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Clinical Trials

Set Alert for Clinical Trials

Lilly/Pfizer’s Tanezumab Safety Takes A Hit With Latest Phase III Results

Larger of two doses of the NGF inhibitor hit two efficacy endpoints, but the rate of joint health outcomes on a composite measure was higher than control by a statistically significant margin.

Clinical Trials Drug Safety

Aptinyx Sees Path Forward In DPN With Long-Term Patients

After disappointing top-line Phase II data in diabetic peripheral neuropathy with NYX-2925, Aptinyx says the full dataset shows significance across endpoints in patients four years or more past diagnosis; a second Phase II study in this subgroup is planned.

Clinical Trials Business Strategies

BIO-Europe Spring 2019: RedHill Preps NDA Submission For Antibiotic Talicia

Gilead Raday, chief operating officer of RedHill Biopharma, talks to Lucie Ellis, executive editor of In Vivo, about recently published late-stage data and next steps for its antibiotic asset, Talicia (RHB-105), for the treatment of Helicobacter pylori infection. 

Clinical Trials Infectious Diseases

Further Iclaprim Analyses Ahead Of Crucial Months For Motif Bio

A 3 May meeting with the FDA is likely to be crucial for the future commercialization strategy for the biotech’s precision-targeted antibacterial.

Infectious Diseases Clinical Trials

CymaBay Following The Leaders, Pursues NASH, PBC Simultaneously

Biotech thinks its PPAR delta agonist will prove much more potent than Genfit’s elafibranor from the same class and will offer a better tolerability profile than Intercept’s OCA.

Liver & Hepatic Business Strategies

NASH News & Notes From The European Liver Meeting

Non-alcoholic steatohepatitis (NASH) was a focal point of EASL’s conference. Madrigal becomes the fifth company into Phase III in NASH, but Viking’s competing THR agonist is progressing also.

Liver & Hepatic Research & Development

India New Trial Rules - Sponsors Interested But 'FAQ' Could Help

India’s new clinical trial regulations could revive sponsor interest in the country, but some norms around local Phase III trial waivers appear open to interpretation and could potentially weigh down momentum.

Clinical Trials India

Cassiopea Hails Breezula's 'Good Hair Day' And Plans FDA Talks On Phase III

Italy-based Cassiopea says “very positive results” from Breezula's 12-month Phase II alopecia trial support progressing  it to Phase III, particularly given the clean safety profile.

Clinical Trials Companies

Pfizer Thinks First-In-Class KHK Mechanism Could Work For NASH, Diabetes

Pfizer has high hopes for ketohexokinase inhibition and other fat-reducing mechanisms in NASH. Data from a small study reported at EASL also suggest its KHK inhibitor could have utility in diabetes.

Liver & Hepatic Research & Development
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