Recently, Australia’s Therapeutic Goods Administration (TGA) made a report from 2021 available to the public. Titled “Nonclinical Evaluation Report BNT162b2 [mRNA] COVID-19 Vaccine (COMIRNATYTM)” the document provides inputs from the preclinical work involving the Pfizer-BioNTech mRNA vaccine BNT162b2 (Comirnaty) via Pfizer Australia pty Ltd. A bombshell actually, the TGA, the agency that is supposed to “safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods” seemingly let the pharmaceutical company in this case dictate the risk-benefit analysis. At the height of the pandemic and the onset of the mass COVID-19 vaccination rollout starting February 22, 2021, the data in this document wasn’t shared with the public. But why not? Would the data (or lack thereof) associated with this report lead to more vaccine hesitancy? ------------------------------------ Join The Conversation! | https://trialsitenews.com/ ... https://www.youtube.com/watch?v=au-z15g7n6A

#Purdue Spin-off Secures $400K for Novel Approach to Treating Lung & Thyroid Cancers & Seeks Biotech Partnerships: Lung and thyroid cancers frequently have deadly consequences and most families can connect with the loss of a loved one due to these killers. Hence, its promising that yet another Purdue spin-off is bringing a novel approach to treating these conditions and the lead investigational product is moving closer to clinical trials. Funding always helps, and recently KinaRX received a $399,933 SBIR Phase I grant from the National Cancer Institute. The funding will help to advance the startups novel platform aimed at producing more effective drugs to treat lung and thyroid cancers. This advanced, Purdue-discovered platform targets gene mutations that help cancers grow and expand within the body. KinaRX is in the market as well to find partnerships. https://www.trialsitenews.com/purdue-spin-off-secures-400k-for-novel-approach-to-treating-lung-thyroid-cancers-seeks-biotech-partnerships/ #AbbVie Inks Deal with Alpine Immune Sciences for CD28/ICOS Inhibitor: Pays $60m Upfront & Up to $805m in Downstream Payments: A Seattle-based biotech developing innovative treatments for cancer and autoimmune/inflammatory diseases secured a $60 million cash payment and up to $805 million in potential drug development, regulatory and commercial milestone payments from major pharmaceutical company AbbVie. Publicly traded via a reverse merger, Alpine Immune Sciences (NASDAQ: ALPN) positions itself as a leading clinical-stage immunotherapy company that was able to negotiate an important drug development and commercialization collaboration deal involving an exclusive worldwide option and license agreement for their proprietary lead compound, ALPN-101. Based on the financial track record thus far, the deal looked like the smart thing to do. https://www.trialsitenews.com/abbvie-inks-deal-with-alpine-immune-sciences-for-cd28-icos-inhibitor-pays-60m-upfront-up-to-805m-in-downstream-payments/ #Engrail #Therapeutics Launches With $32 Million in Series A Financing: Engrail Therapeutics announced the close of a $32 million Series A financing round. Nan Fung Life Sciences (NFLS), the global investment platform of the Nan Fung Group, led the round. The Company plans to use the proceeds from the financing to support the clinical development of its first pipeline asset, ENX-101, a sub-type selective GABA A modulator. Engrail’s scientific approach begins with a thorough biological understanding of disease and rational therapeutic targeting. This in turn enables the company to identify compounds with greater opportunity to address unmet patient needs. When combined with a comprehensive view of clinical development strategy, regulatory considerations, intellectual property and op ... https://www.youtube.com/watch?v=6jNGyGAVEPw

Join us as we go over our top stories from the week: Fred Hutchinson Cancer Research Center Collaborates with Alkermes plc to Conduct Clinical Trial for Novel Immuno-Oncology Drug Candidate. UC San Diego Moores Cancer Center Immunotherapy Clinic Reveals the Future is Now. Pancreatic Cancer Drug Developed by Stony Brook University Moves into Phase III Clinical Trials. Could Autism be an Autoimmune Disorder? Investigators at Beth Israel Deaconess Medical Center (BIDMC) Think Possibly. University of Minnesota Opens First-Ever U.S. Clinical Trial of Engineered iPSC-derived Cell Therapy for Blood Cancer. Odonate Therapeutics Announces Patient Enrollment Completion for CONTESSA, a Phase 3 Study of Tesetaxel in Patients with Metastatic Breast Cancer. Asia-focused Non-Invasive Colon Detection Technology to be Commercialized by Alibaba-backed Digital Health Venture. Privately-Held Segal Clinical Supports Usona Institute’s PSIL201 Clinical Trial Testing the Use of Psilocybin for Major Depression. ASDS Awards Eight Clinical and Cosmetic Research Grants. $14.6 Million in Awards Granted to 43 Multiple Sclerosis Projects by National MS Society. Dynamic University of Rio Grande do Norte Investigator Headed to University of Auckland to Discuss Research into Ayahuasca for Antidepressant Properties. Looking for Earliest Stages of Cancer Leads to Radically Innovative Research by International Alliance. Health Systems Increasingly Step into Clinical Trials Participation: The PIER Consortium™ Example. i-Mab Biopharma Expands its Study of MOR202 for Multiple Myeloma Patients in Dozens of Sites in China. La Jolla Institute of Immunology Adopts Seqster Platform to Support Study Pursuing Personalized Asthma Treatments as part of $6.9M NHLBI Study. .University of Colorado Anschutz Medical Campus Awarded $4M as Part of NIH Commercialization Hub Program called REACH. Timestamps Cancer 00:31 Autism 03:50 Opioid Use 04:20 Clinical Trial News 05:29 Neurodegenerative 07:21 Asthma 07:55 ... https://www.youtube.com/watch?v=_aUh242t290

Join The Conversation! | https://trialsitenews.com/ Dr. Nikolai Petrovsky is a renowned researcher, professor and expert in the field of immunology, endocrinology and vaccine development. He is founder of the vaccine company, Vaxine, a company funded by the US NIH to develop novel vaccine technologies. Dr. Petrovsky has developed a protein subunit vaccine for COVID-19. He also serves as director of endocrinology at Flinders Medical Centre, Australia, and is vice-president and secretary-general of the international immunomics society. Link | https://vaxine.net/ ... https://www.youtube.com/watch?v=BNfyx218i_E