Algernon Announces First Patient Dosed in Phase II IPF and Chronic Cough Human Trial of Ifenprodil

Algernon Pharmaceuticals Inc. announced that the first patient has been dosed in its Phase II idiopathic pulmonary fibrosis and chronic cough clinical study of its re-purposed drug NP-120.
[Algernon Pharmaceuticals Inc. (GlobeNewswire, Inc.)]
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Quadriga BioSciences Initiates Clinical Trial of Innovative, Targeted Treatment for Brain Cancers

Quadriga BioSciences announced that the first patient has been dosed in a Phase I study of QBS10072S in patients with advanced malignancies.
[Quadriga BioSciences]
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MODAG Successfully Completes Phase 1 Study of their Lead Candidate Anle138b and Receives Additional USD 1.4 Million from Michael J. Fox Foundation

MODAG announced the successful completion of its first clinical trial of anle138b (NCT04208152) in healthy volunteers. Based on the positive Phase I study results, MODAG was also able to obtain additional funding of USD 1.4 million from The Michael J. Fox Foundation for parkinson’s research.
[MODAG]
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Cytovia Therapeutics Acquires Worldwide Rights to CytoImmune Therapeutics’ First-In-Class EGFR Dual-Targeting CAR for NK Cell Treatment of Glioblastoma & Other Solid Tumors

Cytovia Therapeutics, Inc announced that it has acquired worldwide rights from CytoImmune Therapeutics for its novel EGFR dual-targeting CAR to be used for NK cell therapy.
[Cytovia Therapeutics, Inc. (GlobeNewswire, Inc.)]
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Rozlytrek, Roche’s First Tumor-Agnostic Therapy, Approved in Europe for People with NTRK Fusion-Positive Solid Tumors and for People with ROS1-Positive Advanced Non-Small Cell Lung Cancer

Roche announced that the European Commission has granted conditional marketing authorisation for Rozlytrek® for the treatment of adult and paediatric patients 12 years of age and older with solid tumors expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory treatment options.
[F. Hoffmann-La Roche Ltd]
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How the Pandemic Might Play Out in 2021 and Beyond

Although the forecasts and timelines vary, modellers agree on two things: COVID-19 is here to stay, and the future depends on a lot of unknowns, including whether people develop lasting immunity to the virus, whether seasonality affects its spread, and – perhaps most importantly – the choices made by governments and individuals.
[Nature News]
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Once Praised for Taming the Pandemic, Asian-Pacific Nations Worry about New Onslaught

Many Asian-Pacific countries have weathered the COVID-19 pandemic remarkably well so far, recording some of the lowest case numbers anywhere and earning praise as models of how to handle the virus. But the sheen is coming off their performance
[ScienceInsider]
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IMAC Holdings Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease

IMAC Holdings, Inc. announced the United States Food and Drug Administration approved its investigational new drug application, which IMAC submitted in May 2020, for the use of umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia, or the gradual loss and slowing down of spontaneous body movement, due to Parkinson’s disease.
[IMAC Holdings, Inc. (GlobeNewswire, Inc.) ]
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Cynata Completes Phase I GvHD Clinical Trial Follow-up with Positive Results

Cynata Therapeutics Ltd. has announced positive results from the two-year follow-up of patients enrolled in the Phase I clinical trial of CYP-001, Cynata’s lead iPSC-derived Cymerus™ mesenchymal stem cell product.
[Cynata Therapeutics Inc.]
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Calidi Biotherapeutics Announces FDA Approval for COVID-19 Treatment Manufactured by Partner: Personalized Stem Cells

Calidi Biotherapeutics, Inc., announced that the Investigational New Drug application submitted by its partner, Personalized Stem Cells, Inc. They have received FDA approval for the treatment of COVID-19 and pneumonia patients using stem cell therapy.
[Calidi Biotherapeutics, Inc.]
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COVID-19 Vaccine Guidelines

With multiple COVID-19 vaccines in and approaching Phase III trials, the FDA has released development and licensure guidelines for these products. The 21-page guidelines detail agency recommendations on everything from manufacturing and preclinical data considerations to trial design, efficacy considerations and post-licensure safety.
[Nature Reviews Drug Discovery]
Mullard, A. (2020). COVID-19 vaccine guidelines. Nature Reviews Drug Discovery. https://doi.org/10.1038/d41573-020-00142-9 Cite
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TYME Announces Orphan Drug Designation for SM-88 as Potential Treatment for Patients with Pancreatic Cancer

Tyme Technologies, Inc. announced that the FDA has granted the company Orphan Drug Designation for its lead pipeline candidate, SM-88, as a potential treatment for patients with pancreatic cancer.
[TYME Inc.]
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