Amarin on track to report CV outcomes data

Positive results from the REDUCE-IT study could ramp up the target market for Amarin's prescription fish oil Vascepa.

By Meg Bryant • Jan. 24, 2018

FDA debuts paper on quality standards, aiming to decrease review times

The Office of Pharmaceutical Quality is aiming to give manufacturers clarity on standards, in line with other FDA initiatives to increase efficiency. 

By David Lim • Jan. 24, 2018

Explore the Trendline➔

Radiopharmaceuticals

A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

By BioPharma Dive staff

Novartis predicts growth pick-up on back of Cosentyx, Entresto

Incoming CEO Vas Narasimhan will soon step into the role, as the Swiss pharma looks to rebound from several years of declining operating profits.

By Ned Pagliarulo • Jan. 24, 2018

Teva's Cinqair fails to deliver in Phase 3 asthma studies

The failure is the latest setback for the embattled drugmaker, which is struggling with high debt and declining revenues.

By Meg Bryant • Jan. 23, 2018

Biotech CEOs: Working with CROs is challenging

Unlike their big pharma brethren, smaller biotechs don't always get preferential treatment. But most find ways to capitalize on those interactions. 

By Lisa LaMotta • Jan. 23, 2018

Astellas, Vical's CMV vaccine comes up short in Phase 3

Topline results from the late-stage trial showed the vaccine missed both its primary and second endpoints. 

By Ned Pagliarulo • Jan. 23, 2018

Opdivo-Yervoy combo 'encouraging' in colorectal cancer

New data from the Phase 2 CheckMate-142 trial points to clinical benefit in hard-to-treat colorectal cancer.

By Suzanne Elvidge • Jan. 22, 2018

Prescribed Reading: Murmurs of M&A, backlash over CRLs

Celgene may make another acquisition, while the FDA Commissioner gets his first negative marks for reneging on a promise. 

By Lisa LaMotta • Jan. 19, 2018

Exelixis details Phase 3 cabozantinib results

Full results showed the drug helped improve survival in previously treated liver cancer patients, but shares fell — likely on some safety worries.

By Ned Pagliarulo • Jan. 17, 2018

AveXis builds out SMA program with new studies

Although Biogen is the current leader in SMA, AveXis is hoping to create a stronger case for its lead candidate with three new trials.

By Jacob Bell • Jan. 17, 2018

Eiger plummets on blood pressure trial fail

The company is axing ubenimex in PAH after a miss in Phase 2.

By Suzanne Elvidge • Jan. 17, 2018

Keytruda aces another lung cancer study

Positive results for Merck in the first-line setting should ease worries about threats from competition.

By Lisa LaMotta • Jan. 16, 2018

Novartis goes 2-0 against J&J in psoriasis

Fresh data support Cosentyx's superiority to Stelara in treating plaque psoriasis.

By Jacob Bell • Jan. 16, 2018

BioPharma Dive's 3 predictions for 2018 and beyond

What trends will shape the biopharma industry in 2018? BioPharma Dive's editors took a stab at predicting how the year may unfold for AI, oncology and neuroscience.

By Ned Pagliarulo • Jan. 12, 2018

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

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