Worldwide Clinical Trials
DECEMBER 7, 2023
Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. As a result, various CROs have undergone significant consolidations and acquisitions of specialized capabilities to address the escalating complexity in clinical trials.
Bio Pharma Dive
DECEMBER 4, 2023
With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples.
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Rethinking Clinical Trials
DECEMBER 6, 2023
In this Friday's PCT Grand Rounds, Ruth Engelberg, Erin Kross, and Robert Lee of the University of Washington will present "A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness." The Grand Rounds session will be held on Friday, December 8, 2023, at 1:00 pm eastern.
Bio Pharma Dive
DECEMBER 4, 2023
Accurate and timely processing of data is imperative to create robust analytical datasets that can be used in the RWE setting.
Drug Discovery World
DECEMBER 7, 2023
A potential schizophrenia treatment, discovered at Vanderbilt University in Tennessee in the US, has been cleared by the US Food and Drug Administration for use in Phase I clinical trials. NMRA-266, an allosteric modulator that works through a mechanism that has been clinically validated in the treatment of disorders like schizophrenia, will be developed by Neumora Therapeutics.
BioSpace
DECEMBER 3, 2023
From the skin to the lungs to the central nervous system, biotech companies are making progress toward delivering RNA therapeutics to multiple targets throughout the body. But challenges remain.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
DECEMBER 8, 2023
In addition to clearing Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, the FDA also granted an early OK to Bluebird bio’s sickle cell treatment Lyfgenia.
Rethinking Clinical Trials
DECEMBER 5, 2023
Health Data Research Network (HDRN) Canada is now accepting applications for its Pragmatic Trials Training Program. This 2-year, virtual, pan-Canadian program will provide training to advanced learners across 3 streams: (1) future trial leaders (faculty-level trainees), (2) postdoctoral fellows, and (3) highly qualified personnel employed in the public and private sectors.
Pharmaceutical Technology
DECEMBER 6, 2023
Seattle Children's launched BrainChild Bio to focus on expediting the development of CAR T-cell therapies in central nervous system tumours.
Fierce Pharma
DECEMBER 8, 2023
Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell | Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell disease (SCD).
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Bio Pharma Dive
DECEMBER 6, 2023
The deal hands AbbVie a portfolio of psychiatric medicines that originated within Pfizer, among them a closely watched schizophrenia treatment that’s in late-stage testing.
BioSpace
DECEMBER 6, 2023
A combination of Merck’s experimental anti-TIGIT antibody vibostolimab and anti-PD-1 drug Keytruda failed to hit its endpoints in a mid-stage non-small cell lung cancer study.
Pharmaceutical Technology
DECEMBER 5, 2023
Professor Timothy Mackey talks about the recent reports of fraudulent Ozempic pens and the challenges in chasing drug counterfeiters.
Fierce Pharma
DECEMBER 8, 2023
Groundbreaking? Game-changing? Transformational? Historic? | Vertex Pharmaceuticals and CRISPR Therapeutics have won an historic FDA approval for their sickle cell disease gene therapy Casgevy. The transformational treatment is a potential cure for the debilitating and life-threatening disease which affects more than 100,000 in the United States, most of them Black.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Bio Pharma Dive
DECEMBER 7, 2023
The funding is indicative of investor interest in an area of drug research that involves at least a dozen startups and multiple publicly traded companies.
Antidote
DECEMBER 7, 2023
Chronic spontaneous urticaria, also called chronic idiopathic urticaria, is a type of chronic hives that come and go unexpectedly. These hives persist daily for a minimum of six weeks without a clear cause or trigger. While this condition can affect anyone at any point, women experience it twice as often as men , and it’s most common between the ages of 20 and 40.
Pharmaceutical Technology
DECEMBER 7, 2023
Japan has granted approval for the sBLA of Bristol-Myers Squibb (BMS) for Abecma to treat relapsed or refractory multiple myeloma (RRMM).
Fierce Pharma
DECEMBER 6, 2023
With an FDA approval in PNH, Novartis has gained its first nod for iptacopan, dubbed two months ago “a pipeline in pill," by analysts at ODDO BHF.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Bio Pharma Dive
DECEMBER 8, 2023
Casgevy, the first CRISPR therapy approved by the FDA, will cost $2.2 million, while a competing genetic medicine also cleared Friday is priced at $3.1 million.
Outsourcing Pharma
DECEMBER 7, 2023
Virtual research organization, ObvioHealth, has just announced the launch of its application programming interface (API) which it says is tailored specifically for digital therapeutics (DTx) clinical trials.
Pharmaceutical Technology
DECEMBER 5, 2023
Oxford Biomedica has signed an agreement to acquire CDMO ABL Europe from Institut Mérieux subsidiary TSGH SAS in a deal worth €15m ($16.27m).
Fierce Pharma
DECEMBER 8, 2023
Three years on, Bristol Myers Squibb is bidding adieu to its top dealmaker. | Three years on, Bristol Myers Squibb is bidding adieu to its top dealmaker. Elizabeth Mily, who replaced BMS’ former M&A czar Paul Biondi back in 2020, is headed for the exit, the company confirmed Friday.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
DECEMBER 8, 2023
The setbacks for Merck demonstrate the challenge drug developers face in improving on Keytruda, which has brought in at least $18 billion so far this year for its maker.
Pharma Times
DECEMBER 8, 2023
One-third of patients who received Pfizer’s COVID-19 vaccine had unintended immune responses - News - PharmaTimes
Pharmaceutical Technology
DECEMBER 6, 2023
IGM will lay off 22% of its staff and suspend four clinical activities to advance autoimmune diseases and colorectal cancer programmes.
Drug Discovery World
DECEMBER 5, 2023
Cancer Research UK (CRUK), Cancer Research Horizons, and precision oncology company Guardant Health have launched a collaboration to advance cancer treatment. The agreement will enable the parties to discuss opportunities for collaboration to support the charity’s research and clinical development activities, focusing primarily on its clinical trials run by its Centre for Drug Development.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Bio Pharma Dive
DECEMBER 6, 2023
The pharma is developing Fabhalta, now cleared for paroxysmal nocturnal hemoglobinuria, for several other rare, complement-driven diseases.
BioSpace
DECEMBER 4, 2023
The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.
Pharmaceutical Technology
DECEMBER 4, 2023
Eli Lilly has received approval from the US FDA for Jaypirca to treat chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL)
Fierce Pharma
DECEMBER 7, 2023
When it comes to manufacturing cell therapies, it's often said that the "process is the product." But churning out these complex, individualized drugs has routinely tripped up even the industry's l | In recent months, Novartis has faced scrutiny from the FDA over Kymriah production shortfalls, a newly posted letter shows. The company says it's working to address the situation.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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