Clinical Trials

Merrimack lung cancer study flops, sending stock sliding

The Cambridge biotech will shutter a trial of its lead pipeline asset in lung cancer after a review panel judged further study to be futile.

By Andrew Dunn • Oct. 19, 2018

Clovis aims at new market for cancer drug Rubraca

Rubraca has fallen behind rival PARP inhibitors in ovarian cancer. But new data unveiled Friday suggests the drug could have promise in prostate cancer.

By Ned Pagliarulo • Oct. 19, 2018

Fresh data expands Pfizer's options for treating first-line kidney cancer

Pfizer's Inlyta, when paired with Keytruda, improved OS in advanced renal cell carcinoma. Yet a different combo of Inlyta plus Bavencio also looks promising.

By Jacob Bell • Oct. 18, 2018

Clean safety data sets up Allergan for 2019 filing of migraine drug

Ubrogepant is aimed at acute treatment of migraine, giving Allergan hope the drug can find a niche in a market newly flooded with preventive therapy.

By Suzanne Elvidge • Oct. 18, 2018

Roche's Kadcyla beats out Herceptin in Phase 3

The data should help to advance the Swiss pharma's plans to reinforce its breast cancer franchise as biosimilar competition to Herceptin creeps in.

By Suzanne Elvidge • Oct. 16, 2018

Alnylam nixes accelerated approval plans for givosiran, pushing back timeline

The biotech will begin a rolling filing to the FDA this year, but doesn't anticipate completing submission of the RNAi therapy until the middle of next year.

By Andrew Dunn • Oct. 15, 2018

Opdivo misses survival goal in small-cell lung cancer study

The clinical setback could weigh on Bristol-Myers' chances of staying competitive in the less common lung cancer type.

By Ned Pagliarulo • Oct. 12, 2018

Trevena's opioid gets thumbs down from FDA adcomm

While the FDA doesn't have to follow the advice of the panel, the negative vote doesn't bode well for the fate of oliceridine. 

By Suzanne Elvidge • Oct. 12, 2018

Gilenya beats Copaxone head-to-head at higher dose, study finds

The multiple sclerosis drugs are top-sellers for their respective makers, Novartis and Teva. Yet a Phase 3b trial showed an efficacy edge for Gilenya.

By Andrew Dunn • Oct. 11, 2018

As clock ticks, EMA launches 3rd phase of Brexit plan

The agency has started to scale back non-urgent activities as its move to Amsterdam draws closer.

By Suzanne Elvidge • Oct. 11, 2018

5-year data shows earlier Ocrevus treatment slows MS progression

Ocrevus is a key drug for Roche's efforts to grow through biosimilar competition to the Swiss pharma's top-selling biologics.

By Suzanne Elvidge • Oct. 11, 2018

FDA clears Vertex, CRISPR to test gene-editing therapy in sickle cell patients

With a clinical hold dating back to May resolved, the companies said they plan to start a Phase 1/2 study of CTX001 in the U.S. by year's end.

By Jacob Bell • Oct. 10, 2018

Roche, Ionis focusing on eye disease through new deal

On the heels of their Huntington's disease collaboration, the companies are teaming up again — this time on a therapy targeting the immune system.

By Jacob Bell • Oct. 10, 2018

Arbutus' clinical challenges trigger stock slide

Shares in the biotech dropped by more than half this week on news of several hurdles in the clinic for its hepatitis B research. 

By Suzanne Elvidge • Oct. 10, 2018

J&J's top-seller Stelara looks set to expand into ulcerative colitis

New data show Stelara led to higher rates of clinical remission and response than placebo. An approval would further expand the biologic's market.

By Andrew Dunn • Oct. 09, 2018

Sarepta builds out gene therapy manufacturing with latest CDMO deal

The biotech is thinking ahead, inking partnerships in recent months with Paragon Bioservices and Brammer Bio to support its gene therapy pipeline.​

By Suzanne Elvidge • Oct. 09, 2018

Celgene showcases Otezla's potential in scalp psoriasis

Patients receiving treatment achieved significant improvements in moderate-to-severe scalp psoriasis compared to placebo, according to fresh Phase 3 data.

By Suzanne Elvidge • Oct. 09, 2018

Loxo, Blueprint drive forward with RET-targeting cancer therapies

No selective inhibitors of the oncogene are currently approved in the U.S. — something both biotechs hope to change with their respective therapies.

By Ned Pagliarulo • Oct. 08, 2018

Merck gets a shot in the arm with expanded label for Gardasil

The HPV vaccine is now also approved for adults aged 27 through 45 years old, widening the addressable market for Merck.

By Suzanne Elvidge • Oct. 08, 2018

Lilly sweetens its position in diabetes with positive 'twincretin' data

Researchers found LY3298176, which targets both GLP-1 and GIP, significantly outperformed placebo on measures of glucose control and weight loss.

By Suzanne Elvidge • Oct. 05, 2018

Roche's flu drug strongly beat placebo. But could one data miss be critical?

Baloxavir marboxil fell short of showing a statistical edge over Roche's older Tamiflu in the overall study population, although it did so in a subgroup. 

By Andrew Dunn • Oct. 04, 2018

Sarepta gene therapy for DMD takes another step forward

Updated results, including data from a fourth boy with Duchenne muscular dystrophy, help to firm up the prospects for the biotech's gene therapy.

By Ned Pagliarulo • Oct. 04, 2018

Gilead's Biktarvy matches GSK's Triumeq in Phase 3 study

Biktarvy is a key drug for Gilead in its battle with GSK for HIV market share. New Phase 3 data could help Gilead make its case. 

By Suzanne Elvidge • Oct. 04, 2018

Roche drug shows benefit in spinal muscular atrophy

Yet attention remains focused on a gene therapy in development by Novartis, which could reshape treatment of the genetic neuromuscular disorder.

By Ned Pagliarulo • Oct. 03, 2018

Seattle Genetics' Adcetris tops chemo in Phase 3 lymphoma trial

An unexpected hit on overall survival could be a boost for the biotech and partner Takeda as they seek to expand the market for Adcetris. 

By Suzanne Elvidge • Oct. 02, 2018