Phase I-II

Sionna raises $111m to take molecules against CF target into the clinic

28-Apr-2022 By Nick Taylor

Newly launched life sciences company Sionna Therapeutics has secured funding to fuel discovery and development of drug candidates to treat cystic fibrosis.

FDA approves Gilead's COVID-19 treatment for young children

26-Apr-2022 By Jenni Spinner

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.

Impel Pharmaceuticals upper-nasal delivery offers hope for migraine patients

26-Apr-2022 By Jenni Spinner

The company’s Precision Olfactory Delivery technology, currently combined with its Trudhesa migraine treatment, reportedly facilitates high absorption rates.

Thread buys CureClick to bring crowdsourced enrollment platform to DCTs

26-Apr-2022 By Nick Taylor

The decentralized clinical trial specialist has acquired CureClick to add to its offerings a platform intended to expand awareness of study participation.

Clinical trial evolution, innovation center of Oracle Health Sciences event

20-Apr-2022 By Jenni Spinner

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.

Break Through Cancer announces $50m to power research collaboration

19-Apr-2022 By Jenni Spinner

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.

FDA draft guidance outlines path to increased trial inclusivity

14-Apr-2022 By Jenni Spinner

The US agency’s latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.

RWE can boost trial acceleration, cost efficiency, and inclusivity

13-Apr-2022 By Jenni Spinner

An expert from trial tech specialist Komodo Health talks about how real-world evidence use could elevate study design, conserve costs, and improve recruitment.

Women hold power in clinical research arena: Greenphire

12-Apr-2022 By Jenni Spinner

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.

Former Johnson & Johnson, Bristol Myers Squibb executive to lead COTA

12-Apr-2022 By Jenni Spinner

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.

Winterlight Labs pitches in on decentralizing Alzheimer’s research

11-Apr-2022 By Jenni Spinner

The biomarker developer is partnering with Alzheimer Center Amsterdam on decentralized assessment of patient cognition and function in preclinical research.

SubjectWell expands trial recruitment marketplace to oncology indications

11-Apr-2022 By Nick Taylor

The recruitment tech specialist has added oncology clinical studies to its marketplace, providing sponsors with a larger pool of patients to choose from.

People on the Move: April 2022

11-Apr-2022 By Jenni Spinner

This month’s news includes hiring, promotions, expansions, and acquisitions at H Clinical, Charles River, DHL Supply Chain, X-Chem, and other key companies.

Future of clinical development highlighted in online event

07-Apr-2022 By Jenni Spinner

Experts from the Decentralized Trials and Research Alliance and Rafael Pharmaceuticals discuss progress and possibilities during Clinical Development Advances.

Noxopharm cancer drug secures Orphan Drug Designation from FDA

05-Apr-2022 By Jenni Spinner

The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma.

Digital Medicine Society launches digital endpoint toolkit

04-Apr-2022 By Jenni Spinner

Working with numerous partners, DiMe has introduced the 3Ps of Digital Endpoint Value to help inclusion of digital endpoints in drug reimbursement decisions.

Embracing clinical tech can benefit all stakeholders: IQVIA

31-Mar-2022 By Jenni Spinner

An expert from the clinical technology solutions provider discusses some of the top challenges associated with technology adoption, and how to tackle them.

Innovative Purdue research leads to FDA-approved prostate cancer treatment

31-Mar-2022 By Jenni Spinner

A renowned university researcher explains the path that laid the foundation and what the novel diagnostic and treatment means for prostate cancer patients.

Ukraine war offers hard lessons for clinical research industry: H1

29-Mar-2022 By Jenni Spinner

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.

UCB’s Fintepla oral seizure treatment receives FDA approval

28-Mar-2022 By Jenni Spinner

The drug has received the agency’s seal of approval to treat seizures associated with difficult-to-treat seizures associated with Lennox-Gastaut syndrome.

Roche, BMS to partner on personalized solutions for cancer patients

28-Mar-2022 By Jenni Spinner

The companies plan to work on developing personalized care solutions via digital pathology to come up with treatment options for patients with solid tumors.

Nipah research to support vaccine development

28-Mar-2022 By Rachel Arthur

A new study will seek to understand the body’s response to the Nipah virus in order to support development of vaccines.

Pancreatic cancer organization adds new clinical trial sites

25-Mar-2022 By Jenni Spinner

The Pancreatic Cancer Action Network has engaged five new clinical trial sites in the US, which will aid in evaluation of Novartis’ investigational therapy.

Decentralized trial links intervention to reduction in urinary incontinence

25-Mar-2022 By Nick Taylor

DCT company ObvioHealth helped digital therapeutic firm Renovia evaluate a way of helping women with incontinence issues strengthen pelvic floor muscles.

Janssen initiates psoriasis trial to bridge racial gaps in care

24-Mar-2022 By Jenni Spinner

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.

Ukraine war dramatically impacting global clinical development: Phesi

24-Mar-2022 By Jenni Spinner

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.

Tech Innovations: March 2022

17-Mar-2022 By Jenni Spinner

The latest news on software, manufacturing solutions, partnerships, and more includes IQVIA, TFF Pharmaceuticals, Quotient Sciences and other key companies.

