Galapagos 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

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

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

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

A guide to clinical trials disrupted by the coronavirus pandemic

Since March, when COVID-19's effects began to be felt most acutely in the U.S., over 230 studies have been suspended, delayed or otherwise affected. 

By Nami Sumida • Updated May 15, 2020

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

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

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

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

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

Coronavirus 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

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

Big 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 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

Fosun, Pfizer to help BioNTech join the mRNA race for a coronavirus vaccine

BioNTech, like other mRNA vaccine developers, is moving at a record pace to begin studies of vaccine hopefuls. But the field's work remains unproven. 

By Ben Fidler • March 16, 2020

Top trends shaping clinical trial patient travel and reimbursement

New services offer clinical trial sponsors unmatched convenience, flexibility, and sophistication, while delivering measurable patient enrollment and engagement results.

March 16, 2020

AstraZeneca and Merck's string of Lynparza successes ends in ovarian cancer

Results from a Phase 3 combination study in the tumor type read out negative, marking a rare miss for the pharmas' fast-growing cancer drug. 

By Jonathan Gardner • March 12, 2020

Rubius scraps lead candidate as it exits rare disease drugmaking

The once richly valued biotech cited manufacturing challenges at a contractor as a factor behind delays to its red blood cell therapy for PKU disease. 

By Jacob Bell • March 12, 2020

Gates, Wellcome hatch $125M plan to speed coronavirus treatments

Gates Foundation, Wellcome and MasterCard aim to accelerate the study of existing and new drugs for current outbreak as well as for future pathogen threats.

By Jonathan Gardner • March 10, 2020

2 newer multiple myeloma drugs fall short in bid for wider market

Phase 3 trials of Bristol Myers Squibb's Emplicti and Takeda's Ninlaro showed no benefit to adding either drug to a Revlimid-based combination in newly diagnosed patients.

By Ned Pagliarulo • March 10, 2020

Acceleron shelves drug after disappointing readout

Despite hitting the main goal of a mid-stage neuromuscular study, Acceleron isn't convinced its drug offers meaningful improvement to muscle function or quality of life.​

By Jacob Bell • March 10, 2020

Hospitals dipping into emergency stocks to combat coronavirus

Community spread of COVID-19 has hospitals bracing for a rush of patients and payers waiving fees for telemedicine consults and extra drug supplies.

By Shannon Muchmore • March 10, 2020

Tracking biopharma's response to the new coronavirus

The ongoing outbreak is a huge test for the biopharmaceutical industry and its ability to supply, develop, and test new drugs without disruption. Keep up with all of BioPharma Dive's coverage here.

By Jacob Bell • Updated July 7, 2020