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

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

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

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

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