The small molecule drug arimoclomol (Miplyffa) has got the green light from the U.S. Food and Drug Administration (FDA) for the treatment of the rare disease Niemann-Pick disease type C (NPC), which until now has lacked FDA-approved therapies.
The Bateman Horne Center of Excellence (BHC) has established itself as a trusted leader in the clinical care, provider education, patient advocacy, and research of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID.
Pam Diamond spent almost three decades practicing medicine and looking at problems in the clinical research arena before changing tack so she could make a bigger impact.
Sanofi, a global pharmaceutical giant, has announced a significant investment of over €1 billion ($1.08 billion) in new bioproduction capacity at three manufacturing sites in France.
Japanese pharmaceutical company Shionogi has announced the first peer-reviewed publication of its phase 3 study investigating ensitrelvir to treat patients with mild to moderate COVID-19 in Japan, South Korea and Vietnam.
Gladstone Institutes seek FDA approval for human clinical trial after single-dose, intranasal TIPs treatment for SARS-CoV-2 infection limits transmission in infected animals by decreased viral shedding.
With updates to the Guideline for Good Clinical Practice Advancements on the horizon, an industry expert offers some perspective on what might be ahead.
A joint study conducted by analysts from Medable and the Center for the Study of Drug Development points toward shorter cycle times, cost savings, and more.
During the Decentralized Trial Technology event, experts from CVS Health, University of Chicago, and ACRP shared insight on what can increase DCT success.
Clinical Trial Navigator, from AmerisourceBergen, is designed to help sponsors pair with oncology practices to boost patient recruitment opportunities.
A representative from life-science services company Azzur Group explains how flexibility and speed can help in reaching the best solution more efficiently.
In this second of a two-part series, a leader from the CRO discusses the types of technologies supporting DCTs and what might lie on the horizon for the field.
In this first of a two-part series, an expert discusses various factors behind the DCT format’s rapid rise and likely longevity in the drug development arena.
On July 20, a collection of noted industry experts will lead a lively discussion on the rapid evolution of DCTs, and what advances might be on the horizon.
The past two years have been full of shifts and shakes in the drug development field, but the change at Outsourcing-Pharma is easy and one for the better.
An expert from the decentralized trial solutions company shares how eCOA and ePRO can be useful tools that improve the collection and quality of such data.
The 32nd iteration of the company’s Beyond Borders report offers an in-depth look at the state of the current market landscape, and what’s on the horizon.
During BIO International, US leaders shared lessons learned from COVID-19, and how government and industry are collaborating to avoid future supply chain crises.
A leader from the site management organization, which already has expanded since opening in 2019, is planning on adding sites and talent to its roster.
An expert from Rockwell Automation explains how integrating flexibility, using advanced technology, can help pharma manufacturing operations weather a storm.
Coming back to the real world June 13-16, the industry event will offer face-to-face learning, networking opportunities, and fun, star-studded opportunities.
This month’s announcements of awards, investments, executive appointment, and expansions include Javara, Thread, uMotif, Lonza, and other notable companies.
The digital medicine solutions developer has received $300m in a Series D investment round, which will be used to help scale up its virtual care offerings.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded a total of $577m to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.
Experts and organizations are honoring the occasion (designed to celebrate research accomplishments and achievements) with insights, education, and more.
The institute will combine the university’s AI, ML, health science, engineering, genomics, and data capabilities to tackle health strategy and inequity.
The digital therapeutics specialist has announced the last patient has ended participation in a study investigating a precision solution for hypertension.
The thin-film freezing specialist reports positive safety and pharmacokinetic data coming out of the Phase I trial of its niclosamide inhalation powder.
This month’s news on partnerships, appointments, expansions, and investment includes Javara, ACG, Phastar, Elligo Health Research, and other notable companies.
A leader from the organizer of the pharmaceutical event discusses what’s in store for the upcoming conference, and for the drug development industry itself.
Introduced by two Republican Congressmen, the American Made Medicine Act is intended to boost domestic drug manufacturing and create jobs in the sector.
The addition of the facility in Pennsylvania will help meet the increasing demand for temperature-controlled clinical packaging, storage, and distribution.
The US agency has expanded its approval of Veklury to include use in pediatric patients 28 days and older who have tested positive for the COVID-19 virus.
The two-day Oracle Health Sciences Connect will gather an array of research experts to discuss how to make the most of emerging technologies and practices.
A leader from the healthcare technology company discusses the conflict’s impact on the region and beyond and the need to better guard against interruptions.
DCT company ObvioHealth helped digital therapeutic firm Renovia evaluate a way of helping women with incontinence issues strengthen pelvic floor muscles.
The company’s analysis of clinical research activity in the region shows the conflict will have long-lasting effects that reach beyond the country’s borders.
The pharmaceutical company has agreed to provide its Paxlovid oral COVID-19 treatment to the global charity, covering 95 low- and middle-income countries.
The pharmaceutical company has announced 24 grants totaling nearly $8m USD to fuel training and support for community health workers and patient navigators.
With two decades of experience as a practicing psychiatrist, mdgroup medical director Arthur Lazarus offers broad experience and strong patient advocacy.
During Outsourcing-Pharma’s March 23 webinar, Clinical Development Advances, leaders from different areas will share innovative technology and practices.
Patient-centric company Belong.life has developed an app designed to inform cancer research by offering a holistic view of the lives of people with cancer.
The pharma company is evaluating its Paxlovid oral treatment, intended for high-risk patients who have tested positive for the virus, in pediatric subjects.
A leader from the Syneos Health company explains how innovative tech can elevate patient recruitment and engagement, even with the challenges DCTs can face.
A leader from the VCRO shares how far the industry has come with decentralized adoption, where opportunities for improvement exist, and what lies ahead.
Changing to DCT is more than merely flipping a switch; two leaders from the Thermo Fisher Scientific business offer advice for implementing the format.
