Tue.Jul 16, 2024

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Non-small cell lung cancer: the global clinical trials landscape 2024

Pharmaceutical Technology

Accounting for around 85% of lung cancer cases worldwide, non-small cell lung cancer is a key research area for clinical trials in 2024.

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Sionna revives AbbVie’s cystic fibrosis drugs, eyeing a shot at Vertex

Bio Pharma Dive

The well-funded startup says drugs AbbVie abandoned last year could form a combination regimen with “superior efficacy” to Vertex’s market-leading medicines.

Drugs 278
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AstraZeneca completes Amolyt Pharma acquisition

Pharmaceutical Technology

AstraZeneca has closed the acquisition of Amolyt Pharma, a company specialising in treatments for rare endocrine diseases.

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Does Walking to Work Burn The Same Calories as Running? Here’s The Science.

AuroBlog - Aurous Healthcare Clinical Trials blog

It’s Monday morning, the alarm goes off and it’s already 7:30 a.m. – and you’re 30 minutes late. Normally you need 45 minutes to walk the 3 kilometres to work, but this morning you’ll be running for 20 minutes.

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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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Vertex sues US over limits on providing fertility services to Casgevy patients

Bio Pharma Dive

In the suit, Vertex argues HHS’ stance forces a “Hobson’s choice” on people with sickle cell seeking to undergo the potentially curative treatment.

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Kyverna wins RMAT designation for stiff-person syndrome for cell therapy candidate

Pharmaceutical Technology

Kyverna’s CEO Peter Maag said the biotech is “eager to start generating data” from a Phase II trial.

Trials 246

More Trending

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German CDMO outlays $980m on GLP-1 manufacturing expansion

Pharmaceutical Technology

As the EU anticipates GLP-1RA shortages throughout 2024, Corden Pharma has pledged $980m to increase manufacturing capacity.

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July 16, 2024: OS-PCORTF Report Focuses on Building Data Capacity for Patient-Centered Outcomes Research

Rethinking Clinical Trials

A recent report from the Assistant Secretary for Planning and Evaluation in the US Department of Health and Human Services outlines 36 projects funded by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund (OS-PCORTF). OS-PCORTF was created to build national data capacity and infrastructure and leverage existing clinical data and federal data for patient-centered outcomes research.

Research 147
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Vertex taps Orum to hunt for better ‘preconditioning’ drugs

Bio Pharma Dive

The deal gives Vertex rights to use Orum’s ADC-like technology to discover gentler preparatory regimens for patients receiving intensive treatments like Casgevy.

Drugs 152
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Rising heart issues warrant urgent need for proactive heart health monitoring: Dr Manoj Durairaj

AuroBlog - Aurous Healthcare Clinical Trials blog

There is an urgent need for proactive heart health monitoring as cardiovascular issues continue to surge globally and India is no exception, cautions Dr. Manoj Durairaj, heart transplant surgeon, president of the Indian Association of Cardiovascular-Thoracic Surgeons, and director of Marian Cardiac Centre and Research Foundation in Pune, Maharashtra.

Research 138
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Cardurion raises another $260M to fuel heart drug pipeline

Bio Pharma Dive

The financing, which ranks as one of the year’s larger private rounds, will help the startup advance a pair of drugs and potentially acquire other medicines.

Drugs 152
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Revolution sets sights on Phase III trial for pan-RAS inhibitor

Pharmaceutical Technology

The Phase III RASolute 302 trial will compare a 300mg dose of the company’s investigational pan-RAS inhibitor RMC-6236 to chemotherapy.

Trials 130
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J&J, BMS and AstraZeneca strike back in appeals after IRA litigation losses

Fierce Pharma

Despite a string of high-profile losses this year, at least three major drugmakers continue to fight back against the Medicare price negotiations being rolled out under the Inflation Reduction Act. | Despite a string of high-profile losses this year, at least three major drugmakers continue to fight back against the Medicare price negotiations being rolled out under the Inflation Reduction Act.

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SOTIO partners with Biocytogen to expand ADC oncology pipeline

Pharmaceutical Technology

SOTIO will pay up to $325.5m in upfront and milestone payments for developing multiple bispecific antibody drug conjugates (ADCs).

