Clinical Trials

Pfizer, Valneva take next step with Lyme disease shot, starting large trial

The experimental vaccine is the most advanced candidate for the tick-borne disease and, if successful, would be the first to reach the market since withdrawal of GSK’s Lymerix.

By Delilah Alvarado • Aug. 9, 2022

Fresh off Enhertu success, AstraZeneca and Daiichi claim progress for next cancer drug

A treatment that AstraZeneca acquired for up to $6 billion in 2020 is showing early promise as a combination agent in lung cancer, where it’s being tested alongside Merck & Co.’s Keytruda.

By Ben Fidler • Aug. 9, 2022

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

Amgen data on KRAS cancer drug disappoints, opening door for rival Mirati

Highly anticipated trial results for Lumakras combinations with immunotherapy fell short of expectations, showing significant liver toxicity that limited dosing.

By Ned Pagliarulo • Aug. 8, 2022

Lilly takes long view on Alzheimer’s drug as FDA starts expedited review

The pharma said Thursday the FDA had accepted its application for donanemab, starting a six month evaluation for potential accelerated approval.

By Ned Pagliarulo • Aug. 5, 2022

Alnylam drug succeeds in key heart disease study, boosting company

The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application.

By Ben Fidler • Aug. 3, 2022

The promise of oral therapies for cytokine inhibition

The science behind new oral therapies for cytokine inhibition and why they could be transformational for patients.

By David Lee, Global Therapeutic Area Head, Immunology • Aug. 1, 2022

Alnylam reveals longer wait for anticipated drug trial results

Important data from the APOLLO study of the biotech's drug Onpattro are due before the end of August, Alnylam said Thursday.

By Ned Pagliarulo • July 28, 2022

Pfizer, BioNTech to study 'bivalent' booster as FDA weighs approach

The small-scale study is part of the companies’ efforts to update their vaccine in time for a potential fall vaccination campaign to help boost waning immunity.

By Christopher Newman • July 27, 2022

BridgeBio advances drug for dwarfism after study data

The highest tested dose of BridgeBio’s drug helped the bones of children with achondroplasia grow faster, leading the company to expand study enrollment.

By Ned Pagliarulo • July 26, 2022

Seagen, Astellas claim positive results in study key to cancer drug's success

The mid-stage trial tested the companies’ drug Padcev with Merck’s Keytruda in first-line bladder cancer. The data are reportedly a factor in Merck’s talks with Seagen over a potential buyout.

By Ned Pagliarulo • July 26, 2022

Vertex to move non-opioid painkiller into late-stage tests after FDA agreement

Trial results released earlier this year showed potential for the drug, which has become one of Vertex’s top pipeline prospects.

By Delilah Alvarado • July 22, 2022

Atara shares sink after update on multiple sclerosis trial

Much-anticipated interim results from Atara’s Phase 2 study revealed little about the likelihood of the trial’s success, spurring a market sell-off.

By Ned Pagliarulo • July 13, 2022

With new data, Pliant drug shows promise in tough-to-treat lung disease

The drug’s potential impact on the lung health of idiopathic pulmonary fibrosis patients, many of whom take medicines from Roche and Boehringer Ingelheim, came as a “surprise” given the study’s small size, according to one analyst.

By Ben Fidler • July 11, 2022

New analysis encourages Intercept to refile NASH drug for approval

The company said the new examination is more “in line” with FDA guidance and still found that its drug, known as OCA, helped reduce liver scarring.

By Jacob Bell • July 7, 2022

FDA, under fire for Aduhelm approval, starts review of another Alzheimer's drug

The regulator could clear Biogen and Eisai’s lecanemab by early January. A decision before Phase 3 results could amplify the criticism the agency already faces, however.

By Jonathan Gardner • July 6, 2022

10 clinical trials to watch in the second half of 2022

The biotech industry's downturn accelerated in the first half of the year. Important study readouts for Eisai, Gilead, Merck and Seagen, among others, could determine whether the slump endures.

By Ben Fidler , Ned Pagliarulo , Jacob Bell • July 5, 2022

Celldex, continuing comeback, adds to early promise for skin disease drug

New study results show the medicine appears as effective, or stronger, than standard care for chronic urticarias, a common condition that drugs from Regeneron and Novartis have struggled to treat.  

By Ben Fidler • July 1, 2022

FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects

Liver problems in trial volunteers led the agency to curtail studies of the drug, marking the second major setback related to Sanofi’s acquisition of Principia Biopharma.

By Jonathan Gardner • June 30, 2022

Jazz drug fails in late-stage study for multiple sclerosis

The drug, part of Jazz’s $7 billion acquisition of GW Pharmaceuticals, didn’t perform significantly better than placebo in treating the muscle spasticity that’s tied to the disease.

By Jacob Bell • Updated June 29, 2022

Sanofi, GSK say dual-acting vaccine prevents COVID-19 from omicron in large trial

A shot the partners have been developing reduced symptomatic infections associated with the variant by 72% compared to a placebo, positioning it as a potential option, if approved, to combat omicron.  

By Jonathan Gardner • June 24, 2022

FDA suspends US testing of Sarepta Duchenne drug over safety concerns

The regulator stopped dosing in the U.S. for a drug that’s meant to be a more potent version of Sarepta's marketed medicine Exondys 51, after a patient experienced dangerously low magnesium levels.

By Ben Fidler • June 23, 2022

UniQure buoyed by early data for Huntington's gene therapy

After one year, researchers detected important protein changes in patients who received a low dose of the experimental treatment. Further testing and functional data are needed to assess its potential, however.

By Jonathan Gardner • June 23, 2022

Biogen, citing insurance challenges, shutters one of its Aduhelm studies

The company says a recent coverage decision by Medicare has forced it to end an observational trial of the Alzheimer's drug after enrolling just 29 participants.

By Jacob Bell • June 22, 2022

Mixed results for PTC Duchenne drug put spotlight on EU approval

A confirmatory study of PTC Therapeutics’ muscular dystrophy treatment Translarna missed its main goal, although the company highlighted the trial’s overall positive results. 

By Ned Pagliarulo • June 21, 2022

Ionis, AstraZeneca claim success for competitor to Alnylam rare disease drug

A medicine at the center of a multibillion-dollar alliance between the two companies passed a major test in transthyretin amyloidosis. Full study details were not disclosed, however. 

By Ben Fidler • June 21, 2022