Colon cancer proves tougher target for Amgen's KRAS drug

A much lower response rate in colorectal cancer than in lung could signal the two tumor types respond differently to blocking KRAS with AMG 510.

By Ned Pagliarulo • Sept. 28, 2019

Cancer immunotherapy boom showing no sign of slowdown

A new report from the Cancer Research Institute found nearly 3,900 drugs in preclinical and clinical development, up 91% from just two years ago. 

By Ned Pagliarulo • Updated Sept. 27, 2019

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

Pfizer's new JAK drug works, but class safety concerns linger

While effective, the class has come under regulatory scrutiny for increasing patients' risk of blood clots and cardiovascular events.

By Jacob Bell • Sept. 27, 2019

Investors conclude there are probably better NASH drugs than Enanta's

The biotech's stock plummeted more than 18% Thursday as data showed its FXR agonist barely cleared the threshold for success in a Phase 2 study.

By Jacob Bell • Sept. 26, 2019

First-of-its-kind trial in ALS spurs hope for brutal disease

A so-called platform study will test five drugs at once, a design that experts say could become a model in rare disease drug development. 

By Andrew Dunn • Sept. 25, 2019

FDA warning slowed immunotherapy use in bladder cancer

Doctors appeared to shift their prescribing following an FDA decision to limit the approvals of Keytruda and Tecentriq in the tumor type, new research found.

By Ned Pagliarulo • Sept. 25, 2019

Medicines Co. gets cholesterol confirmation

The biotech secured positive results from two more Phase 3 trials of inclisiran, clearing a final step before submitting the PCSK9 drug to the FDA.

By Jonathan Gardner • Sept. 25, 2019

Merck, Pfizer execs explain how they tap sites for cancer trials

The decisions hinge on a trial's phase and tumor type but are also affected by certain medical experts and the companies' history with a site.

By Jacob Bell • Sept. 23, 2019

Cancer centers stretching to keep up with pharma's oncology interest

Empty trials, bandwidth constraints and lingering issues with enrollment criteria are on display amid a boom in cancer drug research.

By Jacob Bell • Sept. 23, 2019

Is the future of diabetes treatment better drugs or better care?

Drug manufacturers are trying to push the boundaries of glucose control, but cost concerns could rein in ambitions.

By Jonathan Gardner • Sept. 23, 2019

With eye to competition, Biogen explores higher doses of Spinraza

A Phase 2/3 trial appears aimed at seeing whether a greater dose of the spinal muscular atrophy treatment could deliver better efficacy in adults.

By Ned Pagliarulo • Sept. 20, 2019

Cancer drug trials often at risk of bias, study finds

Randomized controlled studies are not all alike, as researchers determined about half of pivotal studies supporting recent cancer drug approvals in Europe had potential flaws.

By Andrew Dunn • Sept. 19, 2019

Novartis, shadowed by data scandal, renews case for Zolgensma

Presymptomatic infants treated with the gene therapy reached motor milestones consistent with normal development, updated study results showed.

By Ned Pagliarulo • Sept. 19, 2019

Acceleron dealt pipeline setback

The biotech's muscular dystrophy drug ACE-083 failed a Phase 2 trial, putting the spotlight for Acceleron more firmly on Celgene-partnered luspatercept.

By Jonathan Gardner • Sept. 17, 2019

Biogen stops Phase 2 study in another hit to 'high-risk' pipeline

The biotech halted testing of an experimental drug for idiopathic pulmonary fibrosis less than a week after discontinuing its Alzheimer's drug elenbecestat.

By Andrew Dunn • Sept. 17, 2019

Ebola vaccine from Merck takes step toward US approval

As DRC's outbreak persists, Merck plans to increase supply of its experimental V920 drug, aiming to produce 650,000 doses over the next six to 18 months.

By Ned Pagliarulo • Sept. 17, 2019

5 questions ESMO cancer drug data might answer

Can Bristol-Myers convince doctors of Opdivo's potential in lung cancer? Will AstraZeneca remain the king of PARPs? Data set to be unveiled could offer some indication.

By Ned Pagliarulo , Jonathan Gardner • Sept. 16, 2019

Another BACE dropped as Biogen and Eisai halt elenbecestat trials

Data monitors cited an "unfavorable risk-benefit ratio" in deciding to stop the trials, dealing another blow to a drug class that's come up short before.

By Jonathan Gardner • Sept. 13, 2019

Novartis' strong MS results could pose challenge to Roche

Little used in cancer, ofatumumab could find a second life as a multiple sclerosis drug, posting data that show it convincingly beat out Aubagio. 

By Ned Pagliarulo • Sept. 13, 2019

Adverum sinks on first gene therapy data for eye disease

A decline in eyesight post-treatment reflects poorly on the therapy's potential, lengthening the company's odds of catching rival Regenxbio.

By Jonathan Gardner • Sept. 12, 2019

In a 'make or break' moment, Tocagen falls short

The San Diego biotech's lead drug failed to extend survival in a pivotal study for an aggressive type of brain tumor, setting back the company's plans. 

By Andrew Dunn • Sept. 12, 2019

Moderna marks progress toward goal of coaxing medicine from body's cells

Preliminary data suggest Moderna could reach its lofty ambitions for mRNA. "Any protein under the sun we can make," CEO Stéphane​ Bancel told BioPharma Dive.

By Ned Pagliarulo • Sept. 12, 2019

BioMarin talks down worries on gene therapy data differences

BioMarin's R&D head said timing of steroid treatment impacted interim Phase 3 data, which had spurred questions on valrox's durability.

By Andrew Dunn • Sept. 10, 2019

Biomarker data help Merck case for wide use of Keytruda combo

"In the setting of chemo combinations, it does not appear that PD-L1 or TMB influences the outcome," said Merck development head Roy Baynes.

By Ned Pagliarulo • Sept. 10, 2019

The evolution of the patient experience

With the healthcare business model constantly evolving the pharmaceutical landscape, the role of healthcare providers is sure to look radically different in a few decades.

By Ian Wilcox • Sept. 10, 2019