Multiplicity of infection

Innoviva Announces FDA Acceptance and Priority Review of New Drug Application for Sulbactam-Durlobactam (SUL-DUR)

Retrieved on: 
Wednesday, November 30, 2022

The Agency is currently planning to hold an advisory committee meeting to discuss this application.

Key Points: 
  • The Agency is currently planning to hold an advisory committee meeting to discuss this application.
  • SUL-DUR also exhibited a favorable safety profile with statistically significant reduction in nephrotoxicity.
  • Carbapenem-resistant and multidrug-resistant Acinetobacter infections are an urgent and emergent threat due to increasing rates of resistance and few viable treatment options.
  • Our focused and dedicated team looks forward to continuing to work with the FDA throughout the priority review process.

EQS-News: PAION AG announces change in Management Board

Retrieved on: 
Wednesday, November 30, 2022

Dr. James Phillips leaves PAION AG as of 30 November 2022 by mutual agreement with the company.

Key Points: 
  • Dr. James Phillips leaves PAION AG as of 30 November 2022 by mutual agreement with the company.
  • Furthermore, Mr Gregor Siebert, currently a member of the Supervisory Board, will be appointed by the Supervisory Board of PAION AG as a member of the Management Board and Chairman of the Management Board pursuant to section 105 (2) of the German Stock Corporation Act (AktG) for a period from 1 December 2022 until 30 November 2023 to succeed Dr. Phillips.
  • At the same time, we wish Mr. Siebert every success in his role as CEO and Chairman of the Management Board.
  • Gregor Siebert has been a member of the Supervisory Board of PAION AG since May 2022.

EQS-News: PAION AG’S PARTNER TTY BIOPHARM RECEIVES MARKET APPROVAL FOR REMIMAZOLAM IN PROCEDURAL SEDATION IN TAIWAN

Retrieved on: 
Sunday, November 27, 2022

This will allow for PAIONs partner TTY Biopharm Company Limited ("TTY") to launch remimazolam in December 2022 in this market.

Key Points: 
  • This will allow for PAIONs partner TTY Biopharm Company Limited ("TTY") to launch remimazolam in December 2022 in this market.
  • TTY Biopharm is a publicly listed pharmaceutical company with extensive expertise in the development and marketing of innovative pharmaceuticals.
  • Dr. Jim Phillips, CEO of PAION AG, commented: We are very pleased to have found in TTY Biopharm an excellent partner for the development and commercialization of our lead product in Taiwan.
  • Remimazolam, developed by PAION is an ultra-short-acting and predictable intravenous benzodiazepine sedative that has been approved and launched in many countries.

EQS-News: PAION AG enters partnership with Viatris and expands sales activities in Europe

Retrieved on: 
Sunday, November 27, 2022

Under the terms of the collaboration agreement, on the one hand, PAION will receive a upfront payment.

Key Points: 
  • Under the terms of the collaboration agreement, on the one hand, PAION will receive a upfront payment.
  • In addition, Viatris will purchase supply of the products from PAION and also share with them the profits from product sales.
  • Commenting on the sales activities, Dr. Jim Phillips, CEO of PAION AG, said: "We are very pleased to have entered into a long-term partnership with leading global healthcare company Viatris to provide access to medicines for patients in Europe.
  • This is an important milestone for PAION to drive forward its sales activities in Europe in a targeted manner.

Innoviva Reports Third Quarter 2022 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Wednesday, November 9, 2022

Innoviva, Inc. (NASDAQ: INVA) (Innoviva and the Company), a diversified holding company with a portfolio of royalties and other healthcare assets, today reported financial results for the third quarter ended September 30, 2022.

Key Points: 
  • Innoviva, Inc. (NASDAQ: INVA) (Innoviva and the Company), a diversified holding company with a portfolio of royalties and other healthcare assets, today reported financial results for the third quarter ended September 30, 2022.
  • Increase in fair values of equity and long-term investments of $0.1 million in the third quarter of 2022 was mainly due to the volatility in the capital markets.
  • Net cash and cash equivalents totaled $300.8 million, and royalty and product sale receivables totaled $72.3 million as of September 30, 2022.
  • ANORO ELLIPTA global net sales decreased by 15% compared to third quarter of 2021 mainly due to pricing pressures and foreign currency changes."

Entasis Therapeutics, a Wholly Owned Subsidiary of Innoviva, Presents Efficacy and Safety Data from Landmark Phase 3 ATTACK Trial at IDWEEK 2022

Retrieved on: 
Wednesday, October 19, 2022

Results showed that ABC isolates from patients in ATTACK were highly antibiotic-resistant, but >95% susceptible to SUL-DUR.

