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As biomarkers become increasingly relevant in indicating the workings and effects of novel therapies, their potential as valuable clinical and regulatory endpoints is also gaining recognition. Biomarkers can play a crucial role throughout clinicaldevelopment, especially in early phases. Bagyinszky E, et al. 21(10):3517.
15, 2020 07:15 UTC. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinicaldevelopment of ATX01. About AlgoTherapeutix
AlgoTx was founded in 2018 by Stéphane Thiroloix and Olivier Bohuon to develop topical treatments for complex pain and was incubated by Paris Biotech Santé.
16, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) will host two webcast calls for the investment community in conjunction with the European Society for Medical Oncology (ESMO) 2020 Virtual Congress. 20, 2020, at 11:00 a.m. THOUSAND OAKS, Calif. On Sunday, Sept. PDT, David M. Reese , M.D., Reese , M.D., On Monday, Sept.
To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinicaldevelopment.
27, 2020 /PRNewswire/ — Synlogic, Inc. Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced the Company will release its third quarter 2020 financial results before the market opens on Thursday, November 5, 2020. CAMBRIDGE, Mass. ,
30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. Posted: November 2020. GAITHERSBURG, Md., Source: Novavax, Inc. . Source link.
15, 2020 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. Conference Call Information : Date : Thursday, November 5, 2020. ELX-02 is in the early stages of clinicaldevelopment focusing on cystic fibrosis. WALTHAM, Mass., Time : 4:30 p.m. Domestic Dial-in Number : (866) 913-8546.
21 October 2020 — ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinicaldevelopment programme.
Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinicaldevelopment and commercialization. Innovent 2020 Virtual R&D day was successfully held with a lot of attention from domestic and overseas investors. SAN FRANCISCO and SUZHOU, China , Nov.
Sandoz, a Novartis division, today announced progress in the late-stage clinicaldevelopment program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. source Link.
27, 2020 /PRNewswire/ — BioInvent International AB ‘s (publ) (“BioInvent”) (OMXS: BINV) Extraordinary General Meeting (the “EGM”) today resolved to approve the Board of Directors’ resolution on a directed issue of 29,395,311 new shares and 14,697,655 new warrants to CASI Pharmaceuticals Inc.
5, 2020 11:00 UTC. NASDAQ: CNCE) today reported financial results for the third quarter of 2020. Our team has diligently and effectively executed on our plan, and I’m pleased that we have achieved our stated 2020 pipeline milestones.
Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. LEXINGTON, Mass.–(
27, 2020 /PRNewswire/ — Mirati Therapeutics, Inc. The offering is expected to close on or about October 30, 2020 , subject to customary closing conditions. Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinicaldevelopment as a monotherapy and in combinations. SAN DIEGO , Oct.
16, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) announced today that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) Virtual Congress 2020, Sept. 19-21, 2020. 20, 2020 , from 2:25 p.m. – 21, 2020 , from 2:25 p.m. – 20, 2020, at?11:00
27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. ” Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus
Date: Wednesday, October 28, 2020
Time: 10:30AM- 11:50AM ET. AR-301 is a fully human IgG1 mAb currently in Phase 3 clinicaldevelopment targeting gram-positive Staphylococcus aureus ( S.
Legend will receive $75 million from J&J as a clinicaldevelopment-based milestone payment, per a 2017 collaboration pact. Cilta-cel also won a Breakthrough Therapy designation in China in August.
These presentations will take place as part of the IASLC 2020 World Conference on Lung Cancer (#WCLC20) hosted by the International Association for the Study of Lung Cancer (IASLC) taking place virtually January 28-31, 2021. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need.
Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinicaldevelopment program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Sandoz Global Communications.
This donation of the vaccine is another tool in our toolbox of measures to help make the Olympic and Paralympic Games Tokyo 2020 safe and secure for all participants and to show solidarity with our gracious Japanese hosts,” said IOC President Thomas Bach. “We This press release features multimedia. View the full release here: [link].
Ive been involved in therapeutics development for over 25 years, working with small, medium, and large biotech companies. My focus has always been on advancing novel medicines from research to clinicaldevelopment. Over the years, Ive had the privilege of working on more than 25 different products, Bock shared.
Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinicaldevelopment programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
GREEN BROOK, NJ, December 10, 2020 /24-7PressRelease/ — Gianluca Pirozzi, MD, PhD, has been included in Marquis Who’s Who. He became Head of Development for Rare Diseases and Gene Therapy in Sanofi-Genzyme’s office in Cambridge, Massachusetts. positions he assumed in 2020.
