Bio Pharma Dive
JUNE 12, 2024
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.
Pharmaceutical Technology
JUNE 12, 2024
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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Bio Pharma Dive
JUNE 12, 2024
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.
Pharmaceutical Technology
JUNE 12, 2024
GlobalData’s newest update notes the impact of the growing anti-obesity market, apersonalised medicines, real-world evidence, and cell and gene therapies.
Bio Pharma Dive
JUNE 12, 2024
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.
Pharmaceutical Technology
JUNE 12, 2024
Siegfried has announced the signing of binding agreements with Curia Global to acquire an early-phase CDMO site in Grafton, Wisconsin, US.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
JUNE 12, 2024
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
Bio Pharma Dive
JUNE 12, 2024
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.
Pharmaceutical Technology
JUNE 12, 2024
Written Medicine is a digital solution that provides bilingual dispensing labels, described in a presentation at the NHS ConfedExpo conference in Manchester.
Bio Pharma Dive
JUNE 12, 2024
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.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
JUNE 12, 2024
In 2023, MASLD replaced the umbrella term of nonalcoholic fatty liver disease (NAFLD) to avoid the potentially stigmatising language of the former name.
Fierce Pharma
JUNE 12, 2024
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.
Pharmaceutical Technology
JUNE 12, 2024
Software-enabled biotechnology company Cyrus Biotechnology has announced the spinout of Levitate Bio to enhance biopharma AI offerings.
BioSpace
JUNE 12, 2024
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.
Pharmaceutical Technology
JUNE 12, 2024
Novotech’s vice president highlighted the APAC region’s growing clinical presence, drawing attention to Australia and South Korea.
BioSpace
JUNE 12, 2024
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.
Pharmaceutical Technology
JUNE 12, 2024
Syntis Bio is to develop oral therapies targeting a range of metabolic diseases, from obesity to rare conditions.
BioSpace
JUNE 12, 2024
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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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.
Pharmaceutical Technology
JUNE 12, 2024
Gedeon Richter gains rights to Mithra’s estetrol range in addition to subsidiaries Neuralis and Estetra.
BioSpace
JUNE 12, 2024
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.
FDA Law Blog
JUNE 12, 2024
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.
BioSpace
JUNE 12, 2024
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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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
Drug Patent Watch
JUNE 12, 2024
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
BioSpace
JUNE 12, 2024
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.
Pharmaceutical Technology
JUNE 12, 2024
Merck KGaA announced a €62m ($66.
BioSpace
JUNE 12, 2024
Teva Pharmaceuticals lost its patent row with Amneal Pharmaceuticals on Monday as a New Jersey court ruled that some of Teva’s claims over its inhaler product ProAir HFA were improperly listed on the FDA’s Orange Book.
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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.
pharmaphorum
JUNE 12, 2024
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.
BioSpace
JUNE 12, 2024
Among the biggest raises this year, Foresite Capital’s $900 million fund will support biotech companies working in precision medicine and life science infrastructure.
Fierce Pharma
JUNE 12, 2024
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.
BioSpace
JUNE 12, 2024
Biogen recently bolstered its pipeline with a potential $1.8 billion acquisition of Human Immunology Biosciences, following other big players looking to cash in on a global immunology market estimated to grow to $257 billion by 2032.
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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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