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

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

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

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

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

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

Pfizer backs out of PCSK9 development

With PCSK9 inhibitors already on the market failing to gain traction, Pfizer opted to discontinue further development of bococizumab.

By Lisa LaMotta • Nov. 1, 2016

Eisai ups investment in Alzheimer's treatments

Like Biogen, the Japanese drugmaker's AD portfolio could look a lot more attractive if Eli Lilly's related drug solanezumab clears Phase 3. 

By Jacob Bell • Oct. 31, 2016

Astellas furthers oncology focus with Ganymed buy

The deal, which could have Astellas paying upwards of $1.4 billion, gives the company a stronger presence in oncology outside of the blockbuster drug Xtandi.

By Jacob Bell • Oct. 28, 2016

Prescribed Reading: Dealmaking sparse, despite earnings reports

Analysts question Allergan's latest buy, Bristol-Myers shuffles R&D and FDA makes some proclamations about sex. 

By Lisa LaMotta • Oct. 28, 2016

FDA hits AstraZeneca's durvalumab with partial hold, shares tumble

Reports of bleeding among patients with head and neck cancer led to an enrollment stop, unsettling investors who are counting on the PD-L1 inhibitor to boost growth.

By Suzanne Elvidge • Oct. 28, 2016

Lilly, GSK, Gilead outsourced the most in Q3: report

On the service provider side, PRA Health, INC Research and Covance were the most tapped CROs in the period, according to BioPharm Insight. 

By Jacob Bell • Oct. 27, 2016

AstraZeneca readies for PARP fight with Lynparza data

The British pharma said the cancer drug substantially extended progression-free survival in a Phase 3 study, setting up a showdown with Tesaro's rival drug. 

By Suzanne Elvidge • Oct. 27, 2016

The Medicines Co. moves cholesterol drug forward as sales fall

With two other PCSK9 drugs already on the market, the company has its work cut out for it to differentiate its version. 

By Ned Pagliarulo • Oct. 26, 2016

Biogen quiet on new CEO, but signals optimism in Alzheimer's

The Cambridge biotech reported higher revenues in Q3, led by its portfolio of MS drugs. 

By Jacob Bell • Oct. 26, 2016

New patient population means new life for AD drug

Small drugmaker Alzheon is moving toward a Phase 3 trial of its Alzheimer’s disease candidate after a new analysis shows it could work in a subset of patients. 

By Joe Cantlupe • Oct. 25, 2016

Merck, Bristol-Myers set to compete in bladder cancer

Both companies are teeing up their respective checkpoint inhibitors for approval in urothelial cancer but this time will face a market incumbent in Roche's Tecentriq. 

By Suzanne Elvidge • Oct. 24, 2016