Day: September 21, 2020

– Supplemental New Drug Application Planned for Submission in Q1 2021 –CAMBRIDGE, Mass., Sept. 21, 2020 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced the results of the final overall survival (OS) analysis from its global Phase 3 ClarIDHy trial of TIBSOVO® (ivosidenib tablets) in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 (IDH1) mutation. A consistent trend in improved OS was observed in patients treated with TIBSOVO® compared to those randomized to placebo, but was not statistically significant. The OS endpoint can be affected by crossover, so these results should be taken in the context of the large proportion (70%) of patients in the placebo arm who crossed over to receive...

Vincit OyjLehdistötiedote 21.9.2020 kello 14:00Keusote uudistaa rohkeasti toiminta- ja johtamiskulttuuriaan Vincitin työkalujen avullaSosiaali- ja terveyspalvelujen -toimintaympäristö on valtavan muutospaineen edessä niin rakenteellisten kuin toimintaympäristöön kohdistuvien muutostarpeiden osalta. Matala digitalisaatioaste, monimutkaiset rakenteet ja yksikköjen välisen yhteistyön ja tiedonkulun jäykkyys ovat kuntasektorin keskeisiä haasteita tilanteessa, jossa tarvitaan entistä nopeampia ratkaisuja ongelmiin, jotka ovat entistä kompleksisempia. Näitä haasteita Keski-Uudenmaan sote-kuntayhtymä lähtee edelläkävijänä taklaamaan merkittävällä toiminta- ja johtamiskulttuurin päivityksellä. Muutosta lähdetään tekemään Vincitin kehittämän LaaS-mallin avulla.Johanna Pystynen, Head of Leadership Development, Vincit Oyj: “Työelämän murroksen haasteet...

VANCOUVER, British Columbia, Sept. 21, 2020 (GLOBE NEWSWIRE) — ValOre Metals Corp. (“ValOre”; the “Company”; TSX‐V: VO; OTC: KVLQF; Frankfurt: KEQ0) today announced the addition of a second drill rig to accelerate Phase 1 and Phase 2 of the 2020 core drill program on the Company’s 100%-owned Pedra Branca Platinum Group Element (PGE) Project in northeastern Brazil. ValOre has also augmented the on-site technical team to help execute its newly expanded exploration program. With a CAD $500,000 increase to the existing unsecured revolving credit facility, ValOre is completely funded to finish both Phase 1 and Phase 2 drill programs at Pedra Branca.Pedra Branca Exploration Highlights:Phase 1 drill program has tested six targets with 21 diamond drill holes (“DDH”) to date, totaling 2,210 metres (“m”) of 2,875 m planned. See Table 1 below...

—Live presentation highlighting TRV027 as a potential treatment for COVID-19 acute respiratory distress syndrome (ARDS) / abnormal clottingPosters on OLINVYK benefit-risk profile and TRV250 Phase 1 pharmacokinetics—CHESTERBROOK, Pa., Sept. 21, 2020 (GLOBE NEWSWIRE) — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced three presentations at the virtual 2020 American College of Clinical Pharmacology (ACCP) Annual Meeting, taking place from September 21st to 23rd, 2020.The Company will give a live presentation on TRV027, its AT1 receptor selective agonist being studied as a potential treatment for ARDS / abnormal clotting in COVID-19. Additionally, the Company will present...

DURHAM, N.C. and STAMFORD, Conn., Sept. 21, 2020 (GLOBE NEWSWIRE) — Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, and SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced they have entered into a clinical trial collaboration agreement. Per the agreement, PBCAR269A, Precision BioSciences’ wholly-owned investigational allogeneic chimeric antigen receptor (CAR) T cell therapy candidate targeting B-cell maturation antigen (BCMA), will be evaluated in combination with nirogacestat, SpringWorks’ investigational gamma secretase inhibitor (GSI), in patients...

Single Phase 3 trial to be conducted to support an NDA filing of AXS-12 in the treatment of narcolepsy; trial initiation anticipated 1Q 2021Extensive patient safety database, previously obtained through Pfizer exclusive license, to support NDA filingExtensive array of completed nonclinical studies sufficient to support NDA filingCompany to host conference call today at 8:00 AM EasternNEW YORK, Sept. 21, 2020 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the development plan for AXS-12 for the treatment of narcolepsy has been expedited following a Breakthrough Therapy meeting with the U.S. Food and Drug Administration (FDA). AXS-12 is a novel, oral, highly selective and potent norepinephrine...

LATHAM, N.Y., Sept. 21, 2020 (GLOBE NEWSWIRE) — Plug Power Inc. (NASDAQ: PLUG), a leading provider of clean hydrogen and zero-emission fuel cell solutions for the power, energy, and transportation industries, will host its second annual Plug Symposium on Thursday, September 24, 2020.The event presents an opportunity for engaging dialogue on advancing sustainable solutions for an electrified world. The program features a deep dive into the state of the global green hydrogen economy. Alongside Plug Power’s executive leadership, the symposium brings together an impressive roster of speakers from across the industry and stakeholder groups. These experts will provide their perspectives on how the hydrogen and fuel cell industry is adapting to today’s dynamic environment of growth. The speakers will also share their insights on key micro...

AGOURA HILLS, Calif., Sept. 21, 2020 (GLOBE NEWSWIRE) — Mateon Therapeutics “Mateon” (OTC.QB: MATN), a leading developer of TGF-β therapeutics for oncology and COVID-19, announced today that on September 21, 2020, Dr. Vuong Trieu, CEO of Mateon, will be presenting as Webinar “Trabedersen-Drug Development using phosphorothioate antisense platform” at Pharma Forum 2020/ Pharmacology and Toxicology/September 21, 2020. Of significant is the finding that cytokine levels of clinical plasma samples of 12 pancreatic cancer patients of the P001 study of OT-101 in advanced solid tumor patients were measured using the ImmunoSignal cytokine storm assay developed by Eurofins. Nine patients with elevated IL-6 were examined further. More than 50% of these patients (6 of 9) exhibited significant reduction in IL-6 level following 1st cycle of dosing...

SAN CLEMENTE, CA, Sept. 21, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE ‒ Global WholeHealth Partners Corp. (GWHP) announces it had submitted an Emergency Use Authorization (EUA) Application Submission Number: PEUA201789 Acknowledgement Letter date 09/14/2020: for the Global Antigen CoViD19 SARS2 Rapid Test as mentioned in the 8K filing dated September 15th, 2020.Since Global’s antigen tests are lateral flow and are a simple test similar to Nasal Influenza Test, Global is looking forward to continuing with the submission that was filed on September 14, 2020, and join the fight against CoViD19 SARS.HOW IT WORKS:A healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. After waiting 10-15 minutes, the healthcare provider reads the results directly from the testing card. One...

BERKELEY HEIGHTS, N.J., Sept. 21, 2020 (GLOBE NEWSWIRE) — Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC) (Nasdaq: CYCCP) (Cyclacel or the Company), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced that an abstract highlighting clinical data with Cyclacel’s CDK2/9 inhibitor fadraciclib has been selected for an oral presentation at the 32nd EORTC-NCI-AACR (ENA) Symposium 2020 being held virtually on October 24 – 25, 2020. The data is from an ongoing Phase 1 study of fadraciclib as a single agent in patients with advanced solid tumors.Details for the presentations are as follows:Title: Phase 1 safety, pharmacokinetic and pharmacodynamic study of fadraciclib (CYC065), a cyclin dependent kinase inhibitor, in patients with advanced cancers (NCT02552953)Session Title: Late Breaking...