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BioWorld - Tuesday, May 24, 2022
Home » Topics » Clinical

Clinical
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Brain maze

Emergent-see ahead: Wall Street calm as Karuna phase III schizophrenia results to land soon

April 19, 2022
By Randy Osborne
No Comments
With phase III data due from Karuna Therapeutics Inc. with its combo Karxt therapy for schizophrenia, interest is rising in the historically difficult space. Karxt pairs xanomeline, a muscarinic receptor agonist that preferentially stimulates M1 and M4 muscarinic receptors, with trospium, an approved muscarinic receptor antagonist that does not measurably cross the blood-brain barrier, confining its effects to peripheral tissues.
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Shionogi’s COVID treatment could disturb fetal development, impact regulatory approval

April 19, 2022
By Gina Lee
No Comments
Shionogi & Co. Ltd.’s plan to make ensitrelvir, an oral antiviral for COVID-19, the first domestically approved COVID-19 treatment has hit a snag. Animal studies showed the drug, also known as S-217622, disturbed fetal development, according to media reports.
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Beigene’s zanubrutinib meets primary endpoints in phase III trial to treat chronic lymphocytic leukemia

April 19, 2022
By Doris Yu
No Comments
Beigene Ltd.’s BTK inhibitor Brukinsa (zanubrutinib) has met the primary endpoints in a phase III trial to treat patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
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DNA illustration

China clarifies regulations on sharing human genetic resources

April 19, 2022
By Tamra Sami
No Comments
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
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Ukoniq

TG Therapeutics rethinks oncology as stock stumbles

April 18, 2022
By Lee Landenberger
No Comments
A week before the U.S. FDA’s Oncologic Drugs Advisory Committee was to meet and review TG Therapeutics Inc.’s BLA and sNDA for the combo of ublituximab and Ukoniq (umbralisib) for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, the company voluntarily withdrew the submission and now is rethinking its oncology programs. The move was tied to an FDA-requested analysis of phase III data showing that, while study met its primary endpoint, there was an imbalance in updated overall survival (OS) results favoring the control arm. A June 25 PDUFA date had been set for the combination treatment.
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3d illustration of ovarian cancer

Phase III Oval egg set to hatch, VBL foretells the sell in PROC

April 18, 2022
By Randy Osborne
No Comments
As Wall Street awaits data from VBL Therapeutics Inc.’s phase III trial with ofranergene obadenovec (ofra-vec, also known as VB-111) in platinum-resistant ovarian cancer (PROC), the company hosted a key opinion leader conference call on the gene therapy’s likely market reception along with assorted details regarding the upcoming results from the 409-patient experiment known as Oval.
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BK virus in spotlight after Aicuris tie-up; Allovir, Vera face off

April 18, 2022
By Randy Osborne
No Comments
The potential €100 million (US$114 million) deal disclosed Feb. 10 between infectious disease specialist Aicuris Anti-infective Cures AG and Hybridize Therapeutics for a BK virus therapy stimulated interest in the space, where a number of players are seeking a treatment. None exists today.
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Meridian TAVR device in heart model

Clinical trials assess Meridian TAVR for treatment of aortic regurgitation

April 14, 2022
By David Godkin
No Comments
The FDA has given thumbs up to two clinical studies for a transcatheter aortic valve replacement (TAVR) system developed by HLT Inc. to treat aortic stenosis among high-risk patients. Those studies will include aortic regurgitation which also occurs when an aortic valve doesn't open and close tightly enough but for which there are few suitable, noninvasive treatments.
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Trudhesa nasal spray with Precision Olfactory Delivery (POD) technology

Impel’s migraine nasal spray affirmed in new data

April 14, 2022
By Meg Bryant
No Comments
Impel Neuropharma Inc. presented multiple abstracts affirming the effectiveness of Trudhesa (dihydroergotamine mesylate) nasal spray in treating migraine attacks. The data – all subsets from the phase III, open-label, pivotal STOP-301 trial – show that acute use of Trudhesa delivered via Impel’s Precision Olfactory Delivery (POD) technology may enhance patients’ quality of life by reducing migraine-associated disability, prolonging headache-free periods and limiting the number of migraine attacks over time.
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Person on couch holding smartphone displaying Wysa mental health app

AI chatbot provides emotional bond for mental health app users

April 14, 2022
By Catherine Longworth
No Comments
Results from a new peer-reviewed study show people develop emotional bonds with artificial intelligence (AI) therapy chatbots in a similar way to in-person therapists. The study evaluated 1,205 people using a mental health app developed by Wysa Ltd. to assist symptoms of anxiety or depression. The chatbot guides users through therapy exercises including cognitive-behavioral techniques (CBT), dialectical behavior therapy, meditation, breathing and yoga to build mental resilience skills.
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