FDA sets back Novartis plans to expand use of SMA gene therapy

The agency has asked the company to run a new study of the Zolgensma formulation that it aims to bring to older patients with spinal muscular atrophy.

By Ben Fidler • Sept. 23, 2020

Regeneron forges ahead in lung cancer, but will need more to unseat Merck

The biotech's immunotherapy Libtayo looks headed for approval in lung cancer, but surpassing the bar set by Merck's Keytruda remains a challenge.

By Ben Fidler • Sept. 22, 2020

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

Blueprint's bet on itself pays off with rare disease drug data

Study data show Blueprint's first approved cancer drug, Ayvakit, could also work to treat a rare disease, a result that sent the company's shares higher.

By Ned Pagliarulo • Sept. 22, 2020

Merck matches Roche in search for next cancer immunotherapy

The maker of Keytruda unveiled data for three experimental cancer drugs, including results for an anti-TIGIT therapy that compare favorably to those for a similar medicine being developed by Roche.

By Ned Pagliarulo • Sept. 21, 2020

With Eli Lilly data, another drug emerges to stop breast cancers from returning

The highly anticipated results could change how some patients with the most common form of breast cancer are treated — and drive up the costs of care. 

By Ben Fidler • Sept. 20, 2020

Amgen's KRAS drug can shrink tumors for months, but new data leave room for improvement

Study results unveiled Sunday, if replicated later this year, could be strong enough to garner an approval for Amgen's sotorasib, the first KRAS-blocking drug to get this far.

By Ned Pagliarulo • Sept. 20, 2020

Seattle Genetics stays step ahead of rivals with bladder cancer data

Data confirming the company's drug Padcev can extend the lives of bladder cancer patients should strengthen its position with regulators, although Immunomedics is close behind with a competing treatment.

By Jonathan Gardner • Sept. 18, 2020

In unexpected finding, Roche claims arthritis drug may have role in treating COVID-19

Previous study findings from Roche and others had indicated the Swiss drugmaker's Actemra, and other drugs like it, weren't helping patients hospitalized with coronavirus disease. 

By Ben Fidler • Sept. 18, 2020

What to watch as the first late-stage coronavirus vaccine trials near potential readouts

Predictions of results by the end of October look ambitious, as the number of COVID-19 cases needed to generate definitive data could still take months.

By Jonathan Gardner • Updated Sept. 17, 2020

Vaccine makers, in bid for transparency, disclose detailed plans of coronavirus vaccine trials

Moderna was the first to share the so-called study protocol of its Phase 3 trial, spurring Pfizer and AstraZeneca to quickly do the same.

By Ned Pagliarulo • Updated Sept. 19, 2020

Arrowhead shares soar on liver disease data from four patients

Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna.

By Jonathan Gardner • Sept. 16, 2020

Lilly offers first evidence that its antibody drug may help treat COVID-19

The results, from a mid-stage study of Lilly's drug, suggest treatment helped lower virus levels, but the degree to which patients benefited remains unclear. 

By Ben Fidler • Sept. 16, 2020

Pfizer says coronavirus vaccine study still on track for October readout

Unusually, the drugmaker also shared blinded safety results from its ongoing Phase 3 trial, showing participants' side effects were generally mild to moderate.

By Ned Pagliarulo • Sept. 15, 2020

Lilly says its arthritis drug helps speed COVID-19 recovery

The benefit of adding Lilly's Olumiant to Gilead's antiviral Veklury appeared modest, reducing time to recovery by one day in a study of hospitalized patients.

By Ned Pagliarulo • Sept. 14, 2020

AstraZeneca, Oxford vaccine study allowed to restart in UK

Six days after a worrisome illness in a U.K. study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume.

By Ben Fidler • Sept. 12, 2020

NIH starts broad set of studies testing blood thinners against COVID-19

The trials, which involve Bristol Myers and Pfizer's Eliquis as well as other anticoagulants, follow evidence of blood clotting in COVID-19 patients.

By Ben Fidler • Sept. 11, 2020

Sanofi's hemophilia drug comes into focus as delays hit a key competitor

With BioMarin's gene therapy sidelined, attention is turning to other drugs, including one Sanofi acquired when it paid $11.6 billion for Bioverativ. 

By Jacob Bell • Sept. 10, 2020

Intra-Cellular roars back on success in bipolar depression

Widening the number of eligible patients could make Intra-Cellular's schizophrenia pill a blockbuster, analysts forecast.

By Jacob Bell • Sept. 9, 2020

Merck takes aim at Pfizer with pneumonia vaccine data

Results from two Phase 3 studies put Merck in position to ask for FDA approval of its shot later this year. Pfizer may not be far behind with a rival product. 

By Jonathan Gardner • Sept. 9, 2020

Studies of AstraZeneca coronavirus vaccine put on hold for safety review

A participant in a clinical trial of the experimental shot suffered an unexplained illness, triggering an investigation and a global pause in vaccinations.

By Ned Pagliarulo • Updated Sept. 9, 2020

Merck details cough drug data, raising questions about its potential

Merck's drug could be the first-ever treatment for chronic cough, a condition that afflicts millions. But side effects and modest efficacy may limit its use. 

By Jonathan Gardner • Sept. 8, 2020

Researchers publish first data on coronavirus vaccine approved by Russia

While the shot appeared less potent than those being advanced by U.S. and U.K. companies, the Russian vaccine could be used broadly because it doesn't need to be kept frozen.

By Jonathan Gardner • Sept. 4, 2020

Akebia stumbles and clouds the prospects of anemia pills

The biotech's drug was found to be less safe than an injectable anemia medicine in a Phase 3 trial, dimming its potential approval chances.

By Ben Fidler • Sept. 3, 2020

Sanofi, GSK, racing to catch up, begin first human study of coronavirus vaccine

The two vaccine developers are betting their proven technology will lead to a more potent shot than others, making up for their slower pace of testing. 

By Ben Fidler • Sept. 3, 2020

After a rare win, a biotech details long-awaited results for its ALS drug

Newly published data describe what one study investigator deems a milestone in the fight against ALS, a deadly and progressive neurological disorder.

By Jacob Bell • Sept. 2, 2020