Biotech: Page 97
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Intra-Cellular approval keeps focus on FDA's neuroscience review process
Lumateperone, to be sold as Caplyta, had conflicting results in late-stage trials. Its approval suggests the FDA is using a "glass half full lens" to review neuroscience drugs, said one analyst.
By Jacob Bell • Dec. 23, 2019 -
Permission granted by Roche
Roche hands $1B to Sarepta in major return to gene therapy deals
The Swiss pharma acquired a muscular dystrophy treatment for markets outside the U.S. in a pact that could reach a value of $10 billion.
By Jonathan Gardner • Dec. 23, 2019 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.
By BioPharma Dive staff -
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 -
Paratek wins US contract to develop anthrax treatment
A BARDA contract will provide Paratek with up to $285 million, some of which would go toward to acquiring the biotech's antibiotic for a national stockpile.
By Kristin Jensen • Dec. 19, 2019 -
Jacob Bell/BioPharma Dive
Bladder cancer approval gives Seattle Genetics its second drug
Padcev, an antibody-drug conjugate developed jointly with Astellas, will expand Seattle Genetics' business beyond Adcetris.
By Ned Pagliarulo • Dec. 19, 2019 -
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 -
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 -
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 -
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 -
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 -
Getty / Edited by BioPharma Dive
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 -
Jonathan Gardner/BioPharma Dive
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 -
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 -
Jonathan Gardner/BioPharma Dive
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. 9, 2019 -
Jonathan Gardner/BioPharma Dive
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. 9, 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. 9, 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. 9, 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. 9, 2019 -
Brian Tucker/BioPharma Dive
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. 9, 2019 -
Danielle Ternes/BioPharma Dive
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.
Dec. 9, 2019 -
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. 6, 2019 -
Getty / Edited by BioPharma Dive
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. 5, 2019
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