BioCentury | Jul 25, 2020
Politics, Policy & Law

Trump issues drug pricing ultimatum to biopharma CEOs

...United States,” the order states, “to enable Americans without access to affordable insulin and injectable epinephrine...
...available to individuals who “have a high cost sharing requirement for either insulin or injectable epinephrine...
BioCentury | Jul 22, 2020
Management Tracks

Meeker expands role at Rhythm; plus Biogen, Kronos, Citryll, Akcea, ImmunoGen, Circle, Antares and more

...analysis division; Moreno was CSO of Wamberg Genomic Advisors. Cradle is developing fetal genetic analyses. MannKind...
...was VP and president of the advanced insulin management business unit of Medtronic plc (NYSE:MDT). MannKind...
...Inc. Rhythm Pharmaceuticals Kronos Bio Inc. ImmunoGen Inc. Akcea Therapeutics Inc. Circle Pharma Inc. Antares Pharma Inc. Krystal Biotech Inc. BioSpecifics Technologies Corp. Cradle Genomics MannKind...
BioCentury | Feb 1, 2020
Company News

FDA continues its run of indication-first approvals with Aimmune’s peanut allergy therapy

...the very thing it’s intended to prevent. It increased the risk of allergic reaction and epinephrine...
...dose escalation phase and certain other doses be administered in a certified healthcare setting, that epinephrine...
BioCentury | Nov 18, 2019
Politics & Policy

Warren vows quick executive action to seize pharmaceutical IP

...insulin, which Warren said could be “profitably developed for $72 a year,” as well as epinephrine...
BioCentury | Sep 18, 2019
Company News

FDA panel backs Aimmune’s peanut allergy therapy, wants expanded REMS

...comprehensive REMS. Safety concerns from the panelists included the increased risk of allergic reaction and epinephrine...
...included three safeguards: that patients have a valid prescription for injectable epinephrine, that they carry epinephrine...
BioCentury | Mar 18, 2019
Company News

FDA accepts Aimmune's peanut allergy therapy for review

...PALISADE published in the New England Journal of Medicine revealed a higher rate of rescue epinephrine...
BioCentury | Jan 4, 2019
Clinical News

Aimmune submits BLA to FDA for peanut allergy therapy

...PALISADE published in the New England Journal of Medicine showed a higher rate of rescue epinephrine...
BioCentury | Nov 30, 2018
Clinical News

Full data for Aimmune's peanut allergy therapy published in NEJM

...AR101 from Aimmune Therapeutics Inc. (NASDAQ:AIMT), including detailed safety showing a higher rate of rescue epinephrine...
...epinephrine vs. 6.5% of patients who received placebo. Aimmune did report a lower rate of epinephrine...
...separate editorial published in NEJM , Michael Perkin also highlighted the higher rate of rescue epinephrine...
BioCentury | Nov 20, 2018
Clinical News

Aimmune down on safety concerns for peanut allergy therapy

...the company's peanut allergy therapy AR101, including detailed safety showing a higher rate of rescue epinephrine...
...epinephrine vs. 6.5% of patients who received placebo. Aimmune did report a lower rate of epinephrine...
...editorial published Monday in NEJM , Michael Perkin also highlighted the higher rate of rescue epinephrine...
BioCentury | Nov 20, 2018
Company News

ICER to review peanut allergy therapies from Aimmune, DBV

...PALISADE trial of AR101, including detailed safety data that showed a higher rate of rescue epinephrine...
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