Moderna claims positive results in early study for combo COVID, flu shot
Bio Pharma Dive
OCTOBER 4, 2023
The company is planning to start a Phase 3 trial of the vaccine this year, and is targeting a regulatory approval in 2025.
Wed.Oct 04, 2023
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AI Identifies Brain Signals Associated With Recovering From Depression
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 4, 2023
It could soon be possible to measure changes in depression levels like we can measure blood pressure or heart rate. In a new study, 10 patients with depression that had resisted treatment were enrolled in a six-month course of deep brain stimulation (DBS) therapy.
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Strides Pharma gets FDA greenlight to market HIV treatment
Pharmaceutical Technology
OCTOBER 4, 2023
Strides earned market approval in the US as part of a larger government endeavor to address HIV worldwide.
October 4, 2023: Special Biostatistics Grand Rounds Series Begins Friday With Rigorous Methods for Hybrid Studies
Rethinking Clinical Trials
OCTOBER 4, 2023
In this Friday’s PCT Grand Rounds, David Murray of the NIH Office of Disease Prevention will kick off our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “Hybrid Studies Should Not Sacrifice Rigorous Methods.” The session will be held on Friday, October 6, at 1:00 pm eastern and will be moderated by Jonathan Moyer.
Sandoz spins out of Novartis as standalone generic drugmaker
Bio Pharma Dive
OCTOBER 4, 2023
The spinoff, now complete, is a major step in CEO Vas Narasimhan’s plan to refocus Novartis more tightly around novel prescription drugs and new technologies.
FDA grants EUA for Novavax’s updated Covid-19 vaccine
Pharmaceutical Technology
OCTOBER 4, 2023
The US FDA has amended the EUA of Novavax’s adjuvanted Covid-19 vaccine (NVX-CoV2601) to incorporate the 2023-2024 formula.
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Sanofi buys into Teva gut disease drug
Bio Pharma Dive
OCTOBER 4, 2023
The pharma will pay $500 million to collaborate with Teva on the anti-TL1A therapy, which is seen as a competitor to similar drugs from Merck and Roivant.
Pfizer’s Hospira issues recall after glass particles found in injectables
Pharmaceutical Technology
OCTOBER 4, 2023
The voluntary recall issued by Hospira will affect three different injectables following the potential presence of glass particles.
Lilly names new diabetes and obesity chief as Mounjaro sales take off
Bio Pharma Dive
OCTOBER 4, 2023
Company veteran Mike Mason, who took leadership of the division four years ago, is retiring and will be replaced by immunology head Patrik Jonsson.
EY report finds cracks in pharma supply chain operations
Pharmaceutical Technology
OCTOBER 4, 2023
Ernst and Young’s latest report finds supply chain visibility to be a viable route for pharmaceutical resilience.
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
Kate Therapeutics and Capsida Biotherapeutics collaborate on gene therapies
Pharma Times
OCTOBER 4, 2023
The companies aim to bring gene therapies to patients sooner than traditional approaches - News - PharmaTimes
Novartis split complete as Sandoz begins trading on Swiss Exchange
Pharmaceutical Technology
OCTOBER 4, 2023
Novartis will now focus on innovative drugs, whilst Sandoz strengthens its biosimilar business.
In splitting from Novartis, Sandoz makes muted market debut
Fierce Pharma
OCTOBER 4, 2023
After more than a year of preparation, Sandoz has officially parted ways with Swiss drug giant Novartis. But the company's day-one valuation lagged what some analysts had projected. | The generics and biosimilar maker debuted on the SIX Swiss Exchange at 24 Swiss francs ($26.16) for a total valuation of about $11.2 billion. Analysts had previously published ranges of $11 billion to $26 billion for the company, according to Reuters.
Regeneron and Intellia expand partnership to develop CRISPR-based therapies
Pharmaceutical Technology
OCTOBER 4, 2023
Regeneron has entered into an expanded research collaboration with Intellia Therapeutics for the development of CRISPR based therapies.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Merck's COVID antiviral Lagevrio to hit commercial market in November, HHS says
Fierce Pharma
OCTOBER 4, 2023
As long expected, the U.S. government is winding down its distribution of COVID-19 countermeasures. | The government will wind down its Lagevrio distribution ahead of the transition, the Administration for Strategic Preparedness and Response said.
Lilly agrees to buy POINT Biopharma for $1.4bn
Pharmaceutical Technology
OCTOBER 4, 2023
Eli Lilly and Company has signed a definitive agreement to acquire POINT Biopharma for an all-in cash deal value of nearly $1.4bn.
