Clinical Trials
-
GlaxoSmithKline
GSK bets $250M on Vir's antibody approach to treating coronavirus
The companies aim to advance two antibodies developed by Vir directly into Phase 2 testing within the next three to five months, pending regulatory OK.
By Jonathan Gardner • April 06, 2020 -
Incyte
Incyte, Novartis to test repurposed cancer drug in COVID-19
The drugmakers, which are partnered on Incyte's therapy Jakafi, plan to quickly start Phase 3 trials in patients with inflammatory responses tied to COVID-19.
By Ned Pagliarulo • April 03, 2020 -
Elizabeth Regan / Industry Dive
A small NASH drugmaker finds positive data, but coronavirus makes for a 'tricky' path forward
Results from a mid-stage study showed Akero Therapeutics' experimental drug could reduce liver fat in NASH patients, sending shares higher.
By Jacob Bell • March 31, 2020 -
Merck's search for growth outside Keytruda may not end in heart disease
A study of vericiguat, which Merck is developing with Bayer, found the drug kept patients with declining heart function out of the hospital, but couldn't delay death.
By Jonathan Gardner • March 30, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49655318098/in/album-72157713108522106/.
J&J picks top coronavirus vaccine candidate; human tests to start in September
Together with BARDA, the pharma has agreed to spend $1 billion co-funding vaccine research, development and testing.
By Jacob Bell • March 30, 2020 -
Shutterstock.com/goodluz
Sponsored by YourwayStorage and distribution support for clinical trials worldwide
Patient centricity has moved to the forefront of clinical trials. Direct-to-patient services provide convenience and lead to greater participation and retention, addressing two key challenges that face study sponsors.
-
Getty Images
Sanofi adds mRNA to coronavirus vaccine push
A deal with Translate Bio to develop an mRNA-based vaccine adds the newer technology to the French pharma’s pandemic response.
By Jonathan Gardner • March 27, 2020 -
Gilead Sciences Inc.
For CAR-T, coronavirus brings uneven impact to studies, treatment
Cancer cell therapy, approved only for the very sick, depends on a complex and precisely timed series of steps, all of which could be disrupted by COVID-19.
By Ned Pagliarulo • March 27, 2020 -
Getty Images
In rare move, Gilead gives up 'orphan' status for experimental coronavirus drug
After sparking controversy, the biotech asked the FDA to rescind a designation designed to encourage research into therapies for rare diseases.
By Jonathan Gardner • March 25, 2020 -
Courtesy of Galapagos
Q&AGalapagos CEO talks next steps as coronavirus stalls the biotech's top drug
The Belgian drugmaker announced this week that a series of Phase 2 and Phase 3 studies for filgotinib, an immune system regulator, had paused enrollment because of safety concerns related to COVID-19.
By Jacob Bell • March 25, 2020 -
ASCO / Todd Buchanan
Coronavirus forces ASCO, cancer research's top meeting, to move online
State governments, including ASCO's host state of Illinois, are calling for residents to stay home, making the prospect of holding a meeting that draws thousands untenable.
By Ned Pagliarulo • March 24, 2020 -
Novavax's positive flu data bring a stock bump and a spotlight on coronavirus vaccine
A large study found Nanoflu to be non-inferior to Sanofi's Fluzone. Safety results, meanwhile, will add to a database that Novavax said it will use to support its COVID-19 program.
By Jacob Bell • March 24, 2020 -
Photo illustration by Danielle Ternes/BioPharma Dive; photograph by PeopleImages/E+ via Getty Images
A guide to clinical trials disrupted by the coronavirus pandemic
Many more smaller biotechs are now reporting delays, including this week Fate Therapeutics, Novocure, Atara Biotherapeutics and Denali Therapeutics.
By Nami Sumida • UPDATED: March 31, 2020 at 11:49 a.m. -
Courtesy of Roche
Leukemia drug from Roche, AbbVie extends survival, study finds
Paired with chemotherapy, Venclexta succeeded in a Phase 3 acute myeloid leukemia trial just weeks after falling short in another combination study.
By Jonathan Gardner • March 23, 2020 -
Lilly, Galapagos halt trials as coronavirus deepens impact on drug research
The moves likely herald similar announcements by other large drugmakers as medical centers focus resources on treating patients with COVID-19.
By Ben Fidler • UPDATED: March 23, 2020 at 4:45 p.m. -
Remdesivir, chloroquine move to forefront as White House tries to speed coronavirus response
Neither drug is approved for COVID-19, but officials seek to quickly study both in hopes of finding an answer for U.S. coronavirus patients.
By Jonathan Gardner • March 19, 2020 -
In hard-hit Seattle, coronavirus pushes biotechs to a new normal
Local drugmakers are on the frontlines of a pandemic that's affecting travel, clinical research and daily operations. It's forcing them to adapt quickly.
By Jacob Bell • March 19, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49565892277/in/album-72157713108522106/.
Despite 'heroic' effort, coronavirus study finds little benefit to repurposed HIV drug
Results from the trial are the first randomized data to emerge from scores of studies testing repurposed antivirals in patients infected with the coronavirus.
By Ned Pagliarulo • March 18, 2020 -
Jacob Bell / BioPharma Dive
FDA maps out plan for trials as coronavirus starts to threaten drug research
The agency is trying to get ahead of what could be widespread protocol changes to ongoing clinical trials.
By Ben Fidler • March 18, 2020 -
Getty
Sage redraws its plans for failed antidepressant drug
Hoping to chart a path forward after a damaging study setback, Sage will start three new trials of zuranolone this year.
By Ned Pagliarulo • March 18, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.
Q&ACoronavirus led one biotech to pause a key trial, as more begin to follow
Clinical trial timelines are being threatened amid social distancing and a widening outbreak. Provention Bio's decision to suspend a study on Monday was one of the first publicly disclosed examples.
By Ben Fidler • UPDATED: March 18, 2020 at 10:06 a.m. -
CDC/Alissa Eckert, MS. "covid-19 coronavirus on black background". Retrieved from https://www.cdc.gov/media/subtopic/images.htm.
No White House offer for coronavirus vaccine access, CureVac says
An abrupt exit by CEO Daniel Menichella following a meeting with President Donald Trump, and the medical leave taken this week by his successor, were "pure coincidence," a board member said.
By Jonathan Gardner • March 17, 2020 -
Permission granted by University of Pennsylvania
Deep DiveBig pharma shied away from gene therapy for years. Academia picked up the slack
The byproduct was richer licensing fees for universities and a throng of startups, but also questions on fair prices and research priorities.
By Jonathan Gardner • March 17, 2020 -
Regeneron
Regeneron expects its antibody cocktail for coronavirus to enter human testing in early summer
The biotech is prepping manufacturing facilities so that, once the top antibody contenders are selected, clinical production can quickly begin. By the end of the summer, the aim is to make hundreds of thousands of doses per month.
By Jacob Bell • March 17, 2020 -
Regeneron and Sanofi speed Kevzara into coronavirus trials
Positive signs from a Chinese test of Roche's Actemra support the companies' decision to start studying their anti-inflammatory drug against COVID-19.
By Jonathan Gardner • March 16, 2020
