Clinical Trials: Page
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Prescribed Reading: FDA approval spree, tax reform, deals pick up
The agency under Scott Gottlieb has hit a new record for approvals, and the new tax bill has already prompted M&A.
By Lisa LaMotta • Dec. 22, 2017 -
Biogen's Alzheimer's drug fails, putting focus all on aducanumab
A new analysis finds BAN2401 is unlikely to offer clinical benefit in a Phase 2 trial, further raising the stakes for the company's lead Alzheimer's candidate.
By Jacob Bell • Dec. 21, 2017 -
Explore the Trendline➔
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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 -
AbbVie's blockbuster hopeful upadacitinib meets goal in Phase 3
Despite a patient death during the trial, AbbVie's Humira successor is moving full steam ahead in rheumatoid arthritis.
By Lisa LaMotta • Dec. 20, 2017 -
Galera scores trial win for cancer side effect treatment
A Phase 2b study showed the private biotech's lead drug candidate beat out placebo in reducing the duration of a common side effect to chemoradiation.
By Ned Pagliarulo • Dec. 20, 2017 -
Biogen, Ionis looking for new SMA drugs following Spinraza's success
A freshly inked deal has the biotechs looking at antisense oligonucleotide drug candidates for the treatment of the rare muscular disease.
By Jacob Bell • Dec. 20, 2017 -
Allergan, Gedeon Richter plan depression submission
After positive bipolar depression data, Allergan is making plans for a 2018 submission for another indication for Vraylar.
By Suzanne Elvidge • Dec. 19, 2017 -
Shire's new Elaprase formulation fails late-stage trial
SHP609, which is given intrathecally, didn't meet the primary endpoint of a Phase 2/3 study in children with Hunter syndrome.
By Jacob Bell • Dec. 19, 2017 -
Trial miss sets back Merck's Keytruda plans in stomach cancer
Keytruda's failure to show a survival benefit comes three months after winning an accelerated approval as a third-line treatment for advanced gastric cancer.
By Ned Pagliarulo • Dec. 15, 2017 -
Prescribed Reading: Year-end M&A, Showdown at ASH
New data from the American Society of Hematology conference has the industry buzzing.
By Lisa LaMotta • Dec. 15, 2017 -
Alnylam, Sanofi given the all-clear to resume fitusiran trials
The FDA's decision allows a Phase 2 open-label study and the Phase 3 ATLAS program to re-commence.
By Jacob Bell • Dec. 15, 2017 -
Ampio boosted by Phase 3 success in osteoarthritis
After two clinical setbacks, could the third time be the charm for Ampio?
By Suzanne Elvidge • Dec. 15, 2017 -
Courtesy of Regeneron Pharmaceuticals
Regeneron's play for a stake in the I/O market boosted by study success
With five PD-1/L1 inhibitors already approved, Regeneron and partner Sanofi aim to first secure approval for cemiplimab in a currently uncontested indication.
By Ned Pagliarulo • Dec. 14, 2017 -
Elizabeth Regan/BioPharma Dive
ASH 2017: What you missed
This year's ASH conference showcased notable advances in hemophilia and several blood cancers, as cell and gene therapies continue to make strides.
By Ned Pagliarulo • Dec. 13, 2017 -
Aduro's troubled CRS-207 reaches the end of the line
The biotech drops lead listeria-based cancer drug, shifts focus and frees up cash.
By Suzanne Elvidge • Dec. 13, 2017 -
ASH17: argenx shares pop on autoimmune data
In a busy day, argenx reported positive topline results at ASH and announced a proposed U.S. public offering, shooting its stock up by over 80%.
By Suzanne Elvidge • Dec. 12, 2017 -
ASH17: J&J's Darzalex delivers combo win
Inserting the antibody into standard combo regimens is a key part of J&J's plan for expanding use of the drug into the frontline setting.
By Ned Pagliarulo • Dec. 12, 2017 -
ASH17: Spark gene therapy falls behind BioMarin in hemophilia
Mixed data from the biotech's hemophilia A candidate disappointed investors primed by BioMarin's compelling results.
By Ned Pagliarulo • Dec. 11, 2017 -
Courtesy of Eli Lilly
OS miss prompts Lilly to drop Cyramza expansion
While the cancer drug improved PFS in a gastric cancer study, it didn't significantly improve overall survival — limiting its competitiveness.
By Suzanne Elvidge • Dec. 11, 2017 -
Courtesy of Gilead Sciences
ASH17: Benefit of Gilead's CAR-T remains durable over longer term
More than a year after infusion, four in ten patients treated with Yescarta showed no signs of lymphoma.
By Ned Pagliarulo • Dec. 10, 2017 -
ASH17: Seattle Genetics sees market opportunity in cancer combo success
Replacing a toxic chemo agent could make Adcetris a new standard therapy to treat frontline Hodgkin lymphoma.
By Ned Pagliarulo • Dec. 10, 2017 -
ASH17: bluebird bio makes strides in CAR-T, gene therapy
New data on the biotech's multiple myeloma CAR-T therapy were particularly impressive, boosting investor confidence.
By Ned Pagliarulo • Dec. 9, 2017 -
ASH17: BioMarin's gene therapy promises one-time treatment of hemophilia
Updated results from an early trial suggest an effective gene therapy for hemophilia A could be within reach.
By Ned Pagliarulo • Dec. 9, 2017 -
Pfizer's PARP inhibitor showcases efficacy in late-stage trial
For breast cancer patients with specific mutations, treatment with talazoparib resulted in three additional months of progression-free survival versus chemo.
By Jacob Bell • Dec. 8, 2017 -
Prescribed Reading: Dealmaking begins to pick up as 2018 approaches
It's been a slow year for deals, but it looks like Gilead's buy of Kite could be a catalyst for more M&A.
By Lisa LaMotta • Dec. 8, 2017 -
Getty / Edited by BioPharma Dive
Arrowhead data hits the target in chronic hep B
New data from the Arrowhead ARC-520 Phase 2 trial in chronic hepatitis B points to a sustained host response.
By Suzanne Elvidge • Dec. 8, 2017
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