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

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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

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

Gilead and Novo Nordisk pair up to take on NASH

Combinations are seen as the best way to combat the disorder, which is believed to be growing in prevalence thanks to rising obesity rates.

By Jonathan Gardner • April 12, 2019

Wave delays key data readout for Huntington's therapy

Screening and administration challenges are pushing back expected readouts as much as six months, helping to reaffirm Roche and Ionis' leading position.

By Jacob Bell • April 11, 2019

Intercept sputters as it reveals full Ocaliva NASH data to doctors

Side effects and a competitive threat from Gilead derailed what should have been a good day for Intercept. 

By Jonathan Gardner • April 11, 2019

Unblinded: Hervé​ Hoppenot on solving Incyte's 'single asset syndrome'

Last April, a closely watched study of an Incyte cancer drug failed, sending the biotech back to the drawing board. This year could help answer what's next. 

By Ned Pagliarulo • April 10, 2019

Alkermes touts Aristada efficacy on-par with J&J's market leader

Aristada and Invega Sustenna showed similar efficacy in a six-month study evaluating them as treatments for acute exacerbation of schizophrenia.

By Suzanne Elvidge • April 10, 2019

Audentes lays down marker in muscular dystrophy

In a challenge to Sarepta, Solid and Pfizer, a new gene therapy approach aims to deliver a more functional muscle-repairing protein to DMD patients.

By Jonathan Gardner • April 8, 2019

United Therapeutics scraps drug after late-stage miss

A failed trial has pushed the drugmaker to halt development of esuberaprost, which execs thought could expand the market opportunities for Tyvaso.

By Jacob Bell • April 8, 2019

No return for the Merrimack

The cancer drugmaker is shelving another lead candidate and shaving down its workforce — the latest in a year of setbacks.

By Jacob Bell • April 5, 2019

Pfizer wins expanded Ibrance approval using real world data

Relying on EHRs and real-world use of the cancer drug, the FDA broadened Ibrance's label to include men with certain advanced breast cancers. 

By Ned Pagliarulo • April 5, 2019

Allergan eye drug fails to impress on safety, upping pressure ahead of key meeting

Analysts were skeptical of the new data on abicipar, giving investors new reasons to question Allergan's pipeline before a May 1 annual meeting.

By Andrew Dunn • April 3, 2019

Sangamo hemophilia A progress boosts shares

Early data suggest Sangamo's gene replacement therapy could restore near-normal levels of a needed clotting factor. Competitors in the space still maintain a sizable lead, however. 

By Ned Pagliarulo • April 2, 2019

Astellas' AML therapy bests chemo in Phase 3 study

Confirmatory results from the trial back up Xospata's accelerated approval from the FDA last November. 

By Emily Mullin • April 2, 2019

Early pancreatic cancer data give Clovis a new path in PARP market

Yet pharma rival AstraZeneca remains ahead, having posted positive Phase 3 data in pancreatic cancer earlier this year.

By Andrew Dunn • April 2, 2019