Phase III-IV

Priority review granted by FDA for 'landscape changing' colorectal cancer drug

26-May-2023 By Liza Laws

A drug that has the ability to ‘transform the landscape’ for people living with metastatic colorectal cancer (CRC) has been granted priority review by the US Food and Drug Administration (FDA).

Study finds AstraZeneca drug given alongside chemo shows 'strong improvement' for advanced lung cancer patients

22-May-2023 By Liza Laws

Small molecule drug, Tagrisso (Osimertinib) taken alongside chemotherapy has showed a strong improvement in progression-free survival for patients with EGFR (epidermal growth factor receptor)-mutated advanced lung cancer, a phase 3 study has revealed.

Phase 3 study for people with painful, highly inflammatory condition initiated by Galapagos

28-Apr-2023 By Liza Laws

Galapagos NV has announced it has initiated a phase 3 study with small molecule drug filgotinib in patients with the chronic, highly inflammatory condition, active axial spondyloarthritis(AxSpA).

'Compelling results from Karyopharm study using combination of drugs to treat myelofibrosis

20-Apr-2023 By Liza Laws

Symptom improvements have been hailed as ‘very compelling’ after results from a phase 1 study into a combination of drugs to treat myelofibrosis prove positive.

Hutchmed 's rare gastric cancer drug accepted for review in China

20-Apr-2023 By Liza Laws

A drug to treat a rare cancer that grows where the esophagus and stomach join has been accepted for review by the China National Medical Products Administration (NMPA).

Mirum Pharmaceuticals success with study of drug for chronic liver disease

06-Apr-2023 By Liza Laws

A small molecule drug to treat a chronic liver disease has been proven to support treatment across the broadest range of genetic types ever studied.

GSK expands infectious disease portfolio with antifungal deal

04-Apr-2023 By Ben Hargreaves

GSK agrees deal with Scynexis for the exclusive licensing rights to Brexafemme, a first-in-class treatment for fungal infections.

Cingulate and Indegene announce agreement for lead ADHD drug - the first of its kind

31-Mar-2023 By Liza Laws

An agreement has been reached to promote Cingulate Inc’s ‘first true entire active day medication’ designed to treat attention deficit hyperactivity disorder (ADHD).

BPGbio announces partnership with debra of America to help those suffering skin disease

30-Mar-2023 By Liza Laws

Finding a treatment for a skin disease that significantly diminishes the quality of life for those living with it has moved forward to the next phase of trials.

Positive topline results in trial for patients with early breast cancer

28-Mar-2023 By Liza Laws

Patients with early breast cancer (EBC) could benefit from a targeted treatment that can block or interfere with cancer cell growth.

Interview: Hope for those with degenerative brain disease PSP

28-Mar-2023 By Liza Laws

Progressive supranuclear-palsy (PSP) is a very rare brain disease and until recently, it was almost unheard of. Along with many neurodegenerative diseases, it has a high unmet medical need.

UK pushes ahead with biggest clinical trial overhaul in 20 years

27-Mar-2023 By Ben Hargreaves

Amid uncertainty over the future of clinical trials in the UK, the MHRA announces that it will streamline the process of running trials to make the country a more ‘attractive destination’.

AbbVie receives CRL over drug delivery device

27-Mar-2023 By Ben Hargreaves

The US FDA demanded more information about the device, which would deliver ABBV-951 to patients, should the treatment be approved.

Acesion's positive trial data for treatment of atrial fibrillation

19-Mar-2023 By Liza Laws

Positive data from a phase 2 clinical trial has proven the general mechanism of action of SK channel inhibition for treatment of atrial fibrillation (AF), an abnormal heart rhythm.

Noema Pharma raises $112M in Series B financing for nervous system disorders

16-Mar-2023 By Liza Laws

Oversubscribed, series B financing for Noema Pharma’s clinical stage assets has been successfully closed raising $112 million from new and existing investors.

LG Chem targets becoming top 20 oncology company

14-Mar-2023 By Ben Hargreaves

After completing the acquisition of Aveo, the Korean chemical company wants its subsidiary to become a global leader in the therapeutic area within five years.

