Clinical Trials: Page 2

Trial failure dashes Biogen hopes for next Alzheimer's drug

Days after Aduhelm's approval, Biogen said an experimental drug that works in a different way didn't help patients, leading the company to stop research.

By Jonathan Gardner • June 17, 2021

Regeneron antibody cuts risk of COVID-19 death in UK study

The biotech said it will seek an expanded FDA clearance after results from the RECOVERY trial showed its antibody can lower mortality among certain hospitalized COVID-19 patients.

By Kristin Jensen • June 16, 2021

Explore the Trendline➔

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

Biogen gene therapy deal has yet to bear fruit

Another gene therapy from Nightstar Therapeutics, which Biogen bought for $800 million in 2019, has failed in a key clinical study.

By Jacob Bell • June 15, 2021

Sage antidepressant succeeds in key study, but data raise questions

Zuranolone, a drug that's crucial for Sage's future and the focus of a multi-billion dollar bet by Biogen, could be headed for a regulatory review. But new trial results are more mixed than the overall outcome suggests. 

By Ben Fidler , Ned Pagliarulo • UPDATED: June 15, 2021 at 10:39 a.m.

Novavax says vaccine 90% effective against COVID-19 in large trial

Highly anticipated results from a Phase 3 study testing the biotech company's shot showed it to be strongly protective and safe, a potential boon for the world's vaccination efforts.

By Ned Pagliarulo • UPDATED: June 14, 2021 at 9:27 a.m.

Vertex stops work on second rare disease drug after study results disappoint

The biotech said its drug for alpha-1 antitrypsin deficiency wasn't potent enough to advance into further testing, but plans to move others into clinical trials next year.

By Jacob Bell • UPDATED: June 11, 2021 at 10:28 a.m.

Beigene expands into cancer cell therapy with Shoreline pact

The fast-growing biotech will work with Shoreline to develop cancer treatments using natural killer cells, an emerging alternative to T-cell based therapies. 

By Ned Pagliarulo • June 09, 2021

Biogen Alzheimer's approval could open the door for similar drugs

Approval of Aduhelm sets a precedent that could enable some drugs, like Eli Lilly's drug donanemab, to advance quickly and cause other previously sidelined ones to get a second look.

By Jonathan Gardner • June 09, 2021

The FDA approved Biogen's Alzheimer's drug. The company now has years to confirm it works.

Officially, Biogen has until 2029 to complete a study confirming Aduhelm's benefit. But the agency says it hopes to push the drugmaker to finish faster.

By Ned Pagliarulo • UPDATED: June 9, 2021 at 10:33 a.m.

Sponsored by IsoPlexis

Enabling biomarker discovery with unique functional proteomics

The identification of these novel clinical biomarkers allows researchers to better understand complex mechanisms of immune response to diseases, facilitating the development of more effective therapeutics. 

ASCO21: An immunotherapy debate, an NK cell question and the next precision drugs

Moving immunotherapy to earlier lines of treatment holds promise but, at ASCO, sparked debate, too. Fate Therapeutics, meanwhile, renewed its case for natural killer cell therapy. 

By Ben Fidler , Ned Pagliarulo • June 07, 2021

An AstraZeneca, Merck drug slows the return of genetic breast cancer. Will testing speed up?

New study results could make Lynparza a standard adjuvant treatment for people with an inherited form of breast cancer — as long as they know they have it. 

By Ben Fidler • June 03, 2021

Novartis prostate cancer drug extends survival in key test of radiopharmaceutical therapy

Results from the Phase 3 trial, which Novartis plans to use to ask for approval, help validate the pharma's bet on the therapy's original developer, Endocyte.

By Ned Pagliarulo • June 03, 2021

Sanofi rare disease drug hits another setback

The French pharma halted a late-stage trial of venglustat, one of its priority drug candidates, in a type of kidney disease, months after stopping testing in Parkinson's.

By Ned Pagliarulo • June 01, 2021

UniQure moves Huntington's gene therapy to next phase of key trial

Safety monitors cleared the company to test a higher dose after reviewing data from 10 patients, providing some hopeful news after recent setbacks for experimental drugs targeting the genetic disease.

By Jonathan Gardner • May 27, 2021

'A hugely consequential decision:' How Biogen's Alzheimer's drug came to face the FDA

The FDA's decision to approve aducanumb could have far-reaching consequences for patients, Biogen and Alzheimer's research. Here's how the drug's review came about. 

By Ned Pagliarulo • May 27, 2021

Moderna, with new results, set to seek vaccine clearance for young teens

The biotech's shot was strongly protective against COVID-19 in a study of 12- to 17-year-olds, a finding that could soon make it the second vaccine available for adolescents in the U.S.

By Ben Fidler • May 25, 2021

J&J's new cancer drug leads a growing pipeline of dual-targeting antibodies

Pharma and biotech companies alike see potential in using bispecific antibodies for hard-to-treat cancers like leukemia, myeloma and solid tumors.

By Jonathan Gardner • May 24, 2021

A biotech backs off NASH after trial failure

NGM Biopharmaceuticals has decided not to pursue a late-stage NASH program after its drug aldafermin became the latest in a long line of medicines to fail to help patients with the common liver condition.  

By Jacob Bell • May 24, 2021

Sponsored by Yourway

Supporting global decentralized and virtual clinical trials during challenging times and beyond

The risks and challenges incurred on clinical trials logistics by the COVID-19 pandemic have significantly accelerated the adoption of DCT and DTP trials models to keep site investigators and potentially vulnerable and immunocompromised patients safe from infection. 

By Leandro Moreira, SVP of Corporate Development, Yourway • May 24, 2021

Sponsored by PRA Health Sciences

Accelerating patient care through digital transformation and decentralized clinical trials

The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs). 

Closely watched Bristol Myers immunotherapy shows benefit in melanoma

Study results prove, for the first time, that a drug blocking the protein LAG-3 can improve on another immunotherapy.

By Ned Pagliarulo • May 19, 2021

FDA delays a biotech's cancer cell therapy once again

Iovance, which now plans to submit its melanoma treatment to the FDA next year, separately disclosed that its CEO Maria Fardis will resign.

By Kristin Jensen • UPDATED: May 19, 2021 at 12:08 p.m.

Sarepta's Duchenne gene therapy clears study hurdle, although questions linger

A version of the treatment made at commercial scale looks similar to what Sarepta used in early testing. But the findings are no longer the last step before an approval filing, as the company once hoped.

By Ben Fidler • May 18, 2021

Fate offers glimpse at 'natural killer' cell therapy for leukemia

The biotech's treatment is one of a wave of new treatments meant to mimic the effects of NK cell transplants in leukemia, though analysts remain skeptical.

By Ben Fidler • May 14, 2021