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

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

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

BI tapping real-world data for Pradaxa

Boehringer Ingelheim’s reversal agent showed effectiveness in hospital and physician offices caring for AF patients, compared to the standard of care. 

By Joe Cantlupe • Oct. 24, 2016

Prescribed Reading: Only one FDA approval in October so far

While few deals flowed in this week, there was plenty of clinical data dominating pharma news.

By Lisa LaMotta • Oct. 21, 2016

Teva clears submission hurdle for Huntington's drug

Following an initial rejection, the FDA accepted Teva's application and set a goal date for approval. 

By Jacob Bell • Oct. 21, 2016

Alkermes surges on antidepressant success

Yet doubts remain around the drug's chances for approval. While this Phase 3 study succeeded, two previous late-stage studies failed earlier this year.

By Ned Pagliarulo • Oct. 21, 2016

Good and bad news for Gilead

Topline data revealed flops in two out of three Phase 2 trials for Gilead's selonsertib.

By Suzanne Elvidge • Oct. 21, 2016

AbbVie dumps Ablynx RA drug

Ablynx will have to go it alone in Phase 3 while it looks for a new partner for vobarilizumab. 

By Lisa LaMotta • Oct. 20, 2016

Single placebo response derails Rigel study

A Phase 3 trial of Rigel's low-platelet drug missed its primary endpoint, sending company shares into a tailspin. 

By Ned Pagliarulo • Oct. 20, 2016

Lilly breaks 40-year drought in 1L soft-tissue sarcoma

Approval of Lartruvo is another step towards the drugmaker's goal of launching 20 new drugs by 2023.

By Jacob Bell • Oct. 20, 2016

Quantitative modeling for clinical trials

Drug developers have new tools to reduce the likelihood of clinical trial failures, thanks to the emerging field of data science. 

Oct. 18, 2016