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.
Pharmaceutical Technology
OCTOBER 4, 2023
Strides earned market approval in the US as part of a larger government endeavor to address HIV worldwide.
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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.
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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Pharmaceutical Technology
OCTOBER 4, 2023
Ernst and Young’s latest report finds supply chain visibility to be a viable route for pharmaceutical resilience.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 4, 2023
The Union health ministry has issued a draft notification to include antiviral drugs oseltamivir and zanamivir into the Schedule H1 of the Drug Rules, 1945, allowing the retailers to store and sell the drug against prescription by maintaining a separate record for the details of the particular sales.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
Pharmaceutical Technology
OCTOBER 4, 2023
Novartis will now focus on innovative drugs, whilst Sandoz strengthens its biosimilar business.
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.
Pharmaceutical Technology
OCTOBER 4, 2023
The voluntary recall issued by Hospira will affect three different injectables following the potential presence of glass particles.
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.
Pharma Times
OCTOBER 4, 2023
The companies aim to bring gene therapies to patients sooner than traditional approaches - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 4, 2023
The agreement provides Teva with a $500m upfront payment along with potential milestone-based payments of up to $1bn.
Pharma Times
OCTOBER 4, 2023
The approach reduces recovery times and lowers rates of complications - News - PharmaTimes
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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
Pharmaceutical Technology
OCTOBER 4, 2023
The optical imaging agent, FG001, is being evaluated for visualising the malignant tissue during high-grade glioma surgery.
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.
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.
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.
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.
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.
Pharmaceutical Technology
OCTOBER 4, 2023
Regeneron has entered into an expanded research collaboration with Intellia Therapeutics for the development of CRISPR based therapies.
pharmaphorum
OCTOBER 4, 2023
Oncology in the NHS: Situations, challenges, and solutions Mike.
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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.
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.
pharmaphorum
OCTOBER 4, 2023
Navigating EAPs: Clinical trials and the path to investigational drugs Mike.
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.
pharmaphorum
OCTOBER 4, 2023
Sandoz separates from Novartis, valued at just over $11bn Phil.
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Pharmaceutical Commerce
OCTOBER 4, 2023
Exec joins the organization with decades of biopharma experience.
pharmaphorum
OCTOBER 4, 2023
Lilly takes POINT in radiopharma push Phil.
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
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.
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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.
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