Fierce Pharma
OCTOBER 11, 2023
For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate. | For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate.
MedCity News
OCTOBER 11, 2023
Enrollment in Medicare Advantage is increasing, but the program has been drawing scrutiny from the government. Can the program be saved? One expert believes Medicare Advantage is a failed experiment. Another thinks that while the program has its flaws, it shows tremendous potential.
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Fierce Pharma
OCTOBER 11, 2023
Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief m | Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief medicine.
MedCity News
OCTOBER 11, 2023
At HLTH, General Catalyst Principal Candace Richardson discussed some of the questions she frequently asks startups during investment meetings. Some of these include “Do you stratify your outcomes data by different populations to ensure your model works well for everyone?” and “Is serving Medicaid populations on your roadmap?
Fierce Pharma
OCTOBER 11, 2023
Mallinckrodt has essentially walked back its promise to pay $1.7 billion in an opioid settlement thanks to the company's second bankruptcy in just two years. | Mallinckrodt has essentially walked back its promise to pay $1.7 billion in an opioid settlement thanks to the company's second bankruptcy in just two years.
MedCity News
OCTOBER 11, 2023
To address the growing physician shortage, some people argue that the scope of practice should be expanded for skilled healthcare professionals like nurse practitioners and pharmacists. American Medical Association President Dr. Jesse Ehrenfeld said this is a “terrible idea.” He argued that throwing other professionals into physicians’ roles will have poor ramifications of patient safety.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
OCTOBER 11, 2023
A study testing Novo Nordisk’s semaglutide in chronic kidney disease is ending early after an interim analysis met efficacy goals. Detailed results are not yet available, but they could support expanding use of the GLP-1 agonist, which is far and away Novo Nordisk’s top-selling product.
Fierce Pharma
OCTOBER 11, 2023
In the race to develop nonsteroidal topical treatments for autoimmune skin conditions, Dermavant is charging toward the finish line—again. | Dermavant has presented evidence that Vtama provides immediate and long-term relief from the severe itch condition pruritus, the most prevalent symptom of atopic dermatitis. The trial results bolster Dermavant's effort to win a label expansion for the drug.
European Pharmaceutical Review
OCTOBER 11, 2023
Late-breaking data from Roche’s Phase III OCARINA II study have revealed that OCREVUS® (ocrelizumab) subcutaneous injection was comparable to IV infusion in providing near-complete suppression of MRI brain lesion activity over 24 weeks, for relapsing or primary progressive multiple sclerosis (RMS or PPMS) patients. OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, which are thought to be a key contributor to myelin and axonal (nerve cell) damage, noted Roche.
Fierce Pharma
OCTOBER 11, 2023
That didn't take long. | Just two weeks after Biogen completed its buyout of Reata Pharmaceuticals, the combined company is trimming its staff. Reata staffers who worked in roles that are already covered at Biogen are losing their jobs.
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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.
PharmaTech
OCTOBER 11, 2023
The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.
Fierce Pharma
OCTOBER 11, 2023
Fierce Pharma sits down with digital marketing leaders to discuss this year's most innovative topics at Digital Pharma East. Learn more by watching the videos below. | Fierce Pharma sits down with digital marketing leaders to discuss this year's most innovative topics at Digital Pharma East.
MedCity News
OCTOBER 11, 2023
Cancer and pharmacy services are driving up costs for employers. One Mercer exec recently laid out several recommendations for employers to manage these costs.
Fierce Pharma
OCTOBER 11, 2023
With observations ranging from dirty packing rooms to incomplete lab control records, Spectrum Laboratory Products’ new FDA manufacturing write-up reads like a guide on what not to do when producin | With observations ranging from dirty packing rooms to incomplete lab control records, Spectrum Laboratory Products’ new FDA manufacturing write-up reads like a guide on what not to do when producing drug ingredients.
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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
MedCity News
OCTOBER 11, 2023
HLTH 2023 introduced a new program focused on technology trends for and perspectives from payers in a series of conversations around AI, health equity and healthcare innovation.
Fierce Pharma
OCTOBER 11, 2023
After a recent FDA approval and CDC recommendation, Pfizer's Abyrsvo is the first maternal vaccine to protect babies from respiratory syncytial virus (RSV). | The vaccine, if used widely, could generate savings of up to $800 million and cut infant hospitalizations in half, according to a Pfizer study set to be presented at IDWeek 2023.
Pharmaceutical Technology
OCTOBER 11, 2023
Biomarin and CSL Behring’s haemophilia gene therapies have boosted innovation in the field, but assessing their cost effectiveness is less than straightforward.
Fierce Pharma
OCTOBER 11, 2023
At Astellas, we are striving to be the industry’s cutting-edge, VALUE-driven life science innovator. | A culture of encouraging brave ideas to pursue ambitious patient outcomes.
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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.
PharmaTech
OCTOBER 11, 2023
Roche will gain exclusive worldwide rights to develop, manufacture, and commercialize Ionis’ investigational RNA-based therapeutic candidates for Alzheimer's and Huntington's disease.
Medgadget
OCTOBER 11, 2023
Scientists at the University of Galway in Ireland and MIT have collaborated to create a soft robotic implant that can work to fight fibrotic encapsulation and deliver drugs despite the presence of fibrous scar tissue. The device, which the researchers have termed the FibroSensing Dynamic Soft Reservoir (FSDSR), is designed to reside in the body for extended periods and deliver drugs.
PharmaVoice
OCTOBER 11, 2023
Day One Biopharmaceuticals is bucking the cancer drug development trend by working with children and adults simultaneously.
Medgadget
OCTOBER 11, 2023
Researchers at the University of Washington have developed a technique to make saliva collection for diagnostic purposes a little less disgusting and a little more fun and pleasant. Saliva collection often acts as a less invasive alternative than throat swabs in the detection of a variety of pathogens, such as that causing streptococcal soar throat (strep throat).
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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.
PharmaTimes
OCTOBER 11, 2023
The deal gives Kyowa access to a therapy for early-onset metachromatic leukodystrophy - News - PharmaTimes
European Pharmaceutical Review
OCTOBER 11, 2023
As part of newly acquired assets from live biotherapeutics products (LBP) manufacturer Federation Bio, Kanvas Biosciences now has two active microbiome-based clinical programmes. “This acquisition allows us to manufacture and clinically investigate complex microbial consortia much faster than previously envisioned. Rather than devote years to building a manufacturing process from the ground up, we are thrilled to be able to positively impact patients’ lives much faster [by acquiring several key
Pharmaceutical Technology
OCTOBER 11, 2023
GlobalData analyst Wafaa Hasan discusses key topics around cybersecurity for the pharmaceutical industry.
PharmaTimes
OCTOBER 11, 2023
Eligible patients in Scotland will now have access to Nubeqa and Stivarga - News - PharmaTimes
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Pharmaceutical Technology
OCTOBER 11, 2023
Ozempic is approved in the US, Canada, EU, Japan, and Australia as a treatment for type 2 diabetes.
PharmExec
OCTOBER 11, 2023
KYV-101 designed as a CD19 CAR T-cell therapy.
pharmaphorum
OCTOBER 11, 2023
Faron’s Clever-1 drug shows promise in blood cancers Phil.
PharmaTech
OCTOBER 11, 2023
Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the importance of CAR-T as a modality.
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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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