Thu.Mar 14, 2024

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Bristol Myers nabs new FDA nod as Breyanzi brings CAR-T class to chronic lymphocytic leukemia

Fierce Pharma

Just as BeiGene’s Brukinsa encroaches on C | Just as BeiGene’s Brukinsa encroaches on CAR-T territory, Bristol Myers Squibb has brought its CAR-T therapy Breyanzi into chronic lymphocytic leukemia, which is considered the BTK inhibitor class’s home turf.

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A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug

MedCity News

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence.

FDA 128
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Trending Sources

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NICE not sold on Vertex, CRISPR's groundbreaking sickle cell gene therapy Casgevy without more data

Fierce Pharma

Ever since Vertex and CRISPR therapeutics scored a groundbreaking U.K. | In its draft guidance, the U.K.'s cost effectiveness watchdog recognized the need for the sickle cell therapy but needs more data from Vertex on its effectiveness in an updated managed access proposal.

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GE HealthCare & Mass General Brigham Have a Plan to Accelerate Their AI Research

MedCity News

At HIMSS, GE HealthCare and Mass General Brigham announced that they are integrating foundation models into their collaborative AI research and development. Foundation models could help developers create healthcare AI tools “10 times faster than in the past,” according to Parminder Bhatia, GE HealthCare’s chief AI officer.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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BeiGene finally snags FDA approval for PD-1 drug Tevimbra after long delay, Novartis breakup

Fierce Pharma

Twenty months after the FDA’s original target decision date on cancer drug tislelizumab, BeiGene has finally received the U.S. go-ahead. | Twenty months after the FDA's original target decision date, BeiGene has finally received the U.S. go-ahead for its PD-1 inhibitor Tevimbra.

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AstraZeneca Acquisition Brings Drug to Fill a Rare Disease Gap Left by Takeda

MedCity News

AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug.

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More Trending

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GLP-1s Alone Are Not the Answer to America’s Obesity and Chronic Illness Crises

MedCity News

Obesity/overweight is a significant causal factor in chronic illness and cancer. Weight loss can help people with obesity/overweight avoid and/or manage chronic illness. GLP-1s cause weight loss. So, are GLP-1s the answer to America’s obesity and chronic illness crises? Not if we overlook a key problem at the heart of both challenges: lack of access to nutritious food in the land of plenty.

Food 120
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Biocon continues to divest with $150M sale of insulin and other brands to Eris

Fierce Pharma

Biocon and Eris have expanded a previous agreement, with Biocon selling Indian branded formulations businesses to Mumbai-based Eris for $150M.

Sales 196
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HiLabs Secures $39M for AI-Powered Data Management Solutions

MedCity News

HiLabs’ Series B funding round was led by Denali Growth Partners and Eight Roads Ventures and included participation from F-Prime Capital. In total, HiLabs has raised about $41 million.

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GLP-1 surge, oncology stars to power industry's earnings growth over the next 18 months: Moody's

Fierce Pharma

The commercial frenzy of GLP-1 medicines from Eli Lilly and Novo Nordisk has not only resulted in skyrocketing revenue for both companies, it's also expected to be a major driving force behind the | Booming demand for GLP-1 medicines from Novo Nordisk and Eli Lilly has prompted Moody's Ratings to move its 12- to 18-month industry earnings outlook to "positive" after sticking to "stable" since 2022.

Medicine 143
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How Machine Learning Drives Clinical Trial Efficiency

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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Developing a new treatment paradigm for chronic kidney disease

European Pharmaceutical Review

In recent months there have been important development in the kidney disease treatment space. For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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Deep learning model ‘detects 90% of lymphatic cancer cases’

pharmaphorum

Researchers have developed an artificial intelligence algorithm to assist in the diagnosis of lymph node cancer from medical images that has an accuracy of around 90%. The team carried out a retrospective study on the deep learning model, using PET-CT scans from more than 5,000 patients treated for lymphoma at Memorial Sloan Kettering Cancer Centre in the US and the Medical University of Vienna in Austria.

Medical 93
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Developing a new treatment paradigm for IgAN

European Pharmaceutical Review

In recent months there have been important development in the kidney disease treatment space. For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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EMA pins lack of long-term data as rationale for Novartis’ failed Vijoice bid

Pharmaceutical Technology

The EMA raised concerns about the lack of long-term data for Novartis Vijoice in its initial bid, as the Swiss company prepares for a new regulatory submission.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Swedish researchers develop new AI computer model to detect lymphatic cancer

PharmaTimes

In the study, the Lymphoma Artificial Reader System accurately detected 90% of lymphatic cancers

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Innovative method could offer cost-effective sterilisation approach

European Pharmaceutical Review

Research by Terrones-Fernandez et al. has demonstrated a simple, novel system for preparing microbiological culture media, and consequently, development of a new sterilisation method. To evaluate the new sterilisation system, the researchers compared the microbiological properties of media prepared in a microwave (for different exposure times) with those of autoclaved sterilised media.

