GSK arthritis drug comes up short in Phase 2

A negative result on the study's primary endpoint is a disappointing outcome for the British pharma, which had highlighted the candidate as a pipeline leader.

By Suzanne Elvidge • Oct. 23, 2018

ESMO 2018: What you missed over the weekend

Pfizer and Merck KGaA detailed Bavencio's success in kidney cancer, while data for Merck's STING agonist raised questions for its future potential. 

By Ned Pagliarulo • Oct. 22, 2018

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

Lynparza hits a 'home run,' putting pressure on other PARP inhibitors

Data from SOLO-1 showed first-line maintenance therapy with Lynparza cut risk of death or disease progression 70% for certain ovarian cancer patients.

By Jacob Bell • Oct. 22, 2018

FDA delays decision on Bristol-Myers' lung cancer combo

A longer review for the pharma's pairing of Opdivo and Yervoy in first-line non-small cell lung cancer appeared to trigger a 5% stock drop Monday.

By Suzanne Elvidge • Oct. 22, 2018

Loxo's targeted therapy holds up to Roche challenge

Entrectinib, which Roche snagged in last year's buyout of Ignyta, showed strong data in TRK fusion tumors. But are they enough to worry Loxo? 

By Ned Pagliarulo • Oct. 20, 2018

Benefit of Roche's Tecentriq looks limited in breast cancer

Positive Phase 3 results in triple-negative breast cancer put Tecentriq out in front of the immunotherapy field. But a modest benefit in all-comers could mean use is limited to PD-L1 positive patients.

By Ned Pagliarulo • Oct. 20, 2018

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. 9, 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. 9, 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. 9, 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. 8, 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. 8, 2018