Eli Lilly starts first-ever trial of a COVID-19 antibody drug, speeding past rivals

The Indianapolis pharma has quickly moved into human tests of an antibody it's developing with private biotech AbCellera. Initial data are expected before July.

By Ben Fidler • June 1, 2020

COVID-19 could slow progress in reducing cancer death, NCI head warns

American Society of Clinical Oncology meeting attendees were warned of the impact that pandemic-driven delays in diagnosis and therapy could have on cancer patients. 

By Ned Pagliarulo • June 1, 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

Details lacking, but new remdesivir data point to a benefit for 'moderate' COVID-19 patients

The results suggest that Gilead's drug may help a broader swath of patients with coronavirus disease, though the magnitude of benefit is unclear. 

By Jacob Bell • June 1, 2020

How Merck seeks to catch up in the coronavirus drug race

The pharmaceutical giant just became a major player in the global push to develop medicines against COVID-19. Daria Hazuda, vice president of infectious disease discovery, spoke with BioPharma Dive about its plans. 

By Ben Fidler • June 1, 2020

With new Allogene data, same promise, questions surround 'off the shelf' CAR-T

Updated results from Allogene at ASCO's virtual meeting are encouraging, but still don't show whether its allogeneic approach can match autologous CAR-T.

By Ben Fidler • May 29, 2020

AstraZeneca bid to expand lung cancer drug's use boosted by trial data

The ADAURA trial — stopped two years ahead of schedule — showed Tagrisso kept early-stage lung cancer patients from relapsing longer than did placebo.

By Jonathan Gardner • Updated May 29, 2020

Coronavirus vaccine developers plan to enroll tens of thousands in late-stage tests

As initial studies get underway in small groups of volunteers, companies like Pfizer, AstraZeneca and J&J are preparing for large Phase 3 trials.

By Ned Pagliarulo • May 28, 2020

Novartis teams with Mass. Eye & Ear to join coronavirus vaccine chase

The Swiss pharma has become the latest large drugmaker to enter the worldwide race to develop a vaccine for COVID-19, tapping a project developed by gene therapy experts at the Massachusetts Eye and Ear Hospital.

By Jonathan Gardner • May 28, 2020

Novavax buys more manufacturing capacity as first COVID-19 vaccine test begins

The Maryland biopharma has acquired a Czech vaccine developer for $167 million, gaining a facility in Europe that will boost its COVID-19 vaccine production capabilities.   

By Kristin Jensen • May 28, 2020

U.K. grants early access to Gilead's remdesivir for COVID-19 patients

Supplies of the antiviral drug are tight, however, with many of the doses donated by Gilead reserved for use in the U.S. 

By Kristin Jensen • May 27, 2020

Merck makes COVID-19 drug plans clear with flurry of deals

The drugmaker, which for months appeared to be watching the pandemic from the sidelines, will advance two coronavirus vaccine candidates, as well as an oral antiviral drug. 

By Ned Pagliarulo , Ben Fidler • May 26, 2020

New study details show remdesivir speeds COVID-19 recovery, but doesn't help sickest patients

Much anticipated results from an NIH-led trial of Gilead's antiviral drug were published Friday in the New England Journal of Medicine.

By Ned Pagliarulo • Updated May 25, 2020

Coronavirus study in China shows CanSino's vaccine spurs immune responses

But researchers, who conducted the trial in a locked-down Wuhan, aren't yet certain whether those responses will actually confer protection against coronavirus infection.

By Ned Pagliarulo • Updated May 22, 2020

Intercept shares fall as FDA again delays closely watched NASH drug

The FDA has asked for more data on obeticholic acid, which could be the first-ever marketed medicine for non-alcoholic steatohepatitis. The latest delay means the drug likely won’t be approved by the agency's June 26 deadline.

By Jonathan Gardner • May 22, 2020

High expectations cast a shadow over Gilead and Galapagos' positive data

Filgotinib, a drug crucial to the companies' partnership, beat out placebo in a ulcerative colitis study. But lackluster results from a low dose could dim its competitive prospects.

By Jacob Bell • May 21, 2020

More questions than answers as Moderna's coronavirus vaccine speeds ahead

Preliminary results from a Phase 1 study were enough to add $5 billion to Moderna's market capitalization. But they don't answer key questions about the vaccine's safety and effectiveness. 

By Jonathan Gardner • May 19, 2020

Leadership in crisis: How pharmaceutical industry leaders guide their teams while keeping clinical trials moving forward

Brenda Reese, head of North American business development for PSI CRO, discusses what's required of today's life sciences leaders.

May 19, 2020

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

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