The pharma firm has announced the agency has approved the company’s investigational new drug application for its Phase II trial of pemvidutide for obesity.
A representative from IQVIA discusses the particulars of the US agency’s new draft document and shares what it might mean for clinical trial data evaluation.
An expert from the CRO discusses unique challenges associated with running clinical trials that stretch across national boarders and how to conquer them.
The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientific’s Nantheia ATL5, a candidate for treating opioid use disorder.
This month’s list of new technology, partnerships, and other announcements includes items from ObvioHealth, Datavant, HumanFirst, and other industry players.
The pharmaceutical company reports studies have demonstrated the main protease inhibitor of Paxlovid maintains in vitro efficiency against the variant.
The Medicines and Healthcare Products Regulatory Agency has released proposals to bolster trials legislation, asking citizens for input on the suggestions.
Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.
Blue Note Therapeutics has announced the status has been granted to BNT200, a device to treat anxiety and depression in acute myeloid leukemia patients.
The World Health Organization has recommended the drugs for COVID-19 patients, broadening the range of therapies to combat the virus behind the pandemic.
With the amount of available data increasing and technology evolving, says a company leader, the job of data manager is more demanding than ever before.
This month’s news on mergers and acquisitions, hires, and other developments includes notable firms like Altasciences, Protocol First, WuXi STA, and more.
It has been a pleasure for the OSP team to connect with a long list of fascinating industry minds and share the stories; here are a few of our favorites.
OSP’s list of the year’s most-read stories shows readers are interested in M&A activities, new drug candidates, COVID-19 developments, and other hot news.
The pharmaceutical company has announced GMP-related challenges with a manufacturer contracted to fill syringes for Wegovy pens headed to the US market.
Professionals from various corners of the life-sciences field share views on significant challenges of 2021, bright spots, and what to look for in 2022.
A leader from the company discusses how advanced analytical tools can be put to work to help tackle adverse event case processing and compliance issues.
The US agency continues to work with industry professionals on vaccines and treatments for the virus, and to wrestle with current and emerging variants.
The US Department of Justice has charged a former CFO and a former head of corporate communications for allegedly conducting an insider trading scheme.
A leader from the pharmacovigilance solutions firm discusses the ins and outs managing safety documentation and offers advice on how to deal with them.
The US agency has granted approval to Voxzogo, an injectable drug designed to aid growth in children with achondroplasia, the most common form of dwarfism.
A leader from Medicines for Europe will share with CPhI Worldwide attendees a look at medicine production and offer solutions for elevating the industry.
The global pharmaceutical industry event is returning to the real world November 9-11 this year, with online content for professionals opting not to travel.
A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drug trials.
The trial will evaluate a weekly regimen of islatravir and lnecapavir in HIV patients who are virologically suppressed while on antiretroviral therapies.
A leader from the drug development and manufacturing firm talks about the ways in which advanced digital tools stand to revolutionize the pharma field.
The conference (with online and in-person content) is slated to gather professionals for deep conversations and lively collaboration on important topics.
The US agency plans to use the software firm’s Lighthouse technology to improve understanding of COVID-19 and other conditions in long-term care facilities.
A leader from the division of Eli Lilly explains the importance of driving greater trial inclusivity, and why collaboration is vital in making progress.
The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations
The pharma firm reports molnupiravir was shown to cut risk of hospitalization or death by 50% compared to placebos in a positive interim Phase III analysis.
As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.
A logistics leader from the CRO offers advice on navigating borders, cultures, regulatory issues and other important considerations on worldwide studies.
Two experts from the contract research organization offer advice on planning and executing clinical studies with the unique needs of such patients in mind.
Stakeholders in the Rare Disease Cures Accelerator-Data and Analytics Platform initiative are partnering in hopes of bringing treatments to patients faster.
The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.
The US medical research agency plans to offer funding over five years through a newly launched consortium, expected to include 30 sites across the country.
The two companies are collaborating on development of Myfembree, a combination therapy to treat the painful condition affecting millions of women worldwide.
The US agency continues to oversee vaccine and drug development, and to share information and advice for life-sciences professionals and civilians alike.
A representative from Cmed Technology explains how taking stock of existing tech and adding the right new tools can help when switching to virtual clinical studies.
This month’s news on new hires, board launches, acquisitions, and other important news includes items on Pfizer, Javara, Clinical Ink, and other companies.
According to the study, the country’s overreliance on pharmaceutical ingredients manufactured in overseas factories threatens national security and health.
The CRO has launched an initiative that offers help navigating regulatory issues for ultra-rare disease patient advocacy groups that demonstrate a need.
The US Food and Drug Administration continues to review potential preventatives and treatments for the virus, and to offer advice to life-sciences professionals and civilians alike.
Producers of CPhI North America 2021 offer a glimpse at programming, including sessions on COVID-19 challenges, supply chain issues, and more key topics.
A leader from the company says to ensure medicines keep reaching the patients that need them, the industry must revamp outdated technologies and techniques.
The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.
A leader from the topical solutions centered CDMO discusses the differences between approaches by the FDA and EMA, and how to deal with them effectively.
