Clinical Trials: Page 101
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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 -
Explore the Trendline➔
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TrendlineNeuroscience 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 -
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 -
Deep Dive
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 -
Sponsored by Covance
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 -
#BIO2017 Day 3 roundup: Building value and what it costs
There was a lot going on Wednesday at the BIO International Convention, as well as in and around the San Diego area — a major biotech hub.
By Lisa LaMotta • June 21, 2017 -
#BIO2017 Day 2 roundup: A dearth of deals and Hung on Alzheimer's
The BIO International Convention was in full swing on Tuesday with high-profile talks, company presentations and panels on the state of the industry.
By Lisa LaMotta • June 20, 2017 -
Novartis eyes Regeneron's blockbuster Eylea franchise
Brolucizumab, pegged for a blockbuster future by Novartis, matched up to Regeneron's eye drug across two Phase 3 studies.
By Jacob Bell • June 20, 2017 -
Gene therapy: What you need to know
As several promising gene therapies near potential approval, BioPharma Dive explored the challenges and commercial hurdles the treatments could face.
By Lisa LaMotta • June 19, 2017 -
Safety concerns sideline Seattle Genetics' cancer candidate
The West Coast drugmaker stopped vadastuximab talirine investigations after the treatment arm of a Phase 3 study showed a higher rate of death.
By Jacob Bell • June 19, 2017 -
Humira shows its staying power
Pfizer had hoped head-to-head data comparing its JAK inhibitor Xeljanz to Humira would help steal market share, but the newer drug showed mixed results.
By Suzanne Elvidge • June 19, 2017