Category: Clinical Trials

Clinical Trials, Research and Development

FDA Places Clinical Hold on Allogene CAR-T Cancer Trials

October 8, 2021

Via: Genetic Engineering and Biotechnology News

Allogene Therapeutics saw its shares fall more than 40% in early trading Friday after acknowledging that the FDA had placed a clinical hold on its trials evaluating its allogeneic CAR T (AlloCAR T) therapies for cancer. Allogene said the clinical […]

Clinical Trials, Research and Development

FDA grants Enhertu Breakthrough Therapy Designation in breast cancer

October 4, 2021


The FDA granted BTD based on data from the DESTINY-Breast03 phase 3 trial presented during the European Society for Medical Oncology (ESMO) Congress 2021. The results of the phase 3 trial showed that Enhertu reduced the risk of disease progression […]

Clinical Trials, Research and Development

Bad news for Biohaven as verdiperstat flunks first phase 3 test

September 28, 2021

Via: Pharmaphorum

Myeloperoxidase (MPO) inhibitor verdiperstat was no better than placebo in the M-STAR trial in patients with MSA, and looks likely to be abandoned for this indication. It’s not the end of the line for the drug, which Biohaven picked up […]

Clinical Trials, Research and Development

Trials Show COVID Vaccines Well Worth It for Cancer Patients

September 24, 2021


If you have cancer and you think coronavirus vaccines may do you little good, don’t let your hesitation stop you from getting the shots: A pair of clinical trials finds that patients’ immune systems ramped up after vaccination. The findings […]

Clinical Trials, Research and Development

Excision’s CRISPR gene editing therapy for HIV is heading into human testing after FDA clearance

September 17, 2021

Via: FierceBiotech

A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing. Excision BioTherapeutics will usher the CRISPR-based therapy EBT-101 into clinical trials after the FDA cleared an investigational new drug application, according […]

Clinical Trials, Research and Development

Amgen, AstraZeneca dig into data from phase 3 asthma trial, emerging with evidence of efficacy in hard-to-treat subgroup

September 7, 2021

Via: FierceBiotech

Piece by piece, Amgen and AstraZeneca are building the case for their potential asthma blockbuster. The latest brick to fall into place comes from a new slice of phase 3 data, which suggests tezepelumab may be particularly effective in a […]

Clinical Trials, Research and Development

Data points to big win for Jardiance in hard-to-treat heart failure

August 31, 2021

Via: Pharmaphorum

SGLT2 inhibitor Jardiance (empagliflozin) reduced a composite of cardiovascular (CV) death or hospitalisations for heart failure by a significant 21% compared to placebo in HFpEF, regardless of diabetes status, according to results presented at the European Society of Cardiology (ESC) […]

Clinical Trials, Industry, Pharma, Research and Development

Pfizer drug bests Sanofi, Regeneron’s Dupixent in head-to-head study

August 30, 2021

Via: Biopharma Dive

Abrocitinib is one of Pfizer’s top experimental therapies, pegged by the drugmaker for several billion dollars in peak annual sales in the future. But its fate, along with the fate of two other drugs from AbbVie and Lilly that are […]

Clinical Trials, Research and Development

Predicting and improving clinical trial enrolment: A problem for psychiatry

August 6, 2021

Via: Pharmaphorum

The reasons behind this problem, however, are rarely studied or understood. Despite this, new strategies devised over the last five years are beginning to reverse the trend, and both reduce stigma and increase awareness to funnel new patients into these […]

Clinical Trials, Research and Development

EC Confirms Go-Live Date for Clinical Trials Information System

August 5, 2021

Via: Biopharm International

The European Commission (EC) has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022. Notification of the entry into the […]

Clinical Trials, Research and Development

Another one BiTEs the dust as Amgen pauses enrollment for phase 1 bispecific trial

August 4, 2021

Via: FierceBiotech

It’s another one gone and another one gone for Amgen, as the pharmaceutical giant reported the latest clinical stoppage for a bispecific T-cell engager, or BiTE, therapy. Amgen has stopped enrolling acute myeloid leukemia patients in a phase 1 clinical […]

Clinical Trials, Research and Development

Sage scraps 2 zuranolone trials deemed unnecessary for approval

August 3, 2021

Via: FierceBiotech

Sage Therapeutics has terminated two long-suspended phase 3 zuranolone clinical trials after talks with the FDA led it to believe it can seek approval without the data. The biotech shared the update alongside news of a delay to data from […]