Spectrum's Qapzola turned down by FDA

Following the failure of two earlier trials, Spectrum is stepping up to another study to try to prove efficacy.

By Suzanne Elvidge • Nov. 21, 2016

Prescribed Reading: Data, arrests, pricing batter pharma

Gilead falters, ex-Valeant exec indicted, combo data dominates in hep C and pricing worries continue. 

By Lisa LaMotta • Nov. 18, 2016

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

Tetraphase antibiotic holds up in Phase 3

The Massachusetts biopharma is developing several antibiotics against multidrug-resistant bacterial infections. 

By Suzanne Elvidge • Nov. 18, 2016

The ODYSSEY continues for PCSK9s

Regeneron and Sanofi will continue their cardiovascular outcomes study, prolonging the uncertainty surrounding the drug class. 

By Lisa LaMotta • Nov. 17, 2016

Mixed results for Gilead slow momentum

As hepatitis C sales fall, Gilead is under pressure to prove its pipeline's potential. A hit and a miss in two studies of momelotinib won't go far to ease those concerns. 

By Suzanne Elvidge • Nov. 17, 2016

Amgen, Novartis tout top-line migraine results

The drug's success would offer Amgen an entry into the neuroscience space while giving Novartis's Innovative Medicines division a boost.

By Jacob Bell • Nov. 16, 2016

Reversal agents could unclot the NOAC market

Boehringer bolstered evidence for its antidote Praxbind, but the lack of other reversal agents for new oral anticoagulants has limited overall market growth. 

By Suzanne Elvidge • Nov. 16, 2016

Data in hand, The Medicines Co. speeds PCSK9 plans

The New Jersey biopharma has cleared the decks for inclisiran, but will the bet on PCSK9 pay off? 

By Ned Pagliarulo • Nov. 15, 2016

Lilly touts Jardiance heart benefit ahead of FDA decision

Seeking a competitive edge, Eli Lilly presented new findings weeks before the FDA decides on labeling.

By Judy Packer-Tursman • Nov. 15, 2016

Checkpoint inhibitors battle it out in bladder cancer

Merck's KEYNOTE-045 study showed extended survival for Keytruda patients, albeit in a small patient population. 

By Suzanne Elvidge • Nov. 15, 2016

Corbus stock shoots up on autoimmune news

The Norwood, MA-based company's only drug demonstrated a clinical benefit in a rare and chronic form of sclerosis.

By Suzanne Elvidge • Nov. 15, 2016

AASLD: Merck hep C combo slashes virus levels

Competition in the HCV space continues to be fierce as companies develop shorter duration, pan-genotypic therapies. 

By Suzanne Elvidge • Nov. 14, 2016

Dynavax drops on FDA rejection of hep B vaccine

While Dynavax still sees a path to approval for Heplisav-B, the California biopharma is now hunting for a partner to help it advance the program further. 

By Ned Pagliarulo • Nov. 14, 2016

J&J, GSK see mixed results for Humira competitor

Sirukumab, an experimental IL-6 inhibitor, hit on one coprimary endpoint but missed on another. 

By Suzanne Elvidge • Nov. 14, 2016

AASLD: AbbVie reports positive 8-week data in HCV

The combo treatment, being developed in collaboration with Enanta, faces a crowded, mature market.

By Judy Packer-Tursman • Nov. 14, 2016

Prescribed Reading: Trump wasn't the only news in pharma

Bristol-Myers made portfolio changes, Europe welcomed several biosimilars to market, the FDA talked off-label promotion and multiple drugs were hit with holds. 

By Lisa LaMotta • Nov. 11, 2016

Anthera shares slump after lupus trial failure

While nearly half of patients treated with blisibiomod showed improvement, so did over 40% of patients who received placebo. 

By Suzanne Elvidge • Nov. 11, 2016

Arrowhead spanked with clinical hold in hep B

It's a setback for ARC-520, which is forecast to reach as much as $4.5 billion in annual sales by 2020 if approved.

By Judy Packer-Tursman • Nov. 10, 2016

As rival surges forward, Juno touts CAR-T pipeline

CEO Hans Bishop focused on the progress of JCAR017 as the company pushes to win initial approvals for two CAR-T products by 2018.  

By Ned Pagliarulo • Nov. 10, 2016

Kadmon cuts jobs to conserve cash, pay debt

The company lowered its cash burn projections for next year, but says R&D expenses will increase as it pushes candidates through clinical trials.

By Jacob Bell • Nov. 9, 2016

BioInvent tumbles on clinical hold

The Swedish biotech had to shut down a cancer trial after receiving verbal notice from the FDA. 

By Suzanne Elvidge • Nov. 8, 2016

The Medicines Co. abandons heart drug, focus all on PCSK9si

Pulling the plug on MDCO-216 will free up needed resources. But it also raises the stakes for the company's PCSK9 synthesis inhibitor. 

By Ned Pagliarulo • Nov. 8, 2016

Gaining FDA support for a prognostic biomarker, giving patients hope

Having a validated biomarker will help spur new research and clinical trials to find a treatment for ADPKD.

Nov. 8, 2016

Armed with positive data, Biogen accelerates launch prep for SMA drug

Infrastructure and logistics must be adjusted to prepare for greater patient demand, the firm said at a conference

By Judy Packer-Tursman • Nov. 8, 2016

Cempra drug narrowly wins support of FDA panel

Members of the committee raised concerns about safety risks seen in testing of the bacterial pneumonia drug but were convinced by strong efficacy data. 

By Jacob Bell • Nov. 7, 2016