The Company has Now Resumed the ClinicalDevelopment of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. 24, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Tauriga Sciences Inc. On December 18, 2020 – The Company issued the following press release: “Tauriga Sciences Inc. NEW YORK, NY, Dec.
Gilead has been encouraged by early clinical data generated for each of the three programs. By concluding in early to all three programs now, Gilead and Arcus are suitable to accelerate the clinicaldevelopment and advancement of these clinical- stage motes and grease the disquisition of treatment combinations across the portfolios.
1, 2020 /PRNewswire/ — TaiGen Biotechnology Company, Limited (“TaiGen”) ( Taiwan : 4157) announced today that U.S. The first US patent for TG-1000 was successfully prosecuted and granted by the United States Patent and Trademark Office on Jan 14 th , 2020. TAIPEI, Taiwan , Nov. in the near future.”
28, 2020 /PRNewswire/ — Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that it has submitted a CTA (Clinical Trial Authorization) application to the relevant regulatory authorities to start a Phase II efficacy study of its wholly-owned CD40 targeting antibody mitazalimab. CET on December 28, 2020.
11, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain. executive vice president of research and development. “The executive vice president of research and development. “We THE WOODLANDS, Texas, Dec.
29, 2020 /PRNewswire/ — Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that the company has appointed Dr Christina Reimer as Chief Medical Officer. Her international experience in leading clinicaldevelopment and in building development organizations will significantly strengthen our clinical capacity.
COVID-19 have caused delays to submission and processing of the regulatory application to initiate clinicaldevelopment in China.
Due to the unforeseen delays, Targovax has extended the term of IOvaxis’s license option by 3 months, otherwise the agreement remains unchanged.
OSLO, Norway , Jan.
CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. The vaccine candidate chosen for first clinicaldevelopment, CVnCoV, is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs).
22, 2020 07:13 UTC. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We
Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinicaldevelopment. In July 2020, the U.S.
26, 2020 11:00 UTC. We are advancing the clinicaldevelopment of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. CAMBRIDGE, Mass.–( About Moderna.
15, 2020 /PRNewswire/ — Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing.
CARLSBAD, Calif. ,
“Having received RMAT designation from FDA during 2020, we now hope to work closely with regulatory agencies in both the United States and Europe to expedite clinicaldevelopment and the registration path for this therapy.” These results were published in Journal of Clinical Oncology ( Ramos et al.,
26, 2020 /PRNewswire/ – SQI Diagnostics Inc. SQI is accelerating the clinicaldevelopment of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.
SQI intends to submit RALI-dx for EUA to FDA in late Q4 2020.
28, 2020 (GLOBE NEWSWIRE) — Gritstone Oncology , Inc. The newly executed PIPE financing is subject to customary closing conditions and is expected to close on December 30, 2020, and was done in compliance with applicable Nasdaq rules and priced at the “Minimum Price” (as defined in the Nasdaq rules). and Versant Ventures.
01, 2020 (GLOBE NEWSWIRE) — Allena Pharmaceuticals, Inc. The closing of the offering is expected to occur on or about December 4, 2020, subject to satisfaction of customary closing conditions. NEWTON, Mass., per share, less underwriting discounts and commissions. per share, less underwriting discounts and commissions.
Harpoon has four drug product candidates in clinicaldevelopment for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. In April 2020, Harpoon announced dosing of the first patient with HPN217 (BCMA TriTAC) in a Phase 1/2 clinical trial focused on relapsed/refractory multiple myeloma (RRMM).
24, 2020 /PRNewswire/ — Synthetic Biologics, Inc. On February 7, 2020 the NYSE American notified the Company that it accepted the Company’s plan to regain compliance before November 25, 2020 , the end of the compliance plan period. .
ROCKVILLE, Md. , This date has now been extended to May 25, 2021.
for expanding activities in the US with its initial focus on facilitating clinicaldevelopment. Burr Boulevard, Teaneck, NJ 07666
(3) President: Yasushi Miyazawa
(4) Scope of business: Clinical research and development
(5) Paid in capital: US$100,000.
(2) Location: 500 Frank W.
In January 2020, it raised $69 million in Series D, bringing the then-total up to $150 million. The compound was developed in the laboratory of Richard Childs, chief of the Laboratory of Transplantation Immunotherapy with the National Heart, Lung, and Blood Institute (NHLBI). It filed for a U.S. IPO on January 15.
19, 2020 /PRNewswire/ — NeoDynamics AB (publ, (Spotlight Stock Market: NEOD), a MedTech company dedicated to advancing diagnosis and care of breast cancer, announces today that the Company has received the first UK order from the Buckinghamshire Healthcare NHS Trust, London , of its pulse biopsy system, NeoNavia. STOCKHOLM , Nov.
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