Biotech: Page 2
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Global Blood taps Syros for its next act in blood disorders
Fresh off a sickle cell approval, Global Blood is looking to Syros' technology to keep up with the rapid innovation happening there and in beta thalassemia.
By Jacob Bell • Dec. 18, 2019 -
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 -
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 -
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 -
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 -
In stunning twist, FDA approves Sarepta's Duchenne drug it rejected
Following an August rejection of Vyondys 53, Sarepta appealed the FDA's decision through a formal dispute resolution process that led to the agency's about-face.
By Ned Pagliarulo , Jonathan Gardner • Dec. 12, 2019 -
Value-based pricing for gene therapy? Maybe not ready for hemophilia
A small patient population plus large potential savings could make blood-clotting gene therapies an easier sell to payers, biotech executives say.
By Jonathan Gardner • Dec. 11, 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 -
For an 'acquisitive' Gilead, 2020 will be key test for CAR-T plans
Dealmaking, whether partnering or acquiring, is on the mind of Christi Shaw, the new CEO of Gilead's Kite. "Really we have one or two competitors," she told BioPharma Dive. "All of these other ones want us to buy them."
By Ned Pagliarulo • 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 -
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 -
Merck's ArQule buy showcases pharma appetite for targeted cancer drugs
The biotech's experimental drug targeting the BTK protein is of particular interest to Merck & Co., which is acquiring ArQule at more than a 100% premium.
By Jacob Bell • Dec. 09, 2019 -
Dive Awards
Biotech of the Year: Galapagos
The Belgian drugmaker pulled off a rare feat, retaining its independence while collecting a multibillion-dollar investment from Gilead. Now it needs to prove its partner's bet was well placed.
By Jacob Bell • Dec. 09, 2019 -
Dive Awards
Executive of the Year: Josh Bilenker, Loxo Oncology
Along with other recently acquired cancer companies like Ignyta and Array, Loxo proved out a drug development model that Bilenker likens to baseball's "moneyball" thesis.
By Ned Pagliarulo • Dec. 09, 2019 -
Dive Awards
Disruptor of the Year: The Federal Trade Commission
A more active FTC, suggested by the surprise delay for Roche's takeover of Spark, could slow dealmaking in an industry that relies on big pharma buyouts.
By Jonathan Gardner • Dec. 09, 2019 -
Dive Awards
The BioPharma Dive Awards for 2019
A busy year brought an upswing in a storied pharma's fortunes, an industry-shaking mega-merger and the surprise revival of an Alzheimer's drug.
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We're not for sale, Alexion executives declare
After meeting with hedge fund Elliott Advisors, the biotech said its product switching strategy and drug pipeline will drive more value than seeking buyers.
By Jonathan Gardner • Dec. 06, 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 -
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 -
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 -
After FDA rejection, Immunomedics tries again with breast cancer drug
Sacituzumab govitecan would be Immunomedics' first commercial product if the biotech succeeds on its second attempt to convince the FDA.
By Andrew Dunn • Dec. 03, 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
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