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Marcus' Biotech Briefing
EDETEK backs FDA real-time trial efforts, researchers report broad HIV antibody responses in primates, and Saol resubmits SL1009 for rare disease review.
The top 10 stories from Tue Jul 7, 2026 06:48 AM to Wed Jul 8, 2026 06:48 AM
Generated July 8, 2026 at 6:48 AM
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#1 EDETEK to Support the FDA's Real-Time Clinical Trials Initiative with Its R&D Cloud and Sponsor Partnership Program Published 2026-07-07 EDETEK announced it will support the FDA’s Real-Time Clinical Trials Initiative through an R&D cloud and a sponsor partnership program, according to a July 7, 2026 company statement. Covered by: prnewswire.com |
#2 MeiraGTx scores $400M from Oberland Capital to help get 2 gene therapies to commercialization Published 2026-07-07 MeiraGTx received $400 million from Oberland Capital to support development efforts aimed at commercializing two gene therapies. Covered by: fiercebiotech.com |
#3 Saol Therapeutics Resubmits the New Drug Application for SL1009 (DCA) for the Treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD), an Ultra-Rare Disease Published 2026-07-07 Saol Therapeutics announced it has resubmitted its New Drug Application for SL1009 (DCA) to treat pyruvate dehydrogenase complex deficiency, following FDA engagement. Covered by: prnewswire.com |
#4 Prazer Targets The Undruggable With Dual-Pathway TPD Platform Published 2026-07-08 Prazer says it has high hopes for a novel dual-targeted protein degrader platform designed to address targets considered difficult to drug. Covered by: insights.citeline.com |
#5 Catalent and Nanoscope Therapeutics Expand Partnership to Support Late-Phase Development and Commercial Supply of Lead Optogenetic Gene therapy, MCO-010 Published 2026-07-07 Catalent and Nanoscope Therapeutics expanded their partnership to support late-phase development and commercial supply of Nanoscope’s lead optogenetic gene therapy, MCO-010. Covered by: prnewswire.com |
#6 Hengrui, Kailera's GLP-1 pill posts encouraging efficacy but high side effect rates in late-stage China trials Published 2026-07-07 Hengrui Pharma and Kailera Therapeutics reported efficacy in two late-stage China trials of a daily GLP-1 pill for obesity and diabetes, but noted high side-effect rates. Covered by: endpoints.news, biopharmadive.com, biospace.com |
#7 Germline‑Targeting HIV Vaccine Generates Broadly Neutralizing Antibodies in Primates Published 2026-07-08 Researchers at La Jolla Institute for Immunology and Scripps Research report that a germline-targeting HIV vaccination regimen elicited broadly neutralizing antibody responses in outbred rhesus macaques. Covered by: genengnews.com |
#8 Vanda Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Investigational Therapy for Charcot-Marie-Tooth Disease Type 2S Published 2026-07-07 Vanda Pharmaceuticals said the FDA granted Rare Pediatric Disease Designation to VCA-894A, its investigational antisense oligonucleotide therapy for Charcot-Marie-Tooth disease type 2S. Covered by: prnewswire.com |
#9 Vera moves into growing kidney disease space with FDA’s accelerated IgAN nod Published 2026-07-07 Vera Therapeutics’ atacicept, planned as Trutakna, received accelerated FDA approval for primary IgA nephropathy and will compete with Novartis, Otsuka, and possibly Vertex in kidney disease. Covered by: biospace.com |
#10 AstraZeneca Rekindles EGFR-TKI/PD-L1 Approach In NSCLC Published 2026-07-07 AstraZeneca and Abbisko will collaborate on a Phase I/II trial testing osimertinib combined with the oral PD-L1 inhibitor ABSK043 in advanced lung cancer. Covered by: insights.citeline.com |
