Fierce Pharma
JUNE 9, 2023
After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing. | After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.
MedCity News
JUNE 9, 2023
AstraZeneca is paying $85 million to kick off an alliance with Quell Therapeutics focused on developing new cell therapies for autoimmune diseases. Type 1 diabetes and inflammatory bowel disease are the focus of research collaboration.
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Fierce Pharma
JUNE 9, 2023
After overhauling Amarin’s board earlier this year, activist investor Sarissa Capital has set its sights on Alkermes. | Activist investor Sarissa Capital believes Alkermes' long-time CEO Richard Pops has "far too much control" of the board. It's asking for representation after years of rejections.
MedCity News
JUNE 9, 2023
Syntax Health’s new two-sided software-as-a-service solution allows payers and providers (as well as actuaries, network managers and analysts) to collaborate in creating a value-based contract.
Medgadget
JUNE 9, 2023
Researchers at George Washington University have created a swallowable capsule containing a video camera that can assist in identifying lesions in the stomach. However, unlike similar devices that have been developed previously, this capsule can drive around the stomach under the control of a clinician. This allows it to thoroughly navigate and screen the entire area to identify any health issues in the stomach mucosa, such as ulcers or bleeding.
Pharmaceutical Technology
JUNE 9, 2023
WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) protein vaccine (Sf9 cell). This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 9, 2023
Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% to treat the signs and symptoms of dry eye disease. VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.
MedCity News
JUNE 9, 2023
Biological clocks could play an important role in helping to promote healthy ageing and to stem the growing incidence of age-related diseases by improving the quality of life of the aged, reducing mortality and relieving the burden on overwhelmed health and social care resources.
PharmExec
JUNE 9, 2023
The core building blocks of trust must be operationalized for pharma companies to strengthen their social contract, deliver business value, and improve patients’ quality of life.
European Pharmaceutical Review
JUNE 9, 2023
Samsung Biologics, the South Korean contract development and manufacturing organisation (CDMO), has entered into a strategic partnership for the long-term commercial manufacturing of Pfizer’s multi-product biosimilars portfolio. Under the deal, Samsung Biologics said it will provide Pfizer with “additional capacity for large-scale manufacturing of a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.
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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.
PharmaVoice
JUNE 9, 2023
The CEO of Sunstone Therapies said the results of a recent trial testing psilocybin in cancer patients with depression were “remarkable.
MedCity News
JUNE 9, 2023
Laudio — a startup providing software that automates administrative tasks for frontline nurse managers — recently raised $13 million in Series B funds. The company’s platform helps managers complete tasks like patient rounding and schedule making more quickly, as well as provides recommendations on how to better engage staff members.
European Pharmaceutical Review
JUNE 9, 2023
Telix Pharmaceuticals has opened a new radiopharma production facility in the Wallonia region of Belgium, which will serve as the company’s primary manufacturing site for radioisotopes and commercial and clinical products. The 2,800 square metre plant – Telix Manufacturing Solutions – is one of Europe’s largest radiopharmaceutical production facilities, Telix said.
MedCity News
JUNE 9, 2023
Regardless of industry, all legacy companies should be preparing themselves for digital disruption. This may seem daunting, but I can guarantee it will be less painful to start disrupting your own processes today than to find yourself disrupted—or even replaced—tomorrow.
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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
PharmaTimes
JUNE 9, 2023
Erdafitinib boosted survival in patients with certain conditions including metastatic urothelial carcinoma - News - PharmaTimes
PharmExec
JUNE 9, 2023
Amid the shifting focus from primary care to specialty care, using data-driven tactics can create tailored campaigns and meaningful relationships with nurse practitioners and physician assistants.
Copyright Clearance Center
JUNE 9, 2023
The post What AI Will Mean To Book Publishing appeared first on Copyright Clearance Center.
PharmExec
JUNE 9, 2023
Jag Dosanjh, president of US neuroscience and eye care for AbbVie and HBA’s 2023 honorable mentor of the year, shares what leadership qualities are most important in today’s “people industry”—and the impact more voices can make in stakeholder communication and messaging.
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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.
PharmaTimes
JUNE 9, 2023
International data questions the assumption that chronic myeloid leukaemia is now a ‘solved’ disease - News - PharmaTimes
Pharmacy Times
JUNE 9, 2023
The study will assess the use of the drug to treat impaired social motivation, or asociality, which is a difficult-to-treat symptom of schizophrenia that can cause significant functional impairment.
Pharmaceutical Technology
JUNE 9, 2023
Clinical-stage biotech company Upstream Bio has raised $200m in a Series B financing round to advance its UPB-101 to treat allergic and inflammatory diseases. Co-led by Venrock Healthcare Capital Partners (Venrock) and Enavate Sciences, the financing round has seen participation from new investors Wellington Management and Bain Capital Life Sciences.
MedCity News
JUNE 9, 2023
Making EHRs work with and not against clinicians is possible.
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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
JUNE 9, 2023
Astellas Pharma (Astellas) has entered an exclusive licence deal with Kate Therapeutics (KateTx) to develop and commercialise KT430. KateTx will receive an undisclosed upfront payment from Astellas for an exclusive global licence to develop, manufacture and commercialise KT430. KateTx will also receive additional payments linked to development, regulatory and commercial milestones, and royalties on the global sales of the product.
Clarify Health
JUNE 9, 2023
As markets become ever more competitive, hospital diversification is becoming a top strategy for health system leaders. Hospital consolidation continues to accelerate across the U.S. in significant ways. Atrium Health and Advocate Aurora Health made a big splash when they merged into a $27 billion, 67-hospital health system in 2022 to become the fifth largest non-profit health system in the U.S.
Pharmaceutical Technology
JUNE 9, 2023
Rocket Pharmaceuticals has received fast track and orphan drug designations for RP-A601 from the US Food and Drug Administration (FDA) to treat plakophilin-2-related arrhythmogenic cardiomyopathy (PKP2-ACM). RP-A601 is an adeno-associated virus-based gene therapy currently being evaluated as a one-time, potentially curative treatment to improve survival and quality of life for PKP2-ACM patients.
LEVO Health
JUNE 9, 2023
Successful healthcare marketing requires a robust and efficient digital strategy, often including multimedia projects. In this respect, two platforms — YouTube and Vimeo — have established themselves as key players, each offering unique benefits depending on the video intent. But how do you decide which one is the right fit? Let’s dive into the differences between Vimeo vs.
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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
PM360
JUNE 9, 2023
Today, Coefficient Health announced a key hire to lead its creative team. Kim Varady, an award-winning creative veteran with 20+ years of experience in healthcare, joins the agency as Executive Creative Director. Most recently, Kim held a creative leadership role at Klick Health where she helped expand innovation and experience in creative to drive greater value for brands across categories including asthma, animal health, oncology, vaccines, rare disease, and more.
Legacy MEDSearch
JUNE 9, 2023
Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). Over 8.5 million Americans are affected by PAD.
Pharmaceutical Technology
JUNE 9, 2023
The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The new 244,000ft² facility represents Bristol Myers Squibb’s third commercial CAR T [chimeric antigen receptor T-cell] manufacturing facility in the country and the second significant expansion of its 89-acre Devens site.
Pharmaceutical Commerce
JUNE 9, 2023
Agreement provides Vizient clients—including hospital systems and healthcare suppliers—with additional access to logistics solutions, such as warehousing and distribution.
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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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