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Final milestone reached in Cytisinicline Phase III trial
Cytisinicline nears Phase III completion with final data collection from last enrolled subject.
Nanoscope's gene therapy nabs Phase II win in retinitis pigmentosa
MCO-010 met its primary endpoint in a small, sham-controlled Phase IIb trial targeting retinitis pigmentosa.
Positive topline data for Bolt’s BDC-1001 in HER2 solid tumours
BDC-1001 will be further investigated in several Phase II programmes in collaboration with BMS and Roche.
MediMergent uses digital clinical trials platform in cancer trial
The study is using MediMergent’s technology to capture the voice of the patient.
Affimed begins subject dosing in acute myeloid leukaemia therapy trial
The trial will assess the pharmacodynamics, pharmacokinetics, tolerability, and safety of AFM28 monotherapy.
Vaccitech’s chronic Hepatitis B drug sees positive topline data
The Phase Ib/IIb trial has met its primary and secondary endpoints in people with chronic Hepatitis B (HBV) infection.
Intra-Cellular reports positive Phase III trial of Caplyta in MDD and bipolar depression
Intra-Cellular’s Caplyta met the primary and key secondary endpoints of a Phase III trial for mixed features of major depressive disorder and bipolar depression.
German regulator grants approval for Thermosome to begin THE001 trial
The trial’s primary endpoints are THE001’s safety and tolerability and determination of the maximum tolerated dose.
Revive enrols first patient into psilocybin trial for substance use disorder
The Phase I/II trial will investigate psilocybin-assisted psychotherapy with topline results expected in Q3 2023.
Clario introduces Federated Identity Management system
The new FIM system allows users to enforce their own security policies across Clario’s Clinical Platform.
Keytruda plus chemotherapy reduce risk of endometrial cancer
Merck’s Phase III trial results demonstrate improved progression-free survival if chemotherapy treatment is complemented with Keytruda.
Further disappointment for anti-TIGITs: is there a future for this novel target?
An update from Merck & Co on its KeyVibe-002 trial featuring the TIGIT inhibitor vibostolimab, co-formulated with Keytruda (pembrolizumab), with…
Ionis and AstraZeneca report additional positive topline data from a Phase III ATTRv-PN trial
Eplontersen demonstrated statistically significant and clinically meaningful changes in patients with ATTRv-PN at 66 weeks of treatment.
Novartis Phase III Kisqali trial meets primary endpoint of iDFS
The findings showed that Kisqali plus ET reduced the risk of disease recurrence compared to ET alone.
FDA to hold Advisory Committee meeting for BrainStorm’s NurOwn in ALS
In a surprising about-face, the FDA will convene an Advisory Committee to review BrainStorm Cell Therapeutics’s stem cell therapy NurOwn for ALS.
YS Biopharma reports positive data from Covid-19 vaccine trial
The trial assessed the safety, and efficacy of a booster dose of PIKA recombinant protein Covid-19 vaccine.
Novo Nordisk announces positive results from oral semaglutide trial
The PIONEER clinical programme evaluated the effects of the drug on HbA1c and body weight in people with type 2 diabetes.
Consumption of ultra-processed foods increases cancer risk
Noncommunicable diseases (NCDs), such as cardiovascular diseases, type 2 diabetes and some cancers, are collectively responsible for around 74% of…
US FDA releases draft guidance for cancer clinical trials
The draft guidance discusses ways to improve the data available for accelerated approval.
Neurelis announces dosing of first two cohorts in CCM therapy trial
The trial will assess the tolerability, pharmacokinetic parameters, and safety of NRL-1049 in healthy participants.
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