Axovant buoyed by early gene therapy data

After a damaging Alzheimer's setback, Axovant has bet its future on gene therapy. Its programs in Parkinson's and Tay-Sachs are its most advanced.

By Jacob Bell • March 11, 2019

Roche wins first immunotherapy approval for triple-negative breast cancer

The FDA OK, however, is contingent on further study and is only for patients whose tumors express a biomarker called PD-L1.

By Ned Pagliarulo • March 8, 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

AMAG pregnancy drug's future in doubt after key study miss

A confirmatory trial designed to support Makena's approval failed, likely crimping its commercial prospects. Yet the drug may still remain on market. 

By Jacob Bell • March 8, 2019

Allergan depression drug fails in setback for turnaround

Rapastinel, which Allergan once pegged for $1 billion to $2 billion in peak sales, missed its goal in three studies and looks set to fall short in a fourth.

By Ned Pagliarulo • March 7, 2019

Site score card: Expert tips for moving up the ranks

Former site director shares his tips for using metrics to move a study site to the top of a clinical research sponsor’s site list of high performers.

By Sean Walsh, MBA, ACHE • March 7, 2019

Second Vertex triple combo succeeds in cystic fibrosis, setting up crucial choice

The biotech plans to take one of its experimental regimens to the FDA later this year, but wants more data in hand before deciding on which one. 

By Suzanne Elvidge • March 6, 2019

Gilead scores key HIV data as Descovy proves non-inferior to Truvada

Positive results from the DISCOVER trial will support a filing to expand Descovy's use into PrEP, an indication that has been lucrative for Truvada.

By Jacob Bell • March 6, 2019

Alnylam's givosiran clears Phase 3 test in second RNAi win

The biotech plans to submit the drug, which treats a rare genetic disease, to regulators in the U.S. and Europe later this year. 

By Kristin Jensen • March 6, 2019

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

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