The Latest
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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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SponsoredChasing intelligence in health data
New AI tools, combined with the boom in healthcare data and the rise of personalized medicine, will transform clinical trials and drug discovery.
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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 unit
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.
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Amgen not done in quest to prove Repatha
A study set to begin in June will assess the cholesterol drug in patients who are at high risk of — but have not yet had — cardiovascular events like stroke.
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Approval decision delay seen as positive for Karyopharm
The FDA pushed back its target decision date by three months and, in somewhat of a surprise, Wall Street analysts and the market cheered the news.
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Amgen's top-selling Enbrel in balance as key court ruling nears
A decision could come as soon as this month in a court case pitting Amgen against Sandoz, which owns the only U.S. approval of an Enbrel biosimilar.
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Celgene dodges Alvogen bid to overturn Revlimid patent
Alvogen's petition was the last inter partes review challenge facing Celgene, and its rejection could ease some concerns ahead of a key shareholder vote.
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Senate calls on PBMs to give 'patients an explanation,' following pharma CEO hearing
The Senate Finance Committee invited Cigna, CVS, Humana, UnitedHealth's OptumRx and Prime Therapeutics to testify next month.
UPDATED: March 19, 2019 at 4:42 p.m. -
Key drugs from Merck, Roche win wider EU approvals
Label expansions for Hemlibra and Keytruda give the respective pharmas wider markets for their therapies.
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Celgene's Abraxane fails late-stage pancreatic cancer study
A pivotal Phase 3 trial showed the drug combined with chemotherapy did not improve disease-free survival as an adjuvant treatment.
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Aerie's eye drops win FDA approval
Branded as Rocklatan, the drops share an active ingredient with another intraocular pressure drug called Rhopressa that Aerie launched last year.
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NCI Director Ned Sharpless to become acting FDA commissioner
President Trump will name Sharpless, currently the director of the National Cancer Institute, as acting FDA head, HHS Secretary Alex Azar said Tuesday.
UPDATED: March 12, 2019 at 1:52 p.m. -
Biogen sells biologics plant to Fujifilm in $890M deal
After acquiring the site, Fujifilm will become Biogen's supplier, producing the biotech's multiple sclerosis drug Tysabri.
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Lilly's Cyramza comes up positive in first-line lung cancer trial
A late-stage study of certain lung cancer patients found significantly longer progression-free survival for those who received Cyramza versus those who didn't.
