Bio Pharma Dive
OCTOBER 31, 2023
The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.
Pharmaceutical Technology
OCTOBER 31, 2023
ArriVent Biopharma has received the US FDA's breakthrough therapy designation for furmonertinib to treat non-small cell lung cancer.
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Bio Pharma Dive
OCTOBER 31, 2023
Expert advisers are reviewing the companies’ case for approval of what could be the first medicine based on the gene editing technology. Follow their discussion here.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 31, 2023
After a bump, we can expect a bruise. But what if we find ourselves bruising without any noticeable cause? What might be behind it? Should we worry? Around 18 percent of adults report easy bruising. As hematologists (blood doctors), we are often asked for advice when people are worried they might bruise too easily.
Bio Pharma Dive
OCTOBER 31, 2023
Already a partner to Verve, the pharma is paying $200 million upfront and investing another $50 million in Beam to acquire option rights to several gene editing programs.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 31, 2023
Adoption of laser vision correction procedure is picking up in India at a frantic pace, according to ophthalmologists which they attribute to advancements in technology making these treatments minimally invasive, safe and effective with quick recovery and impeccable results.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
OCTOBER 31, 2023
The NIH Pragmatic Trials Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative Demonstration Projects, which will extend the program’s mission to strengthen the national capacity to implement cost-effective, large-scale research studies that engage healthcare delivery organizations as research partners.
Bio Pharma Dive
OCTOBER 31, 2023
The acquisition of Telavant and its TL1A drug was born out of a J.P. Morgan conference meeting, Roivant chief executive Matt Gline said, and reflects the biotech’s flexible business strategy.
Pharmaceutical Technology
OCTOBER 31, 2023
Leading biopharmas are reshaping their strategies after the announcement regarding the first drugs subject to Medicare price negotiations under the Inflation Reduction Act (IRA).
Fierce Pharma
OCTOBER 31, 2023
For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials. | Pfizer's pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.
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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 31, 2023
The laboratory will be operational by Q3 2024, and the first manufacturing suite is expected to be operational in Q3 2025.
BioSpace
OCTOBER 31, 2023
Pfizer, Moderna, Novavax and more are working to combine preventative shots for COVID-19, flu, RSV and other illnesses. Will convenience be enough to overcome vaccine fatigue?
Pharmaceutical Technology
OCTOBER 31, 2023
The platform consists of an intraocular lens with drug-eluting pads and is designed so that patients need not self-administer eye drops post-surgery.
BioSpace
OCTOBER 31, 2023
The investment in the French biotech is one of many the pharma giant has made this year to advance cell and gene therapy development. Cellectis shares skyrocketed over 180% in premarket trading Wednesday.
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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
OCTOBER 31, 2023
Roche and Sarepta’s DMD drug failed to meet its primary endpoint in patients with patients with DMD aged 4-7 years.
BioSpace
OCTOBER 31, 2023
The British biopharma company reported 10% sales growth in the third quarter, driven mainly by robust sales of its respiratory syncytial virus shot Arexvy and shingles vaccine Shingrix.
Pharmaceutical Technology
OCTOBER 31, 2023
The acquisition of the oral methotrexate solution, marketed as Jylamvo, marks the second FDA-approved oncology product in Shorla’s portfolio.
BioSpace
OCTOBER 31, 2023
The regulator has released Mersana Therapeutics’ antibody-drug conjugate XMT-2056 from its clinical hold, allowing the biotech to proceed with Phase I studies of the candidate with a lower starting dose.
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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
OCTOBER 31, 2023
Biotechnology company Vect-Horus has signed a global licence agreement with Novo Nordisk for the development of targeted therapeutics.
BioSpace
OCTOBER 31, 2023
The regulator’s advisory committee on Tuesday found Vertex Pharmaceuticals and CRISPR Therapeutics’ off-target analysis for its sickle cell disease candidate exa-cel to be sufficient.
Pharmaceutical Technology
OCTOBER 31, 2023
Genentech is one of many companies using Sosei Heptares GPCR know-how, with AbbVie, Eli Lilly and Pfizer all on the company’s books.
Fierce Pharma
OCTOBER 31, 2023
As several new JAK inhibitors threaten Incyte’s bread-and-butter Jakafi in myelofibrosis, the company is busy advancing new regimens ahead of the drug’s 2028 patent cliff. | As several new JAK inhibitors threaten Incyte’s bread-and-butter Jakafi in myelofibrosis, the company is busy advancing new regimens ahead of the drug’s 2028 patent cliff.
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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
OCTOBER 31, 2023
The third quarter of 2023 saw a slight fall in deal activity after the recovery in the global M&A market in the second quarter.
Fierce Pharma
OCTOBER 31, 2023
For 170 million euros plus royalties, Galapagos has transferred Jyseleca and its operations to Alfasigma. The deal includes 400 employees who will transfer to Alfasigma.
Pharmaceutical Technology
OCTOBER 31, 2023
Sellas will be meeting with the FDA in Q4 2023 to discuss Breakthrough Therapy Designation for SLS009 as a treatment for r/r PTCL.
Pharma Times
OCTOBER 31, 2023
Around 400,000 eligible patients are set to benefit from the travel offer - News - PharmaTimes
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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.
Pharmaceutical Technology
OCTOBER 31, 2023
AnHeart Therapeutics and Nippon Kayaku have signed an exclusive agreement for the former’s investigational therapy, taletrectinib.
Fierce Pharma
OCTOBER 31, 2023
As Amgen’s $27.8 billion buyout of Horizon Therapeutics became official earlier this month, one of the first orders of business for the California biotech giant was to get acquired blockbuster Tepe | As Amgen’s $27.8 billion buyout of Horizon Therapeutics became official earlier this month, one of the first orders of business for the California biotech giant was to get acquired blockbuster Tepezza back on track.
Pharmaceutical Technology
OCTOBER 31, 2023
BGMA’s technical director, Paul Fleming, discusses changes to the UK pharmaceutical supply chain and how to maintain resilience.
BioSpace
OCTOBER 31, 2023
Optimizing Biomarker Assays to Bridge the Clinical Trial Participation Gap - read this article along with other careers information, tips and advice on BioSpace
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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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