Alkermes surges on antidepressant success

Yet doubts remain around the drug's chances for approval. While this Phase 3 study succeeded, two previous late-stage studies failed earlier this year.

By Ned Pagliarulo • Oct. 21, 2016

Good and bad news for Gilead

Topline data revealed flops in two out of three Phase 2 trials for Gilead's selonsertib.

By Suzanne Elvidge • Oct. 21, 2016

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

AbbVie dumps Ablynx RA drug

Ablynx will have to go it alone in Phase 3 while it looks for a new partner for vobarilizumab. 

By Lisa LaMotta • Oct. 20, 2016

Single placebo response derails Rigel study

A Phase 3 trial of Rigel's low-platelet drug missed its primary endpoint, sending company shares into a tailspin. 

By Ned Pagliarulo • Oct. 20, 2016

Lilly breaks 40-year drought in 1L soft-tissue sarcoma

Approval of Lartruvo is another step towards the drugmaker's goal of launching 20 new drugs by 2023.

By Jacob Bell • Oct. 20, 2016

Quantitative modeling for clinical trials

Drug developers have new tools to reduce the likelihood of clinical trial failures, thanks to the emerging field of data science. 

Oct. 18, 2016

Medicines Co. scores positive results for PCSK9 drug

While two PCSK9 inhibitors are already on the market, The Medicines Company hopes more convenient dosing for its drug could boost competitiveness. 

By Ned Pagliarulo • Oct. 18, 2016

Regeneron, Teva smacked with clinical hold, again

The pair's NGF inhibitor is put on clinical hold for a second time after safety issues crop up in mid-stage studies. 

By Lisa LaMotta • Oct. 17, 2016

Allegro sees success in Luminate eye drug trial

The company hopes Luminate, an integrin peptide therapy, could prove to be a less-burdensome alternative to the commonly used Avastin. 

By Joe Cantlupe • Oct. 14, 2016

TG Therapeutics takes stock hit amid trial changes

Despite an upbeat spin from company execs, investors soured on planned changes to a Phase 3 study of its lead leukemia drug. 

By Joe Cantlupe • Oct. 14, 2016

NeuroVive drops kidney drug after failure

In an R&D setback, NeuroVive discontinued CicloMulsion following a mid-stage miss. 

By Suzanne Elvidge • Oct. 14, 2016

Prescribed Reading: AZ sell-off, Merck wins ESMO, generics dominate

Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.

By Lisa LaMotta • Oct. 13, 2016

Esperion beefs up late-stage cholesterol program

The drugmaker plans to add patients to its Phase 3 trial, changing the design as it faces an uncertain regulatory environment. 

By Lisa LaMotta • Oct. 13, 2016

After setback, Adaptimmune revamps T cell study

No objective responses were seen in an ovarian cancer study, prompting Adaptimunne to modify the pre-conditioning regimen. 

By Suzanne Elvidge • Oct. 13, 2016

Merck KGaA, Pfizer and Transgene team up on cancer vaccine

The French biotech announced collaborations with Merck KGaA and Pfizer to evaluate its HPV-positive head and neck cancer vaccine in combo with avelumab.

By Joe Cantlupe • Oct. 12, 2016

Swiss Auris aims to bounce back from trial miss

Keyzilen, a drug in development for tinnitus, flopped in Phase 2. But Auris believes results seen in two subgroups could help an ongoing Phase 3 study hit its mark. 

By Joe Cantlupe • Oct. 12, 2016

AstraZeneca halts asthma study in blow to Synairgen

Synairgen shares nosedived on news of AstraZeneca's decision, which sets back development of the small biotech's lead candidate. 

By Ned Pagliarulo • Oct. 12, 2016

Supernus readies Phase 3 after positive ADHD data

Shares jumped in initial trading on the news, only to reverse those gains later in the morning. 

By Suzanne Elvidge • Oct. 11, 2016

Exelixis touts kidney cancer drug at ESMO

Strong data in renal cell carcinoma could support Cabometyx as a first-line therapy. 

By Joe Cantlupe • Oct. 11, 2016

Tesaro shakes up PARP battle at ESMO

The biotech reported strong results for niraparib at the medical meeting this weekend, putting it in line for a near-term approval. 

By Joe Cantlupe • Oct. 10, 2016

Novartis' breast cancer drug scores big at ESMO

The Swiss pharma is touting its latest data for ribociclib as it faces off with Pfizer in the closely-watched CDK 4/6 inhibitor class. 

By Joe Cantlupe • Oct. 10, 2016

Bristol bows to Merck in lung cancer

Detailed analysis of Opdivo's lung cancer data hasn't uncovered any silver lining to the first-line failure earlier this year. 

By Suzanne Elvidge • Oct. 10, 2016

Roche stays competitive in I/O race

Tecentriq helped previously treated NSCLC patients live longer compared to standard chemotherapy, regardless of PD-L1 expression. 

By Suzanne Elvidge • Oct. 10, 2016

RedHill adds option for Phase 3 early stop in Crohn's

The biotech is confident an interim analysis next year in its Phase 3 trial will show positive results. 

By Suzanne Elvidge • Oct. 7, 2016

Prescribed Reading: Pharma re-focuses, face-off at ESMO, Hep C boxed

Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.

By Lisa LaMotta • Oct. 6, 2016