Pharmaceutical Technology
OCTOBER 24, 2023
Pear Therapeutics was a pioneer in developing DTx for neurological conditions traditionally treated by evidence-based behavioural or psychological management strategies.
Bio Pharma Dive
OCTOBER 24, 2023
The money will be spread across three investment funds and comes at a time when investment into biotech remains shakier than in years past.
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Pharmaceutical Technology
OCTOBER 24, 2023
SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.
Bio Pharma Dive
OCTOBER 24, 2023
The startup is taking aim at an inflammation-linked protein known as TSLP, which is the target of an approved asthma medicine.
Pharmaceutical Technology
OCTOBER 24, 2023
The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.
Bio Pharma Dive
OCTOBER 24, 2023
Rampart Biosciences closed a Series A round that will fund its goal to develop more potent DNA-based medicines that avoid immune responses.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 24, 2023
The candidate recently went through a Phase II trial, with results to be presented in mid-November.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 24, 2023
The National Accreditation Board for Hospitals and Healthcare Providers (NABH) has released the first edition of NABH Certification standards for stroke care centres. It has urged all the centres across the country to apply for accreditation depending on the self-assessment of the standards.
Pharmaceutical Technology
OCTOBER 24, 2023
Sponsors are being urged to compensate participants in oncological clinical trials, as well as make in-person visits to contract research organisations to keep exploratory studies from slowing down.
Worldwide Clinical Trials
OCTOBER 24, 2023
In the US, a rare disease is one with 200,000 or fewer patients. Rare diseases exist in every therapeutic area and are often the more complex indications of each therapeutic area. While this is a small number of people in each rare disease patient community, the significant and continued growth of rare disease drug development is unsurprising given that there are over 10,000 rare diseases , with more being discovered every 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
OCTOBER 24, 2023
A panel discussion at a Copenhagen conference saw representatives from sponsor organisations sharing their hopes for CROs to take ownership when trials go wrong.
Bio Pharma Dive
OCTOBER 24, 2023
Mixed survival data from a study of Pluvicto in earlier prostate cancer sparked the slower regulatory timeline.
Pharmaceutical Technology
OCTOBER 24, 2023
The award will fund the development of the company’s automated, microfluidic cell and gene therapy manufacturing platform.
BioSpace
OCTOBER 24, 2023
In its most recent round of layoffs this year, the California-based biopharma company is letting go of 350 former Horizon Therapeutics staff whose roles overlap with existing positions at Amgen.
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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
Pharmaceutical Technology
OCTOBER 24, 2023
At the ongoing CpHI Europe meeting, experts outline the key elements that will be expected in future pharma partnerships.
Rethinking Clinical Trials
OCTOBER 24, 2023
Speaker Patrick Lawler, MD, MPH Cardiology and Critical Care Divisions McGill University and University of Toronto Slides Keywords REMAP-CAP; adaptive platform trials; critical care; pneumonia Key Points Clinical trials face challenges that were amplified during the COVID-19 public health emergency, including avoiding shortcomings of prior data, equipoise, heterogeneity of treatment effect, making trials happen quickly, the complexity of studying a single intervention in isolation, and th
Pharmaceutical Technology
OCTOBER 24, 2023
AstraZeneca will pay $75m to Daiichi Sankyo as a milestone payment following the latest EU approval to treat NSCLC patients with a HER2 mutation.
BioSpace
OCTOBER 24, 2023
While the trial was designed to test safety and not efficacy, patients treated with Araclon Biotech’s experimental ABvac40 vaccine saw a 38% drop in disease progression compared to 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
OCTOBER 24, 2023
The Indonesian Ministry of Food and Drug Safety approved Genexine and KGbio's Efepoetin alfa for chronic kidney disease-induced anaemia.
Fierce Pharma
OCTOBER 24, 2023
In the biopharma industry, post-merger layoffs are often a question of when and how many. | In the biopharma industry, post-merger layoffs are often a question of when and how many. In the case of Amgen’s $27.8 billion buyout of Horizon, they came quickly. Around 350 former Horizon employees are being told this week that their positions will be eliminated.
Pharmaceutical Technology
OCTOBER 24, 2023
Amidst a changing, complex Covid-19 marketplace, HDT-Bio looks towards harnessing multivalence for its Covid-19 candidate, HDT-301.
BioSpace
OCTOBER 24, 2023
The oncology company added a fifth indication for its isocitrate dehydrogenase 1 inhibitor, securing the greenlight for treating patients with IDH1-mutated relapsed or refractory myelodysplastic syndromes.
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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.
Pharmaceutical Technology
OCTOBER 24, 2023
Samsung Biologics has entered into a collaboration with Kurma Partners to develop biologics for Kurma's portfolio companies.
Drug Discovery World
OCTOBER 24, 2023
While attending Life Science Baltics 2023, Diana Spencer spoke to Monika Paule , CEO and Co-founder of Caszyme, about creating a company based on CRISPR gene editing and some of the challenges of operating in this dynamic area of research. DS: What was the motivation for launching Caszyme and what challenges did you face creating a viable business?
Pharmaceutical Technology
OCTOBER 24, 2023
Health Canada has granted approval for Sumitomo Pharma Canada’s Orgovyx (relugolix) to treat advanced prostate cancer in men.
Pharma Times
OCTOBER 24, 2023
The funding will allow several projects to support the health of working people - News - PharmaTimes
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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.
Pharmaceutical Technology
OCTOBER 24, 2023
INVO Bioscience has signed an agreement to acquire NAYA Biosciences to establish a publicly traded life science company.
BioSpace
OCTOBER 24, 2023
The company’s respiratory syncytial virus vaccine Arexvy can elicit similar levels of immune protection in adults aged 50 to 59 as in its approved population, finds results from a late-stage study.
Fierce Pharma
OCTOBER 24, 2023
At this year’s congress of the European Society for Medical Oncology (ESMO), Merck & Co. unleashed a flurry of studies showing Keytruda’s power across multiple tumor types. | Across four separate studies, Merck’s PD-1 juggernaut Keytruda—in combination with other cancer meds—charted complete and partial wins in cervical cancer, early breast cancer and stomach cancer.
BioSpace
OCTOBER 24, 2023
Even after the runaway success of mRNA vaccines against COVID-19, the pathway to approval for upcoming would-be mRNA therapeutics has yet to be laid out.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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