Wed.Jun 12, 2024

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Avidity drug for muscular dystrophy shows promise; Syntis takes new approach to weight loss

Bio Pharma Dive

Study results indicated Avidity’s medicine muted target genes. Elsewhere, Syntis revealed obesity drug plans and Nodthera chalked up more positive data for its NLRP3 inhibitor.

Drugs 280
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Data sharing will be key in repairing the UK clinical ecosystem

Pharmaceutical Technology

Lord James O'Shaughnessy, the former health minister, outlines places where the UK is falling behind other countries with clinical research.

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Pfizer gene therapy for Duchenne fails to meet goals of key trial

Bio Pharma Dive

The negative results from the Phase 3 study, called Ciffreo, come a little more than a month after Pfizer said a patient died in another trial of the gene therapy.

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Anti-obesity drugs will be 2024’s defining trend

Pharmaceutical Technology

GlobalData’s newest update notes the impact of the growing anti-obesity market, apersonalised medicines, real-world evidence, and cell and gene therapies.

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

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Regenxbio CEO to step down after 15 years

Bio Pharma Dive

Kenneth Mills will become chair of the gene therapy developer's board while Curran Simpson, the current chief operating officer, will take his place as company head.

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Siegfried to boost drug substances offering with new acquisition

Pharmaceutical Technology

Siegfried has announced the signing of binding agreements with Curia Global to acquire an early-phase CDMO site in Grafton, Wisconsin, US.

Drugs 203

More Trending

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June 12, 2024: Registry-Based DAPA-MI Trial to Be Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Stefan James and Dr. Jonas Oldgren In this Friday’s PCT Grand Rounds, Stefan James and Jonas Oldgren of Uppsala University will present “DAPA-MI – A Pragmatic Registry-Based Double-Blind RCT Trial Designed for Regulatory Evaluation.” The Grand Rounds session will be held on Friday, June 14, 2024, at 1:00 pm eastern. DAPA-MI (Dapagliflozin in Patients With MI) was a registry-based, placebo-controlled trial of dapagliflozin in patients hospitalized for myocardial infarction a

Trials 147
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Foresite, a biotech venture firm, reloads with $900M fund

Bio Pharma Dive

Amid some optimism for biotech startups, the firm sees opportunities to fund companies “at all stages of the productive development life cycle,” said managing director Vik Bajaj.

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Thinking outside of the box: Digitising pharmacy dispensing labels

Pharmaceutical Technology

Written Medicine is a digital solution that provides bilingual dispensing labels, described in a presentation at the NHS ConfedExpo conference in Manchester.

Pharmacy 130
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Flagship taps startup to hunt for obesity drugs that might interest Pfizer

Bio Pharma Dive

The venture firm will work with ProFound Therapeutics to “rapidly surface” protein drug candidates that Pfizer can choose to advance under a partnership it struck with Flagship last year.

Drugs 177
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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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Study finds most patients in TARGET-NASH registry meet revised MASLD criteria

Pharmaceutical Technology

In 2023, MASLD replaced the umbrella term of nonalcoholic fatty liver disease (NAFLD) to avoid the potentially stigmatising language of the former name.

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BMS chief Boerner says company is still hungry for deals after spending more than $20B on M&A last year

Fierce Pharma

As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target | As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target comes along.

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Cyrus Biotechnology to spin out Levitate Bio for biopharma AI

Pharmaceutical Technology

Software-enabled biotechnology company Cyrus Biotechnology has announced the spinout of Levitate Bio to enhance biopharma AI offerings.

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Amid FTC crackdown, judge says Teva inhaler patents are 'improperly listed' in FDA Orange Book

Fierce Pharma

After being called out on some intellectual property claims late last year, Teva has fallen victim to the Federal Trade Commission’s (FTC’s) ongoing crusade against questionable drug patents. | A federal judge in New Jersey ruled that five of Teva’s patents on the metered dose inhaler for its asthma med ProAir HFA are “improperly listed” in the FDA’s Orange Book.

Drugs 119
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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South Korea and Australia on the rise as clinical research hubs

Pharmaceutical Technology

Novotech’s vice president highlighted the APAC region’s growing clinical presence, drawing attention to Australia and South Korea.

