Pfizer gets first positive result for an RSV vaccine in pregnant women

The shot kept newborns from getting severe respiratory infections in a Phase 3 trial, paving the way for the drugmaker to seek approval before its top rivals.

By Jonathan Gardner • Nov. 1, 2022

With positive trial results, Bristol Myers looks to widen use of blood disease drug

Reblozyl, one of the drugmaker’s key assets, outperformed an older anemia drug in early-stage myelodysplastic syndrome, which could double the number of potentially eligible patients. 

By Jonathan Gardner • Oct. 31, 2022

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

What the FDA’s guidance on diversity means for rare disease sponsors

Bringing more diversity to clinical trials is a slow process and it takes time to get right. Learn how Worldwide Clinical Trials can diversify the reach of your orphan drug trial.

Oct. 31, 2022

GSK shelves filing plans for arthritis drug after trial results

GSK said the drug, formerly a top prospect licensed from German biotech Morphosys, showed “limited efficacy” in a Phase 3 study of patients with rheumatoid arthritis.

By Delilah Alvarado • Oct. 27, 2022

AstraZeneca extends run of trial successes with breast cancer drug results

On the heels of a major approval for Enhertu, the pharma reported positive results for two experimental drugs in settings where rival medicines from Roche and Sanofi recently failed.

By Ben Fidler • Oct. 26, 2022

Vaxcyte rides investor enthusiasm for early pneumococcal vaccine data

Encouraging study results for a vaccine with broader coverage than Pfizer’s Prevnar 20 sent Vaxcyte’s valuation soaring and could make the company a potential takeover target.

By Jonathan Gardner • Oct. 24, 2022

Novartis rival to AstraZeneca rare disease drugs succeeds in study

The pharma said iptacopan, one of its top pipeline prospects, outperformed Alexion’s Soliris and Ultomiris in certain patients with a disease called PNH.

By Ned Pagliarulo • Oct. 24, 2022

FDA advisers back withdrawal of controversial drug for preterm birth

A committee of independent experts voted 14-1 that the agency shouldn’t allow the treatment from Covis Pharma to remain on the market while further testing is conducted.

By Jonathan Gardner • Updated Oct. 19, 2022

NGM shares plunge as Merck-partnered eye drug fails Phase 2 test

Executives said the biotech could search for a new partner for the geographic atrophy drug if Merck decides not to license it under an existing deal.

By Ben Fidler • Oct. 17, 2022

GSK sets high bar with trial results for RSV vaccine

With data expected for several other vaccines for the respiratory disease, GSK reported positive clinical trial results showing efficacy above 80%.

By Jonathan Gardner • Oct. 13, 2022

Relmada shares collapse after fast-acting depression drug fails first test

The company blamed a higher-than-expected placebo response for the negative outcome, and is now pinning its hopes on two other trials that are currently underway.

By Ben Fidler • Oct. 13, 2022

Vertex, after setbacks, moves forward with second-generation rare disease drug

The biotech is starting a trial of a new treatment for alpha-1 antitrypsin deficiency following disappointing study results for two earlier compounds.

By Ned Pagliarulo • Oct. 11, 2022

A young biotech’s shares soar on early psoriasis drug results

Study data from Dice Therapeutics, which went public just a year ago, suggest its experimental pill has a chance to challenge marketed drugs from Amgen and Bristol Myers.

By Jonathan Gardner • Oct. 11, 2022

Merck cardiovascular drug succeeds in study, validating $11B buyout bet

Late-stage study results showed sotatercept, which Merck acquired via its Acceleron deal, benefited patients with PAH. The drug could help Merck fill an expected gap in revenue when patents on Keytruda expire.

By Jonathan Gardner • Oct. 10, 2022

Cytokinetics pushes on with late-stage study of ALS drug

A monitoring committee recommended the mid-stage trial continue after reviewing preliminary results. The drug, called reldesemtiv, previously fell short in Phase 2.

By Ned Pagliarulo • Oct. 10, 2022

Allogene starts first pivotal trials of an ‘off-the-shelf’ cell therapy for cancer

The biotech believes the two Phase 2 trials initiated Thursday can support approval applications for what could be the first allogeneic cancer cell therapy.  

By Ben Fidler • Oct. 7, 2022

GSK immunotherapy matches Keytruda in lung cancer trial

The British drugmaker said a mid-stage study of its PD-1 inhibitor Jemperli alongside chemotherapy showed “positive headline” results, which it will present in full later.

By Kristin Jensen • Oct. 5, 2022

Pfizer says PARP inhibitor succeeds in prostate cancer study

AstraZeneca paved the way for PARPs in prostate cancer when it won an approval for Lynparza in advanced patients. Now Pfizer may have a combination treatment for earlier-stage disease.

By Jonathan Gardner • Oct. 4, 2022

KalVista stops work on rare disease drug over safety concerns

The biotech terminated a Phase 2 study after treatment led to serious liver enzyme elevations in multiple patients with hereditary angioedema.

By Ned Pagliarulo • Oct. 4, 2022

Biogen, Denali begin late-stage testing of Parkinson’s drug

Part of a $1 billion alliance the companies formed in 2020, the drug will be tested in a large study of patients who test positive for mutations in a gene called LRRK2.  

By Jacob Bell • Oct. 3, 2022

[PODCAST] Evolution and Innovation in Oncology Therapeutics Development

The “Evolution and Innovation in Oncology Therapeutics Development” podcast series explores the role of multi-biomarkers in precision oncology.

By BioPharma Dive's studioID • Updated Sept. 11, 2023

Biohaven’s ALS drug comes up short in Mass General trial

Run by the hospital’s Healey Center, the platform trial is designed to evaluate several prospective treatments simultaneously and get answers on their potential more quickly.

By Kristin Jensen • Sept. 29, 2022

With little data to go on, experts question how useful Eisai, Biogen’s new Alzheimer’s drug will be

Positive results from a late-stage clinical trial of the drug, called lecanemab, were a surprising success for a field used to setbacks. But doctors and researchers point out that the reported benefit appears relatively modest.

By Jacob Bell • Sept. 29, 2022

Biogen, Eisai data raises hope for other experimental Alzheimer’s drugs

Expectations are now higher for amyloid-clearing drugs from Eli Lilly and Roche after lecanemab showed it can slow the disease’s progression in a large Phase 3 clinical trial.

By Jonathan Gardner • Sept. 28, 2022

In surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial

The companies’ drug lecanemab met all of its goals in the Phase 3 study. The data were a significant finding and provided stronger support for a much-debated hypothesis for treating Alzheimer’s.

By Jonathan Gardner • Updated Sept. 27, 2022