PPD

GH Research Reports Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, February 29, 2024

DUBLIN, Ireland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the year ended December 31, 2023, and provided updates on its business.

Key Points: 
  • DUBLIN, Ireland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the year ended December 31, 2023, and provided updates on its business.
  • As announced in November 2023, both trials were recruiting slower than anticipated, in part due to the closure, for business reasons, of one of the two sites activated in each trial.
  • Subsequently, we have implemented measures to strengthen recruitment of both trials, including the addition of further clinical trial sites.
  • For the trial in patients with PPD (GH001-PPD-203), we now expect completion and availability of top-line data in the third quarter of 2024.

Thermo Fisher Scientific Launches CorEvitas Clinical Registry in Generalized Pustular Psoriasis

Retrieved on: 
Friday, March 8, 2024

Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of a new CorEvitas syndicated clinical registry in generalized pustular psoriasis (GPP).

Key Points: 
  • Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of a new CorEvitas syndicated clinical registry in generalized pustular psoriasis (GPP).
  • This registry, which is open to enrollment, is CorEvitas’ 10th syndicated disease registry and addresses an unmet need for real-world evidence (RWE) related to the clinical and patient-reported outcomes of patients with GPP.
  • Thermo Fisher acquired CorEvitas, a leading provider of gold-standard real-world evidence solutions, in August 2023.
  • The registry was launched with clinical guidance from two leading GPP clinical experts who serve as scientific advisors: Dr. Mark Lebwohl, dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai; and Dr. Bruce Strober, clinical professor, Department of Dermatology at Yale University.

Medidata and Thermo Fisher Scientific’s PPD Clinical Research Business Collaborate to Accelerate Clinical Trials Innovation

Retrieved on: 
Wednesday, February 28, 2024

Medidata , a Dassault Systèmes company and leading provider of clinical trial solutions to the life sciences industry, today announced it has renewed its relationship with the PPD clinical research business of Thermo Fisher Scientific Inc.

Key Points: 
  • Medidata , a Dassault Systèmes company and leading provider of clinical trial solutions to the life sciences industry, today announced it has renewed its relationship with the PPD clinical research business of Thermo Fisher Scientific Inc.
  • The agreement features the Medidata Platform , as well as Medidata Adjudicate and additional Medidata Rave product offerings that support the PPD clinical research business in advancing its customers’ drug development programs.
  • A key element of this relationship is the evolution of PPD TrueCast , a business solution powered by Medidata AI that shortens study timelines by combining patient recruitment and site performance data to deliver powerful predictive models and advanced analytics.
  • “Over the past 15 years, we have built a valued connection with the PPD clinical research business to enhance visibility and decision-making during clinical trials,” said Janet Butler, executive vice president and head of global sales, Medidata.

Catalyst Clinical Research Announces CEO Succession

Retrieved on: 
Wednesday, February 14, 2024

WILMINGTON, N.C., Feb. 14, 2024 /PRNewswire/ -- Catalyst Clinical Research announces today that Nik Morton, the company's president and COO, assumed its CEO role on 12 February 2024. Mr. Morton joined Catalyst as its COO in 2022. Mr. Morton moved into his new position while Nick Dyer, Catalyst's former CEO, has shifted his focus to overseeing the strategic growth of the companies within Project Constellation Holdings, the parent company of Catalyst Clinical Research and Genpro Research.

Key Points: 
  • Nik Morton brings decades of experience in clinical research with senior roles in global operations, digital clinical trials, biostatistics, site and patient access
    WILMINGTON, N.C., Feb. 14, 2024 /PRNewswire/ -- Catalyst Clinical Research announces today that Nik Morton, the company's president and COO, assumed its CEO role on 12 February 2024.
  • Mr. Morton moved into his new position while Nick Dyer, Catalyst's former CEO, has shifted his focus to overseeing the strategic growth of the companies within Project Constellation Holdings, the parent company of Catalyst Clinical Research and Genpro Research.
  • "Nik is an experienced clinical research executive and is uniquely qualified to assume this role," said Nick Dyer, Executive Chair for Project Constellation Holdings.
  • "This is an amazing opportunity to guide Catalyst Clinical Research through its next period of growth and expand on its strengths," Mr. Morton said.

Sage Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Highlights Pipeline and Business Progress

Retrieved on: 
Wednesday, February 14, 2024

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2023.
  • Revenue: Collaboration revenue from sales of ZURZUVAE was $0.8 million in the fourth quarter of 2023, the first quarter of sales.
  • Net Loss: Net loss was $32.7 million for the fourth quarter of 2023 compared to $147.1 million for the same period in 2022.
  • ET to review its fourth quarter and full year 2023 financial results and discuss recent corporate updates.

Thermo Fisher Scientific Expands GMP Laboratory Service Offerings with Biosafety Testing Including Mycoplasma Testing

Retrieved on: 
Tuesday, February 13, 2024

This new service, offered by the analytical testing service of the clinical research business, ensures biopharmaceutical products are free of contaminants, helping customers deliver safe medicines for patients.

