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

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

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

Health equity: the current environment and a path to improvement

Over the last 2 years, a greater spotlight has shone on inequalities in health care, and the greater need to improve health equity.

Sept. 26, 2022

Pfizer, Sangamo set to resume gene therapy study after safety delay

Concerns over blood clotting risk had derailed testing of the hemophilia treatment last year, leading the companies to adjust their trial protocol.

By Delilah Alvarado • Sept. 23, 2022

AstraZeneca gives up on Ionis’ RNA drug for heart disease

The British drugmaker decided the medicine, which works similarly to Novartis’s Leqvio, wasn’t potent enough to justify further testing. 

By Jonathan Gardner • Sept. 23, 2022

Merck to resume testing of closely watched HIV drug, but at lower dose

Safety concerns had derailed a slate of studies involving the drug, called islatravir, last fall. A partial FDA hold remains on any study using a higher dose.

By Ned Pagliarulo • Sept. 20, 2022