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Research Points to Inconsistent Use of Patient Experience Data in FDA Approvals

Sanofi is pressing the U.S. Food and Drug Administration to keep the company’s patient experience data consistent following a review of approved applications required by the 21st Century Cures Act.

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U.S. health officials say there may be more than one cause to vaping-related illness

U.S. health officials said there may be more than one cause to the outbreak of the mysterious lung illness linked to e-cigarette use, and said they do not see a meaningful drop in new cases.

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Gilead and Galapagos Announce Efficacy and Safety Results of Filgotinib in Phase 3 Studies for Rheumatoid Arthritis

Gilead Sciences Inc. and Galapagos NV announced that Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib – an investigational, oral, selective JAK1 inhibitor for the treatment of moderately to severely active rheumatoid arthritis (RA) – are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier during 2019.

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Datavant and Parexel Partner to Harness Real-World Evidence

Parexel will tap into real-world data to connect the biopharmaceutical services provider to data from the company’s clinical trials through a multi-year partnership with Bay Area-based Datavant.

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4D Pharma and Merck Team to Develop Microbiome-based Vaccines

Leeds, UK-based 4D Pharma and Merck/MSD are developing Live Biotherapeutics vaccines, a new class of medicines.

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Kroger, Walgreens to stop sales of e-cigarettes amid U.S. vaping crackdown

Kroger Co. and Walgreens Boots Alliance Inc. will stop selling e-cigarettes at their stores, amid heightened regulatory scrutiny of the product and reports of lung disease and some deaths linked to vaping.

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Quality, efficacy, and impact: making the case for Indian generic manufacturing

India’s ability to produce affordable generic drugs has led to the country’s reputation of being the “pharmacy of the world,” according to Dr. Reddy’s Vice President Radha Iyer.

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New Study Finds Wider Adoption of Biosimilars Could Save States and Taxpayers Billions

A new study conducted by the Pacific Research Institute (PRI) found that wider adoption of biosimilars in the United States would create significant savings to state Medicaid programs and consumers with commercial insurance.

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Novartis Eyes New Cosentyx Approval After Positive Axial Spondyloarthritis Trial

Novartis’ Cosentyx hit the mark in treating patients with non-radiographic axial spondyloarthritis (nr-axSpA) in a Phase III trial.

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Shionogi Reports Positive Results from Cefiderocol Phase III Study in Adults with Pneumonia Caused by Gram-negative Pathogens

Shionogi & Co. Ltd. announced results from APEKS-NP, an international, double-blind, randomized Phase III clinical trial evaluating the efficacy and safety of the investigational antibiotic cefiderocol in patients with nosocomial pneumonia (NP).

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