Wed.May 29, 2024

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J&J antidepressant eases symptoms, improves sleep in key trial

Bio Pharma Dive

The company has put high expectations on the drug, an orexin-2 antagonist called seltorexant, as a cornerstone of its neuropsychiatry pipeline.

Trials 243
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BMS stakes $80m on Prothena’s neurodegenerative candidate

Pharmaceutical Technology

Prothena plans to initiate a Phase I trial in an undisclosed indication by the end of 2024.

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Can robots break the cell therapy bottleneck?

Bio Pharma Dive

A partnership between cell therapy delivery specialist Portal Biotechnologies and precision robotics maker Multiply Labs could address manufacturing hurdles, the CEOs said.

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Verona prepares for anticipated US launch of ensifentrine for COPD in Q3 2024

Pharmaceutical Technology

Ensifentrine is a first-in-class dual phosphodiesterase 3/4 inhibitor to treat chronic obstructive pulmonary disease (COPD).

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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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Something In Pomegranates May Help The Brain Stave Off Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Scientist 244
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Roche’s PI3K inhibitor wins FDA priority review for breast cancer

Pharmaceutical Technology

The US FDA has set an action date of 27 November for the combination therapy of Roche’s inavolisib, Pfizer’s Ibrance, and fulvestrant.

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More Trending

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FDA approves Amgen’s interchangeable biosimilar Bkemv

Pharmaceutical Technology

The US FDA has approved Amgen's Bkemv as an interchangeable biosimilar to Soliris for the treatment of specific rare diseases.

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A biotech working on a new approach to IVF raises $33M in fresh funding

Bio Pharma Dive

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.

Hormones 200
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May 29, 2024: INSPIRE Pragmatic Trial to Be Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

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.

Trials 147
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Merck to buy eye drug developer for $1.3B

Bio Pharma Dive

An acquisition of EyeBio will hand Merck a treatment for diabetic macular edema and age-related macular degeneration that’s ready for pivotal testing.

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

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Study touts targeted chemotherapy delivery method using “chicken feather” protein  

Pharmaceutical Technology

A team at King’s College London has developed a “drug delivery cage” that can be filled with chemotherapy drugs.

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Understanding colon cancer screening guidelines

Antidote

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.

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Leading peptide manufacturers: Custom solutions and quality assurance 

Pharmaceutical Technology

Discover leading peptide manufacturers offering bespoke solutions and stringent quality assurance. Ensure your biotech projects succeed with our expert guide.

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Digital therapeutics firm Akili agrees $34 million takeover

pharmaphorum

More consolidation in the digital health sector as Akili agrees a $34m takeover by Virtual Therapeutics, returning to private hands.

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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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ARVO conference unveils positive Vabysmo data

Pharmaceutical Technology

Vabysmo gained FDA approval in January 2022 in the wet age-related macular degeneration (wAMD) and diabetic macular oedema (DME) spaces.

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With ruling, Pfizer can escape some claims in legal battle over Chantix carcinogen allegations

Fierce Pharma

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.

Drugs 119
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BMS secures another EC approval for Opdivo combination

Pharmaceutical Technology

The European Commission approved Bristol Myers Squibb’s Opdivo combination therapy for urothelial cancer based on Phase III data.

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Working for a mature form of genomic medicines

pharmaphorum

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.

Genome 118
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Merck introduces sterility testing solution for pharma quality control

Pharmaceutical Technology

Merck KGaA has introduced the M-Trace Software & Mobile App to digitise sterility testing in microbial quality control.

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Neurocrine, a regular name on Wall Street’s M&A lists, elevates BD chief to succeed founder and CEO

Fierce Pharma

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.

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Gilead and Cartography enter deal to develop cancer therapies

Pharmaceutical Technology

Cartography and Gilead Sciences partner to discover and develop therapies against new targets and target pairs in oncology.

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After 5-year quest to streamline cell and gene therapy production, Ori Biotech reveals automated platform

Fierce Pharma

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.

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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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Turn Bio and HanAll to develop therapies for age-related conditions

Pharmaceutical Technology

Turn Bio has entered an agreement with HanAll Biopharma to develop therapies for age-related eye and ear ailments.

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NHS and NICE announce plan to adopt innovative medical technologies for patients

Pharma Times

The proposals will help MedTech developers access NHS funding to fast-track products

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Update: MSD confirms $3bn takeover of EyeBio

pharmaphorum

MSD has confirmed a $3 billion takeover deal for ophthalmology biotech EyeBio and its drug candidate for diabetic macular oedema (DME) and neovascular age-related macular degeneration (AMD).

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Pharma Pulse 5/29/24: OpenAI Forms New Committee to Evaluate Safety/Security, Proposed FDA Rule Could Limit Pharmacy Compounding & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharmacy 109
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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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AstraZeneca throws its hat into the oral PCSK9 ring

pharmaphorum

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.

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BHF awards £35m funding to nine UK universities for cardiovascular disease

Pharma Times

Affecting more than 7 million people in the UK, cardiovascular diseases are conditions that affect the heart or circulation

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MSD said to be looking at $1.3bn takeover of EyeBio

pharmaphorum

MSD is reported to be on the brink of agreeing a $1.

Drugs 110
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Tris Pharma Gets FDA Approval for Non-Stimulant ADHD Medication

BioSpace

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.

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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.