Inovio begins first human test of experimental coronavirus vaccine

The biotech follows Moderna and China-based CanSino Biologics into the clinic with a vaccine, some three months after designing it. 

By Ned Pagliarulo • April 7, 2020

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 6, 2020

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

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 3, 2020

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

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

Storage 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. 

March 30, 2020

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

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

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

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

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