Media 88
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AstraZeneca buys rare disease firm Amolyt for $1.05bn

pharmaphorum

AstraZeneca adds a late-stage rare disease therapy to its pipeline, buying Amolyt Pharma and hypoparathyroidism drug eneboparatide for $800 million upfront.

Pharma 94
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Manufacturing facility expansion to advance next-gen vaccine

European Pharmaceutical Review

Overall, the goal of expanded facility is to strengthen [SK biosciences] manufacturing capabilities for global supply [of the pneumococcal conjugate vaccine candidate GBP410]” SK bioscience has announced its manufacturing plant L HOUSE, in Andong, Gyeongsangbuk-do, South Korea, is set to have a facility expansion. The new space will be provide a production base for the next-generation pneumococcal conjugate vaccine candidate GBP410 (SP0202), jointly developed by SK bioscience and Sanofi.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Eli Lilly-backed Zephyr AI secures $111m for precision medicine tech

Pharmaceutical Technology

The funds will be used to expand Zephyr AI's headcount and enhance datasets.

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Cybin bags breakthrough tag for psychedelic depression drug

pharmaphorum

Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.

FDA 87
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Boehringer collaboration could advance first-in-class schizophrenia treatments

European Pharmaceutical Review

Boehringer Ingelheim and Sosei Group Corporation (Sosei Heptares) have agreed a new partnership, which could result in the development of a new schizophrenia treatment targeting GPR52. The companies will work to develop and commercialise Sosei Heptares’ portfolio of first-in-class GPR52 agonists, a novel G protein-coupled receptor (GPCR) target, with the aim of providing a novel precision treatment that addresses positive, negative, and cognitive symptoms of schizophrenia.

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German biotech Tubulis raises €128m for ADC trials

pharmaphorum

Munich-based antibody-drug conjugate (ADC) specialist Tubulis has completed a sizeable Series B2 financing that shows sustained investor appetite for the ADC category, particularly for companies with technologies that can enhance the safety of these drugs.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Roche partners with Cardiff researchers to uncover new research into dementia

PharmaTimes

Affecting 55 million people globally, dementia impairs the ability to remember, think or make decisions

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Build My Health Webinar Highlights New Age for Physician Practices with Rise of GLP1 Drugs for Obesity [Sponsored]

MedCity News

In a webinar last week, BuildMyHealth CEO and Co-founder Dr. Jonathan Kaplan shared how physician practices not only can access the weight loss drug by working with compounding pharmacies, but also use BuildMyHealth to provide this drug to their own patients who are suitable candidates for the drug.

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BIO casts WuXi adrift and backs crackdown on Chinese biotech

pharmaphorum

BIO will sever ties with WuXi AppTec and support the BIOSECURE Act, which would ban federal contracts with Chinese biotechs on national security grounds

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Unveiling the Roadmap: Navigating Medical Sales Rep Requirements

Rep-Lite

Medical sales representatives are the medium through which medical companies sell their healthcare products to providers like hospitals and clinics. They build relationships, understand needs, and offer tailored solutions to these healthcare providers. Medical sales rep requirements include technical knowledge of medical equipment and technologies, sales skills, and interpersonal abilities.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Optimizing Healthcare: The Power of Effective Patient Referrals

Referral MD

The process of managing referrals between healthcare providers can be complex and time-consuming. Inefficient referral management can lead to delayed patient care, increased administrative burden, and decreased overall patient and provider satisfaction. However, modernizing and streamlining referral management processes is now possible with the advancement of technology and the availability of innovative solutions.

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For better insights, assess research performance at the department level

Clarivate

Three ways Clarivate is closing information gaps and establishing reliable data for improved decision-making To win more funding and plan a course for the future, institutions need to understand how their research programs currently perform. According to a 2023 survey of research office staff, the metrics most often relied upon for assessment are published research and citation impact of published research.

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Talent: The Game Has Changed and Rick Barnett Is Redefining How Medical Sales Teams Are Built

Rep-Lite

In a feature by New York Weekly, Rep-Lite takes the spotlight for its innovative approach to talent management in medical sales. Led by Rick Barnett, Rep-Lite pioneers a paradigm shift in assembling sales teams, offering on-demand, contract solutions that redefine efficiency and efficacy. With a plug-and-play model for human assets, Rep-Lite alleviates clients’ burdens, allowing them to focus on driving revenues.

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WuXi splits from BIO as trade body backs BIOSECURE Act

pharmaphorum

The Biotechnology Innovation Organization (BIO) has said it is parting company with Wuxi AppTec, while voicing support for US legislation that would block Chinese biotechs from federal funding and contracts on national security grounds.

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Accelerating Clinical Supply Through Integrated Drug Development

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.