Women, black and Hispanic/Latinx participants were underrepresented in pivotal clinical trials for drugs approved from 2007 to 2017, according to a new report by the Tufts Center for the Study of Drug Development. In the pivotal clinical trials, 44.9% of patients were women. Participants who identified as black or of African descent were the most underrepresented participant group, representing 5.4% of participants in clinical trials.

TG Therapeutics Inc. got a dose of good news when the independent data safety monitoring board recommended that the UNITY-CLL study be stopped early for superior efficacy after an interim analysis showed its umbralisib and ublituximab combination (U2) helped patients with chronic lymphocytic leukemia (CLL).

CYBERSPACE – At a series of new drugs on the horizon sessions at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I, a variety of companies presented preclinical and clinical data for promising early stage oncology products.

Blincyto (blinatumomab, Amgen Inc.), the first FDA-approved bispecific antibody, gained regulatory approval in 2014, but the intervening years have been fairly bleak for bispecific antibodies as companies worked through technical challenges.

In order to redirect health care resources and protect patients during the COVID-19 pandemic, many drug companies have paused enrollment in some or all of their ongoing clinical trials.

In order to redirect health care resources and protect patients during the COVID-19 pandemic, many drug companies have paused enrollment in some or all of their ongoing clinical trials. But patients still in the studies need to be followed for safety and efficacy, creating challenges for the industry.

A survey of 149 companies by Tufts Center for the Study of Drug Development found more than two-thirds of clinical trial sponsors were using or piloting at least four different data sources in their clinical trials.

SAN DIEGO – At the Biocom 10th Annual Global Life Sciences Partnering Conference, panels of pharma executives highlighted what they're looking for to supplement their pipelines and offered advice that ran the gamut from company formation to the courting process to strategies for partnering pipeline drugs and platforms.

SAN DIEGO – At Biocom's 10th Annual Global Life Sciences Partnering Conference, a panel of players intimately familiar with last year's approval of myelofibrosis treatment Inrebic (fedratinib) explained the backstory of how they got the JAK2 kinase inhibitor off an FDA clinical hold, wrangled the rights to the drug back from the big pharma owner that had acquired the drug from Targegen Inc. and eventually helped the drug gain FDA approval after selling the rights to another large company.