Antibody 130
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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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Johnson & Johnson proposes $505M settlement with bankrupt talc miners

Fierce Pharma

As Johnson & Johnson continues to attempt to Texas two-step its way around thousands of claims that its popular talcum powder-based products caused cancer, the drugmaker is putting up hundreds | As Johnson & Johson continues to attempt to Texas two-step its way around thousands of claims that its popular talcum powder-based products caused cancer, the drugmaker is putting up hundreds of millions of dollars to settle a longstanding dispute with a clutch of suppliers.

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Asceneuron gains $100m for neurodegenerative therapeutics

Pharmaceutical Technology

Asceneuron has announced an oversubscribed Series C financing round, securing $100m, for advancing neurodegenerative therapeutics.

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GLP-1 bonanza spurs big investment at CDMO CordenPharma

pharmaphorum

CordenPharma has launched a €900 million ($981 million) investment programme to prepare for an expected surge in demand for peptide production capacity – driven by GLP-1 receptor agonists.The three-year plan revolves around parallel programmes in the US and Europe that will include new builds and upgrades and expansion to its existing facilities, according to the German contract development and manufacturing organisation (CDMO).

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Sumitomo Pharma’s DSP-5336 gains FDA fast track for AML

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast track designation to Sumitomo Pharma America’s (SMPA) DSP-5336 for AML.

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

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Sobi, angling to become a major hematology player, touts momentum across several brands

Fierce Pharma

With several launches underway and partnerships driving sales growth, Sobi is gaining momentum in its quest to become a force in hematology. | The Swedish drugmaker reported 13% sales growth in its hematology portfolio, which includes brands such as Doptelet, Vonjo and Apellis-partnered Empaveli (or Aspaveli in Europe, which is one of Sobi's territories).

Branding 102
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SII and Oxford University’s malaria vax launched in Côte d’Ivoire

Pharmaceutical Technology

The R21/Matrix-M malaria vaccine, co-developed by SII and the University of Oxford, has been launched in Côte d'Ivoire

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Verona's price for COPD treatment Ohtuvayre will result in restricted access, ICER says

Fierce Pharma

ICER has issued an access and affordability alert for Verona Pharma’s COPD drug Ohtuvayre. ICER says it is overpriced at an annual rate of $34,500.

Drugs 114
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How the pandemic exposed faulty links in the supply chain

pharmaphorum

The pandemic has exposed vulnerabilities in global supply chains, particularly in the healthcare sector, concerning the production and distribution of essential medical supplies, such as antibiotics and other medications. Learn more about the impact and potential solutions.

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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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IDT's new 25,000 sq. ft. synthetic biology facility doubles production capacity

BioPharma Reporter

Integrated DNA Technologies (IDT) is doubling down on its commitment to innovation with the launch of a new 25,000-square-foot synthetic biology facility in Coralville, Iowa.

DNA 98
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Novo leads $100m financing for Alzheimer's player Asceneuron

pharmaphorum

Novo Holdings leads $100m financing for Swiss biotech Asceneuron, which is developing an oral tau therapy for Alzheimer's disease

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Study finds Parkinson’s disease SLT more effective than one used in NHS

Pharma Times

The progressive neurodegenerative condition affects around 153,000 people in the UK

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NHS on course to use digital tech to diagnose ADHD

pharmaphorum

A digital diagnostic for ADHD called QbTest should be used by the NHS as an add-on to standard assessment, says new NICE guidance

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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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Navigating Patent Opposition in Drug Patenting: A Comprehensive Guide

Drug Patent Watch

Introduction Patent oppositions are a crucial tool in the pharmaceutical industry, allowing civil society to challenge the validity of patents […] Source

Drugs 97
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‘Big Three’ PBMs to Face House Oversight Accountability as Hawaii Court Delivers Legal Victory

BioSpace

As scrutiny on pharmacy benefit managers mount, a House committee will hold a hearing on the alleged anticompetitive business practices of these middlemen.

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KCL leads first guidelines on immune monitoring for hard-to-treat blood cancer

Pharma Times

Myelodysplastic syndromes are a group of blood cancers that currently affect more than 7,000 people in the UK

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Artiva announces terms for its second IPO attempt

pharmaphorum

Natural killer cell therapy specialist Artiva Biotherapeutics has another go at an IPO, hoping to raise up to $135m

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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.