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

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

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

Safety setback for Pfizer, Lilly pain drug should have Regeneron and Teva feeling nervous

Late-stage tanezumab data raises safety questions all over again for the drug class, putting pressure on a competitor to show a clean side effect profile.

By Jonathan Gardner • April 22, 2019

Keytruda approved in kidney cancer, challenging Bristol-Myers

An early OK for Merck's pairing of Keytruda and Inlyta in frontline renal cell carcinoma adds a powerful competitor to a market important for Bristol-Myers.

By Ned Pagliarulo • April 22, 2019

'This is a cure.' St. Jude's gene therapy succeeds in 'bubble boy' disease study

Treatment has rebuilt the immune systems of 10 boys with the life-threatening condition, allowing them to live normal lives so far.

By Andrew Dunn • April 17, 2019

Sarepta may have seen off another rival in Wave

Toxicity observed with Wave's DMD drug raises questions over whether the biotech can find a safe and effective dose.

By Jonathan Gardner • April 17, 2019

With FDA decision near, Novartis bolsters SMA gene therapy case

Zolgensma could be approved by the FDA within weeks. Fresh clinical data give further evidence of the therapy's benefit, although reports of two deaths invite questions.

By Ned Pagliarulo • April 16, 2019

Clovis shares slide on Rubraca trial discontinuation

An independent review concluded the biotech's PARP inhibitor was unlikely to provide a meaningful clinical benefit to metastatic bladder cancer patients.

By Suzanne Elvidge • April 16, 2019

Pfizer posts positive data for 20-strain pneumococcal vaccine

If approved, the candidate could help to bolster the pharma's $6 billion pneumococcal franchise over the next decade.

By Emily Mullin • April 16, 2019

Kidney data may give J&J diabetes drug an edge

Study shows Invokana keeps patients from needing dialysis or kidney transplantation, potentially handing J&J a marketing advantage.

By Jonathan Gardner • April 15, 2019

Alnylam looks to next RNAi approval, but safety questions linger

With givosiran's efficacy clear, safety looks to be Alnylam's remaining question as one in five patients on the drug experienced a serious adverse event.

By Andrew Dunn • April 12, 2019