Biotech of the Year: Vertex Pharmaceuticals

Vertex watched its stock more than double in 2017 as the company cornered the multi-billion-dollar cystic fibrosis market with strong products and a promising pipeline.

By Jacob Bell • Dec. 4, 2017

Most Damaging Clinical Trial Failure: AstraZeneca's MYSTIC

Imfinzi's miss in non-small cell lung cancer was a huge setback for the British pharma and could relegate the drug as a never-was in the checkpoint inhibitor race.

By Lisa LaMotta • Dec. 4, 2017

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

The BioPharma Dive Awards for 2017

The 2017 BioPharma Dive Awards recognize the industry’s top innovators and disruptors. These executives, companies and trends are transforming the industry and shaping what's to come.

By Ned Pagliarulo , Lisa LaMotta , Jacob Bell • Dec. 4, 2017

Bayer unblinds cancer drug study early to investigate patient deaths

A data monitoring committee raised the alarm after finding more fractures and deaths occurred among patients treated with Xofigo and two other drugs than those on placebo.   

By Ned Pagliarulo • Dec. 1, 2017

Prescribed Reading: Industry CEOs talk PRVs, IPR, PCSK9

Leschly suggests PRVs should be an alternative source of revenue for biotechs; ear health R&D is all clogged up; and execs agree the IPR process should be thrown out. 

By Lisa LaMotta • Dec. 1, 2017

RespireRx breathes easy with PACE data

The company's Phase 2b results are a breath of fresh air for sleep apnea patients.

By Suzanne Elvidge • Dec. 1, 2017

Auris dumps Phase 3 trial after failure

The Swiss biotech terminated the late-stage trial following a setback in the HEALOS study of its hearing loss drug candidate. 

By Lisa LaMotta • Nov. 28, 2017

Pfizer, Merck KGaA's Bavencio falls short in gastric cancer study

The two companies were fourth to market with Bavencio, making it more challenging to differentiate the PD-L1 blocker from rival therapies.

By Ned Pagliarulo • Nov. 28, 2017

Regeneron scraps another Eylea combo

Results from two mid-stage studies indicate Eylea plus nesvacumab didn't beat out the blockbuster drug by itself, pushing Regeneron to ditch Phase 3 development.

By Jacob Bell • Nov. 27, 2017

AstraZeneca launches JV, furthering play for China market

Established together with a large private equity firm, Dival Pharmaceutical will begin life with three preclinical candidates from AstraZeneca's pipeline.

By Ned Pagliarulo • Nov. 27, 2017

Innate, Bristol-Myers' plans stumble with trial miss

The study failure leaves Innate unsure of where to go next with lirilumab.

By Suzanne Elvidge • Nov. 27, 2017

J&J eyes broader market for blood cancer med Darzalex

New study results could support approval of Darzalex in combination with three other drugs as a first-line treatment for certain patients with multiple myeloma.

By Ned Pagliarulo • Nov. 22, 2017

Cytokinetics to discontinue ALS drug after Phase 3 miss

The California biotech will now turn to an earlier clinical candidate, which it hopes could prove more effective in treating the neurodegenerative disease.

By Ned Pagliarulo • Nov. 21, 2017

Ardelyx scraps late-stage drug in another pipeline setback

The move leaves Ardelyx's pipeline with a single Phase 3 candidate that has faced trouble in the clinic and skepticism among investors.

By Jacob Bell • Nov. 21, 2017

New data for Roche's Hemlibra could expand market

Positive data for the drug in hemophilia A patients without inhibitors boosts the treatment's profile beyond its recent approval in a narrower population. 

By Suzanne Elvidge • Nov. 21, 2017

Acorda shuts down tozadenant after patient deaths

After disclosing last week that five patients had died in a trial, Acorda chose to stop all development of its Parkison's disease drug. 

By Lisa LaMotta • Nov. 20, 2017

Roche lung cancer results boost Tecentriq versus I/O rivals

Tecentriq's success in the closely watched IMpower150 study could position the PD-L1 inhibitor to challenge Merck's Keytruda in first-line lung cancer.

By Ned Pagliarulo • Nov. 20, 2017

Galapagos continues in Vertex's shadow

In spite of positive new data for one of its cystic fibrosis candidates, Galapagos hasn't convinced some analysts it has the stuff to compete with market leaders.

By Jacob Bell • Nov. 20, 2017

AstraZeneca touts Tagrisso's CNS benefit

A subgroup analysis of the positive FLAURA study showed Tagrisso cut the risk of CNS disease progression by half when compared to standard of care.

By Suzanne Elvidge • Nov. 20, 2017

MDX mice for Duchenne's

All models are wrong, but some are useful: Novel ways of using MDX mice to study a devastating childhood disease.

By By Toni Ahtoniemi, Senior Manager, Client Services, Charles River Laboratories • Nov. 20, 2017

Prescribed Reading: FDA on approval streak, I/O shines

The regulatory agency granted seven approvals this week, including the first pill with a digital sensor, as well as the go-ahead for a new hemophilia drug. 

By Lisa LaMotta • Nov. 17, 2017

KemPharm eyes 2018 filing for ADHD drug

A recent meeting with the FDA was "successful," the company says, clearing a path forward for development of the drug. 

By Suzanne Elvidge • Nov. 17, 2017

Janssen picks up second GI drug from Ionis

While the $5 million license fee may not mean much to Ionis, Janssen's decision signals continued interest in the biotech's antisense drug platform.

By Ned Pagliarulo • Nov. 16, 2017

Mirati reroutes resources to I/O combo, KRAS programs

The biotech is deprioritizing one of its lead candidates to focus on other assets — namely sitravatinib, which investigators are studying in combination with Opdivo.

By Jacob Bell • Nov. 16, 2017

Acorda faces new trouble with trial halt, safety problems

Serious safety signals in a late-stage trial of its Parkinson's disease drug have pushed the company to stop enrollment into two studies and amend another. 

By Lisa LaMotta • Nov. 15, 2017