CureVac gets German backing for coronavirus vaccine, but says it's independent

An investment of 300 million Euros gives the German government a 23% stake in CureVac, but won't grant the country exclusive national rights to a vaccine nearing human testing.

By Jonathan Gardner • June 15, 2020

Agios, seeking a new strategy, touts positive data and marketing deal

The company has sold off royalty rights to one of its drugs amid a push to focus on a wholly owned medicine it's developing for several blood diseases.

By Jacob Bell • June 12, 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

New CRISPR, gene therapy results strengthen potential for treatment of blood diseases

CRISPR Therapeutics and Vertex can more convincingly say their CRISPR-based medicine is helping three people with beta thalassemia or sickle cell disease, while Bluebird takes another step forward.

By Ned Pagliarulo • June 12, 2020

Moderna to start in July what could be first late-stage coronavirus vaccine trial

The Phase 3 study, which would be run in collaboration with the NIH, is expected to enroll 30,000 participants in the U.S. Other similarly large studies of candidates from AstraZeneca and J&J could quickly follow.

By Ben Fidler • June 11, 2020

Regeneron brings first COVID-19 antibody 'cocktail' into human tests

The biotech has begun a pair of clinical trials testing a two-drug combination in COVID-19 patients. Two other studies, starting later this month, aim to prove the therapy can prevent coronavirus infections.

By Ben Fidler • June 11, 2020

Drug regulators in agreement on coronavirus vaccine trials, FDA official says

Health agencies will be under pressure to clear promising vaccines quickly. But Peter Marks, a top FDA official, said regulators will still want to see large trials to provide proof of safety.

By Jonathan Gardner , Ben Fidler • June 9, 2020

AstraZeneca, already a leader in coronavirus vaccine race, steps up antibody drug work

The British drugmaker has licensed six potential COVID-19 antibodies from Vanderbilt, and could start testing the first of them by early August.

By Ben Fidler • June 9, 2020

Coronavirus vaccines are rolling out quickly. Here's where the pipeline stands.

Fuller data in hand, Pfizer and BioNTech plan to soon seek full U.S. approval for their vaccine in 12- to 15-year-olds. 

By Ned Pagliarulo, Jonathan Gardner, Shoshana Dubnow, Ben Fidler, Nami Sumida • Updated Nov. 24, 2021

Alnylam details data for kidney disease drug under FDA review

Treatment with lumasiran significantly lowered levels of a key chemical correlated with kidney failure, paving the way for what would be Alnylam's third drug approval.

By Jonathan Gardner • June 8, 2020

Lilly gets a 2nd COVID-19 antibody into clinical trials with Junshi's help

The trial start comes days after Lilly began U.S. testing of a similar drug it developed with AbCellera, putting the Indianapolis pharma at the forefront of efforts to engineer antibodies against the new coronavirus. 

By Ned Pagliarulo • June 8, 2020

Sarepta, with new data, plans final push for limb-girdle gene therapy

New results show a higher dose of Sarepta's gene therapy outperformed a lower one, a finding its CEO believes should build confidence in several of its other experimental treatments.

By Ben Fidler • June 8, 2020

Case for hydroxychloroquine in COVID-19 fades as key UK study finds no benefit

A large, controlled trial showed the repurposed malaria drug didn't help patients hospitalized with coronavirus disease any more than standard care. 

By Ned Pagliarulo • June 5, 2020

'Warp Speed' push for coronavirus vaccine accelerates as White House reportedly narrows field

The U.S. government aims to have a vaccine ready by the end of this year or early next, and appears to be counting on large drugmakers like J&J, Pfizer and Merck to deliver on that highly ambitious goal.

By Ned Pagliarulo • June 4, 2020

Hydroxychloroquine offers no COVID-19 protection after exposure, study shows

Results from a closely watched University of Minnesota trial cast more doubt on the repurposed malaria drug's potential to prevent COVID-19. But the study's limitations mean it's likely not the final word. 

By Jonathan Gardner , Ned Pagliarulo • June 3, 2020

COVID-19 studies of malaria, blood pressure pills come under scrutiny

The Lancet and The New England Journal of Medicine issued "statements of concern" regarding two high-profile trials they published, citing gaps in a database used by the authors.

By Jonathan Gardner • Updated June 4, 2020

Bristol Myers follows Zeposia launch with positive data from key study

The drugmaker's new pill would be the only drug in its class to treat ulcerative colitis, but could face competition from Pfizer, AbbVie and Gilead.

By Jonathan Gardner • June 2, 2020

Challenges arise as the need for pediatric studies increases

Pediatric clinical research poses more challenges around enrollment, costs, and trial design.

June 2, 2020

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

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