'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

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

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

Sanofi CEO cautions arthritis drug a 'long shot' in COVID-19, says study results 'imminent'

The drugmaker, along with partner Regeneron, is studying whether Kevzara can ease the severe respiratory symptoms experienced by some patients.

By Ned Pagliarulo • April 24, 2020

Another step for PARPs as AstraZeneca, Merck drug extends lives in prostate cancer

Lynparza is now the first PARP inhibitor to help prostate cancer patients live longer versus hormone therapy, giving it an edge over rival Rubraca.

By Ben Fidler • April 24, 2020

Leaked data on Gilead's remdesivir suggest drug didn't help patients with COVID-19

Summary results from a study conducted in China were posted in error to the WHO's website Thursday, and painted a discouraging picture of the drug's effect on the disease.

By Ned Pagliarulo • Updated April 23, 2020

Malaria drug's potential against coronavirus dims as data mounts

Hydroxychloroquine drew praise from President Donald Trump and TV doctors, but recent NIH guidelines and preliminary data build a case against its use.

By Jonathan Gardner • April 22, 2020

Coronavirus vaccine from BioNTech, Pfizer set to enter testing in Germany

The study will test four versions of BioNTech's mRNA vaccine in 200 healthy volunteers, and is the first to be cleared to begin in Germany. 

By Ned Pagliarulo • April 22, 2020

BARDA director says he was ousted for 'clashes' with HHS over unproven therapies

In an extraordinary statement, Rick Bright said he was forced out as head of BARDA after disagreeing with department leadership on use of unproven malaria pills to treat COVID-19.

By Ned Pagliarulo • Updated April 22, 2020

Trial data help small biotech ready its anti-itch drug for approval

Korsuva, a drug from Cara Therapeutics, has now succeeded in two Phase 3 trials in chronic kidney disease patients, setting the stage for potential approval filings in the U.S. and Europe.

By Jonathan Gardner • April 21, 2020

Positive data keep Bristol Myers and Exelixis in the kidney cancer race

A combination of Opdivo with Exelixis' Cabometyx, if cleared for use, would compete against an approved pairing of Merck's Keytruda and Pfizer's Inlyta.

By Jonathan Gardner • April 20, 2020

Novartis, launching COVID-19 trial, seeks to prove hydroxychloroquine's worth

The Swiss pharma, one of hydroxychloroquine's many generic manufacturers, will soon start a randomized, placebo-controlled study of the malaria pill.

By Ned Pagliarulo • April 20, 2020

US government to back Moderna's coronavirus vaccine with up to $483M

The BARDA grant will allow Moderna to hire 150 more staff and accelerate testing of its vaccine, which entered a Phase 1 study in March and could soon move to a mid-stage trial. 

By Ned Pagliarulo • Updated April 17, 2020

Vir reminds biopharma its original aim is hepatitis B

Vir, which has a closely watched coronavirus program, is also working on what it hopes can be a hepatitis B cure. New Phase 2 data gives it a boost.

By Jonathan Gardner • April 16, 2020

AstraZeneca to study leukemia drug as COVID-19 treatment

The British pharma is the latest drugmaker to test whether one of its existing drugs could help thwart the potentially lethal immune response some COVID-19 patients experience. 

By Ned Pagliarulo • April 15, 2020

Moderna's coronavirus vaccine plan may be possible, but a lot has to go in its favor

While Moderna has advanced rapidly in the month since this story was published, the biotech still faces many of the same challenges in the path to proving its vaccine.

By Ben Fidler • April 14, 2020

Early data on Gilead coronavirus drug raises hope, but answers few questions

Among a small group of COVID-19 patients treated with remdesivir via compassionate use, two-thirds appeared to improve. Without controls, however, it's not yet possible to draw conclusions about the drug's benefit. 

By Ned Pagliarulo • April 11, 2020

Myokardia at inflection point as heart drug readout nears

Results are due soon from EXPLORER, Myokardia's first-ever Phase 3 study and a major test of the company's heart disease treatment mavacamten.

By Jonathan Gardner • April 9, 2020

FDA delays decision on Roche spinal muscular atrophy drug

Roche says the three-month delay is needed for the FDA to review new data for risdiplam, which could become the first oral option for the disabling and often fatal disorder.

By Jonathan Gardner • April 7, 2020