Granuloma

Roivant and Kinevant Sciences Complete Enrollment in RESOLVE-Lung, a Phase 2 Study Evaluating Namilumab for Chronic Pulmonary Sarcoidosis

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torsdag, april 25, 2024

Roivant (Nasdaq: ROIV) and Kinevant Sciences , a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced the successful completion of enrollment in its Phase 2 study evaluating namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung).

Key Points: 
  • Roivant (Nasdaq: ROIV) and Kinevant Sciences , a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced the successful completion of enrollment in its Phase 2 study evaluating namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung).
  • Potentially supportive of registration, RESOLVE-Lung is a randomized, double-blind, placebo-controlled Phase 2 study designed to enroll a minimum of 100 pulmonary sarcoidosis patients whose disease is not well-controlled despite currently available treatment options.
  • “Completing enrollment for this study is an important milestone in our journey to develop a new therapy for those living with pulmonary sarcoidosis.
  • Thus, namilumab has the potential to be the only well-tolerated and effective therapy for sarcoidosis, as well as the first therapy approved specifically for pulmonary sarcoidosis.

ANI Pharmaceuticals Recognizes Sarcoidosis Awareness Month and Patients Living with Sarcoidosis

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torsdag, april 4, 2024

BAUDETTE, Minn., April 04, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) https://www.anipharmaceuticals.com/ (Nasdaq : ANIP) is proud to support the Foundation for Sarcoidosis Research’s (FSR) commitment to sarcoidosis patients and efforts to increase disease awareness during April’s Sarcoidosis Awareness Month.

Key Points: 
  • BAUDETTE, Minn., April 04, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) https://www.anipharmaceuticals.com/ (Nasdaq : ANIP) is proud to support the Foundation for Sarcoidosis Research’s (FSR) commitment to sarcoidosis patients and efforts to increase disease awareness during April’s Sarcoidosis Awareness Month.
  • During the month of April, members of the ANI organization are raising awareness of sarcoidosis by wearing “Say Sarcoidosis” pins offered through FSRs National Awareness Campaign, “Say Sarcoidosis.” In addition, ANI members will also be wearing purple on April 13th in honor of “World Sarcoidosis Awareness Day.”
    According to the FSR, sarcoidosis is a rare inflammatory disease characterized by the formation of granulomas predominately in the lungs and, to a lesser extent, in other organs of the body.
  • “We applaud the Foundation for Sarcoidosis Research’s Awareness Campaign – “Say Sarcoidosis” and their ongoing education and support of people who live with sarcoidosis.
  • “We are grateful for ANI Pharmaceuticals’ commitment to increasing awareness and education about those living with sarcoidosis,” said Mary McGowan, Chief Executive Officer of the FSR.

First patient in the UK is dosed in the OATD-01 Phase 2 KITE study in pulmonary sarcoidosis

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fredag, mars 22, 2024

The world's first administration of the chitotriosidase 1 (CHIT1) inhibitor (or placebo) to patient took place at the Royal Infirmary in Edinburgh.

Key Points: 
  • The world's first administration of the chitotriosidase 1 (CHIT1) inhibitor (or placebo) to patient took place at the Royal Infirmary in Edinburgh.
  • As part of the trial, patients will take a daily fixed dose of 25 mg OATD-01 or placebo tablets for 12 weeks.
  • Patient safety will be monitored regularly through laboratory tests, neurological examinations and ECG and spirometry.
  • The study will involve approximately 20-30 centres in the US, the European Union, Norway and the UK.

Orphan designation: (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol bedaquiline Treatment of tuberculosis, 26/08/2005 Withdrawn

Retrieved on: 
onsdag, april 3, 2024

Orphan designation: (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol bedaquiline Treatment of tuberculosis, 26/08/2005 Withdrawn

Key Points: 


Orphan designation: (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol bedaquiline Treatment of tuberculosis, 26/08/2005 Withdrawn

Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

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torsdag, januari 4, 2024

Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

Retrieved on: 
tisdag, januari 2, 2024

Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Retrieved on: 
tisdag, januari 2, 2024

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Aquyre Biosciences Announces Appointment of Gregory Bowles as President and CEO

Retrieved on: 
tisdag, december 5, 2023

Aquyre Biosciences, Inc. today announced the appointment of Gregory Bowles as President, Chief Executive Officer and member of the Board of Directors.

Key Points: 
  • Aquyre Biosciences, Inc. today announced the appointment of Gregory Bowles as President, Chief Executive Officer and member of the Board of Directors.
  • At Intuitive Surgical during its early years, he was the Capital Sales Manager where he sold the daVinci Robot in Michigan.
  • Greg’s first startup was EndoGastric Solutions where he held positions as Regional Manager and later as Vice President of Sales.
  • While at Aquyre Biosciences, Greg was the Senior Vice President of Sales and Marketing and has been instrumental in building the company’s commercialization efforts.

Cancer therapy shows promise against tuberculosis

Retrieved on: 
torsdag, november 16, 2023

SAN ANTONIO, Nov. 16, 2023 /PRNewswire/ -- A promising new cancer therapy also appears extremely potent against one of the world's most devastating infectious diseases: tuberculosis (TB).

Key Points: 
  • SAN ANTONIO, Nov. 16, 2023 /PRNewswire/ -- A promising new cancer therapy also appears extremely potent against one of the world's most devastating infectious diseases: tuberculosis (TB).
  • - Larry Schlesinger, MD
    Scientists at Texas Biomedical Research Institute (Texas Biomed) found the therapy dramatically reduces TB growth, even for bacteria that are drug-resistant.
  • The therapy evaluated in this study combines two molecules – one is already FDA-approved for cancer patients, and the other is in Phase 1/2 clinical trials for cancer.
  • That's the power of a host-directed therapy targeting the human's immune response versus trying to attack the pathogen directly."