Sat.Sep 16, 2023 - Fri.Sep 22, 2023

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New RSV vaccines can be powerful tools, but rollout poses test

Bio Pharma Dive

Public health officials, as well as drugmakers, are trying to raise awareness of RSV among older adults at risk, and convince them to get an additional respiratory shot alongside those for COVID and flu.

Vaccine 328
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ADDF invest in BrainScope for Alzheimer’s prediction biomarker

Pharmaceutical Technology

The neurotech will receive the investment in Series B equity financing round to invest in Alzheimer’s disease research.

Research 324
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Bioanalysis through automation: Our top four takeaways

Worldwide Clinical Trials

Our team has been working diligently to find a way to revitalize how we use automation, and during WRIB this year, we presented a poster on “Revolutionizing Bioanalysis through Automation: Overcoming Challenges and Unlocking Potential.” In case you missed it, we’ve highlighted the top four takeaways: 1. Instrument Integration: At both hardware and software levels, our integration of multiple bioanalytical instruments created a total laboratory automation (TLA) system for ligand bindi

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September 20, 2023: This Friday’s PCT Grand Rounds Explores the Role of Community Health Workers in Early Childhood Well-Child Care

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Tumaini Rucker Coker of the University of Washington and Seattle Children’s Hospital will present “Community Health Workers in Early Childhood Well-Child Care.” The Grand Rounds session will be held on Friday, September 22, 2023, at 1:00 pm eastern. Coker is the chief of general pediatrics and a professor of pediatrics at the University of Washington School of Medicine and Seattle Children’s Hospital.

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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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Startup AIRNA emerges from stealth to bring RNA editing to a rare disease

Bio Pharma Dive

AIRNA is one of several biotechs to debut plans for target alpha-1 antitrypsin deficiency in recent years, with competitors such as AlveoGene, Wave Life Sciences and Arrowhead Pharmaceuticals.

RNA 317
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FDA accepts Takeda’s NDA resubmission for eosinophilic esophagitis therapy

Pharmaceutical Technology

The US FDA has accepted Takeda’s NDA resubmission for TAK-721 for the short-term treatment of eosinophilic esophagitis (EoE), for review.

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More Trending

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Merck and Eisai's Keytruda-Lenvima combo chalks up 2 more losses, this time in non-small cell lung cancer

Fierce Pharma

Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. | Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. Following a series of trial shortfalls this year in melanoma, colorectal cancer and head and neck squamous cell carcinoma, the duo has missed the mark in yet another set of clinical trials—this time in non-small cell lung cancer.

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Orchard nears FDA decision on rare disease gene therapy

Bio Pharma Dive

Three years after gaining European approval, Libmeldy is now under U.S. review with a deadline set for March.

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Signal: Illumina leads $15m investment in Broken String Biosciences

Pharmaceutical Technology

Embattled biotech giant Illumina has led series A funding into genomics mapping company Broken String Biosciences.

Genome 290
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Pfizer’s Vydura recommended by NICE for acute migraines

Pharma Times

The treatment is the first oral GPCR receptor antagonist class recommended for NHS use - News - PharmaTimes

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

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Merck puts $1.3bn into AI via Exscientia, BenevolentAI deals

pharmaphorum

Merck puts $1.3bn into AI via Exscientia, BenevolentAI deals Phil.

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PBMs, PhRMA trade blame over drug costs in House hearing

Bio Pharma Dive

Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second hearing on the PBM industry.

Pharmacy 290
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Kinnate Biopharma announces 70% layoffs and pipeline restructuring

Pharmaceutical Technology

The company will suspend the development of three assets, considering strategic alternatives for two clinical programmes.

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Evaxion and Afrigen Biologics to develop mRNA vaccine for gonorrhoea

Pharma Times

The collaboration will utilise Evaxion’s EDEN-discovered antigen targets - News - PharmaTimes

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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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Novo Nordisk Foundation pumps $136M into new clinical cell therapy manufacturing 'hub' in Denmark

Fierce Pharma

Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technica | Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technical University of Denmark (DTU) in Lyngby.

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Genentech takes up a deal to make ‘molecular glue’ drugs

Bio Pharma Dive

Targeted protein degradation has emerged as one of the more competitive areas of pharmaceutical research in recent years as scientists develop new ways to reach difficult-to-drug targets.

Drugs 280
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FDA revises biosimilar guidelines for clearer drug labelling

Pharmaceutical Technology

The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.

Drugs 264
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Evaxion validates its infectious disease AI vaccine platform

Pharma Times

The platform identifies antigens to fight against bacterial infectious disease - News - PharmaTimes

Vaccine 139
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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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The fading generics industry and essential medicine supply

pharmaphorum

The fading generics industry and essential medicine supply Mike.

Medicine 134
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Making us more human: Applying artificial intelligence to your clinical resourcing and talent acquisition strategy

Bio Pharma Dive

With the rise of ChatGPT and artificial intelligence (AI), there are many ways the clinical staffing industry can use AI advantageously while removing the stigma that the rise of technology can be dehumanizing.

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Pelican and Primordial Genetics merge to form biotech company Primrose Bio

Pharmaceutical Technology

Pelican Technology has combined business with Primordial Genetics under a deal to create a private biotechnology company Primrose Bio.

Genetics 263
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Cancer Research UK invests £123m in Scotland

Pharma Times

The investment will support research into cancer treatments and diagnosis - News - PharmaTimes

Research 139
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Inside the FDA's Form 483 findings at Novo Nordisk's North Carolina semaglutide plant

Fierce Pharma

Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina product | After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality control lapses, according to a Form 483 seen by Fierce Pharma.

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FDA approves GSK’s new bone cancer drug, helping validate a billion-dollar bet

Bio Pharma Dive

The drug, known scientifically as momelotinib, is now cleared to treat myelofibrosis and will compete against rival medicines sold by Incyte and Bristol Myers Squibb.

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FDA clears Krystal Biotech’s IND for Type 1 AATD treatment KB408

Pharmaceutical Technology

A Phase I trial exploring the gene therapy in patients with alpha-1 antitrypsin deficiency is expected to start in Q1 2024.

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Parkinson’s UK calls on government to mark World Patient Safety Day

Pharma Times

The report outlines ways the government can help patients with Parkinson’s disease - News - PharmaTimes

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Leveraging technology for better women’s healthcare outcomes

pharmaphorum

Leveraging technology for better women’s healthcare outcomes Mike.

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AstraZeneca and Daiichi’s next cancer medicine scores in breast tumors

Bio Pharma Dive

Results show that the medicine helped patients who progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, according to a Friday announcement.

Medicine 182
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Evaxion partners with Afrigen Biologics to develop mRNA gonorrhea vaccine

Pharmaceutical Technology

The collaboration will use Evaxion’s EDEN platform to bring an AI-designed gonorrhea mRNA vaccine to the market.

Vaccine 246
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NICE recommends more genetic testing for links to ovarian cancer

Pharma Times

Around 340,000 to 444,000 people in the UK carry one of nine pathogenic gene variants - News - PharmaTimes

Genetics 136
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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.