Industry News

FDA Grants Breakthrough Device Designation for Biological Dynamics’ Early-stage Pancreatic Cancer Detection Test

10/27/2021

Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita™ platform to detect pancreatic ductal adenocarcinoma earlier in high-risk adults Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Biological Dynamics, Inc., a multiomics liquid biopsy company focused on detecting cancers at the earliest stages, today announced that the U.S. Food…

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Sorrento Announces That COVISTIX™ (COVID-19 Virus Rapid Antigen Detection Test) Has Received a CE Mark and Registration of the Device

10/27/2021

COVISTIX has received CE mark and marketing authorization from FAMHP (Federal Agency for Medicines and Health Products) that enables Sorrento to sell this device in all territories that accept the Qarad EC-Rep (Belgium) CE Mark for commercialization. Distribution contracts are being negotiated. Excerpt from the Press Release: SAN DIEGO, Oct. 20, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”)…

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Inhibikase Therapeutics Announces Dosing of First Parkinson’s Patient in its Phase 1b Clinical Trial of IkT-148009

10/26/2021

Excerpt from the Press Release: ATLANTA, Oct. 19, 2021 /PRNewswire/ — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, today announced dosing of the first Parkinson’s patient in its Phase 1b clinical trial of IkT-148009, an Abelson Tyrosine Kinase, or c-Abl, inhibitor…

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Rakuten Medical and Karkinos Healthcare Announce Strategic Partnership to Expand the Reach of Novel Cancer Care in India

10/26/2021

Excerpt from the Press Release: SAN MATEO, Calif. and MUMBAI, India, Oct. 21, 2021 /PRNewswire/ — Rakuten Medical Inc, and Karkinos Healthcare Private Limited announced a strategic collaboration to expand the reach of novel cancer care to India. This includes a minority stake acquisition in Karkinos Healthcare by Rakuten Medical. Rakuten Medical’s investment marks Karkinos Healthcare’s first international investor. Rakuten…

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Moderna Announces FDA Authorization of a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.

10/25/2021

Emergency Use Authorization (EUA) granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups FDA also authorized the use of Moderna’s booster dose following primary vaccination with other authorized or approved COVID-19 vaccines Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering…

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AmMax Bio Announces Positive Interim Phase 2 Results of AMB-05X for the Treatment of Tenosynovial Giant Cell Tumor (TGCT)

10/25/2021

Intra-articular (IA) Delivery of AMB-05X Demonstrates Proof-of-Concept in TGCT With A Rapid Onset of Tumor Reduction in All Patients Within Six Weeks Interim AMB-05X Data Support Potential for Best-in-Class Therapy for Treatment of TGCT Excerpt from the Press Release: REDWOOD CITY, Calif., Oct. 20, 2021 (GLOBE NEWSWIRE) — AmMax Bio, Inc. (“AmMax”), a private clinical-stage…

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VistaGen Therapeutics Expands Clinical Development of PH94B with Initiation of Phase 2A Trial in Adjustment Disorder

10/22/2021

Study Launches Phase 2A Clinical Program Designed to Explore PH94B’s Potential in Multiple Additional Anxiety Disorders Phase 2A Study in Adjustment Disorder to Run in Parallel with Ongoing Phase 3 Studies in Acute Treatment of Social Anxiety Disorder Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Oct. 14, 2021 (GLOBE NEWSWIRE) — VistaGen Therapeutics, Inc.…

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Immune-Onc Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4), in Patients With Advanced Solid Tumors

10/22/2021

– Multicenter Phase 1 study to evaluate IO-108 as monotherapy and in combination with an anti-PD-1 – – IO-108 is Company’s second program to advance to clinic – Excerpt from the Press Release: PALO ALTO, Calif.–(BUSINESS WIRE)–Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that…

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Benchmark Genome Study Demonstrates Accuracy of Artificial Intelligence in Rapidly Diagnosing Rare Diseases in Critically Ill Patients

10/21/2021

Pivotal study led by Fabric Genomics and Rady Children’s Institute for Genomic Medicine demonstrates that artificial intelligence can enable the accurate and rapid clinical diagnosis of rare diseases in critically ill newborns based on whole-genome or whole-exome analyses Excerpt from the Press Release: OAKLAND, Calif. & SAN DIEGO, Calif.–(BUSINESS WIRE)–Fabric Genomics and Rady Children’s Institute…

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Rhythm Pharmaceuticals Presents New Data on Experience of People Living with Rare Genetic Diseases of Obesity and Provides Updates on Uncovering Rare Obesity® Genetic Testing Program

10/19/2021

— New data in patients with POMC or LEPR deficiency obesity show setmelanotide led to clinically meaningful improvements in health related quality of life measures and hunger — — Updated results from Uncovering Rare Obesity® testing program suggest up to 64.5 percent of individuals with early-onset, severe obesity may carry variants linked to rare genetic diseases of…

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