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

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

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

Biogen eyes quick launch for SMA drug

With new Phase 3 data in hand, the Cambridge-based biotech hopes to win U.S. approval for nusinersen as early as the end of this year or Q1 2017. 

By Ned Pagliarulo • Nov. 7, 2016

How incubators are accelerating early drug development

Pharma has struggled to find innovation, and academics have a poor track record moving compounds forward. Now other players are bridging the gap. 

By Lisa LaMotta • Nov. 7, 2016

Key people to know in early drug development

A handful of people stand out as significant figures in a small community that promotes biotech growth. 

By Ned Pagliarulo , Lisa LaMotta • Nov. 7, 2016

Advice to an emerging biotech

BioPharma Dive spoke to a number of biotechs about how incubators can help solve the problems faced in early drug development. Here's what they said. 

By Ned Pagliarulo • Nov. 7, 2016

5 trends turning biotech toward incubators

High real-estate costs. Scarce lab space. Access to capital. Incubators are ramping up support to help emerging biotechs avoid common pain points. 

By Ned Pagliarulo • Nov. 7, 2016

Prescribed Reading: ASH abstracts hit biotech hard

Companies refocus their M&A strategies, while abstracts from the upcoming ASH meeting disappoint investors and new discoveries could help treat a rare disease. 

By Lisa LaMotta • Nov. 4, 2016

Study flags rare heart risk for Bristol cancer combo

Researchers reported that two patients have died from fulminant myocarditis after being treated with Bristol-Myers Squibb's Opdivo and Yervoy. 

By Suzanne Elvidge • Nov. 4, 2016

Troubled Infinity licenses cancer drug to Verastem

The Cambridge-based biotech is attempting to adjust after a terminated partnership with AbbVie and lackluster trial results buried the company's stock. 

By Jacob Bell • Nov. 3, 2016

Safety issues with Roche drug good for Novo Nordisk

Serious adverse events for a hemophilia drug could keep competition from entering the market. 

By Lisa LaMotta • Nov. 3, 2016

Cempra stock plummets after FDA raises safety concerns

Briefing documents issued ahead of an advisory panel meeting Friday flagged safety concerns with Cempra's lead product, a drug for pneumonia. 

By Jacob Bell • Nov. 3, 2016

How protocol optimization improves clinical trial outcomes

Protocols are the foundation of effective clinical trials — targeting potential recruits, dosages, end points and much more.

Nov. 3, 2016