HEOR and Market Access Strategies in Today’s Drug Development Landscape – Insights from AstraZeneca’s Dr. Heather McDonald
XTalks
OCTOBER 4, 2023
Health economics and outcomes research (HEOR) and market access strategies play a critical role in ensuring that newly approved therapies are made available to patients. Professionals in these roles are facing new challenges when it comes to negotiating coverage for many of the new, innovative treatments that are coming to market. HEOR involves the assessment of the economic implications and real-world outcomes of cutting-edge therapies, providing essential insights into their cost-effectiveness
WHO’s SAGE recommends Takeda’s dengue vaccine
Pharmaceutical Technology
OCTOBER 4, 2023
The WHO SAGE has recommended Takeda’s QDENGA (dengue tetravalent vaccine) for use in high dengue burden and transmission areas.
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.
Boehringer Ingelheim embraces dual-pricing tactic with launch of unbranded Humira biosimilar
Fierce Pharma
OCTOBER 4, 2023
Boehringer Ingelheim, which recently launched the first interchangeable biosimilar to AbbVie’s megablockbuster Humira, is getting in on the industry’s double-pricing trick. | After debuting its branded Humira biosim Cyltezo in July, Boehringer has launched an unbranded copycat of the inflammatory disease drug, simply called adalimumab-adbm injection, which will be sold at an 81% discount to Humira.
FluoGuide imaging agent wins FDA orphan drug designation for glioma surgery
Pharmaceutical Technology
OCTOBER 4, 2023
The optical imaging agent, FG001, is being evaluated for visualising the malignant tissue during high-grade glioma surgery.
Small Percentage of Adults with Early Alzheimer’s Eligible for Leqembi: Study
BioSpace
OCTOBER 4, 2023
Data from the Mayo Clinic shows limited eligibility for the anti-amyloid treatment. However, Michael Irizarry, Eisai’s deputy chief clinical officer, says some patients could still be eligible.
Sanofi continues expansion spree by licencing Teva’s IBD drug for $1.5bn
Pharmaceutical Technology
OCTOBER 4, 2023
The agreement provides Teva with a $500m upfront payment along with potential milestone-based payments of up to $1bn.
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Kyowa Kirin Buys Orchard for Potential $478M as FDA Decision Looms
BioSpace
OCTOBER 4, 2023
The Japan-based pharma is acquiring Orchard Therapeutics for approximately $477.6 million, if all conditions are met. Orchard’s pediatric gene therapy has a PDUFA date set for March 2024.
With key Mounjaro decision ahead, Eli Lilly shuffles its C-Suite deck
Fierce Pharma
OCTOBER 4, 2023
Lilly announced several C-Suite moves, including the retirement of Diabetes and Obesity chief Mike Mason, with his duties assumed by Patrick Jonsson.
FDA Adcomm Backs Neuroblastoma Treatment, Even Without RCT Data
BioSpace
OCTOBER 4, 2023
Despite the lack of a randomized controlled trial for the US WorldMeds’ investigational drug, an FDA advisory committee found that the company provided adequate data to support its benefit in high-risk neuroblastoma.
King Faisal Specialist and Research Centre achieves world-first fully robotic liver transplant
Pharma Times
OCTOBER 4, 2023
The approach reduces recovery times and lowers rates of complications - News - PharmaTimes
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.
Novavax gets green light for updated COVID vaccine
pharmaphorum
OCTOBER 4, 2023
Novavax has been given the go-ahead by regulators in the US for an updated version of its COVID-19 vaccine that targets the XBB.1.5 variant of the coronavirus. The FDA has signed off on the new protein-based shot, which joins two XBB.1.5-directed mRNA-based vaccines from Pfizer/BioNTech and Moderna as options for the upcoming immunisation campaign in the US.
FDA Puts Innate’s Lymphoma Trials on Partial Hold After Patient Death
BioSpace
OCTOBER 4, 2023
Following a fatality due to the rare blood disease hemophagocytic lymphohistiocytosis, the regulator slapped a partial clinical hold on two studies of Innate Pharma’s investigational therapy lacutamab.
Colombia, pursuing healthcare savings, plots compulsory license for ViiV's HIV drug dolutegravir
Fierce Pharma
OCTOBER 4, 2023
After sparring with GSK’s ViiV Healthcare over the price of its HIV medication dolutegravir, Colombia appears to be taking matters into its own hands. | Colombian authorities say they plan to issue a compulsory license for ViiV Healthcare's dolutegravir, which goes by the name Tivicay on its own or as Dovato when combined with other therapeutics.
Advantages of Integrating Budget Management Software with EDC Systems in Clinical Trials.
Cloudbyz
OCTOBER 4, 2023
Electronic Data Capture (EDC) systems are widely used in clinical trials to collect, manage, and analyze data from clinical studies. While EDC systems primarily focus on data capture and management, integrating trial budget management software within the EDC system can offer several advantages: 1. Streamlined Workflow: Combining EDC and budget management functionalities within the same system can create a more streamlined workflow for clinical trial teams.
Accelerating Clinical Supply Through Integrated Drug Development
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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