Clinical Trials: Page 2

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

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

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

Roche's top immunotherapy prospect fails study in tough-to-treat lung cancer

A drug regimen including Roche's closely watched tiragolumab didn't outperform standard treatment in its first large trial, a setback for therapies aimed at a protein called TIGIT.

By Ben Fidler • March 30, 2022

Pfizer inflammatory disease drug hits goal in second study

The drugmaker said etrasimod, an experimental medicine acquired via its Arena buyout, improved remission rates in the second of two studies meant to support its approval in ulcerative colitis.

By Ned Pagliarulo • March 29, 2022

How a long shot ALS drug came before the FDA

A negative vote from independent experts appears to lower the chances of Amylyx's medicine winning FDA approval. Still, FDA officials have cited flexibility and noted the difficulty of its forthcoming decision. 

By Jacob Bell • March 28, 2022

Biogen shelves ALS drug after early-stage trial failure

The study setback raises questions over how well a type of genetic medicine can work in adults with central nervous system disorders like ALS.

By Jonathan Gardner • March 28, 2022

How to accelerate reliable and novel answers with expert-curated biomedical and clinical data

Accelerate your path to novel, reliable answers with expert-curated biomedical and clinical data.

March 28, 2022

FDA rebuffs MEI, Kyowa Kirin as another cancer drug class draws scrutiny

The companies said the FDA is now requiring results from a randomized study in the latest sign the agency is raising the bar for accelerated approval of so-called PI3K inhibitors.

By Jonathan Gardner • March 25, 2022

Pfizer claims study success for drug key to Arena buyout

Etrasimod, the basis of the $7 billion acquisition and a potential rival to Bristol Myers Squibb's Zeposia, has cleared the first of two trials in ulcerative colitis. 

By Kristin Jensen • March 23, 2022

Moderna, with new data, to seek clearance for COVID-19 vaccine in young children

Study results showed two shots of Moderna's vaccine led to similar immune responses as has been observed in young adults, although protection versus omicron was modest. 

By Ben Fidler • March 23, 2022

Argenx boosted by positive trial results for new shot

An easier-to-take version of Vyvgart could help Argenx expand the drug's use in autoimmune disease, potentially adding to the biotech's appeal as an acquisition target.

By Jonathan Gardner • March 22, 2022

Vertex plans path to FDA for top drug prospect

After observing promising results in a small study, Vertex is moving ahead with a pivotal trial for a kidney disease drug that's become a key part of the company's efforts to grow beyond cystic fibrosis.

By Ned Pagliarulo • Updated March 22, 2022

How Merck's 'puzzling' results could impact immunotherapy's role in early lung cancer

New study data add to evidence that checkpoint inhibitors can slow the return of lung tumors. But the results also leave doubt over how best to use the drugs.

By Ben Fidler • March 17, 2022

With trial success in kidney disease, Lilly, Boehringer make case for broader use of diabetes drug

The positive results are the latest evidence supporting a broader role for so-called SGLT2 inhibitors, which started out as diabetes medicines but have since shown promise in a range of metabolic diseases.

By Jonathan Gardner • March 16, 2022

BridgeBio looks for comeback with trial results for muscular dystrophy drug

Positive signs for the experimental treatment could help shore up investor confidence in BridgeBio after the December study failure of a drug for a rare heart condition.

By Jonathan Gardner • March 14, 2022

Nektar, Bristol Myers drug combination fails in late-stage melanoma trial

The trial results were the most significant setback for the companies' four-year-old partnership and will likely force Nektar to cut costs.

By Ned Pagliarulo • March 14, 2022

Sanofi, with positive data in hand, to ask for approval of longer-lasting hemophilia therapy

Patients with severe hemophilia A who were given the drug had, on average, less than one bleeding event over a year, results that Sanofi and partner Sobi believe will pass muster with regulators.

By Jacob Bell • March 9, 2022

Pfizer to test COVID pill in children as vaccinations in US plateau

Supplies of the drug, called Paxlovid, have become more available for adults in the U.S., which recently began rolling out a "test-to-treat" initiative likely to make use of Pfizer's pill. 

By Kristin Jensen • March 9, 2022