Bio Pharma Dive
NOVEMBER 28, 2023
U.S. tax law changes enacted six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.
Pharmaceutical Technology
NOVEMBER 28, 2023
A Phase IIb/III trial studying the company’s immunotherapy izokibep, failed to achieve statistical significance for its primary endpoint
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Worldwide Clinical Trials
NOVEMBER 27, 2023
By: Amy Raymond, PMP, PhD, Senior Director, Therapeutic Strategy Lead, Cellular & Genetic Medicines On November 16, the British regulatory body, Medicines and Healthcare products Regulatory Agency (MHRA) approved exagamglogene autotemcel (exa-cel) to treat severe sickle cell disease for patients ages 12 and up, becoming the first gene editing treatment to receive regulatory approval.
Rethinking Clinical Trials
NOVEMBER 30, 2023
The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2024 Annual Conference until December 11, 2023. This year’s meeting will be held in Milwaukee, Wisconsin, from April 9 to 11, 2024. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems.
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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
NOVEMBER 27, 2023
One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.
Pharmaceutical Technology
NOVEMBER 29, 2023
Aro Biotherapeutics has raised $41.5m in a Series B financing round to advance the development of ABX1100 for Pompe disease.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
NOVEMBER 28, 2023
The workshop summary is now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster.” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.
Bio Pharma Dive
NOVEMBER 29, 2023
Bumpus, a former Johns Hopkins professor, named “creating a new model” for the FDA’s Office of Regulatory Affairs as one of her priorities when she steps into the role.
Pharmaceutical Technology
NOVEMBER 29, 2023
After months of negotiations, the UK's DHSC and the Association of the British Pharmaceutical Industry emerged with a plan on to replace VPAS.
Fierce Pharma
NOVEMBER 28, 2023
In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.
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The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors
Rethinking Clinical Trials
NOVEMBER 29, 2023
In this Friday’s PCT Grand Rounds, Jim Hughes of the University of Washington will continue our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “Guidelines for Design and Analysis of Stepped-Wedge Trials.” The session will be held on Friday, December 1, at 1:00 pm eastern. Hughes is a professor emeritus of biostatistics at the University of Washington.
Bio Pharma Dive
NOVEMBER 29, 2023
Drawn-out negotiations led to a lower price than initially expected, but analysts called the agreement a step forward for the biotech company.
Pharmaceutical Technology
NOVEMBER 28, 2023
The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.
Fierce Pharma
NOVEMBER 28, 2023
As the pandemic eased earlier this year, officials in Poland became vocal critics of the financial obligations laid down by Pfizer’s large vaccine supply pact with the European Union. | As the pandemic eased earlier this year, officials in Poland became vocal critics of the financial obligations laid down by Pfizer’s large vaccine supply pact with the European Union.
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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.
Rethinking Clinical Trials
NOVEMBER 27, 2023
The National Institutes of Health’s Office of Disease Prevention (ODP) issued a new funding opportunity to support implementation studies in treatment and prevention for alcohol, tobacco, and other drugs use and misuse in adult populations that experience health disparities. ODP and participating NIH Institutes and Centers are inviting applications for research projects that test innovative approaches to implementing screening, brief intervention, and referral to treatment or prevention fo
Bio Pharma Dive
NOVEMBER 28, 2023
Fresh off a $7 billion deal with Roche, the chief executive spoke with BioPharma Dive about this year’s “discordant combination” of major biotech achievements alongside market headwinds.
Pharmaceutical Technology
NOVEMBER 27, 2023
Olvi-Vec is currently being evaluated in a Phase III trial as a treatment for platinum- resistant/refractory ovarian cancer.
Fierce Pharma
NOVEMBER 29, 2023
Seeking to identify ways to improve the discovery and production of medicines, Amgen is expanding its partnership with tech giant Amazon. | Amgen is growing its decade-old collaboration with Amazon Web Services—a widely used cloud platform—to create generative artificial intelligence that the companies aim to use to increase the manufacturing throughput of pharmaceuticals.
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.
BioSpace
NOVEMBER 27, 2023
Building on a previous 2021 collaboration, Bristol Myers Squibb is paying $100 million upfront for the development of five cardiovascular targets utilizing Avidity Biosciences’ antibody oligonucleotide conjugates.
Bio Pharma Dive
NOVEMBER 28, 2023
The agency said the benefit of approved treatments like Gilead’s Yescarta still outweighs any such risk, but the alert could slow drugmaker efforts to develop the treatments for wider use.
Pharmaceutical Technology
NOVEMBER 30, 2023
In the past few months, significant interest within the inflammatory bowel disease (IBD) space has been directed towards the therapeutic target, tumour necrosis factor-like cytokine 1A (TL1A).
Fierce Pharma
NOVEMBER 27, 2023
Following similar campaigns mounted by industry players and biopharma trade groups, the United States' Solicitor General has joined a chorus of voices calling on the Supreme Court to overturn an ap | Following similar campaigns mounted by industry players and biopharma trade groups, the United States' Solicitor General has joined a chorus of voices calling on the Supreme Court to overturn an appeals court’s August ruling on the abortion pill mifepristone.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
BioSpace
NOVEMBER 29, 2023
The regulator accepted Karuna Therapeutics' NDA for KarXT and set a PDUFA date of September 26, 2024. If approved, it would be the first new mechanism of action to treat schizophrenia in decades, the company contends.
Bio Pharma Dive
NOVEMBER 30, 2023
The acquisition of ImmunoGen gives AbbVie an approved medicine for ovarian cancer, and continues a pharma spending spree on antibody-drug conjugates.
Pharmaceutical Technology
NOVEMBER 29, 2023
GlobalData’s report assesses the drugs in the Cyclin Dependent Kinase 4 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
Fierce Pharma
NOVEMBER 27, 2023
Following the historic approval of the world’s first CRISPR-based gene-editing therapy in the United Kingdom this month, Vertex Pharmaceuticals has tapped its long-time manufacturing partner Roslin | RoslinCT, the CDMO arm of the Roslin Institute, is set to manufacture Vertex and CRISPR Therapeutics’ exa-cel “across the world” as part of Vertex’s global production network.
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As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. Deviations from the intended supply chain can delay timelines and affect these high value products, which can be detrimental to budgets, but more importantly can have dire effects on the patients whose lives depend on receiving these critical doses safely and on time.
BioPharma Reporter
NOVEMBER 27, 2023
It is five years this month since a ground-breaking change in UK healthcare history happened â with doctors being able to prescribe cannabis-based medicines for the first time.
Bio Pharma Dive
NOVEMBER 27, 2023
Results from the second of two Phase 3 trials testing the blockbuster drug in the respiratory condition showed treatment could reduce attacks and improve lung function.
Pharmaceutical Technology
NOVEMBER 29, 2023
GlobalData’s report assesses the drugs in the Bromodomain Containing Protein 4 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
BioSpace
NOVEMBER 27, 2023
The Ogsiveo tablets are the first approval therapy for the rare subtype of soft tissue sarcomas, which can lead to severe pain and disability and previously were treated primarily through surgery.
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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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