AstraZeneca immunotherapy combination falls short in bladder cancer trial

Results from a Phase 3 bladder cancer study combining two checkpoint inhibitors failed to show a survival benefit, raising questions about other trials.

By Jonathan Gardner • March 6, 2020

Coronavirus spread threatens spring slate of medical meetings

The American College of Cardiology and the American Academy of Allergy, Asthma and Immunology canceled their annual meetings, previously scheduled for March.

By Ned Pagliarulo • Updated March 9, 2020

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Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

A closer look at the Ebola drug that's become the top hope for a coronavirus treatment

Trials are underway in the U.S., China and, soon, other Asian countries to test whether remdesivir, an antiviral developed by Gilead, could have potential against SARS-CoV-2.

By Ned Pagliarulo • March 5, 2020

Takeda starts work on treatment for coronavirus illness

The plan is to take blood proteins of patients recovering from the novel virus and turn them into an immune-boosting therapy that mitigates or prevents illness in others.

By Jacob Bell • March 4, 2020

In a CRISPR first, Editas therapy used to fix genes in the body

A patient with a severe type of inherited blindness was recently treated with Editas and Allergan's CRISPR medicine, marking the first in vivo use of the gene-editing technology in adults. 

By Ned Pagliarulo • March 4, 2020

Karyopharm shares jump on positive study data for multiple myeloma drug

The cancer biotech now plans to ask the FDA to expand Xpovio's approval into earlier lines of treatment for the blood cancer.

By Ned Pagliarulo • March 2, 2020

Sangamo sees vindication in Biogen gene-editing deal

Delivering products nearly ready for clinical testing has sparked greater dealmaking interest from big pharma, Sangamo's CEO told BioPharma Dive.

By Jonathan Gardner • Feb. 28, 2020

Gilead commits to in-house development of coronavirus treatment hopeful

The biotech launched two global, Phase 3 studies of remdesivir, an experimental antiviral already being studied in trials run by Chinese researchers and the NIH.

By Ned Pagliarulo • Feb. 27, 2020

Amgen heart drug passes interim check, setting up year-end readout

Results from a large Phase 3 study of omecamtiv mecarbil, which Amgen developed with Cytokinetics, are due in the fourth quarter. 

By Ned Pagliarulo • Feb. 26, 2020

US begins first study of coronavirus treatment, testing Gilead's remdesivir

Meanwhile, another trial is getting set up in Washington to evaluate Moderna's experimental vaccine, the first vials of which were shipped to NIH Monday.

By Ned Pagliarulo • Feb. 25, 2020

In a nod toward pharma, ICER makes deal to access real-world evidence

A partnership with Aetion will give ICER more information to include in its drug reviews, but could renew debate on the usefulness of evidence collected outside of clinical study.

By Jonathan Gardner • Feb. 24, 2020

GenFit delays data readout, raising doubts about its place in NASH

Thursday's update is the second time results from a large study of the French drugmaker's main drug, called elafibranor, have been pushed back.

By Jacob Bell • Feb. 21, 2020

Teva's neuroscience drug falls short at the finish line

Austedo, a main growth driver for Teva, failed two late-stage studies that were supposed to get the drug approved as a treatment for tics in young patients with Tourette's.

By Jacob Bell • Feb. 20, 2020

Cancer concerns knock Eisai's weight loss drug from market

Eisai has agreed to remove Belviq after the FDA said a post-marketing study found a "range of cancer types" appeared to develop more frequently in patients taking the drug.

By Jacob Bell • Feb. 14, 2020

Merck builds case for Keytruda use in breast cancer

When added to chemo, Merck's immunotherapy kept a difficult-to-treat form of breast cancer from progressing, provided patients had an important biomarker.

By Jonathan Gardner • Feb. 12, 2020

Exelixis prostate cancer data could help stave off competitive threats

As Pfizer makes inroads against Cabometyx in kidney cancer, Exelixis said it will ask the FDA next year for approval in prostate disease.

By Jonathan Gardner • Feb. 11, 2020

Bayer, looking to grow pharmaceutical sales, seeds new research center

The German drugmaker is transferring a "large part" of its small molecule research unit in Berlin to contract developer and manufacturer Nuvisan, with the aim of building a new facility on Bayer's R&D campus.

By Jacob Bell • Feb. 11, 2020

In Alzheimer's, a plan to treat patients earlier doesn't work out for Lilly, Roche

Results from the DIAN-TU study chip away at the amyloid hypothesis' foundation, just as Biogen prepares to file its drug aducanumab for approval.

By Jonathan Gardner • Feb. 10, 2020

Biohaven misses a chance to prove it's more than migraine

One of Biohaven's late-stage drugs proved no better than placebo in a type of severe anxiety — a lost opportunity for the company to showcase a pipeline beyond its lead migraine therapy.

By Ned Pagliarulo • Feb. 10, 2020

Biogen dips as Alzheimer's drugs from Lilly, Roche fail again

Analysts have said that, should the DIAN-TU study miss, it may further paint Biogen's aducanumab and the positive Phase 3 data it generated as an "artifact of luck" within a series of failed amyloid-targeting drugs.

By Jacob Bell • Feb. 10, 2020

Innovations shaking up clinical trial patient recruitment

 From voice assistants to study-specific patient portals, discover the newest innovations for clinical trial sponsors to leverage. 

Feb. 10, 2020

In small study, hints of promise for 'natural killer' cell therapy

None of the 11 patients treated with the CAR NK treatment experienced the severe immune reactions or neurotoxicity that are associated with CAR-T.

By Ned Pagliarulo • Feb. 6, 2020

Sanofi MS drug results set stage for extensive late-stage testing

The drug, a type of enzyme inhibitor that's proven valuable in cancer treatment, will soon head into four late-stage studies across various types of MS.

By Jacob Bell • Feb. 6, 2020

Implementing risk-based quality management: The importance of scalability

Regulators insist on making better use of advancements such as centralized monitoring and analytics to more efficiently maintain quality and safety standards.

Feb. 6, 2020

Regeneron partners with US government to develop coronavirus treatment

The biotech hopes to replicate its past success in quickly advancing a treatment for Ebola. But, as that experience showed, proving a new antiviral isn't easy.

By Ned Pagliarulo • Updated Feb. 4, 2020