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BioWorld - Saturday, December 20, 2025
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Regulatory front for April 9, 2021

April 9, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS, DOJ officials highlight pandemic response needs; FDA says plenty of respirators available; NICE supports use of Danis for variceal hemorrhage.
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Other news to note for April 9, 2021

April 9, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biosig Technologies, Control Bionics, Genetic Technologies, Infinity Biologix, Lucira Health, Numotion, Outset Medical.
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Cuban flag

Three-shot Cuban COVID-19 vaccine candidate moves forward in phase III

April 9, 2021
By Sergio Held
CAJICA, Colombia – Following the start of phase III trials for its COVID-19 vaccine, Soberana 02, Cuban researchers have started phase III trials for Abdala (CIGB-66), another vaccine candidate developed in the island country.
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Other news to note for April 9, 2021

April 9, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aelis, Bioaegis, Deargen, Galapagos, Gilead, Kempharm, Regeneron, Repare, Theralase.
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In the clinic for April 9, 2021

April 9, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: BMS, Celcuity, Cytodyn, Mersana, Oncoinvent, Redhill, Tenax.
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RNA and SARS-CoV-2 virus cell

CDC inks agreement for additional sequencing as FDA grapples with SARS mutations

April 8, 2021
By Mark McCarty
The FDA has its hands full with the impact of the mutations to the SARS-CoV-2 virus, but test developers can count on an ever-increasing base of data for those viruses thanks to a new contract taken by the CDC. The CDC indicated recently that its sequencing efforts and that of other organizations churned out nearly 14,000 sequences for the week of April 3, but Aegis Sciences Corp., of Nashville, Tenn., announced April 7 that it had undertaken an agreement to perform next-generation sequencing of samples from all 50 states and Puerto Rico, ensuring plenty of access to up-to-date information on those mutations.
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Hand adding piece to puzzle

Hologic snaps up Mobidiag in fourth diagnostics acquisition this year

April 8, 2021
By Meg Bryant
Hologic Inc. is tucking in yet another diagnostics manufacturer, this time with the acquisition of Mobidiag Oy for approximately $795 million. The privately held Finnish-French company develops and markets polymerase chain reaction (PCR)-based tests for acute care testing such as gastrointestinal and respiratory infections, antimicrobial resistance management and health care-associated infections.
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Regulatory front for April 8, 2021

April 8, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FCC says no need to revisit telehealth grants; NICE updates sphere usage for hepatocellular carcinoma; Health Canada: Docs, nurses not needed for workplace testing.
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In the clinic for April 8, 2021

April 8, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Diacarta, Electrocore, Gynesonics.
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Patient in hospital bed

Lilly, Beigene see trials for hospitalized COVID-19 patients fall short

April 8, 2021
By Michael Fitzhugh
Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen.
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