Moderna delivers first human data for a coronavirus vaccine

The first volunteers who received low or medium doses of Moderna's vaccine produced what look to be meaningful immune responses, but it's unclear whether that will lead to disease prevention.

By Ben Fidler • May 18, 2020

Safety questions linger as Pfizer preps Duchenne gene therapy for final test

New data presented at the American Society of Gene & Cell Therapy's yearly meeting show promise, but also side effects that haven't been seen with a rival treatment from Sarepta.

By Ben Fidler • May 15, 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

Ousted BARDA director: Hydroxychloroquine push distracted government scientists

Safety concerns led to a clash over how widely to distribute the malaria pill for use against COVID-19, Rick Bright testified to Congress Thursday. 

By Jonathan Gardner • May 14, 2020

Allogene gives first look at an 'off the shelf' cell therapy for lymphoma

Donor-derived cell therapy has been a goal for drugmakers since CAR-T arrived several years ago. New data from Allogene could offer "proof of concept."

By Ben Fidler • May 13, 2020

Roche unveils first data for new type of cancer immunotherapy

Study results for a new type of checkpoint inhibitor were mixed, offering signs of promise as well reasons for caution.

By Ned Pagliarulo • May 13, 2020

J&J myeloma data heat up cell therapy battle

Bristol Myers' regulatory stumble opens the door for other companies developing CAR-T therapies for multiple myeloma to catch up. ASCO data released Wednesday show J&J could be closing the gap.

By Jonathan Gardner • May 13, 2020

A closer look at the race to develop antibody drugs for COVID-19

Eli Lilly, Regeneron and China's Junshi are now testing antibody drugs in clinical trials, while others are close behind. Here's why they will matter.

By Ben Fidler • May 12, 2020

GenFit delivers latest NASH drug failure

The negative results for GenFit's elafibranor deal another another blow to the NASH field, which has seen only one drug make it through late-stage testing.

By Jacob Bell • May 11, 2020

MyoKardia pops as heart drug passes most important test

A late-stage study found patients with a condition similar to heart failure fared better when given MyoKardia's drug. The results sent company shares soaring.

By Jacob Bell • May 11, 2020

Moderna plans earlier start to late-stage test of coronavirus vaccine

A Phase 3 trial of Moderna's experimental vaccine could begin in early summer, several months sooner than what was already an ambitious target for starting this fall.

By Ned Pagliarulo • May 7, 2020

Novo's diabetes drug also appears to work in NASH

Results from a Phase 2 study showed three doses of Novo's semaglutide were better than placebo at resolving the liver disease without worsening fibrosis.

By Jacob Bell • May 6, 2020

Pfizer, BioNTech launch U.S. trial of coronavirus vaccine

Initial vaccine data are expected within weeks as biotech and pharma companies intensify their search for a way to prevent the spread of COVID-19.

By Jonathan Gardner • May 5, 2020

Akebia, chasing FibroGen, nears FDA review with new anemia pill data

The company is one of several aiming to upend the market for injectable anemia biologics, which generate billions of dollars in yearly sales.

By Ben Fidler • May 5, 2020

A coronavirus vaccine may arrive next year. 'Herd immunity' will take longer.

Experimental vaccines for COVID-19 are moving at an unprecedented pace. But that could mean researchers won't definitively know whether they're safe and effective when they do arrive.

By Jonathan Gardner • May 4, 2020

Gilead's remdesivir, shown to hasten COVID-19 recovery, cleared for emergency use by FDA

In a remarkably rapid turn, the FDA authorized the antiviral drug two days after positive results were announced from a closely watched government-run clinical trial.

By Ned Pagliarulo • Updated May 1, 2020

Agios drops as COVID-19 takes a toll on drug studies

The biotech listed nine studies in which it expects coronavirus-related effects on patient enrollment or data collection, including two late-stage trials of its closely watched drug mitapivat​​.

By Jacob Bell • May 1, 2020

'We really did need a win.' Gilead drug no knockout in COVID-19, but results spur optimism

Doctors interviewed by BioPharma Dive said results from an important clinical trial of remdesivir were encouraging, even if its benefit seemed only modest.

By Ned Pagliarulo • April 30, 2020

AstraZeneca, racing past rivals, throws its weight behind Oxford's COVID-19 vaccine

The British drugmaker will take over development of an experimental vaccine that could produce its first clinical results next month.

By Ben Fidler • April 30, 2020

Iqvia cuts sales forecasts as coronavirus pandemic hits trial sites

The company, which helps biotech and pharma firms across the globe run clinical trials, said 80% of research sites are inaccessible due to travel restrictions enacted during the outbreak. 

By Kristin Jensen • April 29, 2020

Gilead drug for COVID-19 clears crucial clinical test

Data from an NIH-led study showed the antiviral therapy helped to speed recovery in patients hospitalized with coronavirus disease.

By Ned Pagliarulo • Updated April 29, 2020

Thrive, chasing Grail with a cancer blood test, finds tumors in seemingly healthy women

A first-of-its-kind trial of 10,000 women supported the test's potential to catch some cancers early. Whether it can truly help people, however, is not yet clear.

By Ben Fidler • April 28, 2020

Pfizer resumes trial recruitment suspended by coronavirus

After pausing enrollment into many studies in March, Pfizer is beginning to resume clinical activities at sites that are currently operational.

By Jonathan Gardner • April 28, 2020

Repurposed arthritis drug disappoints in closely watched COVID-19 trial

A study of Regeneron and Sanofi's Kevzara will continue, but only for patients in the most critical condition after an early look suggested less-severe patients did worse than those taking placebo.

By Jonathan Gardner • April 27, 2020

Regeneron, Sanofi immunotherapy extends survival in previously untreated lung cancer

In a boost to the companies' come-from-behind immunotherapy bid, their drug Libtayo helped patients live longer than did chemotherapy. Improving on Keytruda, however, will be more challenging.

By Ned Pagliarulo • April 27, 2020

Axsome, beating the odds, finds success treating Alzheimer's agitation

The biotech's drug, which has shown promise in treating depression, pulled off an unusual feat in hitting the main goal of a late-stage Alzheimer's study.

By Jacob Bell • April 27, 2020