Fierce Pharma
MARCH 26, 2024
After three years, the crown jewel of Merck’s $11.5 billion acqu | After three years, the crown jewel of Merck’s $11.5 billion acquisition of Acceleron is ready to pay dividends. With the FDA’s approval of Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), Merck is set to launch the first disease-modifying treatment for the condition.
MedCity News
MARCH 26, 2024
Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma.
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Fierce Pharma
MARCH 26, 2024
Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma | Maryland nonprofit Caring Cross has unveiled a partnership with the Brazilian government which is designed to provide access to advanced CAR-T and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduc
pharmaphorum
MARCH 26, 2024
Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be used regardless of underlying genetic mutations.
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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
Fierce Pharma
MARCH 26, 2024
Amgen’s arthritis blockbuster Enbrel already owns an undesirable spot on the list o | The state's new Prescription Drug Affordability Review Board voted to subject the blockbuster arthritis med to an upper price limit, which Amgen calls a violation of the company's constitutional rights.
MedCity News
MARCH 26, 2024
AI is meant to have a synergistic relationship with clinicians rather than replace them, pointed out David McSwain, chief medical information officer at UNC Health, during an interview at HIMSS24. In his view, both humans and AI are fallible, but their errors are usually of a different type — so both should be working together to reduce the overall error rate.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
MARCH 26, 2024
Scott Davis is the CEO of Ekso Bionics, an innovative medical device company making wearable exoskeletons for use in construction but perhaps, more importantly, to help people contending with spinal cord injury.
Fierce Pharma
MARCH 26, 2024
Bristol Myers Squibb cuts hundreds of Mirati staffers months after closing $5.
MedCity News
MARCH 26, 2024
In this episode, we’re joined by Millicent Gorham, CEO of the Alliance for Women’s Health and Prevention (AWHP). AWHP recently launched the EveryBODY Covered campaign, which is advocating for comprehensive coverage of obesity care. Gorham discusses the current state of obesity treatment for women and her goals for the campaign.
Fierce Pharma
MARCH 26, 2024
Demand for GLP-1 medicines from Eli Lilly and Novo Nordisk has exploded across the globe, resulting in on-and-off shortages in the U.S. and beyond. | Médecins Sans Frontières urged GLP-1 drug makers to "relinquish their stranglehold" on the products and license the meds to generics makers to boost access.
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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.
MedCity News
MARCH 26, 2024
During a panel discussion on GLP-1s at the Abarca Forward conference, one health executive stressed the importance of a food-as-medicine approach.
Pharmaceutical Commerce
MARCH 26, 2024
A study of patients with the long-term conditions who are required to switch to high-deductible health plans could potentially be more likely to experience diabetes complications than those who stay in standard insurance plans.
pharmaphorum
MARCH 26, 2024
Nuvation Bio speeds up its path to becoming a commercial-stage biotech with a deal to acquire AnHeart Therapeutics and its late-stage lung cancer therapy taletrectinib
European Pharmaceutical Review
MARCH 26, 2024
Moderna’s next-generation COVID-19 vaccine mRNA-1283 demonstrated a higher immune response against SARS-CoV-2, interim results from the company’s Phase III trial show. These findings were based on data comparing the treatment to mRNA-1273.222 (Spikevax ® ), Moderna’s licensed vaccine for the condition. “We are excited to announce our fourth infectious disease vaccine programme with positive Phase III data,” stated Stéphane Bancel, Chief Executive Officer of Moderna. “mRNA
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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.
pharmaphorum
MARCH 26, 2024
MSD’s Winrevair (sotatercept) has become the first FDA-approved therapy for PAH that addresses the underlying mechanism behind the disease rather than its symptoms
MedCity News
MARCH 26, 2024
Disregarding novel developments on account of imperfection will postpone the advancement of scientific discovery.
pharmaphorum
MARCH 26, 2024
AstraZeneca’s Ultomiris has been approved by the FDA to treat rare autoimmune disease neuromyelitis optica spectrum disorder (NMOSD), six months after an earlier application was turned down with a request for changes to the risk evaluation and mitigation strategy (REMS) for the drug.
Pharmaceutical Technology
MARCH 26, 2024
The US FDA has approved Alexion’s Ultomiris to treat adults with AQP4 Ab+ neuromyelitis optica spectrum disorder (NMOSD).
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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.
pharmaphorum
MARCH 26, 2024
Just four months after ending an 18-year stint as chief executive of BioMarin, Jean-Jacques Bienaimé has been named chairman of Owkin, a specialist in applying artificial intelligence to the discovery and development of drugs and diagnostics. Owkin said Bienaimé will help to grow the company, including taking it through its next fundraising round and expanding its drug discovery, drug development and diagnostics capabilities.
Pharmaceutical Technology
MARCH 26, 2024
The approval from Japan’s Ministry of Health, Labour, and Welfare (MHLW) is based on positive results from two studies.
PharmaTimes
MARCH 26, 2024
According to the World Health Organization, TB is responsible for over one million annual deaths
Pharmaceutical Technology
MARCH 26, 2024
Discover GlycoMimetics Inc.'s groundbreaking patent for treating cancer and related conditions with Formula (I) compound. Learn how this method can reduce chemotherapy side effects and improve patient outcomes.
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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.
PharmaTimes
MARCH 26, 2024
The Companion+ Mobile Safety App will be rolled out to a further 115 users within the UK and US
PharmaVoice
MARCH 26, 2024
A vastly underdiagnosed rare disease presents a challenge to Alnylam’s commercial team, but a family health road trip has patients talking about their hereditary risk.
Clarify Health
MARCH 26, 2024
Historically it has been difficult, if not impossible, for patients to figure out prices for hospital services and procedures ahead of time. However, new regulations from the Centers for Medicare & Medicaid Service in 2021 aim to change that. Under these requirements, hospitals must provide clear prices for the items and services they offer and make them accessible online.
PharmExec
MARCH 26, 2024
In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, explore mixed trial results impact the confidence in their potential real-world effectiveness and potential market adoption.
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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
MARCH 26, 2024
Discover Syros Pharmaceuticals' groundbreaking patent for treating cancer by targeting CDK7 with compounds of Formula (I). Learn about the innovative method and potential new treatment options for solid tumors.
PharmaVoice
MARCH 26, 2024
After his first biotech startup was sold off in parts, Sharei is applying the lessons he’s learned to a new company with a different business model.
Pharmaceutical Technology
MARCH 26, 2024
Discover how Nurix Therapeutics' patent for bifunctional compounds targeting HPK1 activity offers a groundbreaking method for treating diseases, including cancer. Learn more about this innovative approach in pharmaceutical compositions.
PharmaTech
MARCH 26, 2024
The Vacaville, Calif., site acquisition gives Lonza one of the largest biologics manufacturing sites for mammalian cell-based therapies worldwide.
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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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