With new data, J&J steps forward in growing race for oral autoimmune drugs

Phase 2 results show a pill the company is developing is competitive with other oral medicines in testing against psoriasis, among them the TYK2 inhibitors that have drawn significant industry interest.

By Ben Fidler • July 5, 2023

‘Mixed’ results seed doubt about AstraZeneca, Daiichi’s next cancer drug

The medicine delayed disease progression compared to chemotherapy in a closely watched lung cancer trial. But analysts questioned its effect size and safety, and AstraZeneca shares fell more than 8%. 

By Ben Fidler • July 5, 2023

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

What US trial sponsors should know about the GDPR

What is the GDPR and why does it matter to your life sciences company. iliomad Health Data can help you maintain GDPR compliance.

July 3, 2023

Answering Roche, AbbVie and Genmab claim new study success for lymphoma drug

The companies aim to seek an FDA nod for their bispecific antibody, Epkinly, in follicular lymphoma, where it would compete with a recently approved Roche medicine.

By Jonathan Gardner • June 28, 2023

10 clinical trials to watch in the second half of 2023

A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.

By BioPharma Dive Staff • June 28, 2023

With new data, Nkarta battles doubts facing ‘off-the-shelf’ cell therapies

Though a newer regimen showed promise in patients with acute myeloid leukemia, earlier remissions haven’t held up as well as the company hoped.

By Ben Fidler • June 27, 2023

Sanofi chalks up another win for its immune system research

A drug called amlitelimab, which Sanofi acquired through a $1.1 billion acquisition, met the main goal of a mid-stage study testing it in patients with moderate-to-severe eczema.

By Jacob Bell • June 27, 2023

Lilly sets ‘high bar’ with new obesity drug data

The company’s triple-acting drug retatrutide helped Phase 2 study participants lose a quarter of their body weight, more than what’s been observed in testing of other medicines.  

By Ben Fidler • June 27, 2023

Pfizer, citing safety concerns, scraps one of two obesity pill hopefuls

Liver enzyme elevations in early- and mid-stage testing have led the drugmaker to discontinue development of a medicine known as lotiglipron, dealing a blow to its hopes of catching rivals Lilly and Novo Nordisk. 

By Ben Fidler • June 26, 2023

Roivant reports more positive data for inflammation drug

Some analysts see the new results as further confirmation that Roivant's medicine, which homes in on a popular drug target called TL1A, could become a blockbuster treatment for inflammatory bowel disease.

By Jacob Bell • June 22, 2023

UniQure stock tumbles on ‘confusing’ results for Huntington’s gene therapy

While patients appear to be doing better than historical data suggests, mixed results on other measures perplexed analysts and sent shares falling.

By Jacob Bell • June 21, 2023

Patient death spurs FDA to pause test of Arcellx’s Gilead-partnered cell therapy

The company said limitations on “bridging treatment” used to hold cancer in check could be to blame, and is working to change the study’s protocol.

By Jonathan Gardner • June 20, 2023

Bavarian Nordic says chikungunya vaccine succeeds in late-stage study

The shot, which the Danish company acquired from Emergent BioSolutions, spurred protective antibodies against the mosquito-borne virus in older adults.

By Delilah Alvarado • Updated June 20, 2023

Acadia gives once-rejected Prader-Willi drug a second chance

The FDA last year turned back an approval request from the drug’s former developer, Levo Therapeutics. That biotech is now owned by Acadia, which will run a new study designed to boost its odds of success.

By Delilah Alvarado • June 14, 2023

Study of 2seventy Bio’s AML cell therapy paused after patient death

Researchers at study sponsor Seattle Children's have halted testing as they investigate the death and its potential link to the CAR-T treatment.

By Ned Pagliarulo • June 14, 2023

CVS’ departure highlights challenges, opportunities for retail clinical trials

CVS Health was one of the first retailers to launch a clinical trials business. But a number of other competitors followed, arguing they could provide easier access and more diverse studies.

By Emily Olsen • June 12, 2023

Decentralized clinical trials (DCTs): protect your data to reduce risk

Decentralized clinical trials (DCTs) bring many benefits to the clinical research process, and more importantly, the patients. However, it is important to remember the risks if there is no data security process in place. 

June 12, 2023

FDA panel backs full approval for Eisai, Biogen Alzheimer’s drug

In a 6-0 vote Friday, agency advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.

By Jacob Bell • Updated June 9, 2023

FDA advisers back RSV antibody drug for use in infants

The positive panel vote for AstraZeneca and Sanofi’s treatment is the latest development in a flurry of regulatory activity that’s brought forward new options for preventing RSV-related respiratory disease.

By Delilah Alvarado • June 9, 2023

After years of disappointment, cancer vaccines show new promise

Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.

By Jonathan Gardner • June 8, 2023

FibroGen’s Duchenne drug misses mark in first large trial

Despite the setback, FibroGen could still rebound later this year if a study in earlier-stage Duchenne patients who can still walk is successful. 

By Kristin Jensen • June 7, 2023

Closing ASCO: AstraZeneca’s ‘very special’ meeting, more CAR-T survival data and Pfizer’s PARP play

Dramatically positive trial data for AstraZeneca’s Tagrisso capped an important conference for the British drugmaker, while Gilead built a stronger case for its cell therapy Yescarta.

By Ned Pagliarulo , Jonathan Gardner • June 6, 2023

Akero’s NASH therapy, paired with GLP-1 drugs, cuts liver fat in small study

The biotech’s experimental NASH medicine, combined with drugs like Ozempic, helped to improve markers of the fatty liver disease.

By Christopher Newman • June 5, 2023

Biogen scraps late-stage study for Parkinson’s drug

The biotech, which has trimmed various research programs over the past year, cited the trial’s complexity and long timeline as reasons for its discontinuation.

By Jacob Bell • June 5, 2023

AstraZeneca study points to new uses for targeted cancer drug Enhertu

Results from a “basket” trial of the antibody-drug conjugate show it shrank tumors across a half dozen cancers, suggesting a broader role to targeting the protein HER2.

By Ned Pagliarulo • June 5, 2023