Clinical Trials: Page 2

Hint of benefit in Alzheimer's drug study fuel stock surge for Swiss biotech

A once-failed drug being developed by AC Immune and Roche appeared to slow cognitive decline in a small trial. But other study goals were missed, muddying the seemingly positive result. 

By Ned Pagliarulo • Aug. 31, 2021

Pfizer drug bests Sanofi, Regeneron's Dupixent in head-to-head study

Abrocitinib, a JAK inhibitor Pfizer's developing, outperformed Dupixent in treating moderate or severe eczema. Hanging over the study's success, however, is an ongoing review by the FDA of the drug's class. 

By Ned Pagliarulo • Aug. 30, 2021

Explore the 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

AstraZeneca reports study success for rare disease drug acquired in Alexion deal

With positive results from a Phase 3 trial in hand, the British pharma intends to soon seek regulatory approval for the Wilson disease treatment.

By Kristin Jensen • Aug. 26, 2021

With new results, J&J's $1B gamble on a targeted inflammation drug faces long odds

Theravance, which agreed to co-develop a next-generation JAK inhibitor with J&J three years ago, said the experimental drug failed a mid-stage study in ulcerative colitis, leaving its future in doubt.

By Jonathan Gardner • Aug. 24, 2021

Alexion discontinues ALS drug trial due to 'lack of efficacy'

The decision, which follows the recommendation of a data monitoring committee, is yet another setback in the search for more treatments for the neurological disease.

By Shoshana Dubnow • Aug. 23, 2021

A pandemic lesson for every CRO: Empower infrastructure to handle crises

Here are some ways CROs can prepare for the worst and keep their trials moving smoothly.

Lilly's new eczema drug scores in late-stage studies

Positive results help validate the $1 billion acquisition that gave Lilly access to lebrikizumab. Even so, the company could face tough competition from Regeneron and Sanofi's Dupixent.

By Jacob Bell , Ben Fidler • Aug. 16, 2021

Roche sets bar in early lymphoma treatment with Polivy study results

Positive data for the Swiss pharma's antibody-based drug could be a benchmark for CAR-T therapies, which other developers aim to move into early lymphoma treatment, too.

By Jonathan Gardner • Aug. 09, 2021

Regeneron drug extends survival in lung cancer trial, lifting company's hopes in field

The biotech also reported second quarter earnings on Thursday that widely surpassed Wall Street expectations.

By Jonathan Gardner • Aug. 05, 2021

Practical approaches to operationalizing decentralized clinical trials

When appropriate, DCTs can accelerate trial conduct, create a wealth of high-quality data and improve efficiency.

FDA allows Novartis gene therapy trials to resume after nearly 2 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

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

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.

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