Janssen dual action tablet for prostate cancer gets recommended marketing authorization

13-Mar-2023 By Liza Laws

Small molecule drug, Niraparib combined with abiraterone acetate (AA) and prednisone (P) significantly reduces the risk of disease progression, or death, in patients with a type of prostate cancer, a consultant in Spain has said.

Frontotemporal dementia study expanded by Centogene

06-Mar-2023 By Liza Laws

Mutation in the progranulin (GRN) gene is just one of several hereditary factors that can cause frontotemporal dementia, a rare and rapidly progressive neurodegenerative disease.

Finch halts biotherapeutic trial and axes 95 per cent of its staff

26-Jan-2023 By Liza Laws

Finch Therapeutics announced its shock decision to discontinue the PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI) yesterday (Jan 25) saying instead it will focus on ‘realizing the value of its intellectual property estate and...

Bioethics International reveals index to score pharma on trial diversity

12-Jan-2023 By Ben Hargreaves

The not-for-profit organization published its fair inclusion score to measure and rank pharmaceutical companies on their inclusion of women, older adults, and racial and ethnic minoritized patients.

Novartis gets positive results back from oral therapy for PNH

13-Dec-2022 By Ben Hargreaves

The company announced Phase III results showing that hemoglobin levels were increased when patients were treated with investigational oral monotherapy, iptacopan.

Metrion leases facility, adds high-throughput capacity to support ion channel services

08-Dec-2022 By Nick Taylor

Metrion Biosciences has leased a new facility and added high-throughput screening (HTS) capacity to support its ion channel drug discovery projects.

Novartis plans to take malaria treatment through to P3 trials

28-Nov-2022 By Ben Hargreaves

Both Novartis and Medicines for Malaria Venture will progress an optimized version of lumefantrine into late-stage trials.

‘Data is the key’: Strategic partnership leverages AI for cancer clinical trial placement

23-Nov-2022 By Maggie Lynch

Partnership between Massive Bio and Azra AI extends clinical care teams bandwidth to place cancer patients in trials while eliminating unconscious bias.

Survey reveals decentralized clinical trial elements that drive participation in studies

16-Nov-2022 By Nick Taylor

In-home nurse visits, using familiar mobile devices to upload health data, and telemedicine calls with a doctor are the elements of decentralized clinical trials with the biggest positive impact on participation in future studies, according to a survey.

Castor bolsters trial solutions platforms to reach more patients and gain RWE

15-Nov-2022 By Maggie Lynch

Castor adds to its existing decentralized and hybrid clinical trial solutions platform to collect RWE, expand trials to global populations, and integrate virtual trial visits.

With endpoints already met, GSK halts trial into new antibiotic

14-Nov-2022 By Ben Hargreaves

The first oral antibiotic treatment for urinary tract infections in over 20 years appears to be possible, after interim analysis advised for trials to be stopped after endpoints were met.

Clario releases 20 years of data working on decentralized trials

10-Nov-2022 By Ben Hargreaves

The company reveals some of its data on the number of trials and patients that have been supported through its tools.

Oracle and ObvioHealth come together for ‘tight integration’ of data in APAC DCTs

10-Nov-2022 By Maggie Lynch

Oracle and ObvioHealth collaborate on clinical trial solutions using ObviGo to establish a “more complete clinical research ecosystem” in Asia Pacific region.

IQVIA cuts sales guidance as site staff shortages delay execution of deliveries

09-Nov-2022 By Nick Taylor

IQVIA has reduced its full-year sales guidance in response to factors including bottlenecks created by staff shortages at certain sites.

Medable targets oncology trials for decentralized offering

09-Nov-2022 By Ben Hargreaves

Medable announces the launch of a ‘patient-first’ oncology service that the company states will improve patient access, enrolment, and retention for clinical trials.

Industry body points to ‘clear and serious threat’ to clinical research in UK

26-Oct-2022 By Ben Hargreaves

The ABPI releases a report that shows the number of clinical trials taking place in the UK fell by a large amount between the years 2017 and 2021.

Benefiting from Bristol Myers’ input, ConcertAI rolls out digital trial solution

24-Oct-2022 By Nick Taylor

ConcertAI has introduced a digital trial solution informed by its collaboration with Bristol Myers Squibb to simplify patient identification, consent, IRB approval, and contract negotiations.

