Contract research organization

Early-Stage Biotech Investments Were Down 40% in 2023: Novotech Whitepaper

Retrieved on: 
fredag, december 29, 2023
Workforce, Contract research organization, COVID-19, Biotechnology, Laboratory, Clinical trial, Artificial intelligence, Collaboration, Obesity, Growth, Investment, Therapy, Automation, Pressure, Pharmaceutical industry

BOSTON, Dec. 29, 2023 (GLOBE NEWSWIRE) -- Novotech , the leading Asia Pacific centred biotech CRO with global execution capabilities, today published the Navigating the Biotech Landscape whitepaper examining the significant financial shifts that affected the biotech industry in 2023.

Key Points: 
  • BOSTON, Dec. 29, 2023 (GLOBE NEWSWIRE) -- Novotech , the leading Asia Pacific centred biotech CRO with global execution capabilities, today published the Navigating the Biotech Landscape whitepaper examining the significant financial shifts that affected the biotech industry in 2023.
  • Navigating the Biotech Landscape: Insights into Clinical Trials, Funding Trends, Challenges, and Transformations Amidst Covid-19 And Beyond (2023) whitepaper delivers a thorough evaluation of the worldwide financial landscape for biotech clinical trials, offering valuable and actionable insights.
  • “Consequently, investments in early-stage biotech companies declined by 40% in 2023 compared to 2022, marking an unprecedented 55% drop from two years prior,” the whitepaper found.
  • A key disruptive element identified in the whitepaper is the impact of digital transformation in the biotech sector.

Important January 16, 2024 SLRN Deadline Reminder: Kessler Topaz Meltzer & Check, LLP Reminds Acelyrin, Inc. (SLRN) Investors of Securities Fraud Class Action Lawsuit

Retrieved on: 
tisdag, december 26, 2023
Lead, Contract research organization, LLP, SLRN, Court, News, COPY, Insurance, Part, IPO, Patient, Abscess, District court, Pharmaceutical industry

The action charges Acelyrin with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.

Key Points: 
  • The action charges Acelyrin with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.
  • As a result of Acelyrin’s materially misleading statements and omissions to the public, Acelyrin’s investors have suffered significant losses.
  • Kessler Topaz Meltzer & Check, LLP encourages Acelyrin investors who have suffered significant losses to contact the firm directly to acquire more information.
  • The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel.

Acelyrin, Inc. (SLRN) Shareholder Reminder: Kessler Topaz Meltzer & Check, LLP Reminds SLRN Investors of Securities Fraud Class Action Lawsuit Filed on Their Behalf

Retrieved on: 
lördag, december 16, 2023
Lead, Contract research organization, LLP, SLRN, Court, News, COPY, Insurance, Part, IPO, Patient, Abscess, District court, Pharmaceutical industry

The action charges Acelyrin with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.

Key Points: 
  • The action charges Acelyrin with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.
  • As a result of Acelyrin’s materially misleading statements and omissions to the public, Acelyrin’s investors have suffered significant losses.
  • Kessler Topaz Meltzer & Check, LLP encourages Acelyrin investors who have suffered significant losses to contact the firm directly to acquire more information.
  • The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel.

SLRN Class Action Reminder: Kessler Topaz Meltzer & Check, LLP Reminds Acelyrin, Inc. (SLRN) Investors of Securities Fraud Class Action Lawsuit

Retrieved on: 
fredag, december 8, 2023
Lead, Contract research organization, LLP, SLRN, Court, News, COPY, Insurance, Part, IPO, Patient, Abscess, District court, Pharmaceutical industry

The action charges Acelyrin with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.

Key Points: 
  • The action charges Acelyrin with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.
  • As a result of Acelyrin’s materially misleading statements and omissions to the public, Acelyrin’s investors have suffered significant losses.
  • Kessler Topaz Meltzer & Check, LLP encourages Acelyrin investors who have suffered significant losses to contact the firm directly to acquire more information.
  • The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel.

Kessler Topaz Meltzer & Check, LLP Announces a Securities Fraud Class Action Filed Against Acelyrin, Inc.

Retrieved on: 
torsdag, november 30, 2023
Lead, Contract research organization, LLP, SLRN, Court, News, COPY, Insurance, Part, IPO, Patient, Abscess, District court, Pharmaceutical industry

The action charges Acelyrin with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.

Key Points: 
  • The action charges Acelyrin with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects.
  • As a result of Acelyrin’s materially misleading statements and omissions to the public, Acelyrin’s investors have suffered significant losses.
  • Kessler Topaz Meltzer & Check, LLP encourages Acelyrin investors who have suffered significant losses to contact the firm directly to acquire more information.
  • The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel.

ACELYRIN, INC. Provides Update on Izokibep Clinical Development Program

Retrieved on: 
måndag, november 27, 2023
8-K, Quality of life, Conference, Contract research organization, Hidradenitis suppurativa, Arm, Physician, SLRN, Disease, MD, Doctor of Philosophy, Clinical trial, QW, Part, American College, Patient, Safety, Psoriatic arthritis, Pharmaceutical industry

LOS ANGELES, Nov. 27, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today provided an update on its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis (“PsA trial”).

