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

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

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

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

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

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

Bristol Myers data make case for earlier use of bone marrow disease drug

Data released ahead of next month’s ASCO meeting detail how well Bristol Myers’ Reblozyl outperformed the decades-old standard Epogen in treating anemia from myelodysplastic syndromes.

By Ned Pagliarulo • May 25, 2023

J&J antibody drug combination shows promise in multiple myeloma

Bispecific antibodies, like the two J&J is testing together in multiple myeloma, could compete with CAR-T cell therapies in certain treatment lines.

By Jonathan Gardner • May 25, 2023

Apellis abandons ALS drug after study miss

The trial failure is the second for an ALS medicine this week, adding to a lengthy list of study setbacks that have thinned the pipeline of experimental medicines for the disease in recent years.

By Kristin Jensen • May 25, 2023

Annexon claims a silver lining in failed eye drug study

The company’s geographic atrophy drug didn’t slow the growth of eye lesions, as similar medicines have in clinical testing. But executives said it may have helped preserve some patients’ vision.

By Ben Fidler • May 25, 2023

Novo says oral version of obesity drug succeeds in large study

The company plans to seek approvals of the drug, a more convenient form of the popular injectable medicine Wegovy, later this year.

By Christopher Newman • May 23, 2023

Wave shelves ALS drug following trial setback

A small study found patients on the experimental therapy fared no better than those receiving a placebo, dealing yet another blow to Wave’s research efforts.

By Jacob Bell • May 23, 2023

Moderna reports ‘encouraging’ early data for one of its rare disease medicines

Now known for its vaccine research, the biotech said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

By Jacob Bell • May 19, 2023

Teva puts rival to Prometheus, Pfizer drugs at center of turnaround plans

At an investor day, executives highlighted an experimental inflammatory disease drug targeting the protein TL1A as important to their long-term growth.

By Jonathan Gardner • Updated May 19, 2023

PTC’s drug for PKU succeeds in late-stage clinical trial

The biotech plans to discuss the study results with regulators to determine next steps toward an approval application for the rare disease treatment.

By Jacob Bell • May 17, 2023

Roche pushes forward with MS drug amid rivals’ setbacks

The company said its “reversible” BTK inhibitor, which trails competitors from Sanofi and Merck KGaA, succeeded in Phase 2 testing without raising new safety concerns.

By Ben Fidler • May 17, 2023