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The 6 Largest Biopharma Layoffs of 2024 So Far

BioSpace

Despite a surge in the financial markets, multiple Big Pharma companies have announced hundreds or even thousands of cuts. Experts hope for a better second half of the year.

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Syntis Bio launches oral therapies for metabolic diseases

Pharmaceutical Technology

Syntis Bio is to develop oral therapies targeting a range of metabolic diseases, from obesity to rare conditions.

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Moderna’s Next-Gen COVID Vaccine Beats Current Shot in Pivotal Adult Efficacy Trial

BioSpace

Moderna said Thursday it plans to talk to regulators about the next steps after showing its next-generation candidate is more efficacious in adults than the biotech’s existing Spikevax COVID-19 shot.

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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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Bankrupt Mithra cashes in on remaining assets for $188.2m

Pharmaceutical Technology

Gedeon Richter gains rights to Mithra’s estetrol range in addition to subsidiaries Neuralis and Estetra.

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Secondary Cancer Risk Is Low After CAR-T Cell Treatment: Stanford Study

BioSpace

Results of a large Stanford Medicine study, published Wednesday in The New England Journal of Medicine, finds CAR-T therapies carry a low risk of secondary malignancies not related to the CAR-T cells.

Medicine 113
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OTC Hearing Aids: “Nothing to See Here” Says GAO Report

FDA Law Blog

By Sara W. Koblitz & Jeffrey N. Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA once estimated that OTC hearing aids would save patients over $3000.) A recent GAO Report hasn’t found that OTC hearing aids have had much impact.

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How long does a patent last for drugs?

Drug Patent Watch

Sure, here’s a more detailed explanation with examples: Drug Patent Duration Drug patents are granted by the United States Patent and Trademark Office (USPTO) for a period of 20 years… Source

Drugs 111
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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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New study reveals how brain cell communication is linked to Alzheimer’s disease

Pharma Times

Two support cells, microglia and astrocytes, were found to communicate with each other

Research 150
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Pfizer, Flagship Pioneering to Target Obesity Treatments Under 2023 Partnership

BioSpace

Building on last year’s potential $7 billion partnership with Flagship Pioneering, Pfizer and Flagship-founded ProFound Therapeutics will work on discovering new obesity candidates.

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Merck KGaA invests in Life Science business facility in Germany

Pharmaceutical Technology

Merck KGaA announced a €62m ($66.

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Pfizer’s Gene Therapy for Duchenne Muscular Dystrophy Fails Phase III Trial

BioSpace

Pfizer’s investigational Duchenne muscular dystrophy gene therapy, fordadistrogene movaparvovec, failed in a late-stage study to significantly improve motor function in patients versus placebo.

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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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ICL receives £10m donation to advance heart and lung research

Pharma Times

The donation will help scientists and clinicians collaborate and make new advances in research

Research 132
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Merck Eyes Next-Generation Obesity Drugs That Offer Additional Benefits

BioSpace

Seeking to target the lucrative obesity market, Merck is focusing its R&D efforts on next-generation GLP-1 therapies that offer additional benefits beyond weight loss, according to company executives.

Drugs 103
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Insights into Precision Dosing with Dr. Howard McLeod and Dr. Sharmeen Roy – Xtalks Life Science Podcast Ep. 163

XTalks

In this episode, Ayesha spoke with Howard McLeod, PharmD , Director of the Center for Precision Medicine and Functional Genomics, Professor of Pharmacy and Medicine at Utah Tech University and Precision Medicine Advisor at the Geriatric Oncology Consortium; and Sharmeen Roy, PharmD, Chief Strategy and Science Officer at DoseMe , which is the world’s first and largest Bayesian dosing platform designed for clinical practice.

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Opinion: As More Companies Are Targeted by BIOSECURE Act, Investor Relations Crisis Brews

BioSpace

The House Select Committee asks the FBI for a briefing on GenScript’s links to China, fueling the challenge facing public relations and investor relations teams at US biopharma firms and Chinese CDMOs.

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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.