Merck’s COVID-19 treatment falls short in prevention study

The antiviral Lagevrio did not significantly reduce the risk of getting COVID-19 following household exposure to someone infected by the coronavirus.

By Delilah Alvarado • Feb. 21, 2023

Pfizer makes case for PARP-blocking drug in prostate cancer

Full study results, revealed Thursday, could help Pfizer’s Talzenna win approval in the tumor type and compete with AstraZeneca’s rival medicine Lynparza.

By Jonathan Gardner • Feb. 17, 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

Pfizer, Valneva remove half of participants from study of Lyme disease shot

Violations of study standards by a “third-party clinical trial site operator” prompted the partners to stop evaluating a large portion of the volunteers in their trial, the largest test of a Lyme disease vaccine in decades.

By Ben Fidler • Feb. 17, 2023

Pfizer begins plan to challenge Shingrix with an mRNA vaccine

The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine.

By Delilah Alvarado • Feb. 10, 2023

Galapagos nixes EU approval plans after top drug fails in late-stage study

The negative results for Galapagos’ drug filgotinib in a Crohn’s disease study follows a series of clinical disappointments for the company.

By Kristin Jensen • Feb. 9, 2023

Bayer begins key tests for closely watched blood thinner

The company has begun enrolling patients in one of the largest Phase 3 programs in its history, a pair of trials that will test an anticoagulant it believes can be a future blockbuster.

By Christopher Newman • Feb. 8, 2023

Roche rival to AstraZeneca’s Soliris succeeds in late-stage testing

The company said the experimental injection matched Soliris in a Phase 3 study and would soon be submitted to regulators around the world.

By Christopher Newman • Feb. 7, 2023

J&J says drug it acquired from Momenta succeeds in study of ultra-rare condition

Results from a small, mid-stage study of nipocalimab showed promise in treating an autoimmune disorder affecting fetuses and newborns, J&J said.

By Delilah Alvarado • Feb. 6, 2023

Idorsia shares sink on ‘unexpected’ failure of drug study

The Actelion spinout’s drug clazosentan, which is approved for use in Japan, didn’t significantly outperform a placebo in a Phase 3 study of patients with a particular type of stroke.

By Ned Pagliarulo • Feb. 6, 2023

GSK moves hepatitis B drug into late-stage testing

The British drugmaker sees potential for the medicine to be a functional cure for chronic infections, and is beginning two Phase 3 trials to test its promise. 

By Kristin Jensen • Feb. 2, 2023

Novartis confirms it has stopped development of experimental Huntington’s drug

Termination of the branaplam program, according to Novartis, was due to an “overall assessment of the risk-benefit profile” observed in a mid-stage clinical trial that raised safety concerns last year.

By Jacob Bell • Feb. 1, 2023

How are digital biomarkers reshaping Parkinson’s disease research?

Your Parkinson’s disease trials need better data. Hear how digital biomarkers change the game.

Jan. 30, 2023

J&J, Legend’s cancer cell therapy has early success in key clinical trial

The trial is an important test of Carvykti’s potential for earlier use in multiple myeloma and found treatment helped extend progression-free survival over standard regimens.

By Jacob Bell • Jan. 27, 2023

Magenta halts study of targeted conditioning drug after participant’s death

The biotech said one patient died after receiving an experimental antibody drug designed to deplete certain blood and bone marrow cells before a transplant.

By Christopher Newman • Updated Jan. 26, 2023

Bristol Myers says CAR-T therapy curbed leukemia in long-running study

The company’s drug Breyanzi led to remission in adults with chronic lymphocytic leukemia, a blood cancer for which CAR-T therapies aren’t yet approved to treat.

By Ned Pagliarulo • Jan. 26, 2023

Merck reports one success, one setback from late-stage Keytruda trials

The top-selling immunotherapy bested chemo in treating bile duct cancer, but fell short in a study testing it with other drugs for metastatic prostate tumors.

By Ned Pagliarulo • Jan. 25, 2023

Pliant shares jump on new data for lung disease drug

A high dose of the company’s experimental medicine appeared potent in patients with idiopathic pulmonary fibrosis, an elusive target for drugmakers. The results are from a small and short clinical trial, however.

By Ben Fidler • Jan. 23, 2023

Roche says Tecentriq immunotherapy reduces risk of liver cancer recurrence

While the company did not reveal specific study data, the results could help Tecentriq become the first drug approved for adjuvant liver cancer treatment.

By Jonathan Gardner • Jan. 19, 2023

Moderna reports positive RSV vaccine results, pressuring Pfizer, GSK

The biotech’s results appear competitive to past data for RSV shots being developed by GSK and Pfizer. Moderna plans to follow those companies in asking for FDA approval.

By Delilah Alvarado • Jan. 18, 2023

Large study of J&J’s HIV vaccine stopped after shot found ineffective

The result from the nearly 4,000-person trial is the latest setback in a long-running effort to develop a safe and effective shot for HIV infections.

By Ned Pagliarulo • Jan. 18, 2023

FDA approves Alzheimer’s drug from Eisai, Biogen in closely watched decision

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

By Jacob Bell • Updated Jan. 6, 2023

Novocure shares soar on positive lung cancer data

A regimen involving the Swiss biotech’s electrical field-based treatment extended lives in a late-stage trial. But data comparing the medical device to standard chemotherapy is less persuasive.

By Jonathan Gardner • Jan. 5, 2023

Roivant reveals positive data for IBD drug, intensifying rivalry with Prometheus

The results left Wall Street analysts torn about which company holds the advantage as both race to get a new type of therapy to market.

By Jacob Bell • Jan. 4, 2023

10 clinical trials to watch in the first half of 2023

Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s, while a pair of high-priced acquisitions could be put to the test.

By BioPharma Dive staff • Jan. 3, 2023

Pfizer advances diabetes, obesity drug hopeful into mid-stage testing

The pharma dosed the first patient in a Phase 2 study testing a treatment it hopes could compete with closely-watched weight-loss drugs from Lilly, Novo Nordisk and Amgen.

By Kristin Jensen • Dec. 21, 2022