Inovio reworks immunotherapy deal with eye to China

Under an amended agreement, ApolloBio will pay $23 million upfront for exclusive rights within Greater China for Inovio's HPV immunotherapy. 

By Suzanne Elvidge • Jan. 3, 2018

Pfizer teams up with Sangamo to develop ALS gene therapy

The deal expands the pharma giant's investment into gene therapy, building on an earlier deal with Sangamo exploring hemophilia A candidates. 

By Ned Pagliarulo • Jan. 3, 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

AndexXa's route to the market clots again

A three-month delay is the latest setback for Portola's Factor Xa inhibitor antidote, after manufacturing issues had led to the drug's rejection by the FDA in 2016.

By Suzanne Elvidge • Jan. 3, 2018

J&J builds case for ketamine-based depression drug

Recently published Phase 2 results bolster esketamine's clinical potential as the pharma giant plans a 2018 filing in treatment-resistant depression. 

By Ned Pagliarulo • Jan. 2, 2018

Prescribed Reading: FDA approval spree, tax reform, deals pick up

The agency under Scott Gottlieb has hit a new record for approvals, and the new tax bill has already prompted M&A. 

By Lisa LaMotta • Dec. 22, 2017

Biogen's Alzheimer's drug fails, putting focus all on aducanumab

A new analysis finds BAN2401 is unlikely to offer clinical benefit in a Phase 2 trial, further raising the stakes for the company's lead Alzheimer's candidate.

By Jacob Bell • Dec. 21, 2017

AbbVie's blockbuster hopeful upadacitinib meets goal in Phase 3

Despite a patient death during the trial, AbbVie's Humira successor is moving full steam ahead in rheumatoid arthritis.

By Lisa LaMotta • Dec. 20, 2017

Galera scores trial win for cancer side effect treatment

A Phase 2b study showed the private biotech's lead drug candidate beat out placebo in reducing the duration of a common side effect to chemoradiation. 

By Ned Pagliarulo • Dec. 20, 2017

Biogen, Ionis looking for new SMA drugs following Spinraza's success

A freshly inked deal has the biotechs looking at antisense oligonucleotide drug candidates for the treatment of the rare muscular disease.

By Jacob Bell • Dec. 20, 2017

Allergan, Gedeon Richter plan depression submission

After positive bipolar depression data, Allergan is making plans for a 2018 submission for another indication for Vraylar.

By Suzanne Elvidge • Dec. 19, 2017

Shire's new Elaprase formulation fails late-stage trial

SHP609, which is given intrathecally, didn't meet the primary endpoint of a Phase 2/3 study in children with Hunter syndrome.

By Jacob Bell • Dec. 19, 2017

Trial miss sets back Merck's Keytruda plans in stomach cancer

Keytruda's failure to show a survival benefit comes three months after winning an accelerated approval as a third-line treatment for advanced gastric cancer.

By Ned Pagliarulo • Dec. 15, 2017

Prescribed Reading: Year-end M&A, Showdown at ASH

New data from the American Society of Hematology conference has the industry buzzing.

By Lisa LaMotta • Dec. 15, 2017

Alnylam, Sanofi given the all-clear to resume fitusiran trials

The FDA's decision allows a Phase 2 open-label study and the Phase 3 ATLAS program to re-commence.

By Jacob Bell • Dec. 15, 2017

Ampio boosted by Phase 3 success in osteoarthritis

After two clinical setbacks, could the third time be the charm for Ampio?

By Suzanne Elvidge • Dec. 15, 2017

Regeneron's play for a stake in the I/O market boosted by study success

With five PD-1/L1 inhibitors already approved, Regeneron and partner Sanofi aim to first secure approval for cemiplimab in a currently uncontested indication.

By Ned Pagliarulo • Dec. 14, 2017

ASH 2017: What you missed

This year's ASH conference showcased notable advances in hemophilia and several blood cancers, as cell and gene therapies continue to make strides.

By Ned Pagliarulo • Dec. 13, 2017

Aduro's troubled CRS-207 reaches the end of the line

The biotech drops lead listeria-based cancer drug, shifts focus and frees up cash.

By Suzanne Elvidge • Dec. 13, 2017

ASH17: argenx shares pop on autoimmune data

In a busy day, argenx reported positive topline results at ASH and announced a proposed U.S. public offering, shooting its stock up by over 80%.

By Suzanne Elvidge • Dec. 12, 2017

ASH17: J&J's Darzalex delivers combo win

Inserting the antibody into standard combo regimens is a key part of J&J's plan for expanding use of the drug into the frontline setting. 

By Ned Pagliarulo • Dec. 12, 2017

ASH17: Spark gene therapy falls behind BioMarin in hemophilia

Mixed data from the biotech's hemophilia A candidate disappointed investors primed by BioMarin's compelling results.  

By Ned Pagliarulo • Dec. 11, 2017

OS miss prompts Lilly to drop Cyramza expansion

While the cancer drug improved PFS in a gastric cancer study, it didn't significantly improve overall survival — limiting its competitiveness.

By Suzanne Elvidge • Dec. 11, 2017

ASH17: Benefit of Gilead's CAR-T remains durable over longer term

More than a year after infusion, four in ten patients treated with Yescarta showed no signs of lymphoma. 

By Ned Pagliarulo • Dec. 10, 2017

ASH17: Seattle Genetics sees market opportunity in cancer combo success

Replacing a toxic chemo agent could make Adcetris a new standard therapy to treat frontline Hodgkin lymphoma.

By Ned Pagliarulo • Dec. 10, 2017

ASH17: bluebird bio makes strides in CAR-T, gene therapy

New data on the biotech's multiple myeloma CAR-T therapy were particularly impressive, boosting investor confidence. 

By Ned Pagliarulo • Dec. 9, 2017