Biomedical Advanced Research and Development Authority

Century Therapeutics Appoints Brent Pfeiffenberger, Pharm.D., MBA, as Chief Executive Officer

Retrieved on: 
Thursday, November 9, 2023

PHILADELPHIA, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, today announced the appointment of Brent Pfeiffenberger, Pharm.D., MBA, as Chief Executive Officer and member of the Board, effective December 4, 2023. A proven leader with over 20 years of global experience across the healthcare industry, Dr. Pfeiffenberger most recently served as Chief Operating Officer at Neogene Therapeutics, a wholly owned subsidiary of AstraZeneca focused on developing cell therapies for the treatment of cancer. In connection with the appointment, Greg Russotti, Ph.D., who has served as Century’s Interim Chief Executive Officer since April 2023, will assume the role of Chief Technology and Manufacturing Officer, an expanded role from his previous position as Chief Technology Officer.

Key Points: 
  • PHILADELPHIA, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, today announced the appointment of Brent Pfeiffenberger, Pharm.D., MBA, as Chief Executive Officer and member of the Board, effective December 4, 2023.
  • In connection with the appointment, Greg Russotti, Ph.D., who has served as Century’s Interim Chief Executive Officer since April 2023, will assume the role of Chief Technology and Manufacturing Officer, an expanded role from his previous position as Chief Technology Officer.
  • “Brent is a strong leader with extensive experience across the research, development, and commercialization of lifesaving drugs.
  • His unique strategic leadership and operational acumen will serve Century well, and we are thrilled to have him join as Chief Executive Officer,” said Joe Jimenez, Chairman of the Board.

Melinta Therapeutics and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S.

Retrieved on: 
Thursday, November 9, 2023

The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.

Key Points: 
  • The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
  • Venatorx has been assigned a Prescription Drug User Fee Act (PDUFA) target action date for February 22, 2024.
  • The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the cUTI and HABP/VABP indications.
  • Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower middle-income countries.

Gritstone bio Reports Third Quarter 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, November 8, 2023

EMERYVILLE, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today reported financial results for the third quarter ended September 30, 2023 and provided recent corporate and clinical updates.

Key Points: 
  • In oncology, preliminary findings from the randomized Phase 2/3 study of our personalized cancer vaccine, GRANITE, in MSS-CRC are rapidly approaching.
  • The scientific bedrock of GRANITE extends to SLATE, where our collaboration with Steven A. Rosenberg and the NCI is now advancing.
  • Gritstone met its enrollment target of 100 patients randomized in August 2023.
  • An IND to run a Phase 1 study was cleared by the U.S. Food and Drug Administration (FDA) in October 2023.

Government Agencies Emphasize the Importance of Decentralized Methodologies for Future of Clinical Research

Retrieved on: 
Wednesday, November 8, 2023

SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- The Decentralized Trials & Research Alliance (DTRA), a global alliance focused on the adoption of decentralized trials, today concluded its 2023 Annual Meeting, including members from biopharmaceutical companies, government agencies, research sites, healthcare organizations, patient groups, and service and technology companies.

Key Points: 
  • SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- The Decentralized Trials & Research Alliance (DTRA), a global alliance focused on the adoption of decentralized trials, today concluded its 2023 Annual Meeting, including members from biopharmaceutical companies, government agencies, research sites, healthcare organizations, patient groups, and service and technology companies.
  • The DTRA community learned of their strategic intentions regarding decentralized clinical trial (DCT) adoption, drivers to achieve scale with these methods, and the importance of DCT to our research ecosystem.
  • DTRA has harnessed this industry-leading expertise into creating new resources, sharing key learnings, and establishing best practices for research teams to use in implementing DCTs.
  • “Each of our Initiative outputs is available at www.dtra.org and the resources are available to all.”

Battelle Part of Team Selected to Support New Technologies to Prepare for Future COVID-19 Outbreaks

Retrieved on: 
Wednesday, November 8, 2023

These technologies have the potential to enable shorter development timelines for monoclonal antibodies through mRNA, increased efficiency in virus testing, and alternate routes for vaccine administration.

Key Points: 
  • These technologies have the potential to enable shorter development timelines for monoclonal antibodies through mRNA, increased efficiency in virus testing, and alternate routes for vaccine administration.
  • Battelle researchers will develop a human lung microphysiological system (MPS) platform to enable in vitro modeling of SARS-CoV-2 infection and testing of therapeutics.
  • This complex in vitro model is expected to recapitulate relevant human lung biology, including viral pathogenesis and response to medical countermeasures.
  • The MPS model is expected to be established and ready for therapeutic screening in the Fall of 2025.

Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.
  • Dr. Braunstein continued, “We remain acutely focused on advancing our Phase 3 clinical trials in refractory status epilepticus and tuberous sclerosis complex.
  • Net product revenue consists of ZTALMY product sales, which was launched in the U.S. in the third quarter of 2022.
  • Selected Financial Data (in thousands, except share and per share amounts)

Draper Announces BARDA Award Supporting COVID and CBRN Countermeasure Development

Retrieved on: 
Tuesday, November 7, 2023

CAMBRIDGE, Mass., Nov. 7, 2023 /PRNewswire-PRWeb/ -- Draper, a leader in national security and biodefense solutions and technologies, has received an award valued at $26 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), to support the development of tools and technologies to protect people against global infectious disease threats, including COVID-19, and accelerate responses to biothreats in the future.

Key Points: 
  • BARDA awarded Draper $26 million to advance technologies such as Draper's PREDICT96 to support development of vaccines and therapies for COVID and emerging biothreats.
  • "Draper's collaboration with BARDA marks an important milestone in the development of the company's end-to-end MCM evaluation and screening platform," Roger Odegard, senior program manager, National Security/Biosecurity Programs at Draper.
  • Commenting on this partnership, Roger Odegard, senior program manager, National Security/Biosecurity Programs at Draper, said, "Draper's collaboration with BARDA marks an important milestone in the development of the company's end-to-end MCM evaluation and screening platform."
  • Funding for this award comes from BARDA's Chemical, Biological, Radiological and Nuclear (CBRN) Countermeasures and Project NextGen programs.

OPKO Health Reports Third Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Monday, November 6, 2023

OPKO Health presented late-breaking clinical data on RAYALDEE extended-release calcifediol in a poster presentation at the American Society of Nephrology Kidney Week.

Key Points: 
  • OPKO Health presented late-breaking clinical data on RAYALDEE extended-release calcifediol in a poster presentation at the American Society of Nephrology Kidney Week.
  • Operating loss was $25.4 million in the third quarter of 2023 compared with $28.3 million in the third quarter of 2022.
  • Operating loss for the third quarter of 2023 was $64.4 million compared with an operating loss of $87.8 million for the 2022 quarter.
  • OPKO’s senior management will provide a business update, discuss third quarter financial results, provide financial guidance and answer questions during a conference call and audio webcast today beginning at 4:30 p.m. Eastern time.

Stevanato Group Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, October 31, 2023

Stevanato Group S.p.A. (NYSE: STVN), a leading global provider of drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries, today announced its financial results for the third quarter of 2023.

Key Points: 
  • Stevanato Group S.p.A. (NYSE: STVN), a leading global provider of drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries, today announced its financial results for the third quarter of 2023.
  • Adjusted EBITDA margin increased 70 basis points to 27.5% in the third quarter of 2023, compared with the third quarter of 2022.
  • This led to gross profit margin of 32.7% and operating profit margin of 21.2% for the third quarter of 2023.
  • The Company will host a conference call and webcast at 8:30 a.m. (ET) on Tuesday, October 31, 2023 to discuss financial results.

Maxwell Biosciences Appoints Major General (Ret.) Barb Holcomb, RN, BSN, MSN to Its Board of Directors

Retrieved on: 
Wednesday, October 18, 2023

Austin, Texas--(Newsfile Corp. - October 18, 2023) - Maxwell Biosciences ("Maxwell"), a preclinical drug platform company developing a synthetic immune system that may serve as a key biodefense asset, today announced the appointment of Major General (Retired) Barb Holcomb, RN, BSN, MSN to its Board of Directors.

Key Points: 
  • Austin, Texas--(Newsfile Corp. - October 18, 2023) - Maxwell Biosciences ("Maxwell"), a preclinical drug platform company developing a synthetic immune system that may serve as a key biodefense asset, today announced the appointment of Major General (Retired) Barb Holcomb, RN, BSN, MSN to its Board of Directors.
  • This appointment adds one of the world's top national security and biodefense research and logistics executives to Maxwell's board.
  • "I am pleased to welcome General Holcomb's leadership in national security and patient care to Maxwell's board as we approach human trials next year," said Maxwell Biosciences Chairman and CEO Joshua McClure.
  • "General Holcomb is a highly patient-focused medical professional with decades of deep respect within the global and national security biodefense communities.