J&J antidepressant eases symptoms, improves sleep in key trial
Bio Pharma Dive
MAY 29, 2024
The company has put high expectations on the drug, an orexin-2 antagonist called seltorexant, as a cornerstone of its neuropsychiatry pipeline.
Wed.May 29, 2024
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NABL launches comprehensive training programme to enhance competence in reference material production
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 29, 2024
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Can robots break the cell therapy bottleneck?
Bio Pharma Dive
MAY 29, 2024
A partnership between cell therapy delivery specialist Portal Biotechnologies and precision robotics maker Multiply Labs could address manufacturing hurdles, the CEOs said.
Something In Pomegranates May Help The Brain Stave Off Alzheimer’s
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 29, 2024
A substance found in foods like pomegranates, strawberries, and walnuts restored the ability to detect and remove damaged cells in mice modeling Alzheimer’s disease, scientists report in a new paper. The same research team previously found a form of vitamin B3 called nicotinamide riboside (NR) helps remove damaged mitochondria from the brain.
Roche’s PI3K inhibitor wins FDA priority review for breast cancer
Pharmaceutical Technology
MAY 29, 2024
The US FDA has set an action date of 27 November for the combination therapy of Roche’s inavolisib, Pfizer’s Ibrance, and fulvestrant.
A biotech working on a new approach to IVF raises $33M in fresh funding
Bio Pharma Dive
MAY 29, 2024
The Series B funding from Two Sigma Ventures, RA Capital and others will help Gameto develop technology it says could replace hormonal injections and shorten the IVF process.
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Merck to buy eye drug developer for $1.3B
Bio Pharma Dive
MAY 29, 2024
An acquisition of EyeBio will hand Merck a treatment for diabetic macular edema and age-related macular degeneration that’s ready for pivotal testing.
FDA approves Amgen’s interchangeable biosimilar Bkemv
Pharmaceutical Technology
MAY 29, 2024
The US FDA has approved Amgen's Bkemv as an interchangeable biosimilar to Soliris for the treatment of specific rare diseases.
May 29, 2024: INSPIRE Pragmatic Trial to Be Featured in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
MAY 29, 2024
Dr. Shruti Gohil In this Friday’s PCT Grand Rounds, Shruti Gohil of the University of California, Irvine, will present “The INSPIRE Abdominal and Skin/Soft Tissue Infection Trials: Intelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients.” The Grand Rounds session will be held on Friday, May 31, 2024, at 1:00 pm eastern.
BMS stakes $80m on Prothena’s neurodegenerative candidate
Pharmaceutical Technology
MAY 29, 2024
Prothena plans to initiate a Phase I trial in an undisclosed indication by the end of 2024.
The New Age of Decentralized Clinical Trials
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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
Understanding colon cancer screening guidelines
Antidote
MAY 29, 2024
Colorectal cancer, often shortened just to colon cancer, is the third most commonly diagnosed cancer in the United States aside from skin cancers. While there are treatments available, including radiation and chemotherapy, the most important aspect of successful treatment is early detection — which is why knowing the colon cancer screening guidelines is essential.
Leading peptide manufacturers: Custom solutions and quality assurance
Pharmaceutical Technology
MAY 29, 2024
Discover leading peptide manufacturers offering bespoke solutions and stringent quality assurance. Ensure your biotech projects succeed with our expert guide.
Tris Pharma Gets FDA Approval for Non-Stimulant ADHD Medication
BioSpace
MAY 29, 2024
Tris Pharma on Wednesday secured the FDA’s green light for Onyda XR, the first liquid non-stimulant nighttime treatment for attention deficit hyperactivity disorder in pediatric patients.
ARVO conference unveils positive Vabysmo data
Pharmaceutical Technology
MAY 29, 2024
Vabysmo gained FDA approval in January 2022 in the wet age-related macular degeneration (wAMD) and diabetic macular oedema (DME) spaces.
With ruling, Pfizer can escape some claims in legal battle over Chantix carcinogen allegations
Fierce Pharma
MAY 29, 2024
Pfizer chalked up a key win in its legal battle surrounding the now-recalled smoking cessation drug Chantix after a New York judge narrowed the scope of the arguments in play. | The company still faces some claims in a class action lawsuit over the now-recalled smoking cessation med Chantix.
