Bavarian Nordic to scrap RSV vaccine after study setback

The shot failed to meet a key goal of Bavarian Nordic’s Phase 3 study, a finding that separates it from marketed vaccines developed by Pfizer and GSK.

By Delilah Alvarado • July 24, 2023

Gilead drug acquired in $5B buyout fails key blood cancer trial

Treatment with magrolimab proved ineffective in a Phase 3 study in myelodysplastic syndrome, adding to doubts about so-called CD47 inhibitors as well as Gilead’s deal strategy.

By Ben Fidler • July 24, 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

Vir, struggling to build on COVID success, says flu antibody fails key study

The setback cut shares of the once high-flying infectious disease drug developer in half, adding to the challenge facing new CEO Marianne De Backer.

By Delilah Alvarado • July 20, 2023

An Arch-backed biotech pushes its depression drug into late-stage testing

Neumora Therapeutics said its oral medication, which works differently than other antidepressants, was significantly better than placebo at treating major depressive disorder in a mid-stage study.

By Jacob Bell • July 18, 2023

Lilly Alzheimer’s drug slowed disease by roughly half a year, new results show

New data presented Monday at a research conference support Lilly’s case for donanemab, while documenting its risks in greater detail.

By Jacob Bell • July 17, 2023

BridgeBio claims success in heart drug trial, rebounding from earlier failure

The results, which boosted the biotech’s shares by more than 80%, position the company to seek an approval in a deadly heart condition known as transthyretin amyloidosis cardiomyopathy.

By Ben Fidler • July 17, 2023

More convenient form of Roche MS drug succeeds in study

The under-the-skin formulation of Ocrevus can be administered in 10 minutes, versus a longer period for the current intravenous version.

By Kristin Jensen • July 13, 2023

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

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