Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach

The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo.

By Jonathan Gardner • March 17, 2023

Clinical trial researchers are burned out too. Automated data capture is helping.

Manual data transcription increases clinical research coordinator burnout. There is a better way.

By Ben Baumann, OpenClinica Co-Founder and COO • March 13, 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

FDA advisers back earlier use of Roche lymphoma drug

The positive vote comes despite doubts from FDA scientists and increases the chance that Polivy could soon be approved as a first-line treatment alongside a drug regimen called R-CHOP.    

By Jonathan Gardner • March 10, 2023

Lilly reaches end of the road with long-studied Alzheimer’s drug

Prior trial failures hadn’t halted testing of solanezumab, once Lilly’s top Alzheimer’s drug candidate. But its final study defeat may help scientists better understand how to target the brain disease.

By Jonathan Gardner • March 9, 2023

AstraZeneca builds on study successes in early lung cancer

The pharma’s drug Tagrisso extended survival in a trial that stirred debate at ASCO three years ago, while its immunotherapy Imfinzi reduced the risk of relapse in a different study.

By Ben Fidler • March 9, 2023

With PCSK9 pill, Merck aims to succeed where others failed

The company is planning an ambitious Phase 3 program testing its oral cholesterol-lowering drug, which in a mid-stage trial appeared to match the effects of approved injectable competitors.

By Christopher Newman • March 7, 2023

Merck drug data suggest ‘new direction’ for rare blood vessel disease

Treatment with Merck’s sotatercept helped improve the exercise capacity of patients with pulmonary arterial hypertension, anticipated results from a Phase 3 study showed.

By Christopher Newman • March 6, 2023

Esperion shares sink on highly anticipated heart drug results

The company says the findings could spur wider adoption of its pill Nexletol, though shares fell 20% as the data was short of Wall Street expectations.

By Christopher Newman • March 6, 2023

BridgeBio shares jump on dwarfism drug data

The results impressed analysts and suggest the biotech's drug could become a threat to BioMarin's Voxzogo, sending shares up about 60%.  

By Kristin Jensen • March 6, 2023

Kroger Health works to expand access to clinical trials

Kroger Health seeks to increase awareness among more eligible clinical trial participants.

March 6, 2023

Exelixis reports trial failure for cancer drug combination

The setback is the second for the pairing of Cabometyx and Roche’s immunotherapy Tecentriq, dimming Exelixis’ hopes of further expanding its drug’s use before a key patent expires.

By Jonathan Gardner • March 3, 2023

Despite study setback, a biotech plans to push tremor drug into late-stage testing

An experimental medicine from Praxis Precision Medicines missed the main goal of a Phase 2b trial. But there were also some positive findings, which have encouraged the company to press forward.

By Jacob Bell • March 3, 2023

FDA asks advisers to review Lynparza amid growing scrutiny of PARP drugs

The meeting to discuss Lynparza's use as a frontline treatment for prostate cancer follows a string of withdrawals for drugs in its class, and evidence it didn’t meaningfully extend survival in late-stage testing.

By Jonathan Gardner • March 2, 2023

Bristol Myers, J&J plan tests of new blood thinner in nearly 50,000 patients

The Phase 3 program for their medicine, milvexian, will be among the largest in drug development and almost twice the size of what Bayer has planned for a competing treatment.

By Kristin Jensen • March 2, 2023

Merck reports two Phase 3 study misses for Keytruda

The negative results in prostate and lung cancer are rare trial failures for the immunotherapy, and could limit expanded use of the drug in treating those tumor types.

By Jonathan Gardner • Feb. 28, 2023

Following another trial failure, a brain biotech considers ‘strategic alternatives’

Aptinyx has joined a lengthy list of drugmakers looking to cut costs and explore strategic options after hitting setbacks in key clinical studies.

By Jacob Bell • Feb. 28, 2023

Sickle cell pipeline narrows as gene therapy developers rethink research plans

Graphite Bio and Sangamo are stopping work on their respective sickle cell gene therapies, while Intellia revealed partner Novartis ended development of its genetic treatment for the blood disease.

By Ned Pagliarulo • Feb. 23, 2023

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

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