Clinical Trials: Page 60
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Blueprint wins 1st FDA approval with targeted cancer drug
The Boston-area biotech advanced Ayvakit from initial human testing to regulatory approval in just four years, a rapid timeline reflective of the drug's gene-targeted profile.
By Ned Pagliarulo • Jan. 10, 2020 -
Moderna, though early in development, prepares its vaccine for market
The vaccine just began mid-stage testing, but Moderna is already preparing for the next steps, which include a large Phase 3 study and hiring of sales associates.
By Jacob Bell • Jan. 9, 2020 -
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 -
Sponsored by Remarque Systems
Risk-based quality management: Your key to safety and effectiveness
Why is the FDA and other regulators urging clinical trial sponsors to rethink the way they design and run clinical trials?
Jan. 9, 2020 -
Lilly looms over Blueprint as the biotech files targeted cancer drug
Positive results in certain lung cancer patients support Blueprint's decision to submit pralsetinib, a RET-inhibitng drug, for approval in the first quarter.
By Jacob Bell • Jan. 8, 2020 -
US cancer death rate drops by most on record
Reductions in smoking and earlier cancer detection have driven death rates lower, but newer treatments could be playing a larger role, too.
By Ned Pagliarulo • Jan. 8, 2020 -
Jacob Bell/BioPharma Dive
Merck's Keytruda falls short of rivals in 1 lung cancer type
Mixed results could put Merck at a disadvantage in small cell lung cancer, a tumor type which has proved responsive to Roche's Tecentriq and AstraZeneca's Imfinzi.
By Jonathan Gardner • Jan. 7, 2020 -
Elizabeth Regan/BioPharma Dive
Alexion's blockbuster Soliris bested by Apellis in Phase 3 trial
The study result sent shares in Apellis up by more than 20%, as investors saw potential for the Massachusetts biotech to take on Alexion's top-seller.
By Andrew Dunn • Jan. 7, 2020 -
Pfizer, Merck KGaA show immunotherapy's survival benefit in bladder cancer
While cancer immunotherapy hasn't proved as effective in urothelial carcinoma as in other tumor types, Monday's result suggests some success.
By Andrew Dunn • Jan. 6, 2020 -
Trial failure keeps Incyte searching for its next act
A setback for Incyte's experimental drug itacitinib adds to a list of pipeline disappointments for the Delaware biotech.
By Ned Pagliarulo • Jan. 3, 2020 -
Wave's Huntington's drug shows effect but falls short of mark set by Roche and Ionis
The gene-targeting drug lowered levels of a damaging mutant protein, but the therapy's modest effect disappointed investors.
By Jonathan Gardner • Jan. 2, 2020 -
Stealth's rare disease drug falls short in study, sinking shares
The setback could also put in jeopardy an option Stealth recently granted to Alexion to partner on elamipretide following the Phase 3 readout.
By Ned Pagliarulo • Dec. 20, 2019 -
Jacob Bell/BioPharma Dive
AstraZeneca lupus drug shows potential, but it may not be enough for FDA
If approved, anifrolumab would compete against GlaxoSmithKline's Benlysta, the first lupus drug to reach the market in decades.
By Jonathan Gardner • Dec. 19, 2019 -
Getty / Edited by BioPharma Dive
Muscle data doesn't help Solid build faith in its gene therapy
A regulatory delay due to an adverse event, meanwhile, has put Solid further behind Sarepta in the pursuit of a Duchenne muscular dystrophy gene therapy.
By Jonathan Gardner • Dec. 18, 2019 -
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Homology unveils first data for PKU gene therapy, marking early milestone
Data presented Tuesday are from just three patients, but set the pace in a field that includes BioMarin and, most recently, Sangamo Therapeutics.
By Andrew Dunn • Dec. 17, 2019 -
GSK advances blood cancer drug to FDA, but rivals threaten
Belantamb mafodotin, a crucial drug for GSK's ambitions in oncology, could be the first anti-BCMA therapy approved. But new data show it's at risk of being outclassed.
By Ned Pagliarulo • Dec. 17, 2019 -
With trial win, Alnylam to seek approval for first treatment of rare kidney disease
The biotech's RNAi therapy lumasiran appears positioned to become the first drug for primary hyperoxaluria. Potential rivals, though, are close behind.
By Andrew Dunn • Dec. 17, 2019 -
Jonathan Gardner/BioPharma Dive
BeiGene's Brukinsa bet falls short against Imbruvica
The Chinese biotech's recently approved cancer drug wasn't able to beat out Imbruvica in a rare lymphoma, raising questions about its next regulatory filing.
By Jonathan Gardner • Dec. 16, 2019 -
Permission granted by Novartis
Novartis shutters late-stage asthma program, spelling trouble for Gossamer
After four Phase 3 trials fell short, the Swiss pharma is ceasing development of fevipiprant in asthma.
By Andrew Dunn • Dec. 16, 2019 -
Gilead's NASH ambitions buckle under the weight of ATLAS
The Phase 2 ATLAS study was Gilead's last chance to stay in the pack of companies leading the charge toward a first-ever drug for NASH, a fatty liver disease.
By Jacob Bell • Dec. 16, 2019 -
Wave cancels its Exondys competitor and heads back to the lab in muscular dystrophy
Suvodirsen failed to stimulate production of a muscle-building protein, a finding that prompted suspension of development of a second Duchenne drug.
By Jonathan Gardner • Dec. 16, 2019 -
Elizabeth Regan/BioPharma Dive
BioMarin drug for dwarfism meets goal in late-stage study
Positive data in hand, BioMarin plans to soon discuss with regulators filing vosoritide for approval, setting up a consequential year ahead for the biotech.
By Ned Pagliarulo • Dec. 16, 2019 -
Sponsored by Remarque Systems
How to implement risk-based quality management into your clinical trial
Change isn't easy in the pharmaceutical industry, but it's necessary to accommodate the diversity of data sources and study designs.
Dec. 16, 2019 -
Jacob Bell/BioPharma Dive
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 -
Jonathan Gardner/BioPharma Dive
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
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