Clinical Trials

Medicare proposes to limit coverage of Biogen Alzheimer's drug

The program will only cover Aduhelm, which the FDA controversially approved last June, for patients enrolled in rigorous clinical trials, likely forestalling broader adoption of the treatment.

By Jonathan Gardner , Jacob Bell • Updated Jan. 11, 2022

Allogene cleared by FDA to resume 'off the shelf' cancer cell therapy trials

A "chromosomal abnormality" that led regulators to halt Allogene's trials was judged to be unrelated to its technology, a finding with important implications for the field of donor-derived cell therapies.

By Ben Fidler • Jan. 10, 2022

Explore the Trendline➔

Inside the race to bring coronavirus vaccines to the world

More than a dozen shots are cleared for use in some fashion around the world. Producing enough supply and addressing the spread of coronavirus variants are the next challenges. 

By BioPharma Dive staff

BioMarin plans return to FDA with updated data on hemophilia gene therapy

Two-year results from a Phase 3 study of Roctavian show treatment prevented bleeding, potentially giving BioMarin the data it needs to resubmit an application for approval. 

By Ned Pagliarulo • Updated Jan. 10, 2022

Leveraging print and digital communications for patient-centric clinical trials

The demand for communicating and reaching trial participants where they live in the most convenient and effective fashion is growing daily and having a dynamic print solution can help make that happen.

Jan. 10, 2022

Avrobio stops work on rare disease gene therapy after unexpected study results

The biotech's gene therapy was one of the furthest along in testing for Fabry, a rare inherited disease that's become a target for drug developers.

By Ned Pagliarulo • Jan. 4, 2022

10 clinical trials to watch in the first half of 2022

Biotech stocks ended 2021 in a slump. But positive results from eagerly anticipated studies in breast cancer, schizophrenia and Alzheimer's disease could help turn the sector's fortunes around.

By Ben Fidler • Updated Jan. 6, 2022

Allakos shares plunge as company's top drug falls short in studies

The drug's effect in tissue did not appear to translate to a benefit in reducing symptoms, surprising executives at the biotech as well as its investors.

By Kristin Jensen • Dec. 22, 2021

Gilead, following Merck, hits its own safety setback in HIV

The FDA has halted all clinical trials testing the injectable form of Gilead's lenacapavir, for fear that incompatibility between the drug and the vials it's held in could cause contamination.

By Jacob Bell • Dec. 22, 2021

Duchenne patient dies in Pfizer gene therapy study

The tragic news follows changes Pfizer recently made to the design of another study testing the therapy due to side effects seen in some participants. 

By Jonathan Gardner • Dec. 21, 2021

Supporting multi-audience communication in all stages of drug development

Biopharmaceutical companies have ongoing and extensive needs for print and digital communications throughout the drug development life cycle that can benefit from a single-source vendor.

Dec. 20, 2021

EU regulator says member countries can use Pfizer's experimental COVID pill

The European Medicines Agency is still reviewing Paxlovid but, citing fast increasing cases and deaths from COVID-19, offered flexibility to EU countries which may authorize emergency use.

By Ned Pagliarulo • Dec. 16, 2021

Biogen reserves four years for trial meant to confirm its Alzheimer's drug works

In granting approval, the FDA gave Biogen roughly nine years to run and submit results from an additional study of Aduhelm. Now, the company says it will do so in about half the time.

By Jacob Bell • Dec. 16, 2021

Sanofi, GSK say COVID vaccine works as booster, but delay key study results

The companies said their shot spurred increased immune responses in people who had received one of four widely used vaccines. But they still await long-anticipated data from a large Phase 3 study.

By Ben Fidler , Ned Pagliarulo • Dec. 15, 2021

Two cancer cell therapy studies succeeded. Why did a third fail?

Novartis' CAR-T drug Kymriah didn't appear better than standard of care in earlier lymphoma treatment. Its two similar rivals, Gilead's Yescarta and Bristol Myers' Breyanzi, did, raising questions about potential differences. 

By Ned Pagliarulo • Dec. 14, 2021

In final analysis, Pfizer's COVID-19 pill remains highly effective

Full study results show Paxlovid cut the risk of COVID-19 hospitalization or death by about 90% among high-risk adults, matching the interim findings Pfizer disclosed last month.

By Ben Fidler • Dec. 14, 2021

Rebounding from setbacks, Sanofi reveals promising data for hemophilia drug

Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.

By Jonathan Gardner • Dec. 14, 2021

On the hunt for new ALS drugs, researchers see progress, and a long road ahead

The fatal nerve disease has few treatments. But despite continued setbacks, drug developers are hopeful that genetic technologies and a better understanding of biology will bring new options in the not-too-distant future

By Jacob Bell • Dec. 13, 2021

CAR-T therapy trials show promise for earlier use in lymphoma

Study results presented at ASH suggest Gilead's Yescarta and Bristol Myers Squibb's Breyanzi could become replacements for stem cell transplants in treating the blood cancer.

By Ned Pagliarulo • Updated Dec. 13, 2021

Moderna reveals first study results for seasonal flu vaccine

Data from a small Phase 1 trial showed the biotech's vaccine spurred immune responses to four common strains, although they didn't appear significantly greater than an already available shot from Sanofi.

By Ned Pagliarulo • Dec. 10, 2021

Latest Roche results show promise for new type of cancer immunotherapy

Updated Phase 2 data suggested an experimental drug targeting the protein TIGIT could bolster the benefit of Roche's Tecentriq in certain people with advanced lung cancer.

By Ben Fidler • Dec. 10, 2021

Fresh data show UniQure's hemophilia gene therapy appears to hold up

The amount of blood clotting protein found in patients who received the medicine was nearly the same at six months and 18 months post-treatment, according to results disclosed Thursday.

By Jacob Bell • Dec. 9, 2021

Vaccine from Medicago, GSK protective against COVID-19 in large study

The vaccine, which Medicago plans to soon submit to Canadian regulators, would be the first of its type, though supply appears likely to be limited.

By Jonathan Gardner • Dec. 7, 2021

Acadia shares rise on study success for Rett syndrome drug

The biotech claims the results are enough to pursue an approval, but high rates of side effects and modest efficacy could raise questions about the treatment.

By Ned Pagliarulo • Dec. 7, 2021

Vertex, needing research spark, finds promising results in small study of kidney disease drug

The biotech, which has been stung by recent clinical setbacks, plans to soon advance the medicine into late-stage testing.

By Ned Pagliarulo • Dec. 1, 2021

With safety a concern, Merck, Gilead pause study of HIV drugs

Out of an "abundance of caution," the companies halted enrollment in a trial evaluating the combination of Merck's islatravir and Gilead's lenacapavir.

By Jacob Bell • Nov. 24, 2021