JPM18: Novavax investors cheer RSV vaccine update, then pull back

Hungry for good news, Novavax investors jumped at a positive analysis of the biotech's lead candidate.

By Jacob Bell • Jan. 11, 2018

JPM18: Incyte and Syros to collaborate in cancer R&D

In a multimillion-dollar deal, Incyte gets an option to enter the rare blood cancer field.

By Suzanne Elvidge • Jan. 10, 2018

Explore the Trendline➔

Vaccine development

Vaccine developers are investing in shots for RSV, influenza and pneumococcal disease in a newly uncertain regulatory climate.

By BioPharma Dive staff

JPM18: Bluebird set to file 3 drugs for approval by 2019

As clinical development accelerates, CEO Nick Leschly broached some of the thorny questions around the price and value of gene therapy.

By Ned Pagliarulo • Jan. 9, 2018

CNS drugs take center stage: BioPharma's 2018 predictions

Move over oncology, neuroscience is ready for the spotlight in 2018 as drugmakers delve deeper into pain and neurodegenerative disorders.

By Jacob Bell • Jan. 8, 2018

Kala shares tank on mixed dry eye results

The market viewed Kala's Phase 3 results for dry eye warily, despite acceptance of its NDA for another treatment.

By Suzanne Elvidge • Jan. 8, 2018

Zafgen tries again with obesity, rare disease drugs after setback

 The company attempts a turnaround after challenges with top drug candidate.

By Suzanne Elvidge • Jan. 8, 2018

Enteris' endometriosis drug moves ahead with proof-of-concept

Phase 2b data for an oral leuprolide formulation gives Enteris boost to aim for the next stage.

By Suzanne Elvidge • Jan. 4, 2018

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

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