Clinical Trials

15 Feb 2019
- Clinical Trials
- Human Trials
Boehringer Ingelheim and Lilly announce the CAROLINA cardiovascular outcome trial of Tradjenta met its primary endpoint of non-inferiority compared with glimepiride

By PBR Staff Writer

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced CAROLINA (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) met its primary endpoint, defined as non-inferiority for Tradjenta (linagliptin) versus glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE).
13 Feb 2019
Clinical Trials
Human Trials
Boehringer Ingelheim, IBM to integrate blockchain technology into clinical trials

By PBR Staff Writer

Boehringer Ingelheim (Canada) and IBM Canada announced at the Healthcare Information and Management Systems Society (HIMSS) conference in Orlando, Florida, their plans to explore the use of blockchain technology in clinical trials.
12 Feb 2019
Clinical Trials
Human Trials
Gilead’s liver disease drug selonsertib fails to meet primary endpoint in Stellar-4 study

By PBR Staff Writer

Gilead Sciences has announced topline data from the phase 3 Stellar-4 study of its liver disease treatment selonsertib in compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH).
12 Feb 2019
Clinical Trials
Human Trials
NeoTX enters into immuno-oncology clinical trial collaboration with AstraZeneca

By PBR Staff Writer

NeoTX Therapeutics has entered into a clinical collaboration with AstraZeneca Group’s global biologics research and development arm, MedImmune to support Phase 1b/2 studies investigating NeoTX’s naptumomab estafenatox in combination with IMFINZI (durvalumab).
06 Feb 2019
Clinical Trials
Human Trials
Moderna announces dosing of first monoclonal antibody encoded by mRNA in clinical trial

By PBR Staff Writer

Moderna has announced the dosing of the first subject in a phase 1 clinical trial evaluating the safety and tolerability of escalating doses of mRNA-1944 via intravenous infusion in healthy adults.
05 Feb 2019
Clinical Trials
Human Trials
Eisai, Purdue Pharma present efficacy and safety data from second phase 3 study of lemborexant

By PBR Staff Writer

Eisai and Purdue Pharma announced six-month results from SUNRISE 2, a long-term Phase 3 clinical study evaluating the efficacy and safety of lemborexant, an investigational agent being developed for the treatment of insomnia, a sleep-wake disorder.
05 Feb 2019
Clinical Trials
Human Trials
Verseon begins dosing in phase 1 trial of VE-1902 oral anticoagulant

By PBR Staff Writer

Verseon has started dosing of its lead blood thinner candidate VE-1902 in a phase 1 trial held in healthy volunteers at Nucleus Network in Melbourne, Australia.
04 Feb 2019
Clinical Trials
Patient Enrollment
Newron completes patient enrollment in STARS Study

By PBR Staff Writer

Newron Pharmaceuticals has announced the successful completion of patient enrollment in its STARS (Sarizotan for the Treatment of Apneas in Rett Syndrome) clinical study.
31 Jan 2019
Clinical Trials
Human Trials
Eureka Therapeutics announces US FDA clearance of IND application for trial of ET140202 Artemis T-Cell therapy

By PBR Staff Writer

Eureka Therapeutics, a clinical stage biotechnology company developing antibody-TCR (AbTCR) T-cell therapies, announced that the US Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for ET140202 ARTEMIS T-cell therapy in AFP-positive patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer.
31 Jan 2019
Clinical Trials
Human Trials
Genentech halts two phase 3 AD trials of crenezumab over futility

By PBR Staff Writer

Roche’s Genentech has decided to stop two phase 3 trials evaluating its anti-beta-amyloid molecule crenezumab in early Alzheimer’s disease (AD) for futility reasons.

Drug Discovery

Research & Development

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Clinical Trials

Patient Enrollment

Newron completes patient enrollment in STARS Study

Vaccinex completes enrollment for SIGNAL Huntington’s disease trial

Regulation

Drug Filing

FDA extends review period for Incyte’s GVHD treatment Jakafi

AstraZeneca’s RSV drug MEDI8897 gets FDA’s breakthrough therapy designation

Production & Sales

Manufacturing

Neuraxpharm acquires CNS specialty pharma company Farmax

Hitachi Chemical to acquire apceth Biopharma

Packaging & Supply Chain

Packaging

PCI Pharma announces bottling line expansion at Rockford site

PCI announces further investment in infrastructure for packaging of controlled substances

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Clinical Trials

Boehringer Ingelheim and Lilly announce the CAROLINA cardiovascular outcome trial of Tradjenta met its primary endpoint of non-inferiority compared with glimepiride

Boehringer Ingelheim, IBM to integrate blockchain technology into clinical trials

Gilead’s liver disease drug selonsertib fails to meet primary endpoint in Stellar-4 study

NeoTX enters into immuno-oncology clinical trial collaboration with AstraZeneca

Moderna announces dosing of first monoclonal antibody encoded by mRNA in clinical trial

Eisai, Purdue Pharma present efficacy and safety data from second phase 3 study of lemborexant

Verseon begins dosing in phase 1 trial of VE-1902 oral anticoagulant

Newron completes patient enrollment in STARS Study

Eureka Therapeutics announces US FDA clearance of IND application for trial of ET140202 Artemis T-Cell therapy

Genentech halts two phase 3 AD trials of crenezumab over futility

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Research & Development

Patient Enrollment

Drug Filing

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