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

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

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

J&J sees trial data supporting earlier CAR-T use in multiple myeloma

The results, which partially leaked in April, show Carvykti’s potential to be used after a drug called Revlimid fails, rather than reserved for only after several treatments do.

By Ned Pagliarulo • June 5, 2023

Pfizer says antibiotic is effective against tough-to-treat infections

A drug the company acquired from AstraZeneca and developed for gram-negative infections — a growing public health threat — could be headed for a regulatory review later this year.

By Delilah Alvarado • June 2, 2023

Novartis drug helps stop breast cancer’s return in large study

Treatment with Kisqali reduced the risk of disease recurrence when used after surgery, potentially positioning Novartis to win a similar adjuvant approval as Lilly’s rival therapy Verzenio.

By Jonathan Gardner • Updated June 2, 2023

AstraZeneca abandons experimental bowel disease drug

The drugmaker cited testing delays and an evolving “competitive landscape” in its decision to discontinue development of its IL-23 inhibitor brazikumab.

By Delilah Alvarado • June 1, 2023

FDA pauses PepGen’s plans to test muscle disease drug

The company’s oligonucleotide-based treatment is the latest neuromuscular disease therapy to face a regulatory roadblock prior to human testing.

By Christopher Newman • May 31, 2023

Sanofi drug, acquired from a startup, shows early potential in MS

The medicine, licensed from biotech ImmuNext in 2017, is one of two later-stage MS drug prospects in the French drugmaker’s portfolio.

By Ben Fidler • May 31, 2023

Pfizer says hemophilia drug succeeded in Phase 3 study

The drug, called marstacimab, could potentially become another option for hemophilia patients just as new gene therapies arrive on the market in the U.S.

By Jonathan Gardner • May 30, 2023

ASCO puts spotlight on advancing antibody-drug conjugate pipeline

Study abstracts released Thursday give investors and analysts a better look at cancer treatments recently licensed by Merck and BioNTech as well as fresh details on other closely watched ADC candidates.

By Ned Pagliarulo • May 25, 2023