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
Venture financing for innovative radiopharmaceutical drugs witnessed an approximately 550% increase from $63m in 2017 to $408m in 2023 YTD (year-to-date) total deal value in the US.
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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 28, 2023
The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.
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 28, 2023
The emergency use listing is based on non-clinical data where the vaccine demonstrated immune responses against variants in SARS-CoV-2.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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
Bio Pharma Dive
NOVEMBER 28, 2023
Tuesday’s deal signals the pharmaceutical giant's confidence in Avidity Biosciences and its so-called antibody oligonucleotide conjugates.
Pharmaceutical Technology
NOVEMBER 28, 2023
Emergent’s Cyfendus was approved by the US FDA as a post-exposure prophylactic vaccine for anthrax in July.
Bio Pharma Dive
NOVEMBER 28, 2023
The pharma has overhauled its pipeline this year, cutting R&D programs outside of its four main therapeutic areas.
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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
NOVEMBER 28, 2023
The agency has set a PDUFA date of 25 May 2024 for pz-cel, which if approved, Abeona would be eligible for a priority review voucher.
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.
Pharmaceutical Technology
NOVEMBER 28, 2023
Japan’s MHLW has granted approval for Daiichi Sankyo’s Omicron XBB.1.5-adapted monovalent mRNA vaccine as a booster for Covid-19.
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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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
Pharmaceutical Technology
NOVEMBER 28, 2023
Aldeyra has submitted new trial plans to the US FDA, and anticipates NDA resubmission for reproxalap in H1 2024.
Fierce Pharma
NOVEMBER 28, 2023
Gilead Sciences' Kite Pharma cell therapy unit is undergoing a business review that will result in layoffs to about 7% of the organization’s workforce. | Gilead’s Kite Pharma cell therapy unit is undergoing a business review that will result in layoffs to about 7% of the organization’s workforce. In a letter sent to staff this week that was obtained by Fierce Biotech, Kite Pharma Executive Vice President Cindy Perettie previewed a “refreshed business strategy” that would better align the un
Pharmaceutical Technology
NOVEMBER 28, 2023
Opening the first day of the CTO Europe conference, experts set their sights on the impact of digital technologies on oncology trials.
Drug Discovery World
NOVEMBER 28, 2023
An international team of scientists has shown that a stem cell therapy for multiple sclerosis (MS) could prevent further damage to the brain. The early-stage clinical trial was the result of a collaboration between researchers at University of Colorado Anschutz Campus, the University of Cambridge and the University of Milano-Bicocca. “We don’t know yet whether this is the beginning of a fantastic journey or not, but the results are very strong and very consistent,” said Professor Stefano Pluchin
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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.
Pharmaceutical Technology
NOVEMBER 28, 2023
The US Food and Drug Administration (FDA) has granted orphan drug designation for Arcturus Therapeutics’ ARCT-032 for cystic fibrosis.
XTalks
NOVEMBER 28, 2023
Amazon has recently introduced a new Amazon Prime membership benefit aimed at delivering top-notch healthcare through One Medical, an Amazon company. Amazon’s One Medical platform streamlines the process of accessing essential healthcare services, spanning from preventive care to addressing immediate health concerns and effectively managing chronic conditions such as diabetes. “When it is easier for people to get the care they need, they engage more in their health and realize better healt
Pharmaceutical Technology
NOVEMBER 28, 2023
Boehringer Ingelheim has entered an agreement with IBM to leverage the latter’s foundation model technologies for antibody discovery.
XTalks
NOVEMBER 28, 2023
Kesin Pharma has obtained approval from the US Food and Drug Administration (FDA) for its oral suspension antibiotic drug Likmez (metronidazole), designed for patients with dysphagia and difficulty swallowing. Indicated for the treatment of trichomoniasis in adults, amebiasis in both adults and pediatric patients and anaerobic bacterial infections in adults, Likmez is available as an oral suspension, with each 5 mL containing 500 mg of metronidazole.
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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.
Pharmaceutical Technology
NOVEMBER 28, 2023
As per recommendations, Bayer will continue to investigate asundexian in a different Phase III trial with stroke patients.
BioSpace
NOVEMBER 28, 2023
The United States’ relatively high costs have become a political issue on both sides of the aisle. Here’s how international pharmaceutical prices stack up.
Fierce Pharma
NOVEMBER 28, 2023
Dermavant CEO Todd Zavodnick isn’t concerned with the slow uptake of the hyped plaque psoriasis drug Vtama. He points to another breakthrough treatment which took a while to catch on: Botox. | Dermavant CEO Todd Zavodnick isn’t concerned with the slow uptake of hyped plaque psoriasis drug Vtama. He points to another breakthrough treatment which took a while to catch on—Botox.
BioSpace
NOVEMBER 28, 2023
The Swiss pharma is adopting a more streamlined strategy focusing on core therapeutic areas: cardiovascular, immunology, neuroscience and oncology, as well as renal and metabolic diseases.
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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.
Fierce Pharma
NOVEMBER 28, 2023
Novartis is getting more optimistic about its midterm sales potential, thanks to bullish estimates for some blockbuster drugs. | Novartis is getting more optimistic about its midterm sales potential, thanks to bullish estimates for some blockbuster drugs, including Entresto and Kisqali.
Sciensano
NOVEMBER 28, 2023
A new four-year project called the Joint Action on Cardiovascular Diseases and Diabetes ( JACARDI ) was launched in Rome on 27 November 2023. This initiative, engaging ministries, public health bodies, non-governmental organizations, and universities, aims to assist European Union ( EU ) member states in reducing the burden of cardiovascular diseases ( CVD ), diabetes, and associated risk factors, both at the individual and societal levels.
XTalks
NOVEMBER 28, 2023
Biosimilars have emerged as an important factor in modern healthcare, reshaping treatment accessibility and affordability. Biosimilars offer a promising pathway to reducing healthcare costs while maintaining the efficacy and safety profiles of their reference products, the originally approved biologic drugs. The biosimilar industry today is marked by rapid advancements, regulatory evolution and growing market acceptance.
BioPharma Reporter
NOVEMBER 28, 2023
Outsourcing Pharma is delighted to invite you to join our not-to-be-missed webinar on one of the most important areas of the industry â patient centricity â and its solutions.
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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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