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
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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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
The US FDA approved Johnson & Johnson's (J&J) OPSYNVI for chronic treatment in adult patients with pulmonary arterial hypertension.
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The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
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.
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.
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
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 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
Leveraging real-world data (RWD) transforms global clinical trials, enhancing patient engagement and improving regulatory decision-making.
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.
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
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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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
Download our extensive, free list of the leading pharmaceutical packaging companies and labelling machine manufacturers today.
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.
Pharmaceutical Technology
MARCH 25, 2024
Esperion Therapeutics’ Nexletol and Nexlizet are now available for patients with cardiovascular risk in the US.
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.
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
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.
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.
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.
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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
An unnamed Chinese partner takes on AR1001 in an APAC Alzheimer’s market predicted to be worth $2.
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
Three digital health technologies (DHTs) used to support patients with psychosis can be used by the NHS while additional evidence of their benefits is gathered.
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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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
pharmaphorum
MARCH 25, 2024
FDA has turned down a pair of marketing applications for Regeneron’s CD20xCD3 bispecific antibody odronextamab to treat two common forms of non-Hodgkin lymphoma
XTalks
MARCH 25, 2024
As Easter 2024 approaches, a concerning chocolate shortage threatens to cast a shadow over the season’s celebrations. This shortage, attributed to a combination of factors including poor cocoa harvests in West Africa, is poised to impact chocolate lovers worldwide. The Root of the Chocolate Shortage For the past three years, the cocoa industry has grappled with underwhelming harvests, significantly driving up prices.
Pharma Times
MARCH 25, 2024
Estimated to affect 2.
XTalks
MARCH 25, 2024
After more than a decade, Oprah Winfrey returned to prime-time TV last week for an ABC special titled “Shame, Blame and the Weight Loss Revolution” to share her public battle with weight and her decision to use new GLP-1 medications to help manage it. In the hour-long TV special that Oprah hosted, set on a stage reminiscent of her iconic talk show, the talk show icon said, “I took on the shame that the world gave to me.
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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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