Press Releases

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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Cedilla Therapeutics Unveils Lead Programs for the Conditional Inhibition of TEAD and CDK2, Two High Value and Historically Undruggable Cancer Drivers

10/27/2021

–Conditional modulation of proteins in their functional state opens a new dimension in precision oncology– –IND-enabling studies expected to initiate in 1H 2022 for TEAD program and in 2H 2022 for CDK2 program– Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, today revealed its…

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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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Voyager Therapeutics Presents Positive Preclinical Data Supporting CNS-Directed GBA1 Gene Therapy at Virtual Congress of the European Society of Gene and Cell Therapy

10/26/2021

Single AAV intravenous dose achieved widespread CNS distribution and sustained correction of GCase activity in multiple brain regions Excerpt from the Press Release: CAMBRIDGE, Mass., Oct. 20, 2021 (GLOBE NEWSWIRE) — Voyager Therapeutics, Inc. (Nasdaq: VYGR), a gene therapy company developing life-changing treatments and next-generation adeno-associated virus (AAV) platform technologies, today announced the presentation of…

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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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ONO PHARMA USA Announces Initiation of Phase 1 Study of ONO-4685, an Anti-PD-1/CD3 Bispecific Antibody, in Patients with Relapsed or Refractory T-cell Lymphoma in the U.S

10/25/2021

Excerpt from the Press Release: CAMBRIDGE, Mass., Oct. 19, 2021 /PRNewswire/ — ONO PHARMA USA, INC. (President and CEO, Kunihiko Ito) announced the initiation of a Phase 1 study of ONO-4685, an anti-PD-1/CD3 bispecific antibody, in patients with relapsed or refractory T-cell Lymphoma in the U.S. This study is a multicenter, open label, dose escalation Phase 1 study to…

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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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