FDA approves J&J's esketamine as faster-acting depression treatment

Esketamine, chemically related to ketamine, is the first drug approved in decades that works differently from available antidepressants. Yet the OK comes with several strong warnings.

By Ned Pagliarulo • Updated March 6, 2019

Novo, seeking edge in diabetes, posts positive Ozempic data

The Danish pharma's drug faces tough competition from Lilly's rival Trulicity, currently the leader in the market for GLP-1 therapies.

By Emily Mullin • March 5, 2019

Explore the Trendline➔

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

Celgene checks regulatory box for key drug in Bristol-Myers deal

Recent shareholder opposition to the $74 billion buyout has pressured the companies, putting the buyer's rationale for the deal under a microscope.

By Ned Pagliarulo • March 5, 2019

Horizon eyes 2019 filing for its drug following Phase 3 readout

Results from the study supported the efficacy profile for teprotumumab, which could gain an approval next year under Horizon's regulatory timeline.

By Suzanne Elvidge • March 1, 2019

Roche wins US approval of more convenient Herceptin

Treatment with subcutaneous Herceptin takes just a few minutes, rather than the sometimes hour and a half needed to administer the breast cancer drug intravenously.

By Ned Pagliarulo • March 1, 2019

ImmunoGen's lead therapy misses in Phase 3, tanking shares

The company's antibody-drug conjugate failed to improve survival rates in ovarian cancer patients as monotherapy.

By Andrew Dunn • March 1, 2019

Novavax shares slump as RSV vaccine fails in Phase 3 trial

The biotech lost roughly two-thirds of its market cap, falling into penny stock territory on the news. Still, a top official declared: "The vaccine is not dead."

By Andrew Dunn • Feb. 28, 2019

Hurdles of antibiotic R&D on display in Achaogen's divergent study outcomes

A NEJM editorial highlighted the challenges still facing companies in antibiotic development, particularly in serious resistant infections.

By Suzanne Elvidge • Feb. 27, 2019

Gene therapy progress spurs Sarepta buy of Myonexus

Early positive data from three patients with limb-girdle muscular dystrophy support Sarepta's expanding push into gene therapy.

By Ned Pagliarulo • Feb. 27, 2019

AstraZeneca's PARP drug succeeds in pancreatic cancer study

Patients with a certain mutation lived longer without their disease progressing when taking Lynparza as a first-line maintenance therapy versus placebo.

By Jacob Bell • Feb. 27, 2019

Novartis moves forward on CV drug, paying $150M to Ionis, Akcea

The Swiss pharma will now take the lead on a Phase 3 cardiovascular outcomes study after mulling over Phase 2 data from November.

By Andrew Dunn • Feb. 26, 2019

Drug development innovations that work: real-world data studies (Part 2 in a series)

A recent study by the Economic Intelligence Unit (EIU) shows that clinical studies that incorporate real-world data have significant benefits over other trials.

Feb. 26, 2019

In gene editing milestone, first patient treated in Vertex, CRISPR Therapeutics study

The drugmakers believe it to be the first ever company-sponsored use of a CRISPR-based therapeutic in a clinical trial. 

By Ned Pagliarulo • Feb. 25, 2019

Intercept stock drop reflects the high bar set for NASH drugs

Though Intercept's drug Ocaliva did score the first Phase 3 victory against the fatty liver disease, investors still appear skeptical of the drug's prospects.

By Jacob Bell • Feb. 22, 2019

After accelerated approval, Merck's Keytruda fails in liver cancer study

The negative results raise questions about Keytruda's earlier OK, which was based on findings from a smaller Phase 2 trial.

By Andrew Dunn • Feb. 20, 2019

Pfizer tweaks Xeljanz trial after embolism safety signal

An independent analysis raised concerns over the occurrence of pulmonary embolisms among patients receiving 10 mg of Xeljanz twice daily.

By Jacob Bell • Feb. 20, 2019

Pfizer, Lilly roll out more late-stage results for non-opioid pain drug

Yet safety questions on tanezumab and the anti-NGF class persist, making prospects for approval more uncertain even as the FDA encourages non-opoid pain drug development. 

By Andrew Dunn • Feb. 19, 2019

Intercept NASH drug succeeds in field's first positive Phase 3 trial

The results position Intercept to be first to market with a treatment for the fatty liver disease, now the target of substantial drugmaker investment.

By Ned Pagliarulo • Feb. 19, 2019

Hunt for immunotherapy combinations turns up success in kidney cancer

Drug pairings tested by Merck and Pfizer proved effective, and could soon compete with Bristol-Myers' combo in metastatic renal cell carcinoma. 

By Ned Pagliarulo • Feb. 16, 2019

New prostate cancer data puts Bayer drug in line with Pfizer, J&J rivals

Pfizer and J&J are already on the market with products for non-metastatic prostate cancer. Bayer aims to compete with its drug darolutamide.

By Andrew Dunn • Feb. 15, 2019

DBV sets sights on FDA resubmission for peanut allergy treatment

The biotech withdrew its application last December after the FDA asked for details on the company's manufacturing and quality control for Viaskin Peanut.

By Ned Pagliarulo • Feb. 14, 2019

Merck plans trio of Phase 3 Keytruda studies in prostate cancer

Announcement of the trials comes as the drugmaker unveiled mid-stage data from testing of several Keytruda combos in the common cancer type.

By Andrew Dunn • Feb. 14, 2019

J&J's esketamine wins backing of key advisory panel

Committee experts recommended the FDA approve the depression drug, giving cover for the agency to take a more flexible approach in its review.

By Ned Pagliarulo • Feb. 12, 2019

Merck kidney cancer data impresses, putting pressure on Bristol-Myers

Trial results showing a strong survival benefit for Merck's Keytruda in renal cancer could help the pharma make further gains on its immuno-oncology rival.

By Ned Pagliarulo • Feb. 12, 2019

Gilead's lead NASH drug not so STELLAR in first late-stage readout

While predicted by many, selonsertib's failure in STELLAR 4 further dims the drug's prospects as a treatment for the fatty liver disease.

By Jacob Bell • Feb. 12, 2019