Ayala Pharmaceuticals reports promising data from Desmoid Tumors trial

19-Oct-2022

Updated interim results from Part A the RINGSIDE pivotal Phase 2/3 study of the company’s AL102 new drug showed consistent early tumor shrinkage with measures deepening over time, plus good tolerability at all doses.

Big Pharma backs push to compare carbon footprint of site-based and decentralized trials

19-Oct-2022 By Nick Taylor

The Pistoia Alliance has begun an initiative to measure and compare the carbon footprint of site-based and decentralized clinical trials.

Walmart steps into clinical trials claiming ability to improve diversity

18-Oct-2022 By Ben Hargreaves

Walmart joins rival retailers by launching its service for clinical trial recruitment, stating that it will focus on older, rural, women and minority populations.

Lightship and Acclinate partner to improve clinical trial diversity

11-Oct-2022 By Ben Hargreaves

The two companies will work together with the aim of increasing access and engagement in clinical trials for underrepresented populations.

TransCelerate CEO: Speeding drug development a ‘win-win’ for all concerned

28-Sep-2022

TransCelerate BioPharma continues to work towards “bringing new medicines to patients faster”. We caught up with the organization’s CEO to hear about its main achievements over the past decade and learn about what comes next.

Q&A: Precision for Medicine VP on the present & future of personalized medicine

27-Sep-2022

Outsourcing-Pharma caught up with Esther Mahillo, VP of Operational Strategy and Feasibility, Precision for Medicine to talk about advancements in patient enrollment in oncology and rare disease clinical trials.

Epic launches program to ‘unify’ clinical research with care delivery

22-Sep-2022 By Ben Hargreaves

Epic’s Life Sciences program is released with the aim to connect providers, pharmaceutical companies, and medical device manufacturers to recruit research participants, expand clinical trial access, and to speed up therapy development.

Thermo Fisher hails PPD’s wins of ‘very large’ customers following merger

20-Sep-2022 By Nick Taylor

Thermo Fisher Scientific’s clinical service unit PPD has won some “very large” customers since becoming part of the broader group in a mega-merger, according to CEO Marc Casper.

Australian CRO Avance buys C3 Research to support sponsors as programs advance

15-Sep-2022 By Nick Taylor

Australian CRO Avance Clinical has expanded in North America by acquiring C3 Research Associates, positioning it to continue supporting sponsors as they move into later-phase studies that need US sites.

ObvioHealth shares lessons from first fully-virtual urogynecology clinical trial

14-Sep-2022

The trial for Renovia’s leva Pelvic Health System used ObvioHealth’s platform to deliver real-time data while their virtual site team engaged with the patients via the app, resulting in a 94.5% compliance rate.

Bayer taps Clariness to build patient insights into clinical trial review process

13-Sep-2022 By Nick Taylor

Bayer Pharma has enlisted Clariness to support its new study review process by providing pre-clinical trial patient insights and post-trial feedback.

Use of RWE, AI elevating drug development: Sidley

12-Sep-2022 By Jenni Spinner

A fleet of legal professionals offers advice and perspective on important considerations when harnessing artificial intelligence and real-world evidence.

Real-world evidence helps accelerate research: Wolters Kluwer Health

12-Sep-2022 By Jenni Spinner

Experts from the health information specialist explain how the use of RWD and RWE has helped speed up and improve the development of therapies and vaccines.

Clarify, Datavant team up to securely connect first-party and real-world data

07-Sep-2022 By Nick Taylor

The companies will work together to help clients connect information sources, giving stakeholders a better overview of the clinical patient experience.

CVS Health agrees to acquire Signify Health

06-Sep-2022 By Jenni Spinner

With the purchase, the company is looking to advance its plans to connect with potential trial participants and spread awareness of study participation.

DTRA glossary aims to promote adoption of decentralized format

06-Sep-2022 By Jenni Spinner

The Decentralized Trials and Research Alliance is offering the research resource to increase awareness, understanding, and acceptance of the study format.

Patient-centric approach benefits more than the patient: Quanticate

06-Sep-2022 By Jenni Spinner

A representative from the biometric contract research organization explains how taking a ‘patient comes first’ attitude can lead to a range of improvements.