The clinical trial tech firm has announced a $220m Series D funding round which will boost its efforts to improve inclusivity and representation in studies.
The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.
The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.
The pharmaceutical firm and university have launched T-REX, a multi-year partnership focused on increasing health outcomes for underrepresented populations.
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 clinical technology company discusses some of the pain points in data collection and analysis, and tools that can help users level up.
ObvioHealth and 1nHealth have joined to launch an initiative aimed at helping clinical trials avoid being shut down by smoothing the change to decentralized.
Leaders from the R&D tech company weigh in on how use of artificial intelligence has grown, ongoing challenges to effective adoption, and what lies ahead.
The agency has approved an expanded indication for Qelbree extended-release capsules to treat attention deficit hyperactivity disorder in younger patients.
A leader from the life-science organization discusses how collaboration could lead to a broad range of benefits for everyone along the drug discovery pipeline
A leader from the health tech company explains how voice-based technologies could transform monitoring of patients with dementia, Alzheimer’s, and other conditions.
Newly launched life sciences company Sionna Therapeutics has secured funding to fuel discovery and development of drug candidates to treat cystic fibrosis.
The addition of the facility in Pennsylvania will help meet the increasing demand for temperature-controlled clinical packaging, storage, and distribution.
The company’s Precision Olfactory Delivery technology, currently combined with its Trudhesa migraine treatment, reportedly facilitates high absorption rates.
The decentralized clinical trial specialist has acquired CureClick to add to its offerings a platform intended to expand awareness of study participation.
The latest news on expansions, innovations, awards, and more includes items from Eversana, DHL Supply Chain, X-Chem, Medidata, and other notable companies.
An expert from the health tech company explains how AI, natural language processing, and other tools can improve pharmaceutical product safety reporting.
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.
The one-year-old organization is giving $50m USD in grants to encourage scientists from five cancer research centers to work together on cancer solutions.
The company’s recent purchase by Drug Safety and Pharmacovigilance Services Solutions reportedly will fuel expansion of its Reportum PV platform technology.
The US agency’s latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.
An expert from trial tech specialist Komodo Health talks about how real-world evidence use could elevate study design, conserve costs, and improve recruitment.
A recent online event hosted by the patient services company invited a number of women to share their experience and insights working in the research field.
The partnership among three research and data specialists is aimed at creating a global database to support faster development of novel cancer treatments.
Miruna Sasu has been named president and CEO of the company, which uses RWD and analytics in advancing oncology drug development and clinical trial diversity.
The biomarker developer is partnering with Alzheimer Center Amsterdam on decentralized assessment of patient cognition and function in preclinical research.
The recruitment tech specialist has added oncology clinical studies to its marketplace, providing sponsors with a larger pool of patients to choose from.
This month’s news includes hiring, promotions, expansions, and acquisitions at H Clinical, Charles River, DHL Supply Chain, X-Chem, and other key companies.
Experts from the Decentralized Trials and Research Alliance and Rafael Pharmaceuticals discuss progress and possibilities during Clinical Development Advances.
The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma.
Working with numerous partners, DiMe has introduced the 3Ps of Digital Endpoint Value to help inclusion of digital endpoints in drug reimbursement decisions.
An expert from the clinical technology solutions provider discusses some of the top challenges associated with technology adoption, and how to tackle them.
A renowned university researcher explains the path that laid the foundation and what the novel diagnostic and treatment means for prostate cancer patients.
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.
The drug has received the agency’s seal of approval to treat seizures associated with difficult-to-treat seizures associated with Lennox-Gastaut syndrome.
The companies plan to work on developing personalized care solutions via digital pathology to come up with treatment options for patients with solid tumors.
The Pancreatic Cancer Action Network has engaged five new clinical trial sites in the US, which will aid in evaluation of Novartis’ investigational therapy.
DCT company ObvioHealth helped digital therapeutic firm Renovia evaluate a way of helping women with incontinence issues strengthen pelvic floor muscles.
The pharmaceutical company's clinical study is intended to examine critical gaps in care for people of color living with moderate to severe plaque psoriasis.
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 agency has approved Lynparza for use in the US as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.
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 latest news on software, manufacturing solutions, partnerships, and more includes IQVIA, TFF Pharmaceuticals, Quotient Sciences and other key companies.
The medication adherence specialist is joining IT4Anxiety, a project focused on dealing with anxiety in patients with mental disorders, via technology.
A leader from the patient recruitment specialist discusses the industry’s ongoing challenges with patient population diversity, and potential solutions.
While strides have been made recruiting more representative patient populations, more can and should be done, according to an Oracle Health Sciences leader.
A leader from the trial platform company discusses how patient experience can be enhanced when the clinical trial team shares a background with the subjects.
