BioCentury | Dec 22, 2020

Dec. 21-23 Regulatory Quick Takes: positive CHMP opinion for Pfizer-BioNTech COVID-19 vaccine; plus Urovant’s approval, a Feb. 9 adcomm for Keytruda in TNBC, NMPA reviewing a subcutaneous PD-L1, and more

CHMP recommends conditional approval of Pfizer-BioNTech COVID-19 vaccineEMA’s CHMP recommended granting a conditional MAA for Comirnaty (BNT162b2) from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) to prevent COVID-19 in individuals 16 years of age and...
BioCentury | Oct 17, 2020

CHMP’s October recommendations

EMA’s CHMP has backed autologous cells therapies Tecartus, from Gilead, and Lebmeldy, from Orchard, in its October set of opinions. The agency recommended conditional marketing approval for Tecartus brexucabtagene autoleucel from the Kite Pharma Inc....
BioCentury | Feb 15, 2020
Translation in Brief

COVID-19 therapy from Emory and diagnostic from Sherlock co-founders; plus Genentech, Homology and more

Emory, UNC to test nucleoside analog against COVID-19 The Emory Institute for Drug Development and University of North Carolina at Chapel Hill are conducting preclinical studies of nucleoside analog to treat COVID-19, an Emory University...
BioCentury | Feb 4, 2020

Co-founded by UPenn’s Wilson, Passage Bio outlines clinical goals in new IPO filing

Less than a year after emerging from stealth mode, gene therapy company Passage Bio revealed new details about its pipeline and clinical timelines through the filing of a prospectus for its planned IPO. Founded in...
BioCentury | Oct 30, 2019
Politics & Policy

Cuccinelli accepts responsibility for decision to deport patients

...for Patients” ). Bueso traveled to the U.S. to participate in a trial of Naglazyme galsulfase...
BioCentury | Sep 20, 2019
Politics & Policy

Administration reverses policy decision on deferred action for patients

...the U.S. from Guatemala as a child and participated in the original trial of Naglazyme galsulfase...
BioCentury | Sep 11, 2019
Politics & Policy

Few answers from hearing on medical deferred action

...the U.S. from Guatemala as a child and participated in the original trial of Naglazyme galsulfase...
BioCentury | Sep 4, 2019
Politics & Policy

U.S. reconsidering deportation orders for patients receiving medical treatment

...Jean-Jacques Bienaimé, chairman and CEO of BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), told BioCentury. BioMarin manufacturers Naglazyme galsulfase...
BioCentury | Mar 29, 2019
Clinical News

Orchard planning MAA for leukodystrophy stem cell gene therapy

Orchard plans to submit an MAA to EMA in 2020 for OTL-200 to treat metachromatic leukodystrophy after reporting that the therapy met a co-primary endpoint of improving motor function at two years following treatment in...
BioCentury | May 11, 2018

Takeda hits the gas

Takeda Pharmaceutical Co. Ltd.’s proposed acquisition of Shire plc is an acceleration of -- not a departure from -- CEO Christophe Weber’s stated strategy to build a top-tier global pharma, according to management. On May...
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