Clinical Trials: Page
-
Abeona set to fly into Phase 3 after FDA chat
Following FDA guidance, Abeona is scooting EB-101 straight into Phase 3 for "butterfly disease."
By Suzanne Elvidge • July 19, 2017 -
Elizabeth Regan/BioPharma Dive
CymaBay touts positive seladelpar liver results
Results from a lower dose study showed efficacy without the liver toxicity issues, driving up shares of the stock.
By Suzanne Elvidge • July 18, 2017 -
Explore the Trendline➔
Getty Images
TrendlineRadiopharmaceuticals
A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.
By BioPharma Dive staff -
New data from Alzheon shows long-term benefit for Alzheimer's
APOE4 homozygotes who received higher doses of Alzheon's candidate over multiple years had "sustained cognitive and functional benefits."
By Jacob Bell • July 17, 2017 -
Deep Dive
What do we know about the amyloid theory for Alzheimer's?
A growing knowledge of the science behind the disease is allowing researchers to better test potential therapies.
By Jacob Bell • July 17, 2017 -
Deep Dive
5 trends shaping Alzheimer's drug development
Almost all Alzheimer’s drugs have failed. But pharma continues to invest millions in hopes of finding a hit, motivated by market opportunity and armed with lessons learned.
By Ned Pagliarulo • July 17, 2017 -
Genentech BD: Alzheimer's continues to be a priority
Genentech's Tom Zioncheck sat down with BioPharma Dive to talk about the big biotech's work in Alzheimer's disease.
By Lisa LaMotta • July 17, 2017 -
Deep Dive
Alzheimer's drug developers still hoping for a homer
The unmet need presented by the ever-growing patient population coupled with better science has the Alzheimer's disease pipeline filling up.
By Malorye Allison Branca • July 17, 2017 -
Prescribed Reading: Rumors, blood and history in the making
Rumors swirl about a new CEO at Teva, hemophilia drugs are getting exciting and the first CAR-T therapy could be coming.
By Lisa LaMotta • July 14, 2017 -
VBI Vaccines takes a shot at HBV Phase 3
Third-generation vaccines could have a stab at the harder-to-protect older population.
By Suzanne Elvidge • July 13, 2017 -
FDA panel unanimously backs approval of Novartis CAR-T
If approved later this year for an aggressive type of leukemia, Novatis' tisagenlecleucel would be the first CAR-T therapy OK'd for commercial use.
By Ned Pagliarulo • July 12, 2017 -
FDA
Woodcock: We need better biomarkers
The CDER director says precision medicine has come a long way, but biomarkers will bring the advances even further.
By Lisa LaMotta • July 12, 2017 -
Kadmon ROCKing some positive results
The biotech's ROCK2 inhibitor cut steroid use post-transplant for two-thirds of patients.
By Suzanne Elvidge • July 12, 2017 -
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 -
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 -
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 -
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 -
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
Previous
