Clinical Trials: Page 2
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Biogen's Alzheimer's drug gets caught in Sarepta's spotlight
The unexpected approval of Sarepta's Vyondys 53 has some wondering how lenient the FDA might be in reviewing aducanumab. Others, however, see little impact.
By Jacob Bell • Dec. 13, 2019 -
UniQure, Pfizer updates hint at gene therapy potential in hemophilia B
The two companies are advancing toward market one-time treatments for the blood disorder, with Takeda about to begin clinical testing of its own therapy.
By Jonathan Gardner • Dec. 10, 2019 -
Leukemia rivals try to stay ahead as Merck, Lilly chase
Merck's surprise buyout of ArQule will heat up competition in a class of cancer drugs that includes AbbVie and J&J's Imbruvica and AstraZeneca's Calquence.
By Jonathan Gardner • Dec. 10, 2019 -
SponsoredGet ready for 2020: What to know about the 15 most important trends impacting healthcare
New report reveals the critical trends and market changes impacting biopharmaceutical companies in the year ahead.
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New drugs for sickle cell excite but, at ASH, a recognition that more is needed
Approvals for Adakveo and Oxbryta double the number of treatment options for sickle cell disease in the U.S., bringing hope that more may soon follow.
By Ned Pagliarulo • Dec. 09, 2019 -
As CAR-T presses ahead in multiple myeloma, alternative approaches gain supporters
Three different ways of attacking the blood disease are emerging, raising hopes for life-extending drugs for the sickest patients.
By Jonathan Gardner • Dec. 09, 2019 -
Dive Awards
Readout of the Year: Aducanumab's surprise revival
If approved, the Alzheimer's drug would likely earn billions. But researchers are divided over whether Biogen's data show an unexpected benefit, or are just a statistical mirage.
By Jacob Bell • Dec. 09, 2019 -
Sangamo keeps pressure on rivals with updated hemophilia data
Longer follow-up on Sangamo and Pfizer's gene therapy show treated patients continue to be free of bleeds, but one patient's results could spark new questions.
By Ned Pagliarulo • Dec. 07, 2019 -
Biogen's Alzheimer's pitch yields few converts
The drugmaker's about-face on aducanumab has divided the Alzheimer's field. A closely followed CTAD presentation didn't appear to bridge the gap.
By Jacob Bell • Dec. 07, 2019 -
Myeloma cell therapies, now in pharma hands, move into spotlight
Long-awaited results from Bristol-Myers and Bluebird position the drugmakers to win a first-in-class CAR-T approval. Rival J&J, however, appears close behind.
By Ned Pagliarulo • Dec. 07, 2019 -
Cancer gene therapy backed by Blackstone gets trial win
Results released Thursday are the first to be presented from a Phase 3 study of the therapy, which was recently made the cornerstone of a new company launched by Blackstone and Ferring.
By Jonathan Gardner • Dec. 05, 2019 -
The clearest picture of Biogen's Alzheimer's drug is still fuzzy
Biogen laid out its best case for aducanumab on Thursday, but even more detailed data couldn't clear up the uncertainties that have made its surprising decision to revive the drug so controversial.
By Jacob Bell • Dec. 05, 2019 -
Trial setback strikes blow to Sage antidepressant ambitions
SAGE-217 failed to meet the main goal of a Phase 3 depression study, a result that cut the drugmaker's market value by roughly $4 billion.
By Ned Pagliarulo • Dec. 05, 2019 -
New approval for Roche's Tecentriq heats up lung cancer battle with Keytruda
One Wall Street analyst expects the FDA's OK will help Tecentriq outpace Bristol-Myers Squibb's Opdivo in 2020 in the non-small cell lung cancer market.
By Jonathan Gardner • Dec. 04, 2019 -
What to watch as Biogen presents its all-important Alzheimer's data
During what some have called the biotech event of the year, doctors will be paying close attention to how Biogen accounted for missing data in its pivotal aducanumab studies.
By Jacob Bell • Dec. 04, 2019 -
Biogen scores a rare lupus win, lending support to its new immunology focus
In a two-part study, Biogen's BIIB059 hit both primary endpoints. But statistical significance, as well as a lack of safety data, create some uncertainty about the drug's future prospects.
By Jacob Bell • Dec. 03, 2019 -
Wave faces key test in bid to challenge Sarepta in DMD
Forthcoming trial results will show whether Wave's experimental drug can compete with Sarepta's Exondys 51 in Duchenne muscular dystrophy.
By Ned Pagliarulo • Nov. 27, 2019 -
Global Blood's sickle cell drug wins FDA approval, joining Novartis' Adakveo
A list price of roughly $10,000 a month puts Global Blood's Oxbryta slightly higher than what Novartis' Adakveo will cost.
By Jonathan Gardner • UPDATED: Nov. 26, 2019 at 10:04 a.m. -
2 NASH drugmakers have wildly different Mondays
Shares of Intercept Pharmaceuticals rose on a positive FDA update, while CymaBay Therapeutics plummeted following a clinical trial setback.
By Jacob Bell • Nov. 25, 2019 -
'I believe the drug works.' Biogen CMO defends decision to submit Alzheimer's drug to FDA
The biotech is staking hopes for an approval of aducanumab on one Phase 3 trial it controversially declared a success last month.
By Ned Pagliarulo • Nov. 22, 2019 -
SponsoredPayer perceptions of real world evidence in the rare disease space
In a new survey, Syneos Health® asked payers how they look at RWE in orphan drugs.
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Myovant to submit lead drug for prostate cancer approval after Phase 3 results
Next year will be a test of Myovant's commercial ambition, as the Roivant spin-off also plans to file relugolix for clearance in uterine fibroids.
By Andrew Dunn • Nov. 19, 2019 -
Rubius delays first clinical readout, as crowded PKU field marches on
With patient enrollment advancing more slowly than expected, the biotech pushed back the first look at human clinical data for its red blood cell therapeutic platform.
By Andrew Dunn • Nov. 14, 2019 -
Reata's kidney data gets a tepid response from investors
Despite hitting the main goal of a Phase 3 study, Reata's drug showed that Alport syndrome patients must keep taking it to avoid further kidney decline.
By Jacob Bell • Nov. 12, 2019 -
Solid gene therapy trial halted again by FDA
Shares in Solid fell to a new low as the biotech's muscular dystrophy treatment dropped further behind the leader Sarepta Therapeutics.
By Jonathan Gardner • Nov. 12, 2019
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