Key Points: 
  • Results showed that ABC isolates from patients in ATTACK were highly antibiotic-resistant, but >95% susceptible to SUL-DUR.
  • This study evaluated PPK in 373 subjects, including 110 patients who received SUL-DUR and underwent PK sampling in the pivotal Phase 3 ATTACK trial.
  • In addition to the oral presentations, three poster presentations highlighted additional SUL-DUR and ATTACK trial details and results.
  • All Entasis IDWeek 2022 presentations will be made available on the Entasis website https://www.entasistx.com/our-science/presentations-by-event.

T2 Biosystems Highlights Multiple New Studies Demonstrating Improved Rapid Detection Across Several Patient Populations

Retrieved on: 
Friday, October 14, 2022

The studies were conducted in Europe and published in the Journal of Clinical Microbiology, Microbiology Spectrum and the Journal of Fungi.

Key Points: 
  • The studies were conducted in Europe and published in the Journal of Clinical Microbiology, Microbiology Spectrum and the Journal of Fungi.
  • Given the mounting evidence of additional clinical utility, we are exploring expansion of product claims through future regulatory submissions, stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • The growing awareness of the benefits of our technology can help T2 Biosystems positively impact the lives of more patients, advance the standard of care, and drive continued product adoption.
  • A study conducted at the Klink Favoriten hospital in Vienna, Austria, reported several highlights regarding usage of T2 Biosystems products to detect COVID-19 superinfections in ICU patients.

Entasis Therapeutics, a Wholly Owned Subsidiary of Innoviva, Announces Data on SUL-DUR to be Presented at IDWeek 2022

Retrieved on: 
Wednesday, October 12, 2022

Innoviva is a diversified holding company with a portfolio of royalties and innovative healthcare investments and assets.

Key Points: 
  • Innoviva is a diversified holding company with a portfolio of royalties and innovative healthcare investments and assets.
  • Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR/BREO ELLIPTA and ANORO ELLIPTA.
  • Forward-looking statements should not be relied upon as representing the Companys views as of any date subsequent to the date hereof.
  • Trademark reference:Innovivaand theInnovivalogo are registered trademarks or trademarks ofInnoviva, Inc.or its affiliates inthe United Statesand/or other countries.

LifeMine Therapeutics Expands Management Team with Appointments of Martin Stahl, Ph.D., as Chief Scientific Officer and Louis Plamondon, Ph.D., as Executive Vice President and Head of CMC

Retrieved on: 
Thursday, October 6, 2022

LifeMine Therapeutics Inc., a biopharmaceutical company reinventing drug discovery by mining genetically-encoded small molecules (GEMs) from the biosphere, today announced the appointments of Martin Stahl, Ph.D., as chief scientific officer and Louis Plamondon, Ph.D., as executive vice president and head of CMC.

Key Points: 
  • LifeMine Therapeutics Inc., a biopharmaceutical company reinventing drug discovery by mining genetically-encoded small molecules (GEMs) from the biosphere, today announced the appointments of Martin Stahl, Ph.D., as chief scientific officer and Louis Plamondon, Ph.D., as executive vice president and head of CMC.
  • Dr. Stahl, former global head of lead discovery at Roche, will also lead LifeMines operations at its European offices in Basel, Switzerland.
  • Martin and Louis are stellar additions to the LifeMine executive team and share in our vision to reinvent small molecule drug discovery through genomic search and retrieval from the biosphere, said Gregory Verdine, Ph.D., co-founder, president and chief executive officer of LifeMine.
  • Martin and Louis experience and expertise will only help further accelerate our efforts.

Innoviva to Participate in the Morgan Stanley 20th Annual Global Healthcare Conference

Retrieved on: 
Thursday, September 8, 2022

Innoviva, Inc. (Nasdaq: INVA) (Innoviva), a diversified holding company with a portfolio of royalties and a growing portfolio of innovative healthcare assets, today announced that Pavel Raifeld, Chief Executive Officer, will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on Wednesday, September 14th at 11:10 a.m. Eastern Time.

Key Points: 
  • Innoviva, Inc. (Nasdaq: INVA) (Innoviva), a diversified holding company with a portfolio of royalties and a growing portfolio of innovative healthcare assets, today announced that Pavel Raifeld, Chief Executive Officer, will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on Wednesday, September 14th at 11:10 a.m. Eastern Time.
  • Innoviva is a diversified holding company with a portfolio of royalties and innovative healthcare investments and assets.
  • Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR/BREO ELLIPTA and ANORO ELLIPTA.
  • ANORO, RELVAR, BREO, TRELEGY and ELLIPTA are trademarks of the GSK group of companies.