FDA lifts clinical hold on Concert drug

Concert can now restart testing of its hair loss drug under an amended protocol.

By Suzanne Elvidge • July 11, 2017

Arena pumps out positive results for hypertension drug

Ralinepag improved pulmonary vascular resistance in a Phase 2 study, giving Arena a lift in its bid to pivot away from its disappointing weight-loss franchise. 

By Jacob Bell • July 10, 2017

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

Safety issues for Novartis CAR-T therapy main focus of FDA

Documents released ahead of a key advisory meeting Wednesday show the agency is primarily concerned with the safety risks of what could be the first CAR-T therapy approved.

By Ned Pagliarulo • July 10, 2017

Prescribed Reading: I/O is the only game in town

Immuno-oncology dominates dealmaking, clinical trial data and regulatory action. 

By Lisa LaMotta • July 7, 2017

Further support for Opdivo as it beats out Yervoy

Bristol-Myers Squibb continues to build the case that the PD-1 inhibitor is a better option than its older immunotherapy. 

By Suzanne Elvidge • July 6, 2017

PTC and Roche report solid data for Spinraza rival

The biotech and its big pharma partner reported promising preliminary data for their spinal muscular atrophy drug at a conference over the weekend.

By Lisa LaMotta • July 5, 2017

Daiichi Sankyo pulls plug on Coherus biosimilar

The Japanese company said it would no longer develop the Enbrel biosimilar in Japan — leaving Coherus without any pharma backers for the copycat biologic. 

By Ned Pagliarulo • July 5, 2017

A hit and a miss for Daiichi Sankyo's pain drug

Mirogabalin hit its mark in post-herpetic neuralgia, but three other late-stage studies in fibromyalgia pain came up short. 

By Suzanne Elvidge • July 5, 2017

Prescribed Reading: Gottlieb pushes for efficiency at FDA

The Chief is trying to fulfill promises, while deal activity continues to stagnate in the sector as the industry waits on news from Washington. 

By Lisa LaMotta • June 30, 2017

A head above the rest? Drugmakers face off in migraine market

CGRP inhibitors could represent a step-change in the treatment of migraine — and potentially rake in billions of dollars in future sales for the four drugmakers developing them.

By Ned Pagliarulo • June 30, 2017

Alkermes needs to prove safety to succeed with 3831

The biotech has shown its anti-psychotic is effective, but it needs stronger safety data to unseat the market leader in the space. 

By Jacob Bell • June 30, 2017

Gemphire's cholesterol drug shows promise in Phase 2

Gemcabene, in-licensed from Pfizer, showed strong efficacy and safety in a handful of patients with a rare genetic disorder. But questions remain about the drug's future.

By Jacob Bell • June 29, 2017

Teva partner flunks second program this year

Xenon reported its topical pain drug missed all its endpoints. The failure follows a misstep with its acne program in March.

By Lisa LaMotta • June 28, 2017

Early results show promise for Ra's rare disease drug

The biotech is touting positive results from two PNH patients in its Phase 2 trial, indicating it will open enrollment for a switching phase of the study.   

By Jacob Bell • June 28, 2017

Innate becomes the latest loser in MS

The Australian biotech, which has several big-name investors, lost most of its value after reporting a mid-stage loss.

By Lisa LaMotta • June 27, 2017

Merck succeeds where others failed, but skepticism abounds

The big pharma reported positive data for its CETP inhibitor; a class plagued by a string of failures. Yet, prospects for the drug are still unclear.

By Lisa LaMotta • June 27, 2017

Alder scores CGRP win but investors not impressed

Shares in the Washington biotech fell by a fifth in early Tuesday trading despite positive results from a Phase 3 study testing the migraine drug eptinezumab. 

By Ned Pagliarulo • June 27, 2017

Alnylam lines up Phase 3 for another RNAi drug

Early results from givosiran in acute hepatic porphryia gives the biotech confidence it can launch a Phase 3 program by the end of this year. 

By Ned Pagliarulo • June 26, 2017

Neothetics reduced to nothing after failed double chin trial

The tiny biotech will need to evaluate options for the future now that its only drug has failed. 

By Lisa LaMotta • June 26, 2017

Seattle Genetics' Adcetris succeeds in study but shares slide

Positive results for Adcetris in a key Phase 3 study could help expand the label for the blood cancer drug, but markets didn't appear encouraged. 

By Ned Pagliarulo • June 26, 2017

OSE stock tumbles on trial pause

The investors are looking askance at OSE Immunotherapeutics as temporary halt on lung cancer study wallops the company's value.

By Suzanne Elvidge • June 26, 2017

Roche's could-be hemophilia blockbuster scores in clinic

Nearly 63% of patients taking emicizumab had no bleeds during the median observation time versus 5.6% in the active comparator arm.

By Jacob Bell • June 26, 2017

Prescribed Reading: What we know from BIO

A closer look at the trends everyone was talking about at BIO, FDA continues its approval spree and Novartis has heart. 

By Lisa LaMotta • June 23, 2017

End-to-end drug & diagnostic development support for a new immuno-oncology agent: A case study

Immuno-oncology drug development is inherently complex and requires special considerations across the entire spectrum.

June 22, 2017

Low on cash, ImmunoCellular halts study and looks for a lifeline

The microcap biotech is evaluating "strategic alternatives," including a potential merger, restructuring or sale.

By Suzanne Elvidge • June 22, 2017