Array gets a win in colorectal cancer

Data for the biotech's triple combination missed expectations, but investors drove shares up to a near record high.

By Jonathan Gardner • May 21, 2019

BioCryst meets late-stage study goal, but falls short of competition

The biotech's stock tumbled 50% when markets opened Tuesday, as BioCryst's Phase 3 results failed to stack up to rival therapies.

By Andrew Dunn • May 21, 2019

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

Long-term heart data reassures for Medicines Co.

Inclisiran maintained cholesterol-lowering benefit with fewer side effects than competing Amgen and Sanofi/Regeneron products.

By Jonathan Gardner • May 20, 2019

The NASH dash runs into some early hurdles

In a trio of articles, BioPharma Dive explored the key problems the NASH field faces and what's being done to solve them.

By Jacob Bell • May 17, 2019

AbbVie brain cancer drug fails late-stage study in another oncology setback

An interim review found the glioblastoma drug didn't improve survival, leading the biotech to end the trial early and halt enrollment for other studies.

By Andrew Dunn • May 17, 2019

Breast cancer survival data buoys Macrogenics and Puma

Macrogenics touts signs of an overall survival benefit over Herceptin for margetuximab, while Puma's new Nerlynx study points to a delay in progression, for a price.

By Jonathan Gardner • May 16, 2019

Biotech in the spotlight at ASCO as pharma takes back seat

Few major data sets are expected from immunotherapy leaders like Merck, Roche and Bristol-Myers. Instead, studies by Amgen, Macrogenics, Blueprint and Seattle Genetics are drawing attention.  

By Ned Pagliarulo • May 16, 2019

Pfizer touts late-stage win for JAK drug that could duel with Dupixent

While a thin top-line readout leaves questions on safety, Pfizer says its experimental drug succeeded in a pivotal atopic dermatitis trial.

By Andrew Dunn • May 15, 2019

Solid's gene therapy stumble makes Sarepta's lead clearer

Drug-related blood and liver side effects seemed to spook Solid investors.

By Jonathan Gardner • May 14, 2019

Myovant reports a Phase 3 success, but Wall Street isn't cheered

Results showed Myovant's uterine fibroids drug met its goal, but comparisons to a similar treatment from AbbVie appear to have sapped investor optimism.

By Ned Pagliarulo • May 14, 2019

Fibrogen confuses as it tries to explain blood-boosting drug data

The company claims roxadustat is as safe as Epogen when used to treat anemia in kidney-disease patients, but can't say whether the FDA will agree.

By Jonathan Gardner • May 10, 2019

Bristol-Myers' Opdivo fails in Phase 3 glioblastoma test

In the study, Opdivo failed to prolong overall survival in combination with radiation for the hard-to-treat cancer.

By Kristin Jensen • May 9, 2019

AstraZeneca's share dilution gamble on Daiichi drug pays off

The U.K.-based pharma sold $3.5 billion worth of shares to pay for a partnership with Daiichi Sankyo on a breast cancer project. Positive trial data suggest the money wasn't wasted.

By Jonathan Gardner • May 8, 2019

Roche risdiplam data heats up SMA rivalry with Novartis

The oral agent looks like it could give gene therapy Zolgensma a run for its money.

By Jonathan Gardner • May 7, 2019

AstraZeneca blood cancer drug hits study goal early

The results for Calquence help justify AstraZeneca's majority stake in Acerta, but chasing down Imbruvica remains a tall order.

By Ned Pagliarulo • May 7, 2019

Epidiolex sales beat Wall Street's bar as GW Pharma reports trial success

The biotech sold more than double what was expected during the cannabis-derived medicine's first full quarter on the market. 

By Andrew Dunn • May 7, 2019

Novartis makes final Zolgensma pitch before FDA decision

The most severe spinal muscular atrophy patients showed sustained benefit, the company said in a data update at a neurology meeting.

By Jonathan Gardner • May 6, 2019

'Pathbreaking' Ionis trial offers way forward in Huntington's disease

Full results published in NEJM showcase what one researcher called the "best piece of news that's emerged from any clinical trial" in the neurodegenerative disease. 

By Ned Pagliarulo • May 6, 2019

Cytokinetics, Astellas fall short in ALS trial, but spin a success story

While the Phase 2 study failed to achieve its primary goals, the biotech argued it has a clinically meaningful result anyway.

By Andrew Dunn • May 6, 2019

Trelegy success gives GSK some respiratory respite

Tumbling sales for Advair have weighed on the British pharma's respiratory business, making positive data for Trelegy in asthma welcome news.

By Ned Pagliarulo • May 3, 2019

Novo seeks Victoza label expansion with fresh pediatric trial results

While Eli Lilly's Trulicity has surpassed Victoza as the GLP-1 market leader, Novo's drug could see a boost if approved for diabetic children.

By Andrew Dunn • April 29, 2019

Another late-stage miss knocks Gilead from its leading NASH position

Having failed a second Phase 3 study, the biotech has decided to stop testing selonsertib as a monotherapy in its ATLAS program.

By Jacob Bell • April 25, 2019

Clinical biomarkers expected to lift R&D productivity: Iqvia

Recent figures paint a gloomy picture of an industry struggling to efficiently develop new medicines. Yet several changes underway could change that, Iqvia predicts. 

By Emily Mullin • April 24, 2019

In R&D, small biotechs hold their own against big pharma

Though their R&D budgets are dwarfed by those of larger drugmakers, emerging biotechs filed nearly half of the 59 drugs OK'd by the FDA last year.

By Ned Pagliarulo • Updated July 26, 2019

Teva gives up on cluster headache for Ajovy, ending Phase 3 study

The trial discontinuation hands Eli Lilly an opportunity to differentiate its migraine therapy, Emgality, with a cluster headache indication.

By Andrew Dunn • April 23, 2019