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Rapt slapped with phase II hold on CCR4 prospect

On the verge of top-line data from its phase IIb trial with oral small-molecule CC chemokine receptor 4 (CCR4) antagonist zelnecirnon in atopic dermatitis (AD), due around the middle of this year, Rapt Therapeutics Inc. said the U.S. FDA has imposed a clinical hold on that study with the otherwise promising drug, also known as RPT-193, in AD as well as the phase IIa trial with the same compound in asthma.

Rapt-therapeutics-inc , Rapt-therapeutics , Rapt-therapeutics-inc- , Zelnecirnon , Rpt-193 , Atopic-dermatitis , Asthma , Clinical-hold , Bioworld , Clinical , Respiratory

Clinical psychologist Marie de Hennezel visits Whangārei to talk death and ageing

World-renowned French clinical psychologist and psychotherapist Marie de Hennezel is in Whangārei to share her expertise on death and ageing well. She sat...

New-zealand , Hennezel , Lorraine , France , Northland , New-zealand-general- , New-zealanders , French , Katy-mandeno , French-ministry-of-health , Northland-rugby-club-rooms-on-riverside-dr , World-renowned-french

Live by the SORD: Applied Therapeutics looks to rare disease NDA

Based on positive phase III study data, Applied Therapeutics Inc. plans to take its CNS-penetrant aldose reductase inhibitor to the U.S. FDA to talk about an NDA for treating the rare disease sorbitol dehydrogenase (SORD) deficiency. SORD, a hereditary axonal neuropathy created by sorbitol dehydrogenase gene mutations, affects about 3,300 people in the U.S. and about 4,000 in Europe, according to Applied Therapeutics.

Therapeutics-inc , Applied-therapeutics , Applied-therapeutics-inc- , Govorestat , At-007 , Sorbitol-dehydrogenase-deficiency , Sord , Rare-disease , Bioworld , Clinical , Neurology-psychiatric

Deficiencies at F742: Emerging Trends in the Enforcement of New Regulations

Vicarious learning is useful when it comes to survey deficiencies—that is, learning about the reasons for deficiencies in other facilities enables us to examine the practices, polices, and procedures in our own facility.

Colorado , United-states , Ohio , Missouri , Illinois , Pennsylvania , America , American , Timothy-legg , Treatment-services-for-mental-psychosocial , Pennsylvania-department-of-health , Human-services

Global eClinical Solutions Market Outlook 2024-2028: Industry to Reach $13.48 Billion by 2028, Driven by Interoperability and Telehealth Adoption

Dublin, Feb. 14, 2024 (GLOBE NEWSWIRE) -- The "eClinical Solutions Global Market Report 2024" report has been added to ResearchAndMarkets.com's offering.The global eClinical solutions market size has grown rapidly in recent years. It will grow from $7.59 billion in 2023 to $8.47 billion in 2024 at a compound annual growth rate (CAGR) of 11.6%. The growth observed in the historical period can be attributed to several key factors, including the expansion of healthcare digitalization, the widesprea

Dublin , Ireland , Japan , France , South-korea , United-kingdom , Brazil , United-states , Australia , Indonesia , Germany , India

Kalvista's oral hereditary angioedema drug hits phase III goals

Kalvista Pharmaceuticals Inc. is promising to “change the paradigm” in the treatment of hereditary angioedema, after announcing positive phase III data for its oral on-demand kallikrein inhibitor sebetralstat. Rather than waiting four to five hours to self-administer therapy, as is the case for approved injectable on-demand therapies, there was a median time to dosing of 10 minutes after the start of an attack in the 136-patient placebo-controlled trial.

Kalvista-pharmaceuticals-inc , Kalvista-pharmaceuticals , Kalvista-pharmaceuticals-inc- , Oral-kallikrein-inhibitor , Sebetralstat , Hereditary-angioedema , On-demand , Hae-attacks , Bioworld , Clinical , Dermatologic

Deficiencies at F699: Emerging Trends in the Enforcement of New Regulations

One of the major changes in the revised regulations included tags for which many skilled nursing facilities were not adequately prepared to address, specifically F699, which addresses the provision of “trauma-informed care.”

Pennsylvania , United-states , Michigan , Minnesota , Massachusetts , New-york , America , Americans , Timothy-legg , Mental-health-provider-shortage , Full-texts , Informed-care

Street likes Luna wet AMD phase II but Adverum wanes

With Adverum Biotechnologies Inc.’s preliminary safety and efficacy data made public from the ongoing Luna phase II trial testing gene therapy ixoberogene soroparvovec (ixo-vec) in wet age-related macular degeneration (AMD), Wall Street promptly began stacking the results against those of competitors. CEO Laurent Fischer pointed out that ixo-vec boasts the “highest rate of injection-free patients of any study of any program at any dose.”

Laurent-fischer , Adverum-biotechnologies-inc , With-adverum-biotechnologies , Wall-street , Adverum-biotechnologies-inc- , Ixoberogene-soroparvovec , Wet-age-related-macular-degeneration , Bioworld , Gene-therapy , Ocular , Clinical , Diabetic-macular-edema

Synlogic pulls plug after peek at phenylketonuria phase III data

Synlogic Inc. jolted Wall Street with news that the firm is scrapping for futility Synpheny-3, its pivotal study with labafenogene marselecobac (SYNB-1934) for phenylketonuria, and will evaluate strategic options. Shares of the Cambridge, Mass.-based firm (NASDAQ:SYBX) fell 48.7%, or $1.68, to end Feb. 9 at $1.77. Synlogic will cease operations and reduce its workforce by more than 90%, retaining only certain employees to help with the wind-down.

Cambridge , Cambridgeshire , United-kingdom , Nasdaq , Synlogic-inc , Wall-street , Phenylketonuria , Synlogic-inc- , Labafenogene-marselecobac , Synb-1934 , Pku