drugs, Immunosuppressants, Antineoplastic drugs, Aromatic amines, Multiple myeloma, Lenalidomide, Food and Drug Administration, Daratumumab

The Company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes available.

Key Points: 
  • The Company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes available.
  • The Company plans to submit complete data from the OCEAN-study to the International Myeloma Workshop meeting in Vienna on September 8-11, 2021.
  • The information was submitted for publication, through the agency of the contact persons above, on July 28, 2021, at 16:30 (CET).
  • They have all developed resistance to their last line of therapy, and within 18 months from the study start to lenalidomide, the most used drug in multiple myeloma.

IMIDomicsTM Closes $16.5 Million Series A Financing to Advance its Precision Discovery Platform for Immune-Mediated Inflammatory Diseases

Retrieved on: 
Tuesday, July 27, 2021
Biotechnology, Pharmaceutical, Health, Medical specialties, Clinical medicine, Medicine, Abdominal pain, Autoimmune diseases, Immunosuppressants, TNF inhibitors, Cause, Immune-mediated inflammatory diseases, Immunomodulatory imide drug, Ulcerative colitis, Arthritis

IMIDomics Inc., a drug discovery company focused on patients with immune-mediated inflammatory diseases (IMIDs), has announced the completion of a $16.5 million Series A financing round.

Key Points: 
  • IMIDomics Inc., a drug discovery company focused on patients with immune-mediated inflammatory diseases (IMIDs), has announced the completion of a $16.5 million Series A financing round.
  • IMIDomics Precision Discovery Platform combines and analyzes clinical, epidemiologic, and biomolecular data to uncover new insights about IMIDs including lupus, Crohns disease, rheumatoid arthritis, and ulcerative colitis.
  • IMIDomics has established a Precision Discovery Platform that leverages patient data to reveal the fundamental mechanisms that drive immune-mediated inflammatory diseases.
  • This integrated capability, called the IMIDomics Precision Discovery Platform, enables precision medicine for IMID patients and will lead to therapies that address needs not addressed by current medicines.

Pfizer Provides Update on U.S. FDA Review of Abrocitinib and XELJANZ® Filings

Retrieved on: 
Wednesday, July 21, 2021
Biotechnology, FDA, Health, Pharmaceutical, Clinical trials, Health care, Life sciences, Immunosuppressants, Tofacitinib, Pfizer, Health, Clinical trials, Food and Drug Administration, Abrocitinib, XELJANZ® (tofacitinib), the ORAL Surveillance Study, Pfizer: Breakthroughs That Change Patients’ Lives, ABROCITINIB, XELJANZ® (TOFACITINIB), THE ORAL SURVEILLANCE STUDY, PFIZER: BREAKTHROUGHS THAT CHANGE PATIENTS’ LIVES

Pfizer is continuing to work with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to review the full results and analysis.

Key Points: 
  • Pfizer is continuing to work with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to review the full results and analysis.
  • Patients treated with XELJANZ* are at increased risk for developing serious infections that may lead to hospitalization or death.
  • * Unless otherwise stated, XELJANZ in the Important Safety Information refers to XELJANZ, XELJANZ XR, and XELJANZ Oral Solution.
  • Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

U.S. Food and Drug Administration Expands Indication for PROGRAF® for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients

Retrieved on: 
Tuesday, July 20, 2021
Medical specialties, Clinical medicine, Medicine, Organ transplantation, Transplantation medicine, Immunosuppressants, Macrolides, Cardiac surgery, Tacrolimus, Transplant rejection, Immunosuppressive drug, Heart transplantation

NORTHBROOK, Ill., July 20, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for PROGRAF® (tacrolimus) for the prevention of organ rejection in adult and pediatric lung transplant recipients.

Key Points: 
  • "The current approval expands the indications for PROGRAF from liver, kidney and heart transplants to adult and pediatric patients who receive a lung transplant in combination with other medicines to help prevent organ rejection."
  • The FDA granted Orphan Drug Designation (ODD) to PROGRAF for the prevention of rejection after lung transplant in September 2019.
  • PROGRAFis a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart or lung transplants, in combination with other immunosuppressants.
  • PROGRAF is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, heart or lung transplant.

Sorrento Announces Its Partner Mabpharm Has Received Marketing Approval In China For Infliximab Biobetter

Retrieved on: 
Tuesday, July 20, 2021
Drugs, Life sciences, Health care, Immunosuppressants, TNF inhibitors, Biotechnology, Monoclonal antibodies, Infliximab, Janssen Pharmaceutica, Biopharmaceutical, Biologics license application, National Medical Products Administration

China National Medical Product Administration (NMPA) has granted Mabpharm approval to marketINFLIXIMAB biobetter in China.

Key Points: 
  • China National Medical Product Administration (NMPA) has granted Mabpharm approval to marketINFLIXIMAB biobetter in China.
  • Sorrento holds commercialization rights outside of China and intends to meet with regulatory agencies to determine best path to registration for the US and Europe.
  • SAN DIEGO, July 20, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics (Nasdaq: SRNE) announced today that its partner Mabpharm Ltd (HK:2181) has received approval of its New Drug Application for its infliximab biobetter antibody in China.
  • Sorrento holds exclusive commercial rights to this product outside of China and plans to file a Biologics License Application (BLA) for the infliximab biobetter antibody in the United States and Europe in 2021.

China Tocilizumab Market Investigation Report 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 20, 2021
Health, Biotechnology, Countries, Immunosuppressants, Tocilizumab, Health care, Forms of government, China

The "Investigation Report on China's Tocilizumab Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Investigation Report on China's Tocilizumab Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.
  • By 2020, Tocilizumab has registered a number of studies in China, and its indications include RA, sJIA, and CRS.
  • According to the market research, as the Tocilizumab market will expand from 2021 to 2025, its sales will continue to grow.
  • 2 Sales of Tocilizumab in China, 2016-2020
    2.3 Sales of Tocilizumab by Dosage Form in China, 2016-2020
    3 Analysis of Major Tocilizumab Manufacturers in China, 2016-2020
    4 Prices of Tocilizumab for Different Manufacturers in China, 2020-2021
    5 Prospect of Chinese Tocilizumab Market, 2021-2025
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210720005521/en/