The Latest
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Jazz gets OK for sleep drug, avoids black box warning
Solriamfetol, a treatment for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea, should launch in mid-2019, Jazz said.
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SponsoredOptimizing protocol design and enhancing patient enrollment
Using their extensive proprietary data sources, Covance guided an emerging pharmaceutical company who was uncertain about how to balance the selection of the right patients for their trial endpoints with the ability to achieve rapid patient recruiting.
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FDA's Gottlieb defends agency response to valsartan contamination
Responding to questions at an event this week, the outgoing FDA chief also pointed to forthcoming regulations aimed at improving oversight of manufacturing process changes.
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Novo uses a PRV to submit oral semaglutide to FDA
The much-anticipated submission of the first oral GLP-1 agonist has gone ahead, boosted by Novo's recently purchased priority review voucher.
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Abeona readies manufacturing ahead of Phase 3 trial
The biotech plans to begin Phase 3 study of cell therapy by mid-2019, a step made possible by ongoing development of its manufacturing capabilities.
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Pfizer makes sure it won't get left out of the gene therapy deal boom
The big pharma now holds an exclusive option to acquire all shares of a privately held gene therapy biotech based in France.
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Merck, NGM Bio extend research deal through 2022
Tucked in that announcement, however, was news Merck has handed back to NGM rights to two candidates for the treatment of obesity.
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Gene therapy progress spurs competition in biotech buyouts
Nightstar Therapeutics, the latest gene therapy biotech bought, fielded interest from four drugmakers before agreeing to an $800 million offer from Biogen.
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Sage's postpartum depression drug is approved. Now comes the hard part
Zulresso's label requires women to undergo a 60-hour infusion and only in certain settings, factors that may hamper the drug commercially.
UPDATED: March 20, 2019 at 9:12 a.m. -
Soon to depart, Scott Gottlieb keeps focus on greater drug competition
Increasing competition remains the outgoing FDA commissioner's remedy for drug market failures, which persist despite heightened public scrutiny.
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Pfizer, Merck KGaA miss again in ovarian cancer
Bavencio, the companies' PD-L1 antibody, has fallen short in three ovarian cancer trials, adding to its struggles to make gains in the immuno-oncology market.
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FDA issues partial hold on studies of AbbVie, Roche drug in multiple myeloma
A higher proportion of deaths were observed in the treatment arm versus control group of a study testing Venclexta in the blood cancer.
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Alexion adds to pipeline with 2 early-stage R&D deals
Research collaborations with Affibody and Zealand are the latest examples of Alexion's push to prepare for a future beyond its blockbuster drug Soliris.
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Roche's Tecentriq secures another immunotherapy first
The drug is the first immunotherapy approved for first-line small cell lung cancer, and the first new initial treatment option for the cancer type in decades.
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In 'golden age' for CDMOs, Thermo Fisher invests $150M in pharma services
The lab and instruments giant has expanded in the contract pharma and biotech markets following a multi-billion dollar deal for Patheon two years ago.
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Gilead raises prices on top-selling HIV treatments
The biotech hiked prices on more than a dozen products, including six HIV medicines that each surpassed $1 billion in 2018 sales.
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Aimmune's peanut allergy drug finally gets an approval timeline
An FDA decision could come by late January 2020 — about a year after Aimmune filed the oral therapy, called AR101, with the agency.
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Biohaven pays $105M for GW Pharma's priority review voucher
The purchase speeds up the regulatory timeline for Biohaven's oral CGRP drug — and could help it leapfrog Allergan's rival therapy, currently under review.
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Amarin's Vascepa shows 30% CV risk reduction in new analysis
The fish oil-derived pill reduced total cardiovascular events by a wide margin against placebo, but the new look does little to answer lingering questions.
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Dermira shares double on positive eczema data
The dermatology-focused biotech is now mulling a late-stage trial that would test two higher-dose regimens of its drug, lebrikizumab.
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Heart benefits to AstraZeneca's Farxiga detailed in new findings
While the SGLT-2 inhibitor showed a heart benefit across a wide range of Type 2 diabetes patients, the effect appeared greatest in those with reduced ejection fraction.
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FDA's Gottlieb calls for greater adoption of new clinical trial tools
The outgoing agency chief expressed frustration with limited industry use of study methods he sees as enabling faster and more effective clinical testing.
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Sandoz CEO to depart as Novartis doubles down on biosimilars
Richard Francis, who helmed the Novartis generics unit for five years, plans to depart at the end of March.
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Deep DiveUnblinded: Scott Gottlieb on biosimilars' precarious moment and the gene therapy boom
The outgoing FDA chief spoke with BioPharma Dive a day before his surprise resignation, detailing how drugmaker "shenanigans" have evolved and weighing in on gene therapy's inflection point.
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Apple heart study: Early proof of concept, or a bit of a gimmick?
Cardiologists at the ACC meeting said the Apple Watch's foray into health monitoring needs more data to prove its value.
