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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.
Basel, September 23 , 2020 – Novartis Gene Therapies recently received feedback from the US Food and Drug Administration (FDA) following their review of data from the STRONG study of the intrathecal (IT) formulation of AVXS-101 in older patients with spinal muscular atrophy (SMA).
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.
The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinicaldevelopment. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 The Bayer brand stands for trust, reliability and quality throughout the world.
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.
The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinicaldevelopment. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 The Bayer brand stands for trust, reliability and quality throughout the world.
22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), 22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. SUZHOU, China and ROCKVILLE, Md. , SUZHOU, China and ROCKVILLE, Md. ,
The NCT03763149 study is a phase 1a clinical study evaluating the tolerability, safety, and PK/PD properties of IBI188 (letaplimab) as monotherapy for advanced malignancies that failed in standard treatments.
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SAN FRANCISCO , U.S. and SUZHOU, China , Nov.
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].
New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinicaldevelopment programme. Roche highlights featured at ESMO Virtual Congress 2020. Overview of key presentations featuring Roche medicines at ESMO 2020. Join this event on Roche’s LinkedIn page here. Abstract title. Abstract number.
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.
30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. vice president of immunology development at Lilly.
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.
The most recent data from the Surveillance, Epidemiology, and End Results Program (SEER) of the US National Cancer Institute (NCI) estimated 19,940 new cases of AML and 11,180 deaths from this disease in the United States in 2020. ”
Reference.
1. DeSantis CE, Lin CC, Mariotto AB, et al.
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.”
30, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), 30, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), This was officially announced by the Shenzhen Stock Exchange (“SZSE”) on December 25, 2020 , which has been effective since December 28, 2020. SUZHOU, China and ROCKVILLE, Md.,
It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinicaldevelopment process.
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.
12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. Accessed October 2020.
Accessed October 2020.
Posted: November 2020. NCT identifier: NCT04380688. Available online.
19, 2020 — A recently approved rheumatoid arthritis medication appears to be an effective second-line therapy when biologic treatments start to fail, a new clinical trial reports. She is executive medical director of immunology clinicaldevelopment for the pharmaceutical company AbbVie in North Chicago, Ill.
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).
18 December 2020 — The US Food and Drug Administration (FDA) has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anemia of chronic kidney disease (CKD).
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
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