The state of the clinical trial supply chain: what you need to know
Pharmaceutical Technology
DECEMBER 6, 2023
The clinical trial market is in a state of flux; to navigate it, supply chain optimisation will be essential.
Sat.Dec 02, 2023 - Fri.Dec 08, 2023
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The Power of Personalization Amid the Changing CRO Landscape
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.
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Revolutionizing clinical trials: Unlocking peak efficiency with total laboratory automation in bioanalysis
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.
December 6, 2023: Jumpstarting Communication About Goals of Care, in This Week’s PCT Grand Rounds
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.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Clinical Trials Nexus 2023 Reflections: The Clinical Trial Industry and Vendors
Worldwide Clinical Trials
DECEMBER 5, 2023
Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.” Among the panel participants included representatives from Teva, Blue Rock Therapeutics, and BMS.
Overcoming scalability challenges in real-world data processing for transformative patient care
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.
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Moving RNA Therapeutics Beyond the Liver
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.
CRISPR Reorganizes CAR-T Pipeline Ahead of FDA’s Landmark Decision
BioSpace
DECEMBER 4, 2023
The gene editing company is dropping two programs and favoring its next-generation assets CTX112 and CTX131, which it will continue to develop in oncology but will also test in autoimmune diseases.
CRISPR therapy for sickle cell approved by FDA in gene editing milestone
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.
December 5, 2023: Applications Open for HDRN Canada Pragmatic Trials Training Program
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.
Seattle Children’s Hospital launches BrainChild Bio for CNS therapies
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.
Study reveals motor neuron region is affected in ALS
Pharma Times
DECEMBER 6, 2023
The neurological condition currently affects one in 300 people in the UK - News - PharmaTimes
Radiopharma startup Artbio raises $90M in sign of field’s momentum
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.
Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales
FDA Law Blog
DECEMBER 4, 2023
By Larry K. Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner.
The New Age of Decentralized Clinical Trials
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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
Q&A: Tackling the rise of fake anti-obesity drugs on the market
Pharmaceutical Technology
DECEMBER 5, 2023
Professor Timothy Mackey talks about the recent reports of fraudulent Ozempic pens and the challenges in chasing drug counterfeiters.
New £20m NIHR project announced to combat HIV in England
Pharma Times
DECEMBER 4, 2023
In England, an estimated 4,500 people are living with undiagnosed HIV - News - PharmaTimes
AbbVie to buy Cerevel in $8.7B bet on brain drugs
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.
FDA approves bluebird's sickle cell disease gene therapy. Can Lyfgenia overcome CRISPR’s halo?
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).
How Machine Learning Drives Clinical Trial Efficiency
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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.
FDA fast tracks Solid Biosciences’s Duchenne gene therapy
Pharmaceutical Technology
DECEMBER 7, 2023
The FDA has granted fast track designation to Solid Biosciences’s gene therapy SGT-003 for the treatment of DMD.
Lung cancer screening recommended in Scotland, Wales and Northern Ireland
Pharma Times
DECEMBER 7, 2023
The disease is one of the leading causes of cancer deaths in the UK - News - PharmaTimes
Pricey new gene therapies for sickle cell pose access test
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.
FDA endorses Novartis' 'pipeline in a pill,' granting first nod for potential blockbuster Fabhalta
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.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Japan approves BMS’ Abecma for multiple myeloma treatment
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).
Cambridge researchers redesign future mRNA therapeutics
Pharma Times
DECEMBER 8, 2023
One-third of patients who received Pfizer’s COVID-19 vaccine had unintended immune responses - News - PharmaTimes
Novartis gets FDA approval of closely watched rare disease drug
Bio Pharma Dive
DECEMBER 6, 2023
The pharma is developing Fabhalta, now cleared for paroxysmal nocturnal hemoglobinuria, for several other rare, complement-driven diseases.
Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls
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.
Signal: US lays out plan to seize govt-funded drug patents to lower cost
Pharmaceutical Technology
DECEMBER 8, 2023
The newly announced plans would allow third parties to manufacture such drugs if manufacturers make them unaffordable.
KCL molecular communication system to revolutionise drug delivery
Pharma Times
DECEMBER 5, 2023
The platform safely and effectively replicates the electric signalling process compounds - News - PharmaTimes
Roche joins obesity drug chase with $2.7B deal for startup Carmot
Bio Pharma Dive
DECEMBER 4, 2023
The acquisition of Carmot, which had been planning an IPO, will hand Roche three weight loss medicines in early clinical testing.
Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy
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.
The New Age of Decentralized Clinical Trials
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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.
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