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 9 hours ago

Explore the Trendline➔

Cell therapy

Six CAR-T cell therapies are now approved in the U.S., and their continued emergence has helped fueled further research into next-generation approaches.

By BioPharma Dive staff

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

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

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

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

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

Gene therapy consortium targets eight rare diseases for clinical trials

Backed by nearly $100 million, the public-private consortium aims to create a standard development roadmap for gene therapies using AAV viral vectors.

By Christopher Newman • Updated May 16, 2023

Sanofi, AstraZeneca study results add support for their RSV drug in infants

The antibody reduced RSV infections requiring hospitalization by 83% in a large study, bolstering evidence for the drug ahead of a U.S. approval decision later this year.

By Christopher Newman • May 12, 2023

Alzheimer’s doctors see promise, limits in Lilly’s latest drug data

While some see the new donanemab results as adding to a “watershed moment” in Alzheimer’s research, others say they reinforce the limitations of so-called anti-amyloid therapies.

By Jacob Bell • May 10, 2023

Roche pays China-based biotech $70M for a new HER2 drug

The drug, currently in Phase 1, is an oral medicine designed to cross the blood-brain barrier and better treat HER2 tumors that have spread to the brain.

By Jonathan Gardner • May 9, 2023

FibroGen’s anemia pill falls short in blood cancer study

The medicine, available in Europe but rejected two years ago by U.S. regulators, didn’t eliminate the need for blood transfusions among patients with myelodysplastic syndrome.

By Jonathan Gardner • May 5, 2023

Valneva, Pfizer push back timeline for Lyme disease vaccine

After issues with a contract research group, the partners now expect to file an approval application for their shot in 2026, one year later than initially anticipated.

By Delilah Alvarado • May 4, 2023

Lilly’s new Alzheimer’s data may both help and hinder rival Biogen

The success of Lilly’s donanemab in slowing Alzheimer’s progression should reinforce the potential of Leqembi — a similar, recently approved medicine from Eisai and Biogen — but may also make for stiff competition.

By Jacob Bell • May 3, 2023

Lilly drug slows Alzheimer’s decline in large study

The company plans to quickly submit an application for U.S. approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab.

By Jonathan Gardner , Ned Pagliarulo • Updated May 3, 2023