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

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

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

AstraZeneca immunotherapy combination falls short in bladder cancer trial

Results from a Phase 3 bladder cancer study combining two checkpoint inhibitors failed to show a survival benefit, raising questions about other trials.

By Jonathan Gardner • March 6, 2020

Coronavirus spread threatens spring slate of medical meetings

The American College of Cardiology and the American Academy of Allergy, Asthma and Immunology canceled their annual meetings, previously scheduled for March.

By Ned Pagliarulo • Updated March 9, 2020

A closer look at the Ebola drug that's become the top hope for a coronavirus treatment

Trials are underway in the U.S., China and, soon, other Asian countries to test whether remdesivir, an antiviral developed by Gilead, could have potential against SARS-CoV-2.

By Ned Pagliarulo • March 5, 2020

Takeda starts work on treatment for coronavirus illness

The plan is to take blood proteins of patients recovering from the novel virus and turn them into an immune-boosting therapy that mitigates or prevents illness in others.

By Jacob Bell • March 4, 2020

In a CRISPR first, Editas therapy used to fix genes in the body

A patient with a severe type of inherited blindness was recently treated with Editas and Allergan's CRISPR medicine, marking the first in vivo use of the gene-editing technology in adults. 

By Ned Pagliarulo • March 4, 2020

Karyopharm shares jump on positive study data for multiple myeloma drug

The cancer biotech now plans to ask the FDA to expand Xpovio's approval into earlier lines of treatment for the blood cancer.

By Ned Pagliarulo • March 2, 2020

Sangamo sees vindication in Biogen gene-editing deal

Delivering products nearly ready for clinical testing has sparked greater dealmaking interest from big pharma, Sangamo's CEO told BioPharma Dive.

By Jonathan Gardner • Feb. 28, 2020