Clinical Trials: Page 102
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BioMarin, Spark, raising the stakes for hemophilia
The hemophilia market heats up as exciting technology, including gene therapy and RNA interference, are changing the the disease landscape.
By Lisa LaMotta • July 12, 2017 -
Sponsored by PPD Laboratories
There's an app for that: Busy investigators can now manage clinical trials on the go
Tapping into a ubiquitous trend among businesses, one major CRO lab is developing an app to communicate more efficiently with its clients, investigators and clinical trial managers.
By Roni Robbins • July 11, 2017 -
Explore the Trendline➔
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TrendlineOncology's research boom
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
By BioPharma Dive staff -
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 -
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 -
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 -
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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
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