NGM’s closely-watched NASH prospect flops, cutting shares in half and spurring R&D rethink

A phase 2b trial of NGM Biopharmaceuticals’ aldafermin in nonalcoholic steatohepatitis (NASH) has missed its primary endpoint, sending shares in the biotech tumbling. NGM has pulled plans to enter phase 3 in light of the midstage failure of the FGF19 analog. California-based NGM ramped up expectations for aldafermin last year when it delivered midphase data linking […]

DECENTRALIZED TRIALS & RESEARCH ALLIANCE (DTRA) LAUNCHES TO DEMOCRATIZE AND ACCELERATE CLINICAL TRIALS

December 10, 2020 – An historic alliance of life sciences and healthcare organizations seeks to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The Decentralized Trials & Research Alliance (DTRA) plans to unite stakeholders, including healthcare companies, regulators, patient groups and research organizations, with a mission to make clinical trial participation widely accessible […]

Japan Grants Patent to Brainstorm Covering Technique for NurOwn

The Japan Patent Office has granted a patent to Brainstorm Cell Therapeutics covering the proprietary technique that generates the company’s cell-based therapy NurOwn from mesenchymal stem cells (MSCs). Through this technique, researchers can harness MSCs directly from a patient and mature them into cells that produce high levels of neurotrophic factors, which are compounds that […]

Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta® (ofatumumab) in newly diagnosed treatment-naïve adults with relapsing multiple sclerosis

New post hoc data from Phase III ASCLEPIOS trials showed newly diagnosed, treatment-naïve patients experienced reductions in annualized relapse rates, MRI lesion activity and reductions in time to disability worsening when treated with Kesimpta vs teriflunomide(1) Additional safety data in over 1,800 patients who continued Kesimpta treatment or switched therapy from previous studies reinforce the […]

Trump Administration’s Operation Warp Speed Accelerates AstraZeneca COVID-19 Vaccine to be Available Beginning in October

Responding to President Trump’s call to develop 300 million doses of SARS-CoV-2 vaccine by January under Operation Warp Speed, the U.S. Department of Health and Human Services (HHS) and AstraZeneca are collaborating to make available at least 300 million doses of a coronavirus vaccine called AZD1222, with the first doses delivered as early as October […]

NOVARTIS IMMUNO-ONCOLOGY DRUG CANDIDATE FAILS SKIN CANCER TRIAL

ZURICH (Reuters) – Swiss drugmaker Novartis said on Saturday that its investigational spartalizumab immuno-oncology drug mixed with the approved medicines Tafinlar and Mekinist failed in a late-stage trial for a type of advanced skin cancer. The drug did not improve progression-free survival in previously untreated patients with BRAF V600 mutation-positive cutaneous melanoma, compared to Tafinlar […]

Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19

FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ — Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) […]