Clinical Trials

Tavneos® (avacopan) recommended by England’s NICE for the treatment of AAV (GPA/MPA)

Retrieved on: 
Thursday, August 18, 2022 - 6:00am

We very much welcome NICEs decision, which means that eligible patients and clinicians have another choice of treatment for this debilitating condition.

Key Points: 
  • We very much welcome NICEs decision, which means that eligible patients and clinicians have another choice of treatment for this debilitating condition.
  • NICEs decision represents a major advancement for the treatment of GPA/MPA in the UK, said Prof. David Jayne, Professor of Clinical Autoimmunity, University of Cambridge.
  • Patients will now have access to a new therapy option that could help them optimize their treatment outcomes.
  • Tavneos was developed by ChemoCentryx, Inc., who is also developing Tavneos for the treatment of patients with C3 Glomerulopathy (C3G) and hidradenitis suppurativa (HS).

Exscientia Business Update for Second Quarter and First Half 2022

Retrieved on: 
Wednesday, August 17, 2022 - 9:01pm

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220817005681/en/
    Recent developments in the Companys pipeline, collaborations, and operations, as well as financial results for the second quarter and first half 2022, are summarised below.
  • In addition, Exscientia will host a conference call Thursday, August 18 at 1:30 p.m. BST / 8:30 a.m.
  • In the first half of 2022, we delivered on major new and existing collaborations, advanced our pipeline programmes, and marked the 10-year anniversary of Exscientias founding.
  • A replay will be available for 90 days under "Events and Presentations in the Investors and Media section of the Exscientia website .

bluebird bio Announces U.S. Commercial Infrastructure to Enable Patient Access to ZYNTEGLO®, the First and Only FDA-Approved Gene Therapy for People with Beta-Thalassemia Who Require Regular Red Blood Cell Transfusions

Retrieved on: 
Wednesday, August 17, 2022 - 7:32pm

This outcomes measure is recognized by payers and providers as clinically meaningful and straightforward to track through claims data.

Key Points: 
  • This outcomes measure is recognized by payers and providers as clinically meaningful and straightforward to track through claims data.
  • bluebird bio has the longest and most robust clinical program in transfusion-dependent betathalassemia (TDT) in the field of gene therapy.
  • ZYNTEGLO is a first-in-class, one-time ex-vivo LVV gene therapy approved for the treatment of beta-thalassemia in adult and pediatric patients who require regular red blood cell transfusions.
  • ZYNTEGLO is indicated for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions.

bluebird bio Announces FDA Approval of ZYNTEGLO®, the First Gene Therapy for People with Beta-Thalassemia Who Require Regular Red Blood Cell Transfusions

Retrieved on: 
Wednesday, August 17, 2022 - 7:03pm

The Cooleys Anemia Foundation applauds the FDAs approval of ZYNTEGLO for people with betathalassemia who require regular red blood cell transfusions.

Key Points: 
  • The Cooleys Anemia Foundation applauds the FDAs approval of ZYNTEGLO for people with betathalassemia who require regular red blood cell transfusions.
  • bluebird bio has the longest and most robust clinical program in transfusion-dependent betathalassemia (TDT) in the field of gene therapy.
  • ZYNTEGLO is a first-in-class, one-time ex-vivo LVV gene therapy approved for the treatment of beta-thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions.
  • ZYNTEGLO is indicated for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions.

An Impact Company Committed to Improving the Health of Patients Worldwide, MedinCell Publishes Its 2021-2022 ESG Annual Report

Retrieved on: 
Wednesday, August 17, 2022 - 5:00pm

It is a virtuous process of continuous improvement at all levels of the company.

Key Points: 
  • It is a virtuous process of continuous improvement at all levels of the company.
  • This year, we implemented an ESG committee at the highest level of governance to guarantee the sustainability of our commitment.
  • We have also improved our extra-financial performance by working on several topics such as transparency, environment, corporate governance, and ethics.
  • MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.

Tevogen Bio Appoints Three Prominent Healthcare Leaders to its Board of Directors

Retrieved on: 
Wednesday, August 17, 2022 - 3:20pm

These nationally prominent healthcare leaders join Tevogens Board, effective immediately, alongside existing board members, Curtis Patton, Ph.D., and CEO Ryan Saadi , M.D., M.P.H.

