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The Pulse of the Pharmaceutical Industry

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Eversana expands global channel management capabilities

Eversana – a leading independent provider of global, commercial services to the life science industry – announced the expansion of the company’s channel management and 3PL (third party logistics) operation with the addition of a new 260,000 square foot Verified-Accredited Wholesale Distributor (VAWD) certified distribution center in Memphis, Tennessee.

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Heron Announces Positive Topline Results from Phase 3b Clinical Study of HTX-011 in Total Knee Arthroplasty

Heron Therapeutics Inc. announced positive topline results of a multi-center postoperative pain management study in which 51 patients undergoing total knee arthroplasty surgery received the investigational agent HTX-011 together with a scheduled postoperative regimen of generic, oral analgesics (acetaminophen and celecoxib).

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Heron Therapeutics Resubmits NDA to FDA for HTX-011 for the Management of Postoperative Pain

Heron Therapeutics Inc. resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the commercial-stage biotechnology company’s HTX-011, an investigational agent for the management of postoperative pain.

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Bausch Health Files Lawsuit Against Sandoz

Bausch Health Companies Inc., together with wholly owned subsidiary Salix Pharmaceuticals Inc.’s licensor Alfasigma SpA, announced the filing of a lawsuit against Sandoz Inc. alleging patent infringement of 14 patents by the Novartis division’s submission of an Abbreviated New Drug Application for Xifaxan

(rifaximin) 550 mg tablets.

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FDA Approves Janssen’s Darzalex Combo Regimen for Newly Diagnosed, Transplant-Eligible Patients with MM

The U.S. Food and Drug Administration approved Janssen’s Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.

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FDA Clears High Sensitivity Troponin-I Blood Test

Abbott’s ARCHITECT STAT High Sensitivity Troponin-I blood test received clearance from the U.S. Food and Drug Administration to help identify heart attacks several hours sooner than standard troponin tests and help improve diagnosis in women.

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Amgen Announces Positive Results From Two Phase 3 Blinctyo Studies In Pediatric Patients With Relapsed ALL

Amgen announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase 3 trial (20120215) showed that the primary endpoint of event-free survival was met.

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Mallinckrodt Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of StrataGraft Regenerative Tissue

Mallinckrodt plc announced positive top-line results from the global biopharmaceutical company’s pivotal Phase 3 clinical trial of the investigational StrataGraft regenerative tissue.

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FDA approves Novo Nordisk’s oral diabetes drug

The U.S. Food and Drug Administration approved Novo Nordisk’s Rybelsus (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

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Outcome Health Launches New Campaign to Transform “Point of Care” through “Moments of Care”

Outcome Health launched “In These Rooms” – a bespoke campaign to transform the strategy of the industry from “point of care” to “moments of care.”

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October 2019 Focus: Top 50 Company Profiles & Financials, Outcomes Creativity Index, and more!


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