Key Points: 
  • This new service, offered by the analytical testing service of the clinical research business, ensures biopharmaceutical products are free of contaminants, helping customers deliver safe medicines for patients.
  • “There is a growing need globally for biosafety testing, including for new cell and gene therapy targets being discovered and as treatments expand.
  • To ensure their safety, regulatory requirements mandate testing for the presence of pathogens, including mycoplasma.
  • The PPD Laboratory services team’s GMP lab in Middleton offers fully integrated solutions for pharmaceutical product development, including method development and validation, compendial verifications, stability testing, quality control and release testing.

Linden Capital Partners and Ontario Teachers’ Pension Plan Launch Initiative Focused on Clinical Research Advancement

Retrieved on: 
Thursday, February 8, 2024

Linden Capital Partners (Linden) and Ontario Teachers’ Pension Plan (Ontario Teachers’) are pleased to announce they are partnering on a transformative platform, led by Dr. John Potthoff , with the goal of revolutionizing the clinical research ecosystem.

Key Points: 
  • Linden Capital Partners (Linden) and Ontario Teachers’ Pension Plan (Ontario Teachers’) are pleased to announce they are partnering on a transformative platform, led by Dr. John Potthoff , with the goal of revolutionizing the clinical research ecosystem.
  • This strategic initiative is centered around investing in exceptional companies and deploying cutting-edge technology to foster seamless connections and collaborations among patients, research sites, pharmaceutical companies, and the broader clinical research community.
  • The platform will be led by Dr. John Potthoff, who is currently the Chairperson of Elligo Health Research ®.
  • Our commitment is to address these challenges head-on and catalyze positive change in our industry.”
    Vision for a Unified Clinical Research Ecosystem: The initiative is dedicated to building a more unified and efficient clinical research ecosystem.

Global Anxiety Disorders And Depression Treatment Market Analysis & Forecast 2024-2034: Market By Drug Class; By Indication; By Distribution Channel; and By Region - ResearchAndMarkets.com

Retrieved on: 
Thursday, February 8, 2024

The "Global Anxiety Disorders And Depression Treatment Market Analysis & Forecast 2024-2034: Market By Drug Class; By Indication; By Distribution Channel; and By Region" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Anxiety Disorders And Depression Treatment Market Analysis & Forecast 2024-2034: Market By Drug Class; By Indication; By Distribution Channel; and By Region" report has been added to ResearchAndMarkets.com's offering.
  • The global anxiety disorders and depression treatment market size was estimated to be USD 21.56 billion in 2023 and is expected to reach at USD 41.83 billion by 2034 with a CAGR of 6.21% during the forecast period 2024-2034.
  • Rising research & development activities for the development of innovative drugs for the treatment of anxiety & depression disorders is predicted to boost the market growth during the forecast period.
  • This application pertains to the use of cariprazine as an add-on treatment for individuals with major depressive disorder (MDD) who are already undergoing antidepressant therapy.

atai Life Sciences Appoints Anne Johnson as Chief Financial Officer

Retrieved on: 
Tuesday, February 6, 2024

NEW YORK and BERLIN, Feb. 06, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”) today announced that Anne Johnson, the Company’s interim Chief Financial Officer since October 2023 and Chief Accounting Officer since August 2022, has been named Chief Financial Officer (CFO).

Key Points: 
  • NEW YORK and BERLIN, Feb. 06, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”) today announced that Anne Johnson, the Company’s interim Chief Financial Officer since October 2023 and Chief Accounting Officer since August 2022, has been named Chief Financial Officer (CFO).
  • Anne succeeds Stephen Bardin as the Company’s CFO while Stephen will continue in an advisory role until March 31, 2024 to support the transition.
  • “Anne has been an integral member of our team for over three years and has demonstrated the executive leadership, financial acumen, and track record to lead our financial organization with excellence,” said atai Co-founder and Chief Executive Officer, Florian Brand.
  • “I am honored to take on the leadership of atai’s world-class finance team and look forward to continuing to build a strong financial foundation to advance our R&D programs,” said Anne Johnson.

Lipocine Announces Confirmation of Dosing Regimen for Pivotal Study of LPCN 1154

Retrieved on: 
Tuesday, February 6, 2024

LPCN 1154 is an oral neurosteroid being developed by Lipocine for the treatment of postpartum depression (PPD).

Key Points: 
  • LPCN 1154 is an oral neurosteroid being developed by Lipocine for the treatment of postpartum depression (PPD).
  • Oral LPCN 1154 comprising a bioidentical neuroactive steroid with 48-hour outpatient dosing is targeted to provide rapid relief with robust efficacy.
  • Based on positive results of the 2023 multi-arm crossover pilot PK study, Lipocine recently completed a single arm PK study (N=8) utilizing the "to be marketed" formulation and target dosing regimen.
  • "We believe these results support the design of the planned NDA enabling pivotal study," said Dr. Mahesh Patel, President and CEO of Lipocine.