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BioWorld - Wednesday, February 11, 2026
Home » Topics » Clinical

Clinical
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Ear illustration

Proqr procures strong phase I/II data and an FDA chat for next steps

March 24, 2021
By Lee Landenberger
RNA therapy developer Proqr Therapeutics NV’s phase I/II study of adults with Usher syndrome and non-syndromic retinitis pigmentosa met all its key objectives, prompting the company to plan two parallel pivotal phase II/III studies that could start by year-end. The company wasted no time as it has already discussed next steps with the FDA to support the therapy’s registration “as soon as possible,” Aniz Girach, Proqr’s chief medical officer, told investors during a March 24 investor call.
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Long COVID word cloud

U.K. study shows burden of lingering symptoms for post-COVID-19 patients

March 24, 2021
By Nuala Moran
LONDON – A U.K.-wide study has found that seven out of 10 patients hospitalized with COVID-19 infection were continuing to suffer physical and mental health problems five months after discharge.
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In the clinic for March 24, 2021

March 24, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Akari, Assembly, Basilea, Brainstorm, Clover, Dare, Durect, Dynavax, Eirgenix, Guerbet, Hutchmed, Krystal, Myovant, Nascent, Novo, Partner, Pfizer, Proqr, Revive, Theratechnologies.
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Box of Astrazeneca COVID-19 vaccine vials

Astrazeneca will publish findings from U.S. COVID-19 vaccine trial after DSMB criticism

March 23, 2021
By Nuala Moran
LONDON – Astrazeneca plc promised to publish the primary analysis of the phase III U.S. trial of its COVID-19 vaccine by the morning of March 25, after chastisement from the data safety monitoring board (DSMB) for using “outdated” information in the interim results published on March 22.
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Product image

Insulet’s Omnipod insulin delivery system hits its mark in pivotal diabetes trial

March 23, 2021
By Mary Ellen Schneider
Insulet Corp. reported positive results from a pivotal trial of its Omnipod 5 automated insulin delivery system for patients with type 1 diabetes. The tubeless, wearable insulin delivery system lowered hemoglobin A1c (HbA1c) – a critical diabetes measure – in children, adolescents, and adults, and improved the time that patients were in the target blood glucose range. The data was presented at ENDO 2021, the Endocrine Society’s annual meeting, which was held virtually this year.
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Health professional pointing stethoscope at Clinical Trial words, icons

Dragon Boat moves anti-CSF-1R antibody candidate to the clinic

March 23, 2021
By Elise Mak
Like its distinctive name, Dragon Boat Biopharmaceutical Co. Ltd., of Shanghai, raced to victory with the Chinese IND approval for its anti-CSF-1R monoclonal antibody candidate BC-006, marking an important milestone for the company as it embraces a growing focus on innovative medicines.
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Ear and sound waves illustration

Frequency hears bad news from a phase IIa study of its lead candidate

March 23, 2021
By Lee Landenberger
A phase IIa study of Frequency Therapeutics Inc.’s lead candidate in treating hearing loss showed it fared no better than placebo, but the company said its faith in the candidate is bolstered by the belief the study was hampered by trial design issues and by data from another study.
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Ionis shares sink as Roche quits dosing phase III HD drug following IDMC opinion

March 23, 2021
By Michael Fitzhugh
Shares of Ionis Pharmaceuticals Inc. (NASDAQ:IONS) fell 21.7% to $43.59 on March 23 after its longtime partner, Roche Holding AG, decided to stop dosing the antisense oligonucleotide tominersen in a global phase III manifest Huntington's disease (HD) study. Roche subsidiary Genentech Inc. said the move was based on an independent data monitoring committee's preplanned assessment of the drug's risk-benefit profile.
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In the clinic for March 23, 2021

March 23, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Anokion, Frequency, Ideaya, Incyte, Ionis, Lineage, Neoimmunetech, Novartis, Omeros, Oramed, Precigen, Recordati, Regeneron, Roche, Sojournix.
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Diagram of Hemocath intelligent HF monitoring platform

Major test awaits less invasive device for detecting congestive heart failure

March 22, 2021
By David Godkin
TORONTO – Hemocath Ltd. is gearing up for a first-in-human trial of a device that addresses two critical metrics for the treatment of heart failure: pulmonary artery and central venous pressure. Hemocath’s pulmonary artery catheter (PAC) is part of a larger heart failure monitoring platform and is intended to assess fluid status in patients with severe or worsening congestive heart failure. The hope is to replace larger, more invasive catheters inserted into a patient’s neck.
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