Novartis gets second trial win for blockbuster hopeful

The company plans to seek broad approval of the oral medication, iptacopan, next year after it met its primary endpoint in a new pool of patients with the rare blood disease PNH.

By Kristin Jensen • Dec. 8, 2022

Relmada sinks further as depression drug fails second large trial

The company claimed an “unplausible” placebo response caused both studies to fail and is making substantive changes to its other remaining late-stage trial as a result. 

By Ben Fidler • Dec. 8, 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

Prometheus shares soar on new data for inflammation drug

Having scored positive results in two key studies for ulcerative colitis and Crohn’s disease, Prometheus now intends to advance the drug, called PRA023, into pivotal testing.

By Jacob Bell • Dec. 7, 2022

Esperion, without data, says cholesterol pill lowered heart risk in study

The large cardiovascular outcomes trial is a major test for Esperion, which has struggled to sell its drug Nexletol since winning U.S. approval in 2020.

By Ned Pagliarulo • Dec. 7, 2022

MEI, Kyowa stop lymphoma drug trials after FDA meeting

The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors. 

By Jonathan Gardner • Dec. 6, 2022

Novartis prostate cancer drug succeeds in study key to company’s sales hopes

The positive results could help Novartis secure approval for earlier use of the radiopharmaceutical drug Pluvicto, potentially broadening the number of eligible patients by several times the current market.

By Ned Pagliarulo • Dec. 5, 2022

With new data, Nkarta builds case for ‘natural killer’ cell therapy

The updated study results add to evidence that such therapies may help treat B-cell lymphomas. But it’s still unclear how long their effects could last. 

By Ben Fidler • Dec. 5, 2022

When it comes to small populations, biotechs need to think big

Maria-Cruz Morillo, global therapeutic operations lead for rare diseases at Allucent, discusses the unique challenges of rare disease drug development and how the right expertise can help.

Dec. 5, 2022

We must improve diversity in clinical trials. These 5 steps will help.

The pandemic shined a light on the importance of diversity in clinical trials. Syneos Health can help your team devise a diversity strategy.

Dec. 5, 2022

Roche study failure gives Alzheimer’s researchers new clues in drug quest

Detailed clinical trial data for Roche's gantenerumab showed treatment cleared far less toxic protein from patients' brains than expected, potentially explaining its divergent result from Eisai’s lecanemab.

By Jonathan Gardner , Delilah Alvarado • Dec. 1, 2022

Lilly’s Alzheimer’s drug bests Aduhelm in plaque clearance study

The company's experimental treatment donanemab reduced amyloid levels in the brain by more than Biogen's approved medicine, but the data’s significance is unclear until Lilly reveals results from a larger study next year. 

By Ned Pagliarulo • Dec. 1, 2022

What to make of Eisai and Biogen’s Alzheimer’s drug results

At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. Still, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.

By Jacob Bell , Ned Pagliarulo • Nov. 29, 2022

CinCor shares dive after blood pressure drug fails key trial

The company, one of several testing a drug for resistant hypertension, had previously pulled off one of the top performing biotech IPOs this year.

By Gwendolyn Wu • Nov. 28, 2022

Axsome says drug eased Alzheimer’s symptom in positive study

Shares of the New York-based biotech rose by a third Monday morning, as fresh clinical trial results showed its drug AXS-05 both delayed and prevented the recurrence of Alzheimer’s agitation.

By Jacob Bell • Nov. 28, 2022

FDA grants speedy review to Sarepta’s Duchenne gene therapy

The agency will decide on an accelerated approval of Sarepta’s treatment by May 29, months before results are expected from a potentially confirmatory Phase 3 trial.

By Jonathan Gardner • Nov. 28, 2022

Mainstreaming cell and gene therapy – Realizing its potential

The challenges biopharma companies face in running clinical trials and tips on how to surmount those obstacles.

Nov. 28, 2022

A unified, connected foundation is transforming the future of digital trials

A holistic approach allows stakeholders to adapt to the ever-increasing number of clinical trials and data points.

By Jodi Helmer • Nov. 21, 2022

Editas to seek partner for CRISPR medicine after lackluster study results

While the biotech will not develop the gene editing therapy further on its own, CEO Gilmore O’Neill claimed the data are still a meaningful demonstration of what CRISPR can accomplish. 

By Ned Pagliarulo • Nov. 17, 2022

Moderna data supports use of omicron booster over original vaccine

New results show the two-pronged booster the FDA cleared in August sparks a stronger immune response against omicron and its subvariants than Moderna’s original shot.

By Jonathan Gardner • Nov. 14, 2022

Trial failures end latest hope for Roche’s Alzheimer’s drug

Eight years after gantenerumab failed a Phase 3 study, the drug came up short in late-stage testing again, proving unable to meaningfully slow cognitive decline in two closely watched trials. 

By Delilah Alvarado , Ben Fidler • Nov. 14, 2022

Early data hint at benefit for Amgen’s obesity drug

Newly released study results suggest treatment could lead to quicker weight loss, on less frequent dosing, than therapies from Eli Lilly and Novo Nordisk.

By Jonathan Gardner • Nov. 8, 2022

GSK myeloma drug comes up short in confirmatory test

The drug, Blenrep, did not outperform a standard treatment in relapsed or refractory multiple myeloma, setting back GSK's plans to confirm the conditional approval it received in 2020.  

By Ned Pagliarulo • Nov. 7, 2022

Amgen to test new way to lower heart risk with large drug trial

Buoyed by strong mid-stage study results, the biotech will soon start a cardiovascular outcomes trial of a drug designed to target a genetic risk factor called lipoprotein(a).

By Ned Pagliarulo • Nov. 7, 2022

Bispecific cancer drugs and gene therapy advances: What to watch at this year’s ASH meeting

Competition is increasing behind newly approved drugs from Roche and J&J, while the long-term benefit of gene therapies for chronic blood disorders is being put to the test.

By Ben Fidler , Ned Pagliarulo • Nov. 4, 2022

Abeona to submit cell therapy for approval after positive results for skin disorder treatment

The company said its therapy, which could become the first drug for a type of epidermolysis bullosa, helped heal wounds and reduce pain in a clinical trial.

By Jacob Bell • Nov. 3, 2022