BMS secures another EC approval for Opdivo combination
Pharmaceutical Technology
MAY 29, 2024
The European Commission approved Bristol Myers Squibb’s Opdivo combination therapy for urothelial cancer based on Phase III data.
UK-based company selling breakthrough cannabis-based medicines now supplying the US
Outsourcing Pharma
MAY 29, 2024
UK based Celadon Pharmaceuticals Plc, that specializes in the development, production, and sale of breakthrough cannabis-based medicines, announced that it has begun shipping to the US.
Merck introduces sterility testing solution for pharma quality control
Pharmaceutical Technology
MAY 29, 2024
Merck KGaA has introduced the M-Trace Software & Mobile App to digitise sterility testing in microbial quality control.
The New Age of Decentralized Clinical Trials
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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.
After 5-year quest to streamline cell and gene therapy production, Ori Biotech reveals automated platform
Fierce Pharma
MAY 29, 2024
After half a decade spent developing an automated manufacturing platform, Ori Biotech believes it's ready to make a mark on the cell and gene therapy field. | Ori has revealed an automated cell and gene therapy manufacturing platform. The company says its tech is flexible enough to transition between projects at various stages of development.
Gilead and Cartography enter deal to develop cancer therapies
Pharmaceutical Technology
MAY 29, 2024
Cartography and Gilead Sciences partner to discover and develop therapies against new targets and target pairs in oncology.
BridgeBio Builds on Positive Phase III Data for Acoramidis in ATTR-CM
BioSpace
MAY 29, 2024
Additional analyses from BridgeBio Pharma’s late-stage study show the oral drug candidate’s improved clinical outcomes in transthyretin amyloid cardiomyopathy patients.
Turn Bio and HanAll to develop therapies for age-related conditions
Pharmaceutical Technology
MAY 29, 2024
Turn Bio has entered an agreement with HanAll Biopharma to develop therapies for age-related eye and ear ailments.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Working for a mature form of genomic medicines
pharmaphorum
MAY 29, 2024
In a new episode of the pharmaphorum podcast, Rahul Kakkar, CEO of gene editing company Tome, speaks with web editor Nicole Raleigh about programmable genomic integration (PGI) technology.
Study touts targeted chemotherapy delivery method using “chicken feather” protein
Pharmaceutical Technology
MAY 29, 2024
A team at King’s College London has developed a “drug delivery cage” that can be filled with chemotherapy drugs.
Biohaven’s Phase I Data for Lead Protein Degrader Disappoints Investors
BioSpace
MAY 29, 2024
Despite Biohaven’s bispecific protein degrader cutting autoantibody IgG levels by up to 37% in an early-stage study, investors saw it as “below the high bar” of 60%, according to William Blair analysts.
Digital therapeutics firm Akili agrees $34 million takeover
pharmaphorum
MAY 29, 2024
More consolidation in the digital health sector as Akili agrees a $34m takeover by Virtual Therapeutics, returning to private hands.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Immunovant Shifts Focus to Other FcRn Inhibitor, Gives Rival Vyvgart Breathing Room
BioSpace
MAY 29, 2024
The Roivant spinout is shifting its attention away from batoclimab to anti-FcRn candidate IMVT-1402, which will target autoimmune disorders, while allowing argenx’s Myasthenia Gravis drug Vyvgart to maintain its lead position for now.
AstraZeneca throws its hat into the oral PCSK9 ring
pharmaphorum
MAY 29, 2024
AstraZeneca has reported the first clinical data with its oral PCSK9 inhibitor AZD0780, which it hopes could offer an alternative to current injectable drugs used to lower cholesterol.
BioNTech Secures $145M to Boost mRNA Vaccine Capabilities in Africa
BioSpace
MAY 29, 2024
As BioNTech struggles to establish its footing in a post-pandemic world, the biotech has secured $145 million from the Coalition for Epidemic Preparedness Innovations to expand its mRNA operations in Rwanda.
Neurocrine, a regular name on Wall Street’s M&A lists, elevates BD chief to succeed founder and CEO
Fierce Pharma
MAY 29, 2024
Neurocrine Biosciences’ dealmaking prospects may soon get another round of attention with the installment of a new CEO. | Neurocrine Biosciences' dealmaking prospects may get another round of attention with the installment of a new CEO. The neuroscience company's three-decade veteran Kevin Gorman will soon hand the top job to long-time BD chief Kyle Gano.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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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