Thu.Mar 14, 2024

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Madrigal wins FDA approval of first drug for MASH

Bio Pharma Dive

Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.

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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.

Medicine 312
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German biotech Tubulis cashes in on ADC ‘momentum’ with €128M financing

Bio Pharma Dive

The funding for the startup, which partnered with Bristol Myers Squibb last year, adds to a surge of recent investments in developers of antibody-drug conjugates.

Antibody 318
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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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BIO changes stance, backs bill to limit China’s role in US biotech

Bio Pharma Dive

Pressed by lawmakers, the lobbying group is also “taking steps” to end its relationship with Wuxi-AppTec, a major contract manufacturer to the biopharmaceutical industry.

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Plastic Found Inside More Than 50% of Plaques From Clogged Arteries

AuroBlog - Aurous Healthcare Clinical Trials blog

Plastics are now everywhere, with tiny fragments found in several major organs of the human body, including the placenta. Given how easily the microscopic particles infiltrate our tissues, it’s vital that we learn exactly what kinds of risks they could pose to our health.

Research 226

More Trending

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DTAB recommends formation of a sub-committee on classification of OTC drugs

AuroBlog - Aurous Healthcare Clinical Trials blog

In continuation to the efforts of the drug regulatory experts to amend the Drug Rules, 1945 and incorporate necessary provisions to decide a drug to be declared as over-the-counter (OTC), the Drugs Technical Advisory Board (DTAB) has recommended to constitute a sub-committee.

Drugs 189
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Swedish researchers develop new AI computer model to detect lymphatic cancer

Pharma Times

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

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Almirall to license Eloxx’s ZKN-013 for rare skin conditions

Pharmaceutical Technology

Almirall has signed a licence agreement to gain the rights for Eloxx Pharmaceuticals’ ZKN-013 for rare dermatological disease indications.

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J&J, Novo support Asgard’s push to make ‘in vivo’ cell therapies

Bio Pharma Dive

The Swedish biotech will use the investment to advance a kind of personalized cancer therapy that reprograms tumor cells inside the body.

In-Vivo 140
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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AstraZeneca snaps up Amolyt for $1.05bn to boost rare disease pipeline

Pharmaceutical Technology

AstraZeneca will pay an upfront purchase price of $800m along with a potential regulatory milestone payment of $250m.

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Roche partners with Cardiff researchers to uncover new research into dementia

Pharma Times

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

Research 129
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Xcovery edges closer to FDA approval for NSCLC ALK inhibitor

Pharmaceutical Technology

The new drug application included data from the Phase III eXalt3 study, published in JAMA Oncology in September 2021.

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March 14, 2024: IMPACT Collaboratory Announces New Statistical Tools for Pragmatic Trials

Rethinking Clinical Trials

The NIA IMPACT Collaboratory, a program to advance pragmatic clinical trials of interventions for people living with dementia and their care partners, announced a new collection of statistical tools for researchers. The tools are available on a new Statistical Tools webpage that will be updated as new resources become available. The program’s Design and Statistics Core developed the statistical tools and related resources to aid in the design and analyses of pragmatic trials embedded in he

Trials 124
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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LGM Pharma announces advanced analytical services

Pharmaceutical Technology

Contract development and manufacturing organisation LGM Pharma has announced the advancement of its analytical testing services.

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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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Patient organisations need to tackle transparency

Pharmaceutical Technology

Research puts the spotlight on potential financial conflicts of interest (COI) and limited disclosure practices in pharmaceutical patient-focusing relationships.

Research 130
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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA approves Mirum’s LIVMARLI for cholestatic pruritus

Pharmaceutical Technology

The US FDA has granted approval for Mirum Pharmaceuticals’s LIVMARLI (maralixibat) oral solution to treat cholestatic pruritus.

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7 things to know about multiple sclerosis

Antidote

Receiving a multiple sclerosis (MS) diagnosis can feel overwhelming and isolating for many. MS is a neurodegenerative disease that often involves challenging symptoms — but knowing what to expect and what resources are available can help.

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Novartis exercises option to acquire IFM Due for $835m

Pharmaceutical Technology

Novartis has exercised an option for the acquisition of all outstanding capital stock of IFM Due for $835m.

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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.

Drugs 115
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The New Age of Decentralized Clinical Trials

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.

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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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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.

Drugs 115
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BMS’s Breyanzi Becomes First CAR-T Therapy for Two Types of Leukemia

BioSpace

The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.

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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.

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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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National Nutrition Month 2024 + Low Sugar Juice Technologies – Xtalks Food Podcast Ep. 150

XTalks

March marks National Nutrition Month 2024 — a time when the food industry, health professionals and communities across the globe unite to emphasize the importance of making informed food choices and developing sound eating and physical activity habits. In this episode of the Xtalks Food Podcast, Sydney talks about the history of National Nutrition Month as well as how various food industry stakeholders can contribute to the significant month.

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FDA Adcomm to Tackle Complexity of CAR-T for Multiple Myeloma

BioSpace

BMS and J&J will meet with the Oncologic Drugs Advisory Committee Friday to discuss their CAR-T therapies Abecma and Carvykti as the companies seek their approval as earlier lines of treatment.

Drugs 109
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Charles River inks viral vector production pact for Navega's chronic pain gene therapy

Fierce Pharma

After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy pact—this time centered on an adeno-asso | After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy pact—this time centered on an adeno-associated virus 9 (AAV9) candidate meant to serve as a non-opioid alternative for rare disease patients li

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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.

Trials 105
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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.