AARDEX to monitor adherence in patients with PTSD, neurodegenerative diseases

17-Mar-2022 By Nick Taylor

The medication adherence specialist is joining IT4Anxiety, a project focused on dealing with anxiety in patients with mental disorders, via technology.

Praxis: ‘No quick fix’ for increasing clinical trial inclusivity

16-Mar-2022 By Jenni Spinner

A leader from the patient recruitment specialist discusses the industry’s ongoing challenges with patient population diversity, and potential solutions.

Oracle: How can clinical trials better fill the patient inclusivity gap?

16-Mar-2022 By Jenni Spinner

While strides have been made recruiting more representative patient populations, more can and should be done, according to an Oracle Health Sciences leader.

Diverse site staff better fits inclusive patient population: Inato

16-Mar-2022 By Jenni Spinner

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.

Eversana patient enrollment platform targets hard-to-reach populations

16-Mar-2022 By Jenni Spinner

The Seeker Health digital patient enrollment platform is intended to help trial teams find patients from populations that are typically hard to connect with.

RWD-based software aimed at reaching underrepresented patient communities

16-Mar-2022 By Jenni Spinner

Cloud-based Clarify Trials is real-world evidence-based software intended to improve recruitment of clinical study patients from underrepresented communities.

BMS commits $8m in grants to fuel health equity mission

16-Mar-2022 By Jenni Spinner

The pharmaceutical company has announced 24 grants totaling nearly $8m USD to fuel training and support for community health workers and patient navigators.

The right tech can fill gap between lab scientist and data: ACD/Labs

16-Mar-2022 By Jenni Spinner

An expert from the R&D tech provider discusses how automation, integration, and other tools can help with effective access and analysis of lab information.

Psychiatrist brings patient-first perspective to clinical services company

15-Mar-2022 By Jenni Spinner

With two decades of experience as a practicing psychiatrist, mdgroup medical director Arthur Lazarus offers broad experience and strong patient advocacy.

Industry experts discuss clinical revolution in online event

14-Mar-2022 By Jenni Spinner

During Outsourcing-Pharma’s March 23 webinar, Clinical Development Advances, leaders from different areas will share innovative technology and practices.

Enveric taps University of Calgary to study psychedelic therapy in cancer-related distress

14-Mar-2022 By Nick Taylor

The pharma company and academic institution will explore the viability of a psychedelic treatment to help patients suffering from cancer-related distress.

Pfizer kicks off Phase II/III study for pediatric COVID-19 treatment

10-Mar-2022 By Jenni Spinner

The pharma company is evaluating its Paxlovid oral treatment, intended for high-risk patients who have tested positive for the virus, in pediatric subjects.

Connecting patients to sites, info key to study success: StudyKIK

09-Mar-2022 By Jenni Spinner

A leader from the Syneos Health company explains how innovative tech can elevate patient recruitment and engagement, even with the challenges DCTs can face.

Despite rapid DCT evolution, there’s still room for progress: Curavit

09-Mar-2022 By Jenni Spinner

A leader from the VCRO shares how far the industry has come with decentralized adoption, where opportunities for improvement exist, and what lies ahead.

Making the jump to decentralized requires a thoughtful approach: PPD Clinical Research Services

09-Mar-2022 By Jenni Spinner

Changing to DCT is more than merely flipping a switch; two leaders from the Thermo Fisher Scientific business offer advice for implementing the format.

Oncology decentralized trials call for special consideration: Encapsia

09-Mar-2022 By Jenni Spinner

A leader from the eClinical solutions provider talks about the unique considerations that cancer studies have at every stage, and how technological solutions can help address them.

Medidata, Circuit Clinical partner in decentralized clinical trial push

08-Mar-2022 By Nick Taylor

Integrated research organization Circuit Clinical will standardize its decentralized operations with Medidata’s RAVE and myMedidata technological offerings.

Eversana, Thread connect RWD and decentralized trial platforms

07-Mar-2022 By Nick Taylor

The two companies, along with Datavant, will combine real-world data and decentralized platforms to yield better patient information management and insights.

People on the Move: March 2022

03-Mar-2022 By Jenni Spinner

This month’s announcements include hiring, expansion, and acquisition news from companies like DFE Pharma, ClinOne, Novartis, LEGO, Benchling, and more.

scope 2022

Data history visibility keeps clinical studies on track: Almac

01-Mar-2022 By Jenni Spinner

Experts from the clinical tech firm talk data challenges and how monitoring technology can enable sites and sponsors to better manage audit trail reviews.

Medable, Cognizant to collaborate on decentralized trial tech

01-Mar-2022 By Nick Taylor

Medable has added Cognizant to its Medable Partner Network, designed to help companies launch their clinical trials more quickly and run them more efficiently.

rare disease day 2022

Rafael Pharmaceuticals reports progress with rare cancer drug

01-Mar-2022 By Jenni Spinner

The company (which specializes in developing therapies for rare cancers) currently is working on a number of candidates, including its lead drug CPI-613.

rare disease day

Rare diseases, very special patients highlighted in event

28-Feb-2022 By Jenni Spinner

The recent Outsourcing-Pharma webinar hosted a trio of industry experts highlighting challenges, opportunities, and innovations in the rare disease realm.