Genmab stumbles after J&J dumps Darzalex combo trial

After an imbalance of patient deaths in a combo study of Darzalex and Tecentriq, Genmab partner Janssen is re-evaluating further combo studies. 

By Suzanne Elvidge • May 29, 2018

AstraZeneca's Imfinzi delivers survival benefit in Stage 3 lung cancer

While the British pharma still lags rivals in the metastatic lung cancer market, Imfinzi has carved out a leading position in the earlier, Stage 3 setting. 

By Ned Pagliarulo • May 25, 2018

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

Prescribed Reading: J&J seen with most M&A potential; Drug pricing plan ripples

The pharma giant has the greatest flexibility to ink a deal, according to a recent Leerink report. Elsewhere, drug pricing remained center stage in D.C. 

By Lisa LaMotta • May 25, 2018

Genmab hits roadblock in non-Hodgkin lymphoma

Results from a Phase 3 study of Arzerra didn't turn up positive for Genmab and partner Novartis, dimming prospects for the cancer biologic. 

By Suzanne Elvidge • May 25, 2018

Cancer drug spending climbs, with top winners earning lion's share

Iqvia found the top 35 cancer drugs accounted for 80% of the roughly $110 billion the world spent on oncology therapeutics last year. 

By Ned Pagliarulo • May 24, 2018

From IND to FPI: How to set up your US study for success

Clinical trials are complicated, but following certain planning and management strategies can equal study success. 

By Lauren Neighbours, PhD, RAC, US Head Regulatory, PSI CRO • May 23, 2018

Esperion talks cholesterol drug pricing after third positive study

The biotech's cholesterol-lowering therapy could fill the gap between statins and high-cost PCSK9 inhibitors.

By Suzanne Elvidge • May 23, 2018

Right to Try bill clears House, headed for Trump signature

FDA chief Scott Gottlieb had expressed reservations about the impact on agency authority.

By David Lim • May 22, 2018

Momentum grows for hemophilia gene therapies

One-time treatments developed by BioMarin and the team of Spark and Pfizer promise to transform how hemophilia A and B, respectively, are treated. 

By Ned Pagliarulo • May 22, 2018

Pharma turn to NASH unlikely to mirror meteoric rise of hep C

Hopes of a hepatitis C-sized market could be dashed by the complexity of and challenges in diagnosing the lesser-known liver disease. 

By Ned Pagliarulo • May 21, 2018

NASH drug pipeline headed toward uncertain market

The fatty liver disease has dozens of treatments in the global pipeline. But investors are treading lightly, casting doubt on the market opportunity.

By Jacob Bell • May 21, 2018

Nabriva ready for FDA, EMA filing for antibiotic candidate

The biotech has plans for a New Drug Application after a second positive Phase 3 study.

By Lisa LaMotta • May 21, 2018

Brain Talk: Cracking the code of Alzheimer's and dementia

Alzheimer's is one of the most challenging diseases to treat. Researchers face an uphill battle when it comes to developing new treatments and finding a cure.

May 21, 2018

Hemlibra's latest HAVEN results impress

Fresh late-stage data reinforced the Roche drug's strong efficacy profile, and offered reassurance that its safety and dosing support patient switches from other treatments.

By Jacob Bell • May 21, 2018

Liver safety the death knell for J&J Alzheimer's drug

Another BACE inhibitor bites the dust after safety signals push the pharma to discontinue development. 

By Suzanne Elvidge • May 21, 2018

Prescribed Reading: FDA, CMS take aim at drug pricing

Government agencies announced moves to bring down high drug prices, though the market doesn't seem worried just yet.

By Lisa LaMotta • May 18, 2018

5 takeaways from the first look at cancer's biggest conference

Study abstracts released ahead of the ASCO annual meeting gave investors new data to pore over for dozens of key cancer drugs.

By Ned Pagliarulo • May 17, 2018

Lilly's CGRP drug succeeds in 'worst kind of migraine'

Galcanezumab significantly lowered the number of weekly attacks experienced by patients with episodic cluster headache but failed to meet its goal for chronic cluster headaches.

By Jacob Bell • May 15, 2018

aTyr Pharma tumbles on corporate restructure, job cuts

The biotech is laying off 30% of its workforce and shuttering an immuno-oncology effort after preclinical failures.

By Suzanne Elvidge • May 15, 2018

AstraZeneca lung drug comes up short in COPD

Fasenra missed its primary endpoint in a key study designed to support broadening of the biologic's use beyond asthma. 

By Ned Pagliarulo • May 11, 2018

Prescribed Reading: ShiTake a go; Novartis in hot water

Takeda finally secured its takeover of Shire. Elsewhere, Novartis came under fire for payments it made to Trump's lawyer. 

By Lisa LaMotta • May 11, 2018

Puma shares plummet as results from key trial delayed

A slower-than-expected event rate in Puma's NALA study means results may not be available until Q4 or potentially as late as 2019.

By Suzanne Elvidge • May 11, 2018

Tecentriq stumbles in Phase 3 colon cancer study

The trial, which paired Tecentriq with the MEK blocker Cotellic, could have helped Roche gain an edge over its rivals in that tumor type. 

By Ned Pagliarulo • May 10, 2018

MedCo uses a Phase 2 analysis to build its PCSK9 case

A prespecified analysis of ORION-1 inclisiran data adds to the company's argument for the long-acting synthetic PCSK9.

By Suzanne Elvidge • May 8, 2018

J&J's ketamine-based antidepressant sees mixed results in Phase 3

The near-miss in a second late-stage study somewhat complicates the case J&J is building for esketamine, a nasal spay it hopes to soon file for approval.

By Ned Pagliarulo • May 7, 2018