A biotech scraps two cancer trials in latest setback for emerging drug class

ALX Oncology’s decision to end studies in leukemia and myelodysplastic syndrome follows a similar setback from Gilead and casts further doubt on drugs known as CD47 inhibitors.

By Jonathan Gardner • Aug. 11, 2023

Novartis says drug helps control chronic hives in studies

The studies are another example of drugmakers exploring how so-called BTK inhibitors can be used to treat diseases outside of blood cancer. 

By Kristin Jensen • Aug. 9, 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

Novo obesity drug protects heart health in large trial

2023 was a breakout year for GLP-1 drugs, which have shown dramatic weight loss benefits. Study results in August proved Novo’s Wegovy could protect the heart, too, a finding that may change obesity treatment.

By Jonathan Gardner • Updated Aug. 8, 2023

How the right technology and tools can accelerate progress in rare disease clinical trials

The need for more research into rare diseases is clear, but researchers face significant challenges. Fortunately, technology has created opportunities to innovate in clinical trials for rare diseases.

Aug. 7, 2023

Amgen says KRAS drug met goal in late-stage colon cancer trial

The company disclosed the study result alongside second quarter earnings showing Lumakras sales were flat versus the same period one year prior.

By Ned Pagliarulo • Aug. 3, 2023

Gilead-backed cell therapy startup Kyverna adds fresh funds for new strategy

A treatment licensed from the NIH and in clinical testing for lupus is the startup’s lead program, while its founding “Treg” cell therapy research matures, according to CEO Peter Maag.

By Ben Fidler • Aug. 3, 2023

Lilly adds to case for Mounjaro’s weight-loss benefits with new study data

The results showed that enrollees who’d already lost weight after diet and exercise shed pounds after receiving Mounjaro, while those who stopped treatment gained weight back. 

By Jonathan Gardner • July 27, 2023

FDA declines to review Biohaven’s latest drug in setback to pipeline

While the FDA doesn’t think the brain disease treatment merits an evaluation, Biohaven is still pushing for one and has requested a further meeting.

By Delilah Alvarado • July 27, 2023

Moderna, Merck advance cancer vaccine into late-stage test

The companies are enrolling people with melanoma in a Phase 3 trial aimed at testing whether the shot can prevent disease recurrence.

By Jonathan Gardner • July 26, 2023

Stoke faces new doubts in search for ‘Spinraza for epilepsy’

Shares fell after the biotech’s Dravet syndrome treatment missed investor expectations. But Stoke CEO Ed Kaye claims the company now better understands its drug and how to test it.

By Ben Fidler • July 25, 2023

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

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