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Home » Authors » Brian Orelli

Articles by Brian Orelli

Hand holding IPO, financial icons

IPOing in a pandemic: How to raise $100M+ from your spare bedroom

May 26, 2020
By Brian Orelli
The pandemic hasn't kept biotechs from going public. In fact, through the first five or so months of the year, the industry has raised more than $3.3 billion through IPOs, more capital than biotechs have raised during the first five months of any of the previous 20 years.
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Doctor and patient consultation

Clinical trials still lack diversity, FDA encouraging inclusiveness

May 18, 2020
By Brian Orelli
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.
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Leukemia illustration
The umbralisib and ublituximab band

TG Therapeutics sings U2 interim success in CLL

May 5, 2020
By Brian Orelli
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).
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Cancer cell, dropper, test tubes
AACR 2020

New drugs on the horizon highlighted at AACR

April 28, 2020
By Brian Orelli
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.
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Antibodies
1+1=5

After a slow start, bispecific antibody space takes off

April 27, 2020
By Brian Orelli
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.
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Telehealth illustration
COVID-19

Amid pandemic, companies scramble to salvage trials, move virtual

April 14, 2020
By Brian Orelli
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.
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Telehealth illustration
COVID-19

Amid pandemic, companies scramble to salvage trials, move virtual

April 13, 2020
By Brian Orelli
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.
Read More

Menlo's serlopitant whiffs in two phase III studies

April 6, 2020
By Brian Orelli
Menlo Therapeutics Inc. announced a double dose of bad news with negative results for two phase III trials testing its NK1 receptor antagonist, serlopitant, as a treatment for pruritus (itch) associated with prurigo nodularis, a skin disease characterized by hard, itchy nodules.
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Head filled with digital data
'It's really not going to scale'

Companies face challenges with increasing clinical trial data sources

March 24, 2020
By Brian Orelli
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.
Read More
Biocom panel
Biocom Global Life Sciences Partnering Conference

Pharmas share their needs, wants and offer some advice

March 2, 2020
By Brian Orelli
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.
Read More
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