Tag Archives: type-industry &amp; policy

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Italfarmaco Receives FDA Rare Pediatric Disease Designation for Givinostat in Duchenne Muscular Dystrophy, Announces Completed Enrollment in EPIDYS Phase III Trial

The US FDA have granted a Rare Pediatric Disease designation to The Italfarmaco Group’s proprietary histone deacetylase inhibitor, Givinostat, for the treatment of Duchenne Muscular Dystrophy, which allows an expedited review process for new treatment modalities. The company also announced the completion of patient enrollment in the EPIDYS Phase III trial.

[ITALFARMACO S.p.A.]

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Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft vs Host Disease Study

Pluristem Therapeutics Inc. announced that it has received clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II. The study will evaluate PLX-PAD cells in the treatment of steroid-refractory chronic graft vs. host disease and is led by Principal Investigator Prof. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov Hospital, Israel.

[Pluristem Therapeutics Inc.]

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FDA Approves Expanded Indication for Merck’s KEYTRUDA^® (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

Merck announced that the FDA has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.

[Merck & Co., Inc.]

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Mirum Pharmaceuticals Announces Partnership With EVERSANA to Support Launch and Commercialization of Maralixibat for Alagille Syndrome in the United States

Mirum Pharmaceuticals, Inc. announced it has partnered with EVERSANA™, a leading provider of commercial services to the life science industry, to lead the US market access, distribution and patient services for maralixibat.

[Mirum Pharmaceuticals, Inc.]

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Scientific Pioneers Recognized by 2020 Royal Society of Edinburgh Medals

The Royal Society of Edinburgh, Scotland’s National Academy, has announced the winners of its highly prestigious medals, which recognize exceptional achievement in science, academia and public engagement.

[The Royal Society of Edinburgh]

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Targovax Announces That the ONCOS-102 and Durvalumab Trial Successfully Completes Part 1 in Colorectal Cancer

Targovax ASA announced that the colorectal cancer cohort in part 1 of the ONCOS-102 and durvalumab trial in colorectal and platinum-resistant ovarian cancer that has spread to the peritoneum has met the pre-defined efficacy threshold of patients without progression at the end of week 24. The second part of the colorectal expansion cohort is now open for recruitment.

[Tragovax]

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Noxxon Announces Successful Completion of Patient Recruitment for Second Dose Cohort In Phase I/II Brain Cancer Study of NOX-A12 Plus Radiotherapy

Biotechnology company NOXXON Pharma N.V. announced that all three patients of the second dose cohort have been enrolled into the brain cancer clinical trial testing CXCL12 inhibitor, NOX-A12, and have already received the planned initial treatment. The Phase I/II clinical study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external beam radiotherapy in newly diagnosed brain cancer patients.

[Noxxon Pharma N.V.]

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Phenomic AI Launches with $6 Million Financing and an AI/ML Platform for Targeting the Tumor Stroma

Phenomic AI, announced the official launch of the company with US$6 million seed financing. The proceeds of the financing will support preclinical studies for two validated cancer drug targets in the tumor stroma, discovered with the company’s platform as well as discover and advance additional drug targets into the company’s pipeline.

[Phenomic AI (Businesswire, Inc.)]

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Apexigen’s APX005M Granted Orphan Drug Designations for the Treatment of Esophageal and Gastroesophageal Junction Cancer and for the Treatment of Pancreatic Cancer

Apexigen, Inc. announced that the US FDA has granted orphan drug designation status to APX005M for the treatment of esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer.

[Apexigen Inc.]

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Inventiva Receives FDA Breakthrough Therapy Designation for Lead Drug Candidate Lanifibranor in NASH

Inventiva announced that the FDA has granted Breakthrough Therapy designation to lanifibranor, the company’s lead drug candidate, for the treatment of NASH.

[Inventiva]