Tue.Nov 28, 2023

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Pharma benefited from basing business overseas. An international tax effort could spur a rethink.

Bio Pharma Dive

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.

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Radiopharmaceuticals reach record high with $408m in venture financing for 2023

Pharmaceutical Technology

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.

Drugs 246
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FDA investigating cancer risk linked to CAR-T cell therapy

Bio Pharma Dive

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.

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FDA accepts Orexo’s NDA for opioid overdose medication

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.

Drugs 263
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Roivant’s Matt Gline on raising capital and biotech’s outlook in 2024

Bio Pharma Dive

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.

Marketing 183
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Novovax’s Omicron-targeting Covid-19 vaccine obtains WHO emergency listing  

Pharmaceutical Technology

The emergency use listing is based on non-clinical data where the vaccine demonstrated immune responses against variants in SARS-CoV-2.

More Trending

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Acelyrin claims errors by CRO Fortrea led to late-stage trial downfall

Pharmaceutical Technology

A Phase IIb/III trial studying the company’s immunotherapy izokibep, failed to achieve statistical significance for its primary endpoint

Trials 246
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Bristol Myers pours $100M into RNA drugs for cardiovascular diseases

Bio Pharma Dive

Tuesday’s deal signals the pharmaceutical giant's confidence in Avidity Biosciences and its so-called antibody oligonucleotide conjugates.

RNA 161
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Emergent wins $75m BARDA contact for anthrax vaccine

Pharmaceutical Technology

Emergent’s Cyfendus was approved by the US FDA as a post-exposure prophylactic vaccine for anthrax in July.

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Novartis sees brighter sales future as R&D revamp continues

Bio Pharma Dive

The pharma has overhauled its pipeline this year, cutting R&D programs outside of its four main therapeutic areas.

Sales 152
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Abeona’s cell therapy secures priority approval date for rare skin disorder

Pharmaceutical Technology

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.

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FDA investigates 'serious risk' of secondary cancer following CAR-T treatment

Fierce Pharma

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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Japan approves Daiichi Sankyo’s Covid-19 booster vaccine

Pharmaceutical Technology

Japan’s MHLW has granted approval for Daiichi Sankyo’s Omicron XBB.1.5-adapted monovalent mRNA vaccine as a booster for Covid-19.

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Pfizer takes Poland to court over alleged missed COVID-19 vaccine payments

Fierce Pharma

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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The New Age of Decentralized Clinical Trials

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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FDA rejects Aldeyra’s dry eye drug, asks for more clinical data

Pharmaceutical Technology

Aldeyra has submitted new trial plans to the US FDA, and anticipates NDA resubmission for reproxalap in H1 2024.

Drugs 147
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Gilead cuts 7% of staff at Kite Pharma unit as 'refreshed business strategy' introduced

Fierce Pharma

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

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CTO Europe 2023: Cancer clinical trials shift as sector goes digital

Pharmaceutical Technology

Opening the first day of the CTO Europe conference, experts set their sights on the impact of digital technologies on oncology trials.

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Stem cell therapy shows promise in advanced MS

Drug Discovery World

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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Accelerating Clinical Supply Through Integrated Drug Development

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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FDA grants orphan drug status for Arcturus’ cystic fibrosis therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted orphan drug designation for Arcturus Therapeutics’ ARCT-032 for cystic fibrosis.

Drugs 130
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Amazon Prime’s New One Medical Benefits Merge Tech and Healthcare

XTalks

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

Pharmacy 104
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Boehringer to leverage IBM’s technologies for antibody discovery 

Pharmaceutical Technology

Boehringer Ingelheim has entered an agreement with IBM to leverage the latter’s foundation model technologies for antibody discovery.

Antibody 130
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Likmez: First FDA-Approved Liquid Option of the Antibiotic Metronidazole

XTalks

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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How Machine Learning Drives Clinical Trial Efficiency

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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Bayer’s stock drops to new 18-year low after asundexian trial termination

Pharmaceutical Technology

As per recommendations, Bayer will continue to investigate asundexian in a different Phase III trial with stroke patients.

Trials 130
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Novartis dials up midterm sales projection, fleshes out Kisqali's $7B-plus goal

Fierce Pharma

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.

Sales 103
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21 European countries unite in the EU Joint Action JACARDI to reduce the burden of cardiovascular diseases and diabetes

Sciensano

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.

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Dermavant CEO draws Botox comparison to instill Vtama confidence amid slow psoriasis uptake

Fierce Pharma

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.

Botox 102
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Innovations in Biosimilars: Insights and Trends from Samsung Bioepis

XTalks

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.

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After Cyfendus' full approval, Emergent clinches $75M anthrax vaccine supply pact in US

Fierce Pharma

Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the Uni | Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the United States.

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Clinical trial reveals positive results for treating children with rare gliomas

Pharma Times

Tafinlar and Mekinist led to a 56% overall response rate in children with BM-HGG - News - PharmaTimes

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Not to be missed - our patient centricity in action webinar with three top speakers

BioPharma Reporter

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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.