Bio Pharma Dive
MARCH 25, 2024
The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.
Pharmaceutical Technology
MARCH 25, 2024
The US FDA approved Johnson & Johnson's (J&J) OPSYNVI for chronic treatment in adult patients with pulmonary arterial hypertension.
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Bio Pharma Dive
MARCH 25, 2024
Despite the late-stage victory, shares of the New York-based biotech dipped more than 3%. One analyst argued that Axsome’s drug has “largely been falling under investor radars.
Pharmaceutical Technology
MARCH 25, 2024
Cancer Research UK and the CRIS Cancer Foundation have awarded a £1.7m ($2.1m) grant for developing the lung cancer vaccine LungVax.
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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
Bio Pharma Dive
MARCH 25, 2024
As precision medicine expands into a growing number of therapeutic areas, the “one size fits all” approach to drug development is becoming less common.
Pharmaceutical Technology
MARCH 25, 2024
The FDA granted accelerated approval for the drug back in November 2022, and granted priority review in December 2023.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MARCH 25, 2024
The CRISPR-based assay significantly accelerates the current diagnostic process, which can last for months and could revolutionise the way NTM infections are diagnosed.
Bio Pharma Dive
MARCH 25, 2024
Worth about $138 million upfront, the deal is another example of pharma interest in new drugs for inflammatory conditions like Crohn’s.
Rethinking Clinical Trials
MARCH 25, 2024
The Patient-Centered Outcomes Research Institute (PCORI) announced the release of its new Foundational Expectations for Partnerships in Research. The resource is an update of the 2014 PCORI Engagement Rubric. It builds on a growing body of evidence about engaging patients and other partners in patient-centered comparative effectiveness research. A webinar on April 4 will explore the foundational expectations, which PCORI describes as “building blocks for meaningful, effective, and sustaina
Bio Pharma Dive
MARCH 25, 2024
Leveraging real-world data (RWD) transforms global clinical trials, enhancing patient engagement and improving regulatory decision-making.
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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
MARCH 25, 2024
The University of Birmingham has secured £350,000 in funding to develop a flavoured "lollipop" for the early detection of mouth cancer.
BioSpace
MARCH 25, 2024
The National Institutes of Health claims BioNTech is in default regarding alleged royalty payments the agency contends it is owed in connection with the company’s COVID-19 vaccine Comirnaty.
Pharmaceutical Technology
MARCH 25, 2024
Novo Nordisk will pay up to $1.1bn in upfront and milestone-based payments, with the acquisition expected to close in Q2 2024.
Fierce Pharma
MARCH 25, 2024
Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. | Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. officials are pressing the company to pay royalties linked to the commercialization of its lucrative Pfizer-partnered COVID-19 vaccine.
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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
MARCH 25, 2024
Download our extensive, free list of the leading pharmaceutical packaging companies and labelling machine manufacturers today.
Fierce Pharma
MARCH 25, 2024
In 2023, Eli Lilly CEO David Ricks received a 24% boost in pay from $21.4 million to $26.6 million. The increase coincides with the company's booming sales.
Pharmaceutical Technology
MARCH 25, 2024
Gilead Sciences has concluded the acquisition of CymaBay Therapeutics in a transaction valued at approximately $4.3bn.
Fierce Pharma
MARCH 25, 2024
With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a | With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a nod from the U.S. regulator for its newest PAH treatment.
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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
MARCH 25, 2024
Esperion Therapeutics’ Nexletol and Nexlizet are now available for patients with cardiovascular risk in the US.
BioSpace
MARCH 25, 2024
AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.
Pharmaceutical Technology
MARCH 25, 2024
An unnamed Chinese partner takes on AR1001 in an APAC Alzheimer’s market predicted to be worth $2.
BioSpace
MARCH 25, 2024
The early-stage study showed that Viking Therapeutics’ oral obesity candidate VK2735, a dual agonist of the GLP-1 and GIP receptors, elicited a 3.3% reduction in mean body weight. The company plans to start a Phase II trial.
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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.
Fierce Pharma
MARCH 25, 2024
Nearly five years after an FDA approval for Soliris in neuromyelitis optica spectrum disorder (NMOSD), AstraZeneca’s follow-on C5 drug Ultomiris has entered the rare neurological disease, as well.< | Nearly five years after an FDA approval for Soliris in neuromyelitis optica spectrum disorder (NMOSD), AstraZeneca’s follow-on C5 drug Ultomiris has entered the rare neurological disease, as well.
BioSpace
MARCH 25, 2024
Stoke Therapeutics reported results for Dravet syndrome studies showing clinically meaningful effects, including reductions in convulsive seizure frequency, supporting the potential for disease modification.
Fierce Pharma
MARCH 25, 2024
The four years since the start of the COVID-19 pandemic have yielded many advances against the coronavirus, including Moderna and Pfizer’s groundbreaking mRNA vaccines. | The agency granted emergency use authorization to Invivyd's Pemgarda, a monoclonal antibody for those who are immunocompromised and unlikely to receive adequate protection from marketed mRNA vaccines.
BioSpace
MARCH 25, 2024
Brazil’s Ministry of Health and nonprofit Caring Cross announced a collaboration Tuesday aimed at local manufacturing of CAR-T cell and stem cell gene therapies at a much lower cost than Europe and the U.S.
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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
MARCH 25, 2024
When it comes to questioning drug patents, the U.S. Federal Trade Commission (FTC) isn’t backing down. | After filing a challenge in November against more than 100 patents in the FDA’s Orange Book—and persuading several drugmakers to retract their intellectual property (IP) protections in the process—the U.S. Federal Trade Commission is now calling out uncooperative companies in court.
pharmaphorum
MARCH 25, 2024
Novo Nordisk has agreed to buy Cardior Pharmaceuticals for $1.1 billion, adding expertise in RNA therapeutics and a heart failure therapy in mid-stage trials.
BioSpace
MARCH 25, 2024
Axsome clinched a late-stage victory for its chronic sleep disorder candidate AXS-12, which demonstrated significant improvement in cataplexy—the sudden loss of muscle tone while a person is awake—after five weeks.
BioPharma Reporter
MARCH 25, 2024
The recent submission of clinical trial data for Sanofi/Regeneronâs Dupixent and Veronaâs Ensifentrine to the U.S. FDA indicates the entry of new therapies for chronic obstructive pulmonary disease (COPD) in 2024.
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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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