FDA places two combo studies of Roche's Tecentriq on partial hold

The decision follows recruitment halts for a number of other trials involving PD-(L)1 inhibitors in certain blood cancers due to safety concerns.

By Suzanne Elvidge • Sept. 18, 2017

AstraZeneca's Bydureon falls short in heart study

Lack of a heart benefit means a comeback for Bydureon probably isn't in the cards.

By Lisa LaMotta • Sept. 14, 2017

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

Lilly's baricitinib fails to outshine Sanofi's Dupixent

A mid-stage study in atopic dermatitis hit its goal, but results appeared to fall short of the mark set by Sanofi and Regeneron's already approved treatment.

By Lisa LaMotta • Sept. 14, 2017

Pfizer, Astellas eye wider market for prostate cancer drug

Xtandi's broader commercial prospects were a key factor in Pfizer's decision to pick up the drug in a $14 billion acquisition of Medivation last fall.

By Ned Pagliarulo • Sept. 14, 2017

Lexicon, Sanofi drug could be first oral for type 1 diabetes

Positive results in three Phase 3 trials could set the SGTL1/SGLT2 inhibitor up to be the first oral treatment for the less common form of the chronic condition.

By Lisa LaMotta • Sept. 13, 2017

New estimate puts cost to develop a cancer drug at $648M

An analysis published in JAMA found that developing cancer drugs may cost significantly less than previously thought. 

By Lisa LaMotta • Sept. 13, 2017

Amicus drops wound drug after trial miss

The biotech had hoped its drug could become the first approved treatment for a devastating genetic skin condition.

By Ned Pagliarulo • Sept. 13, 2017

AbbVie keen on JAK inhibitor despite safety concerns

Upadacitinib could be a potential best-in-class drug, but patient deaths have raised safety concerns. 

By Lisa LaMotta • Sept. 12, 2017

Sage stock sinks after epilepsy drug fails to beat placebo

Brexanolone's striking failure in SRSE makes an upcoming readout for the drug in postpartum depression all the more critical for Sage.

By Ned Pagliarulo • Sept. 12, 2017

Blockbuster hopeful Dupixent succeeds in asthma study

Strong results should help Sanofi and Regeneron expand the drug's market, yet new competition could complicate those plans.

By Ned Pagliarulo • Sept. 11, 2017

ESMO: New momentum for AstraZeneca as lung cancer studies impress

Still reeling from a damaging setback this summer, the British drugmaker hopes strong clinical results for Imfinzi and Tagrisso could help it gain an edge.

By Ned Pagliarulo • Sept. 11, 2017

J&J moves away from hep C due to rival drugmakers' cures

The big pharma is shuttering its program for JNJ-4178, a hep C combo regimen, as it refocuses R&D investments around hep B treatments.

By Jacob Bell • Sept. 11, 2017

ESMO: Lilly breast cancer drug keeps pace with Pfizer, Novartis rivals

Results presented at ESMO over the weekend show abemaciclib cut the rate of disease progression in advanced breast cancer patients by nearly half.

By Ned Pagliarulo • Sept. 9, 2017

ESMO: Clovis seeking new indication on positive ARIEL3 data

Strong results in all types of advanced ovarian cancer patients has the biotech looking to expand the market for its PARP inhibitor.

By Lisa LaMotta • Sept. 8, 2017

ESMO: Foundation biomarker test could help boost immunotherapy

Data presented by Foundation and Roche offer up some of the first evidence that tumor mutation testing can be performed using only a blood sample.

By Ned Pagliarulo • Sept. 8, 2017

NewLink surges on fresh indoximod data

Advanced melanoma patients treated with a combo of the drug and Keytruda demonstrated median progression-free survival of nearly 13 months.

By Jacob Bell • Sept. 8, 2017

Prescribed Reading: PD-1, CAR-T threatened by clinical holds

Highly innovative oncology technologies may be life-saving, but they have also raised major safety concerns.

By Lisa LaMotta • Sept. 8, 2017

Opdivo combo shows early survival benefit in kidney cancer

The positive results change the story for the Opdivo/Yervoy pairing, which had previously failed to clearly improve progression-free survival in renal cell carcinoma. 

By Ned Pagliarulo • Sept. 7, 2017

AstraZeneca sees first-in-class potential for asthma biologic

Unlike other drugs, tezepelumab targets a "master switch" thought to drive multiple inflammatory pathways that are active in patients with severe asthma. 

By Ned Pagliarulo • Sept. 7, 2017

Alnylam pauses clinical trials of hemophilia drug after patient death

A fatal thrombotic event in a Phase 2 study of fitusiran has reignited investor worries over the company's RNAi platform.

By Jacob Bell • Sept. 7, 2017

Verastem bet on blood cancer drug pays off with trial success

The Boston biotech plans to file for U.S. approval of duvelisib early next year based on positive data from its Phase 3 DUO study. 

By Ned Pagliarulo • Sept. 6, 2017

Sobi orphan drug approved for simpler dosing

Approval of a once-daily regimen for the rare disease cuts the treatment burden for patients and caregivers.

By Suzanne Elvidge • Sept. 6, 2017

Insmed soars on strong results for inhaled antibiotic

A quick filing for approval is expected now that the biotech has positive late-stage results in hand. 

By Lisa LaMotta • Sept. 5, 2017

Cell and gene therapies: From clinical to commercial

There is a natural flow from clinical trial logistics to commercial logistics. Proactive planning during the early stages is vital for a product's commercial success.

Sept. 5, 2017

Death in Cellectis CAR-T trial leads to clinical hold

Another patient death in CAR-T trials pushed the Food and Drug Administration to place two early trials on clinical hold. 

By Lisa LaMotta • Sept. 5, 2017