Key Points: 
  • These nationally prominent healthcare leaders join Tevogens Board, effective immediately, alongside existing board members, Curtis Patton, Ph.D., and CEO Ryan Saadi , M.D., M.P.H.
  • The Board is tasked with further strengthening Tevogens organizational readiness as the company pursues its bold growth strategy.
  • Lindee Goh leads Tapestry Networks healthcare practice, working with public and private sector leaders to develop effective strategies to improve clinical outcomes while fostering sustainable healthcare innovation.
  • Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises.

Omeros Corporation Receives Interim Response from FDA on Formal Dispute Resolution Request for Narsoplimab

Retrieved on: 
Wednesday, August 17, 2022 - 1:40pm

Omeros Corporation (Nasdaq: OMER) today announced that the United States Food and Drug Administration (FDA) provided an interim response to the companys formal dispute resolution request submitted to the Agency in June, appealing the earlier decision by the FDA review division to issue a complete response letter for the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Key Points: 
  • Omeros Corporation (Nasdaq: OMER) today announced that the United States Food and Drug Administration (FDA) provided an interim response to the companys formal dispute resolution request submitted to the Agency in June, appealing the earlier decision by the FDA review division to issue a complete response letter for the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
  • Formal dispute resolution is an official pathway that enables a sponsor to appeal a decision by an FDA division to a higher authority within the Agency, in this case the Office of New Drugs (OND).
  • As part of FDAs standard procedures for dispute resolution, Omeros and OND met last month to discuss the appeal.
  • Per FDA guidelines for formal dispute resolution, a final decision from OND was to be rendered within 30 calendar days of the meeting unless the deciding official in OND required additional information.

Sonoma Biotherapeutics Expands Board of Directors with Appointments of Katina Dorton, J.D., MBA, and John Davis, M.D., MPH

Retrieved on: 
Wednesday, August 17, 2022 - 1:00pm

Sonoma Biotherapeutics, Inc. , a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases, today announced the appointments of Katina Dorton, J.D., MBA, and John Davis, M.D., MPH, to its Board of Directors.

Key Points: 
  • Sonoma Biotherapeutics, Inc. , a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases, today announced the appointments of Katina Dorton, J.D., MBA, and John Davis, M.D., MPH, to its Board of Directors.
  • John is a highly-respected and accomplished leader in drug development and a rheumatologist with vast experience in industry and academia.
  • He will provide critical expertise as we move our Treg therapies into the clinic to treat rheumatoid arthritis and other autoimmune diseases.
  • We are pleased to welcome Katina and John to our board.

Bristol Myers Squibb Completes Acquisition of Turning Point Therapeutics, Expanding Precision Oncology Portfolio

Retrieved on: 
Wednesday, August 17, 2022 - 1:31pm

Bristol Myers Squibb (NYSE:BMY) announced today that it has successfully completed its acquisition of Turning Point Therapeutics, Inc. (Turning Point), in an all-cash transaction.

Key Points: 
  • Bristol Myers Squibb (NYSE:BMY) announced today that it has successfully completed its acquisition of Turning Point Therapeutics, Inc. (Turning Point), in an all-cash transaction.
  • With the completion of the acquisition, Turning Point shares have ceased trading on the NASDAQ Global Select Market and Turning Point is now a wholly owned subsidiary of Bristol Myers Squibb.
  • Turning Point has distinguished itself in the field of precision oncology, and this acquisition will further strengthen our leading oncology franchise, said Elizabeth Mily, Executive Vice President, Strategy & Business Development, Bristol Myers Squibb.
  • Neither Bristol Myers Squibb nor Turning Point undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Cybin and Clinilabs Granted Schedule I DEA License for CYB003 Phase 1/2a First-In-Human Clinical Trial

Retrieved on: 
Wednesday, August 17, 2022 - 1:00pm

"Obtaining a DEA license for our Phase 1/2a trial is the final step clearing the way to begin dosing participants in our first-in-human study of CYB003.

Key Points: 
  • "Obtaining a DEA license for our Phase 1/2a trial is the final step clearing the way to begin dosing participants in our first-in-human study of CYB003.
  • The DEA license is a federal requirement for any investigators who intend to study, produce, analyze, or otherwise work with Schedule I controlled substances.
  • Importantly, participants in the trial that are currently being treated with antidepressants will be allowed to remain on their antidepressant medication.
  • Using the Montgomery-Asberg Depression Rating Scale, the trial will assess rapid onset of antidepressant effect on the day of dosing.