AstraZeneca

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AZ’s benralizumab; Sanofi, Regeneron set; Nordisk preps; European countries offer

AstraZeneca's new benralizumab helps severe asthma patients cut back on steroids AstraZeneca's respiratory candidate benralizumab can help some severe asthma patients cut down on—or even stop—the unsavory steroid pills they use daily to stave off attacks, a new study showed. Dubbed Zonda, the phase 3 trial found tha...

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Lilly moves ahead; Authorities raid; Bristol-Myers, AZ in legal; PhRMA expected to weed out

Lilly moves forward with biologics plant expansion in Ireland Eli Lilly has confirmed that it will move forward with plans to add a manufacturing line at its site in Kindsdale, County Cork in Ireland. The construction might begin in coming months and commissioning will begin in 2019. The expansion is expected to add...

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Tesaro puts AstraZeneca; XELJANZ® receives; Innovus nabs; Alexion brings

Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparib Tesaro’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod on 27th March, months before its scheduled decision date. Apart from getting approval, Zejula also got a broader label than its head-to-head rival,...

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Therapeutics
Letter for AstraZeneca; Patheon on API plant; Sanofi, Regeneron’s Dupixent; Cerulean Pharma and Daré Bioscience enter into deal; Lilly on price hikes

AstraZeneca slapped with second Complete Response Letter Having a potential blockbuster sidelined because of manufacturing issues is bad enough, but AstraZeneca has now had that experience twice—both times receiving a complete response letter from the FDA. For a second time, AstraZeneca has received a complete respo...

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Novartis’s Entresto; AZ, J&J and Lilly sharply cut death rates; CAR-T drugs worth; FDA warns

Novartis heart-failure med Entresto cuts A1c, insulin starts in diabetics Novartis has been mining a pivotal study of Entresto, its heart-failure med, for more insights ever since it was first published in 2014. Now, a new analysis shows that Entresto beat an older med at reducing blood sugar levels in heart failure...

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GSK consolidates DT and TT vaccine, AZ gears up for FDA filing, Novartis comes up with flex pricing, Concordia reports loss

GSK consolidates DT and TT vaccine production in Hungary plant, adding 100 jobs With GlaxoSmithKline’s vaccines sales expanding, it figures it needs expanded production as well and some of that will happen at a 10-year-old plant in Hungary as well as Germany. GlaxoSmithKline said on Monday that it would invest £40 m...

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Business Cocktail

Sanofi pays €120M to buy into AstraZeneca RSV program Sanofi has paid €120 million ($126 million) upfront and committed to up to €495 million more for a stake in AstraZeneca’s experimental monoclonal antibody against respiratory syncytial virus (RSV). The agreement will see Sanofi and AstraZeneca equally share costs...

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AstraZeneca announces; Trivitron launches; BrainStorm Cell Therapeutics validates

AstraZeneca announces availability of Saxa / Dapa FDC in UK UK-based AstraZeneca has announced the availability of Qtern for adult patients with type 2 diabetes in the country. Quern is a fixed dose combination of saxagliptin and dapagliflozin. The tablet received marketing authorization from the European Commission...

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U.K. weighs drug rationing; Applying Digital; FDA slaps Florida

U.K. weighs drug rationing as NHS England's budget tightens: report Patients in the U.K. face yet another barrier to access as a tough budget situation has forced the country’s healthcare system to consider rationing costly drugs. Among them are medicines from Johnson & Johnson, Merck and Roche. Beginning in Apr...

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Novartis joins; Sanofi weighs Actelion; Valeant and Takeda’s $10B deal; Astellas scouts pipeline

With $496M CNS sale, Novartis joins other Pharma companies casting off tired meds The latest Big Pharma to join the asset-sale party is Novartis, which is in talks to offload some of its older central nervous system (CNS) drugs, including Ritalin for attention deficit disorder and Exelon patch for Alzheimer’s. The p...

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