Dermira acne drug misses the mark, surprising investors

In two Phase 3 trials, DRM01 failed to meet any of its study objectives, pushing the biotech to discontinue further development of the drug.

By Ned Pagliarulo • March 5, 2018

Positive data pushes G1 to speed up development of its CDK inhibitor

Treatment with trilaciclib significantly improved immune system function for small cell lung cancer patients, building a stronger profile for G1's main drug.

By Jacob Bell • March 5, 2018

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

Shire's HAE candidate boosted by new Phase 3 data

The FDA is expected to decide on approval of lanadelumab by August, potentially adding to Shire's existing HAE portfolio.

By Suzanne Elvidge • March 5, 2018

Roche, Ionis showcase potential of Huntington's disease drug

Early data suggest Ionis' candidate, which Roche paid $45 million to license, could lower levels of a mutant protein responsible for driving the disease.

By Ned Pagliarulo • March 2, 2018

Verona lifted as main asset shows promise in CF

Shares of the U.K.-based biotech rose more than 25% after its drug, RPL554, significantly improved patients' lung function in a small Phase 2 study.

By Jacob Bell • March 2, 2018

Prescribed Reading: Sketchy subgroup analyses, puzzling probes

Several companies used creative thinking when evaluating clinical trial results, while others played the game of excluding details when informing investors.

By Lisa LaMotta • March 2, 2018

DBV reveals cloudy results for milk allergy patch

Despite unclear results from a mid-stage trial, the French biotech touted positive data from a subpopulation of patients in the milk allergy study.

By Lisa LaMotta • Feb. 27, 2018

ObsEva boosted by positive infertility drug results

Topline data from a Phase 3 study showed ObsEva's drug helped improve the rate of ongoing pregnancy for IVF patients versus placebo.

By Lisa LaMotta • Feb. 26, 2018

Messy Phase 2 data for Arca's heart drug leave investors unimpressed

The study failed to show Gencaro's superiority over a commonly used beta blocker. But an apparent benefit in U.S. patients has Arca pushing ahead.

By Ned Pagliarulo • Feb. 26, 2018

Cancer and the microbiome: What's old is new again

A healthy gut may improve how well cancer patients respond to immunotherapy. A big unanswered question is why.

By Ned Pagliarulo • Feb. 26, 2018

Bellicum outlines path to restart US studies of cell therapy

Investors appear relieved by the relatively modest nature of changes required by the FDA to lift a clinical hold on trials of BPX-501.

By Ned Pagliarulo • Feb. 23, 2018

Prescribed Reading: Deals sputter in, warning letter frenzy

Small bolt-on deals and acquisitions keep trickling in, unloved therapeutic areas get positive data, and CDER warnings letters rise under Gottlieb. 

By Lisa LaMotta • Feb. 23, 2018

Oral form of Novo's Ozempic hits primary endpoint in first Phase 3

Novo Nordisk's oral GLP-1 drug improves long term blood glucose control in a six-month trial.

By Suzanne Elvidge • Feb. 23, 2018

Apellis touts new data for eye drug hopeful

Further follow-up of AMD patients treated with Apellis' drug appeared to support earlier Phase 2 results.

By Suzanne Elvidge • Feb. 23, 2018

Gilead taps Sangamo to expand cell therapy after Kite buy

The big biotech is trying to expand its know-how and pipeline in its recently acquired area of cell therapies.

By Lisa LaMotta • Feb. 22, 2018

AbbVie fibroids drug meets Phase 3 endpoint

In the primary analysis of the late-stage study, AbbVie's elagolix reduced heavy menstrual bleeding.

By Suzanne Elvidge • Feb. 22, 2018

Aimmune knocks down DBV with positive peanut results

The peanut allergy space heats up as Aimmune reports strong data for its late-stage treatment.

By Lisa LaMotta • Feb. 20, 2018

CAR-T growing up with big pharma's big bet

Major acquisitions by Celgene and Gilead should catalyze further investment into the technology needed to make CAR-T work smoothly. Yet cell therapy's commercial potential remains an open question.

By Ned Pagliarulo • Feb. 20, 2018

$690M deal in peril after Lilly ends mid-stage studies

Lilly shuts the door on rheumatoid arthritis for its BTK collaboration project; what's next remains to be seen.

By Suzanne Elvidge • Feb. 20, 2018

AstraZeneca's Imfinzi wins FDA lung cancer nod

The British big pharma snaps up the first FDA approval of a therapy for unresectable stage 3 patients with non-small cell lung cancer.

By Suzanne Elvidge • Feb. 20, 2018

Prescribed Reading: Landscape-changing deals and Alzheimer's shake-ups

A relatively large research collaboration could change the deal landscape. Elsewhere, the Alzheimer's development picture is getting a makeover. 

By Lisa LaMotta • Feb. 16, 2018

FDA pushes pharma to continue efforts in Alzheimer's

In new guidance to industry, the regulator signaled greater flexibility around the use of biomarkers in studying the neurodegenerative disease.

By Suzanne Elvidge • Feb. 16, 2018

Biogen shares fall after unexpected 'variability' in Alzheimer's studies

Company executives insisted the pre-planned check did not change their confidence in aducanumab, which has become Biogen's key pipeline asset.

By Ned Pagliarulo • Feb. 15, 2018

Pfizer, Merck KGaA lung cancer drug fails

The duo's checkpoint inhibitor Bavencio failed to beat out chemotherapy in the key setting of non-small cell lung cancer. 

By Lisa LaMotta • Feb. 15, 2018

Fresh data sets up showdown for Lilly's Taltz vs Cosentyx

In the highly competitive IL-inhibitor space, securing new indications has been a key strategy for drugmakers looking to gain an edge.

By Jacob Bell • Feb. 14, 2018