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 292
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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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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
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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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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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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.

More Trending

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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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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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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 148
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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 189
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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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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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 136
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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 134
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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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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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Junshi, Coherus' PD-1 inhibitor Loqtorzi scores in phase 3 liver cancer trial

Fierce Pharma

Junshi revealed that a phase 3 trial of Loqtorzi plus Avastin prolonged the survival of first-line patients with hepatocellular carcinoma.

Trials 129
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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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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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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NICE declines to look again at depression drug Spravato

pharmaphorum

Johnson & Johnson has slammed a decision by NICE not to carry out a new appraisal of its antidepressant Spravato, claiming it has “grave concern” about access to new mental health treatments through NHS England.

Drugs 108
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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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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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Pharma Pulse 6/12/24: The Healthcare System is Changing—So How Should We Respond?, What the Apple-OpenAI Deal Means for Four Tech Titans & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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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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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The Rise of Specialty Benefit Managers: What Pharma Should Know

Fierce Pharma

By Steve Callahan, Director, Advisory & Insights, MMIT | New research shows that many payers are relying heavily on third-party specialty benefit managers to reduce costs across multiple therapeutic areas.

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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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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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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.

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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.