Clinical Trials

Trial setback casts doubt on a biotech's respiratory virus drug

As vaccines for respiratory syncytial virus progressed, Enanta used its hepatitis C know-how to develop an antiviral pill. Yet data in lower-risk patients raise questions of whether it can work.

By Jonathan Gardner • May 19, 2022

Scientists home in on cause of Duchenne gene therapy side effect

An unusual collaboration among gene therapy developers suggests certain mutations could be behind "peculiar" side effects experienced by several patients treated in clinical trials.

By Jonathan Gardner • Updated May 18, 2022

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

Gilead, having resolved manufacturing issues, forges ahead with HIV drug

The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

By Jacob Bell • May 17, 2022

Bristol Myers' Opdivo comes up short in bladder cancer trial

The top-selling immunotherapy failed to improve survival in first-line urothelial carcinoma, a tumor type that's proved difficult to treat with drugs like Opdivo.

By Ned Pagliarulo • May 16, 2022

Key Bristol Myers drug holds up in long-term psoriasis study

Deucravacitnib, forecast by Bristol Myers to hit $4 billion in peak sales, is under FDA review with an approval decision due by September. The agency's view of its safety will be key to its future.

By Jonathan Gardner • May 12, 2022

In first, Verve gets clearance to test base editing inside the body

Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S. and U.K., too. 

By Kristin Jensen • May 11, 2022

Roche cancer immunotherapy fails another trial, casting doubt on emerging drug class

A treatment combination involving Roche's anti-TIGIT medicine tiragolumab missed its goal in a Phase 3 lung cancer study that was viewed as a proof point for the drug class.

By Ben Fidler • May 11, 2022

J&J ends hepatitis B, HPV vaccine work with Bavarian Nordic

The companies' hepatitis B program never reached clinical testing, while J&J said it would no longer develop an HPV vaccine because of the "widespread uptake" of effective shots from other companies.

By Ned Pagliarulo • May 9, 2022

Argenx drug succeeds in trial, beats sales forecasts

The biotech reported positive results from a study meant to expand Vyvgart's use to another immune disorder, while sales from the drug's first quarter on the market exceeded expectations.

By Kristin Jensen • May 5, 2022

Pfizer cleared to restart hemophilia gene therapy trial

While a voluntary pause in dosing new patients will remain in place, the FDA's decision puts the study back on track to deliver data in 2023.

By Jonathan Gardner • May 3, 2022

FDA rejects two China-developed cancer drugs

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.

By Jonathan Gardner • May 2, 2022

Vertex surprised by FDA halt of diabetes cell therapy study

The regulator determined Vertex had "insufficient information" to test higher doses of the therapy, which showed promise in the first two patients treated.

By Ned Pagliarulo • May 2, 2022

Ionis, AstraZeneca change a key trial, fueling more questions about a genetic heart disease

The partners increased the size and length of a large study in transthyretin amyloidosis cardiomyopathy, a decision that has implications for Alnylam, which is testing two of its drugs for the disease. 

By Ben Fidler • May 2, 2022

Lilly's closely watched diabetes drug scores in obesity trial

Called tirzepatide, the drug significantly lowered weight loss in a large study, findings that add to growing evidence that a class of medicines originally meant for diabetes may effectively treat obesity.

By Jonathan Gardner • April 28, 2022

Roche stumbles in latest setback for an emerging group of breast cancer drugs

The Phase 2 failure marks the second negative result in two months for a closely watched group of medicines, known as SERDs, that are being developed by several large pharmaceutical companies.

By Jonathan Gardner • April 25, 2022

How a surprise finding made an Alnylam study one of biotech's most 'polarizing' trials

A study testing Alnylam's drug Onpattro in a deadly heart condition was once seen as a sure bet. Now the trial is the source of much debate, and its outcome could influence how future treatments for the disease are developed.

By Ben Fidler • April 25, 2022

FDA panel supports agency push to raise approval bar for certain cancer drugs

Though agency advisers were hesitant to label an entire drug class, they backed the FDA's interest in demanding randomized trials of PI3 kinase-blocking drugs, a decision that could impact future research.

By Jonathan Gardner • April 22, 2022

Bristol Myers scraps $2B Nektar partnership after trial failures

The companies have halted testing in kidney and bladder cancer, one month after ending a skin cancer study. Nektar executives are now preparing plans to conserve cash.

By Jonathan Gardner • April 18, 2022

AbbVie, Genmab, with new data, prep FDA application for dual-acting cancer drug

Fresh trial results intensify competition with Roche to deliver the first lymphoma drug that marries antibody technology with an immunotherapy pathway.

By Jonathan Gardner • April 14, 2022

FDA clears Gilead to restart some studies of top cancer drug

The agency's OK is a needed reprieve for Gilead, whose dealmaking strategy in oncology has come under scrutiny from analysts and investors.

By Ben Fidler • April 12, 2022

AACR 2022: NK cell promise, more TIGIT questions and extending CAR-T's reach

This year's meeting on early cancer research featured promising study results from German biotechs BioNTech and Affimed as well as details from a "practice-changing" lung cancer trial.

By Ben Fidler , Ned Pagliarulo • April 11, 2022

[Podcast] Breaking Down Barriers: How Bladder Cancer Innovations Benefit Patients and Treatments for Other Diseases

Recent breakthroughs in bladder cancer treatment are helping patients combat one major challenge to current options — the bladder permeability barrier. These treatments also have implications for other cancers and diseases. This podcast explains how.

By BioPharma Dive's studioID • April 11, 2022

Vertex gets positive trial results for non-opioid painkiller in boost to pipeline

After several attempts at designing a drug for acute pain, Vertex has a candidate it's ready to take into late-stage testing following two successful Phase 2 studies.

By Ned Pagliarulo • March 31, 2022

FDA advisers narrowly side against an experimental ALS drug, likely lowering its approval chances

The panel of independent experts found clinical trial evidence generated by the drug's developer, Amylyx Pharmaceuticals, insufficient to establish the treatment's effectiveness.

By Jacob Bell • Updated March 30, 2022

Adagio plans comeback for COVID drug, but is it too late?

The biotech said it will ask the FDA for approval of its antibody treatment after positive results from two trials. But relatively few participants were exposed to omicron, potentially raising questions about its utility.

By Jonathan Gardner • March 30, 2022