Pharmaceutical

Varian Receives FDA 510(k) Clearance for Halcyon and Ethos Radiotherapy Systems Featuring HyperSight Imaging Solution and Announces First Patient Treatment

02/07/2023

Achieves CE Mark for Halcyon and Ethos Radiotherapy Systems Featuring HyperSight Excerpt from the Press Release: PALO ALTO, Calif., Feb. 2, 2023 /PRNewswire/ — Varian, a Siemens Healthineers company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as CE mark, for Halcyon® and Ethos™ radiotherapy…

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Eloxx Pharmaceuticals Announces First Patients Enrolled in Phase 2 Clinical Study Evaluating ELX-02 for the Treatment of Alport Syndrome

02/06/2023

Topline results expected in first half of 2023 Trial sites open in Australia and United Kingdom Excerpt from the Press Release: WATERTOWN, Mass., Jan. 25, 2023 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced that the first patients have now been enrolled in…

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Denali Therapeutics Announces Achievement of RIPK1 Milestone for Phase 2 Clinical Trial Initiation in Multiple Sclerosis by Sanofi

02/03/2023

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Jan. 25, 2023 (GLOBE NEWSWIRE) — Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases and lysosomal storage diseases, today announced that its partner Sanofi has commenced dosing…

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Vial Announces Enrollment of First Patient in Phase II Clinical Trial TLL018-205 for the Treatment of Plaque Psoriasis Sponsored by Highlightll Pharmaceutical

01/23/2023

Excerpt from the Press Release: SAN FRANCISCO, Jan. 19, 2023 /PRNewswire/ — Vial, a global tech-enabled CRO providing next-generation clinical trial management services, announced that the first patient has been enrolled in the clinical trial TLL018-205, a Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of TLL-018 in human subjects with moderate…

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Madrigal Announces Additional Positive Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH with Liver Fibrosis

01/13/2023

As previously reported, resmetirom demonstrated improvements in NASH and liver fibrosis on liver biopsies, the primary endpoints of the MAESTRO-NASH trialA supportive analysis using consensus reads of digitized biopsy images by the central pathologists replicated the positive primary endpoint resultsThese data will be presented at the NASH-TAG Conference on Friday January 6th, 2023 Excerpt from…

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Sionna Therapeutics Announces Advancement of Cystic Fibrosis Pipeline Programs and Presentation at J.P. Morgan 41st Annual Healthcare Conference

01/12/2023

– Enrolling Phase 1 study of lead NBD1 modulator, SION-638, following IND clearance from the FDA; data expected in the second half of 2023 – – SION-109, targeting complementary mechanism ICL4, on-track for IND submission in the first half of 2023 – – Three additional development candidates nominated for progression including two Series 2 NBD1…

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Alnylam Submits CTA Application for ALN-KHK, an Investigational RNAi Therapeutic for the Treatment of Type 2 Diabetes

01/09/2023

–Company Expects to Initiate a Phase 1/2 Study for ALN-KHK in Early 2023, with Initial Results Expected in Late 2023 – Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi (RNA interference) therapeutics company, announced today that the Company has submitted a Clinical Trial Authorization (CTA) application to Health…

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Maze Therapeutics Announces Completion of Phase 1 First-in-Human Trial Evaluating MZE001 as a Potential Oral Treatment for Pompe Disease

12/20/2022

MZE001 was Well-Tolerated and Reduced Glycogen Accumulation in Blood Cells in Healthy Volunteers, Supporting Advancement into Phase 2 Clinical Trial Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Maze Therapeutics, a company translating genetic insights into new precision medicines, today announced the completion of its first-in-human clinical trial designed to evaluate the safety, tolerability,…

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Rezolute Announces Initiation of a Phase 2 Study of RZ402 in Patients with Diabetic Macular Edema

12/19/2022

RZ402 is an oral therapy being developed as a potential alternative to invasive and suboptimal injections into the eye Excerpt from the Press Release: REDWOOD CITY, Calif., Dec. 15, 2022 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of…

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Moderna and Merck Announce mRNA-4157/V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination with KEYTRUDA(R) (pembrolizumab), Met Primary Efficacy Endpoint in Phase 2b KEYNOTE-942 Trial

12/16/2022

mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy in stage III/IV melanoma patients with high risk of recurrence following complete resection Results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical…

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