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Advanced strategies and tools are being implemented to establish the safety and efficacy of new therapeutic modalities, with the development of new biomarkers becoming one of the most relevant approaches for enhancing the precision and utility of early-stage studies.
15, 2020 07:15 UTC. The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinicaldevelopment of ATX01. More information at www.algotx.com. Source link.
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.
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. pivotal Phase 3 trial update. South Africa Phase 2b trial update. GAITHERSBURG, Md.,
In just two years, CTMC has advanced eight therapies into clinicaltrials, harnessing genetic engineering to enhance T-cell effectiveness in the fight against cancer. Ive been involved in therapeutics development for over 25 years, working with small, medium, and large biotech companies.
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. ,
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).
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.
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.
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.
Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinicaldevelopment and commercialization. that are fast progressing clinicaltrials. Innovent 2020 Virtual R&D day was successfully held with a lot of attention from domestic and overseas investors.
Heerspink, Professor of ClinicalTrials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee.
29 , 2020 /PRNewswire/ — Gannex, a wholly owned company of Ascletis Pharma Inc. Prior to joining Gannex, Dr. Prior to joining Gannex, Dr. Palmer was Head of Liver Disease ClinicalDevelopment at Takeda Pharmaceuticals. The clinicaltrial application of ASC09F has been approved. SHANGHAI , Nov.
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. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.
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/ — 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.
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.
22, 2020 07:13 UTC. The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. The FOCUS trial is Ultimovacs’ fourth Phase II clinicaltrial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We Mascha Binder, M.D.,
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.
Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinicaltrial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinicaltrials are actually managed by these organizations?
The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinicaltrials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinicaltrials to combat Covid-19.
15, 2020– Gilead Sciences, Inc. Nasdaq: GILD) and Novo Nordisk A/S (NASDAQ Copenhagen: NOVO B) today announced results from a Phase 2 proof-of-concept trial. The results were presented at The Liver Meeting Digital Experience (TLMdX), November 13–16, 2020 (Late Breaker #L02). FOSTER CITY, Calif. &
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.
Clinicaltrial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinicaltrial. About previously-published preclinical results.
.–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinicaltrial.
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.
About NCT03763149 Trial.
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SAN FRANCISCO , U.S. and SUZHOU, China , Nov.
To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020.
BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone.
27, 2020 10:45 UTC. –( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2020.
2020.
for the third quarter of 2020.
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for the third quarter of 2020. .
Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinicaltrial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.
(NYSE: PFE), today announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15. The trial builds on previous positive Phase 2 trials and includes both adult and pediatric participants with the aim to support acceleration of the vaccine candidate’s pediatric program.
SIGNAL Phase 2 trial data continue to support cognitive benefit and reduced brain atrophy with pepinemab treatment in Huntington’s disease. Data provide strong rationale for continued development in Huntington’s and other slowly progressive neurodegenerative diseases, including Alzheimer’s. ROCHESTER, N.Y.,
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].
In lean times such as 2023, we saw a shift towards several “hot” areas driven by massive commercial potential, clinically (± commercially) validated mechanisms, and exits that encouraged further investing, even at the early stage. Additional trials (e.g.,
Patient enrollment of EXCELLENCE pivotal trial reaches 98%. The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.
15, 2020 /PRNewswire/ — Alume Biosciences, Inc. This grant will support Alume’s clinicaldevelopment of its novel nerve illumination technology in surgery. Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use. LA JOLLA, Calif. ,
New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinicaldevelopment programme. Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer.
Kunwar Shailubhai will host a conference call on Wednesday, 2 December 2020 at 4:15 p.m. Dr. Shailubhai will provide updates on the Company’s proposed move from AIM to the Standard Segment of the Main Market of the London Stock Exchange, ongoing clinicaltrials, as well as other recent developments in Tiziana Life Sciences.
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. ,
Expect to initiate INZ-701 Phase 1/2 clinicaltrials for ENPP1 and ABCC6 deficiencies in first half of 2021.
12, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc.
H1 2021: Initiation of Phase 1/2 clinicaltrial.
H1 2021: Initiation of Phase 1/2 clinicaltrial.
As part of the collaboration, Hummingbird will be leveraging Tempus’ AI-enabled platform and proprietary data, as well as joining its TIME Trial® Network, for rapid identification, site activation and efficient enrollment of cancer patients who have NRG1 fusions and meet eligibility criteria for HMBD-001 clinicaltrials.
14, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases (“the Company”), today announced the pricing of an underwritten public offering of 6,320,000 shares of common stock at a public offering price of $43.50 NEW YORK, Dec.
5, 2020 /PRNewswire/ — Third quarter 2020 revenues increased 32% to $2.29 Third quarter 2020 EYLEA ® U.S. Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07
Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. All patients in the trial received a HER2 test, and the results were centrally confirmed. 6 More than two million cases of breast cancer were diagnosed in 2020 resulting in nearly 685,000 deaths globally.6
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