Clinical Trials

FDA allows Novartis gene therapy trials to resume after nearly two year pause

After reviewing animal study data submitted by the Swiss pharma, the FDA cleared spinal injections of Zolgensma for study in older patients with SMA.

By Jonathan Gardner • Aug. 03, 2021

Pfizer's fast progress shines spotlight on an emerging vaccine race

The big drugmaker surprised analysts and investors this week by projecting Phase 3 results next year, which could put the company on pace with a rival shot from GlaxoSmithKline.  

By Jonathan Gardner • July 30, 2021

Explore the Trendline➔

Trendline

Inside the race to bring coronavirus vaccines to the world

More than a dozen shots are cleared for use in some fashion around the world. Producing enough supply and addressing the spread of coronavirus variants are the next challenges. 

By BioPharma Dive staff

Biogen, Ionis tout data from early study of RNA-based Alzheimer's drug

The companies said that patients treated with their experimental drug BIIB080 had reductions in a protein called tau, which research indicates is tied to Alzheimer's but isn't yet proven to impact the course of the disease. 

By Jacob Bell • July 27, 2021

Denali drug for rare brain disease disappoints investors

New data from an early-stage study of Denali's drug for Hunter syndrome look "noisy" and even "uninterpretable," according to some analysts. Company shares fell by 15% Monday morning.

By Jacob Bell • July 26, 2021

Seres, after earlier success, fails a key test for microbiome drugs

A pill made of gut bacteria wasn't effective at treating ulcerative colitis in a closely watched study that was viewed as a proof point for the emerging field.

By Ben Fidler • July 22, 2021

Cytokinetics heart drug succeeds in mid-stage study, boosting shares

Treatment with one of the biotech's drugs improved heart function in a small trial, an outcome that could help the company rebound and potentially challenge a rival medicine from Bristol Myers Squibb. 

By Ned Pagliarulo • July 19, 2021

Sponsored by Clinical Ink

How real-time data keeps infectious disease studies moving in times of crisis

One COVID-19 study, 1,000 seniors — ahead of schedule. Find out how eSource made it happen.

Sponsored by Yourway

Integrating sourcing, packaging, labelling and distribution for efficient clinical kitting

Efficient execution of clinical trials requires the provision of medicines and all other critical materials to be carefully delivered on time to clinical sites or patient's homes. 

Merck details an immunotherapy 'milestone' in early breast cancer

Three months after a rare FDA rejection, Merck has data showing Keytruda can slow the return of triple-negative breast cancer but not, as of yet, proving whether the drug extends lives.

By Ben Fidler • July 15, 2021

Celldex pins its hopes for a comeback on skin disease drug

After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech.

By Ben Fidler • July 09, 2021

Moderna puts seasonal flu vaccine ambitions to the test

Having proved mRNA's might in COVID-19, the biotech company aims to develop similar vaccines for other respiratory illnesses caused by influenza, RSV and metapneumovirus.

By Ned Pagliarulo • July 07, 2021

As Arrowhead falters, lungs remain a tough target for RNA drugs

The biotech's decision to pause testing of a cystic fibrosis drug is the latest reminder of the difficulty of delivering RNA medicines into the lungs.

By Ben Fidler • July 06, 2021

Lilly, Boehringer say diabetes drug first to succeed in hard-to-treat heart failure

The results are a potentially significant finding that could help change how heart failure patients with preserved ejection fraction are treated, and will support the companies' application for the drug's approval.

By Ned Pagliarulo • July 06, 2021

CureVac vows to seek vaccine approval despite low efficacy in COVID-19 study

Final results from CureVac's large Phase 3 study showed an overall efficacy of just 48%, although the German biotech emphasized stronger protection against more severe disease and in younger adults.

By Ned Pagliarulo • July 01, 2021

Roche partner sees promise for anti-COVID 19 pill in early study

A pill from Atea Pharmaceuticals rapidly reduced the amount of virus in the blood of patients with COVID-19, a step forward in drugmaker efforts to develop easier-to-take treatments for the disease.

By Kristin Jensen • June 30, 2021

Pfizer's neuroscience spinout scores in schizophrenia

Cerevel Therapeutics on Tuesday revealed positive results from an early-stage study of one of its drugs, doubling the price of the company's stock.

By Jacob Bell • June 29, 2021

Gilead matches Bristol Myers in showing benefit to earlier CAR-T treatment

A study of Gilead's Yescarta found the cell therapy dramatically outperformed chemotherapy and stem cell transplant in treating lymphoma, a result that could support much broader use of the drug.

By Ned Pagliarulo • June 28, 2021

Sponsored by Koneksa Health

The time is ripe for wearables in oncology clinical trials and cancer treatment

Wearables can minimize trips to clinic sites and may provide study participants and cancer patients with a feeling of having more control over how they manage their own illness.

Deep Dive

Intellia, with first results, delivers a 'landmark' for CRISPR gene editing

Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research.  

By Ben Fidler • June 26, 2021

FDA advisers vote down Incyte cancer drug as agency takes tougher line

The committee voted 13-4 to recommend the FDA wait for more clinical trial data from Incyte, which is aiming to win approval for what would be the eighth PD-1 or PD-L1 inhibitor.

By Ned Pagliarulo • June 25, 2021

Arcus claims positive study results for lung cancer drug, but shares no details

The lack of specific data frustrated analysts, but shares in Arcus rose by double digits Thursday. Partner Gilead is expected to make a decision on whether to license the drug later this year. 

By Kristin Jensen • June 24, 2021

A year after getting UniQure's gene therapy, hemophilia patients are still doing better

New results from a key study show the treatment's benefit is holding up well over time. But the FDA wants to see more data, delaying when UniQure and partner CSL expect to file for approval.

By Jacob Bell • June 22, 2021

Merck says Keytruda extends survival in cervical cancer study

Results from a Phase 3 study could help Merck secure a full approval for use of Keytruda in the tumor type, potentially extending the therapy's edge over rival therapies.

By Jonathan Gardner • June 22, 2021

Long-term Zolgensma data backs up gene therapy's use in youngest patients

With more and more states screening for SMA at birth, the study results are important for assessing Zolgensma's benefits when given very early on.

By Jonathan Gardner • June 21, 2021

GSK, Vir build case for COVID-19 antibody drug with new study data

Final clinical trial results confirmed treatment dramatically reduced the risk of hospitalization and death among adults with mild-to-moderate COVID-19.

By Ned Pagliarulo • June 21, 2021