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As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. Safety biomarkers account for adverse effects of a therapy under study. There are several types of biomarkers to consider.
In the rapidly advancing field of cell therapies, Dr Jason Bock has emerged as a leader, known for his innovative approach to optimising the development process. With over 25 years of experience in therapeutics, Bock has played a pivotal role in shaping the future of cell therapies, particularly through his work at CTMC.
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.
Novartis Gene Therapies to initiate new pivotal confirmatory study to evaluate use of AVXS-101 intrathecal (I T ) formulation in older patients with SMA to further support registration. Novartis Gene Therapies remains confident in the overall benefit-risk profile for patients on treatment.
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.
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. Source link.
Bayer announced today the initiation of the CONFIDENCE study, a Phase II, three-arm study that will investigate simultaneous initial combination therapy with finerenone and the SGLT2 inhibitor empagliflozin, compared with finerenone alone and empagliflozin alone respectively in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).
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.
The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.
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 therapydevelopment and manufacturing.
CARLSBAD, Calif. ,
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 clinical trial application of ASC09F has been approved. SHANGHAI , Nov.
23, 2020 15:07 UTC. Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. A2 anticipates that the successful development of its allogeneic Tmod candidate therapy will enable subsequently developed allogeneic Tmod candidates.
Patients are going to be randomized to receive either finerenone 10mg or 20mg or placebo on top of individually tolerated maximum labeled doses of a renin-angiotensin system (RAS)-blocking therapy like an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). billion euros. billion euros.
The FDA’s January 2020 guidance, Chemistry, Manufacturing and Control (CMC) [1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics.
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.
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. executive vice president of Research and Development at Amgen. 20, 2020, at?11:00
“We are very pleased that EMA has acknowledged the potential Tessa’s CD30 CAR-T therapy holds for patients with Hodgkin Lymphoma” said Jeffrey H. These results were published in Journal of Clinical Oncology ( Ramos et al., BEDMINSTER, N.J. and SINGAPORE , Jan. Buchalter , President and CEO of Tessa Therapeutics.
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.
–( 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 clinical trial. 22, 2021 12:00 UTC.
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/ — 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.
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. ,
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. .
for the third quarter of 2020. KENILWORTH, N.J.–(
NRG1 fusions are a rare genetic mutation that are increasingly recognized as a driver of multiple tumor malignancies, and an actionable target for HER3 targeted therapy. Up to 1% of all solid tumors harbor NRG1 fusions, therefore, it is important to identify this patient population and developtherapies that can treat them. [1].
Cancer has become the second largest health threat in the world, with about 10 million people dying of cancer in 2020. Fu, 2022) Clinical research progress of ADC After decades of efforts, more than 100 ADCs are currently under clinicaldevelopment.
At the beginning of my career, during my scholarship, I worked for two years at a research institute where I set up a research project focused on the study of metronomic oral therapies for patients with metastatic breast cancer (BC). That paper, of which I was in the authorship, remains a current point of reference for that therapy usage.
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.
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.
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].
Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck Research Laboratories. Worldwide, it is estimated there were nearly 431,300 new cases of kidney cancer diagnosed and almost 179,400 deaths from the disease in 2020. In the U.S.
NEW YORK–(BUSINESS WIRE) November 23, 2020 — Pfizer Inc. It is a lifelong disease that requires constant monitoring and therapy. treatments that “bypass” the need for clotting factor treatment to help the body form a normal clot). Approximately 20% of participants will be adolescents (ages between 12 to <18 years old).
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.
LONDON–( BUSINESS WIRE )– Ixaka Ltd , an integrated cell and gene therapy company focused on the natural power of the body to cure disease, launches today. The new business will continue to develop Ixaka’s proprietary technologies – concentrated multi-cell therapies (MCTs) and targeted nanoparticle (TNP) therapeutics.
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
16, 2020 02:47 UTC. Nasdaq: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the pricing of an underwritten public offering of 3,725,000 shares of its common stock at a public offering price of $21.50
Merck has an extensive clinicaldevelopment program in lung cancer and is advancing multiple registration-enabling studies, with research directed at earlier stages of disease and novel combinations. In 2020 alone, there were more than 2.2 For further information, please visit the ETOP website: www.etop-eu.org.
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.
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.
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.
Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. In 2020, 78 percent of orphan drugs and biologics approved were targeted therapies.
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. .
SUZHOU, China and ROCKVILLE, Md. , 4, 2021 /PRNewswire/ — Ascentage Pharma (6855.HK),
12, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. Separately, Fast Track Designation facilitates the potential expedited development and review of a drug for the treatment of a serious or life-threatening disease and that has demonstrated the potential to address unmet medical needs.
Third Quarter 2020 Financial Results.
Merck is continuing to study KEYTRUDA, in combination or as monotherapy, as well as other investigational products across multiple settings and stages of RCC including adjuvant and advanced or metastatic disease through our broad clinicaldevelopment program, which includes over 20 clinical studies and more than 4,000 patients.
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.
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