Key Points: 
  • LOS ANGELES, Nov. 27, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today provided an update on its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis (“PsA trial”).
  • In September 2023, ACELYRIN disclosed top-line results from Part B of its Phase 2b/3 trial evaluating izokibep for the treatment of moderate-to-severe Hidradenitis Suppurativa (“HS trial”).
  • The CRO does not conduct any trials on behalf of ACELYRIN beyond the izokibep clinical program.
  • ACELYRIN’s team recently identified clinical trial execution errors involving its CRO and one of the vendors engaged by the CRO.

10x Genomics Launches Xenium Catalyst Network

Retrieved on: 
onsdag, december 20, 2023
Biology, Contract research organization, Partnership, Drug discovery, Medicine, Collection, Business, Research, 10x Genomics, Tissue, McDonnell Genome Institute, Sundaram, Cancer, Genomics, K2, Macrogen

PLEASANTON, Calif., Dec. 20, 2023 /PRNewswire/ -- 10x Genomics, Inc., (Nasdaq: TXG), a leader in single cell and spatial biology, today announced the launch of its Xenium Catalyst Network, a global group of technically qualified research institutions that will accelerate access to Xenium proof-of-concept data for researchers worldwide. The four founding members of the Xenium Catalyst Network will add significant capacity for the company's Xenium Catalyst Program, a technical access service launched earlier this year for prospective customers.

Key Points: 
  • The four founding members of the Xenium Catalyst Network will add significant capacity for the company's Xenium Catalyst Program, a technical access service launched earlier this year for prospective customers.
  • 10x Genomics expects to add more research institutions to the Xenium Catalyst Network in 2024.
  • "K2bio, a novel full service preclinical Contract Research Organization (CRO), welcomes our partnership with 10x Genomics and the Xenium Catalyst Network," said Kieron Jones, CEO at K2bio.
  • "Participating in the 10x Genomics Xenium Catalyst Network will help us deliver state-of-the-art spatial genomics services," stated Michael Heinz, Director of Research Operations at the McDonnell Genome Institute.

Ergomed strongly positioned for future growth in new partnership with Permira

Retrieved on: 
tisdag, november 14, 2023
Acquisition, Miro, Patient, Contract research organization, Partnership, Growth, Health care, PV, Fine chemical, Permira, Pharmacovigilance

Investment to focus on commercial expansion, technology and strategic M&A

Key Points: 
  • Investment to focus on commercial expansion, technology and strategic M&A
    Guildford, UK and London, UK – 14 November 2023: Ergomed plc ("Ergomed") and Permira Advisers LLP ("Permira"), are pleased to announce the completion of the acquisition of Ergomed by funds advised by Permira (the “Permira Funds”) for £703.1 million.
  • Ergomed operates in growing markets which benefit from increasing complexity, regulatory requirements and outsourcing rates.
  • Permira brings operational expertise, a global network, capital and, equally importantly, a like-minded approach to how to accelerate our growth.
  • Through this partnership, we will help Miro and the team to further build and accelerate on the very strong foundation they have already laid.”

MMS Supported MAPS Public Benefit Corporation NDA Submitted to FDA for First Psychedelic-Assisted Therapy for PTSD

Retrieved on: 
onsdag, december 13, 2023
Veterans, Defense, Other Health, Other Science, Pharmaceutical, Research, Software, Mental Health, Professional Services, Data Management, Science, Practice Management, Technology, Physical Therapy, Clinical Trials, Managed Care, Data Analytics, Health, Military, NDA, Medical writing, Post-traumatic stress disorder, PBC, MDMA, MMS, Psychotherapy, MAPS, FDA, New Drug Application, Contract research organization, PTSD, Pharmacovigilance, Pharmaceutical industry, Risk management

MMS, a data-focused Clinical Research Organization (CRO), announced MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.

Key Points: 
  • MMS, a data-focused Clinical Research Organization (CRO), announced MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.
  • MAPS PBC is developing investigational MDMA-assisted therapy for individuals with post-traumatic stress disorder (PTSD).
  • Over a year ago, MAPS PBC selected MMS as its CRO partner for the development of NDA for MDMA-assisted therapy for PTSD.
  • We are grateful to MAPS PBC for entrusting MMS to be a part of this process.”
    As MAPS PBC’s CRO, MMS provided regulatory strategy and operations, pharmacovigilance, medical writing, and biometrics services.

Managing Service Providers including CRO (Contract Research Organisation) and CMOs Oversight to comply with ICH GCP (Good Clinical Practice) R3 Training Course - ResearchAndMarkets.com

Retrieved on: 
onsdag, december 6, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, ICH, RFP, Good clinical practice, CMOS, Contract research organization, ICH GCP, Pharmacovigilance, Fine chemical

The "Managing Service Providers including CRO (Contract Research Organisation) and CMOs oversight to comply with ICH GCP (Good Clinical Practice) R3 Training Course" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Managing Service Providers including CRO (Contract Research Organisation) and CMOs oversight to comply with ICH GCP (Good Clinical Practice) R3 Training Course" conference has been added to ResearchAndMarkets.com's offering.
  • This event is designed for personnel involved in CRO/vendor management and oversight in the pharmaceutical, biotechnology, animal health and medical device industries including those working in clinical research, regulatory affairs, pharmacovigilance, manufacturing, clinical outsourcing, contracts, quality, clinical operations, vendor management and global QA/compliance.
  • On this course you will learn how to prepare a request for proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource.
  • You will also cover the techniques for successfully managing CROs/ vendors and the shared responsibilities required by the sponsor and the service provider.