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Susceptibility or risk biomarkers can detect the likelihood of a patient developing a disease or medical condition, which is crucial for treatments that are most effective before the onset of symptoms. A biomarker is a measurable indicator of a biological process, disease state, or response to a treatment.
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. TILs were specifically developed to target solid tumour cancers, Bock explained.
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.
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.
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. ,
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.
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. ,
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.
to enhance outcomes, new treatments which will target kidney-specific disease mechanisms are highly desired,” said Hiddo L. Christian Rommel, Member of the chief Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4
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. Aflibercept is a key treatment in ophthalmology.
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. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics.
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. CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata.
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. HIV/AIDS: ASC09F is a FDC treatment of HIV targeting protease. SHANGHAI , Nov.
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.
Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. Harpoon has four drug product candidates in clinicaldevelopment for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. “I
If successful, the results of the CONFIDENCE study could be of great significance to clinicians when considering how to optimize disease management and further delay kidney disease progression, while also providing additional insights into the safety of using these treatments in combination.”. billion euros. billion euros.
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.
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/ — 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 top protein neutralized the virus with similar or greater potency than antibody treatments with Emergency Use Authorization status from the U.S. Notably, the top protein also neutralized all tested SARS-CoV-2 variants, something that many clinical antibodies have failed to do. Food and Drug Administration (FDA).
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., About Vaccinex, Inc.
We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinicaldevelopment program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”. About 108,000 people of more than 140 nationalities work at Novartis around the world.
for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. .–(BUSINESS WIRE) January 15, 2021 — Daiichi Sankyo Company, Ltd. In the U.S., Sammons Cancer Center and the W.W. Caruth, Jr.
Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of the novel combination of the cancer treatments copanlisib and rituximab. submission is for the treatment of patients with relapsed indolent B-cell non-Hodgkin’s lymphoma (B-iNHL). Fields, M.D.,
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 clinical trials, as well as other recent developments in Tiziana Life Sciences.
12, 2020 14:00 UTC. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. Preclinical data show SLV213 is a potent inhibitor of SARS-CoV-2 infection.
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.–(
FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. 24, 2020– Alnylam Pharmaceuticals, Inc. The approval of Oxlumo is a further testament to the impact RNAi therapeutics can have in transforming the treatment of severe, life-threatening diseases like PH1. CAMBRIDGE, Mass.–(BUSINESS
As a non-opioid, SRP-001 also eliminates abuse potential, positioning it as a safer and effective drug candidate for the treatment of acute and neuropathic pain and migraine headache. He is spearheading the scientific and clinicaldevelopment and fundraising of South Rampart Pharma and technology development efforts.
The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. About VIR-7831 / GSK4182136.
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.
The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Sage Therapeutics, Inc.
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. INDIANAPOLIS , Oct.
Submitted CTA for INZ-701 for the treatment of ENPP1 deficiency to United Kingdom regulatory agency.
Received Rare Pediatric Disease and Fast Track Designations for INZ-701 for the treatment of ENPP1 deficiency.
12, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc.
BOSTON, Nov.
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.
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.
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
Results from the Phase III IMpassion131 study, evaluating Tecentriq in combination with paclitaxel for the treatment of people with metastatic TNBC and whose tumours expressed PD-L1, did not meet its primary endpoint of progression-free survival . Roche’s Chief Medical Officer and Head of Global Product Development. “We
04, 2020 (GLOBE NEWSWIRE) — LogicBio Therapeutics , Inc. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). LEXINGTON, Mass., Commenting on the announcement, Daniel Gruskin, M.D.,
Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel antibody drug into clinical trials for the treatment of HER3-driven cancer. Hummingbird Bioscience is an innovative clinical-stage biotech company focused on developing revolutionary therapies against hard-to-drug targets for improved treatment outcomes.
Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. Vivet Therapeutics is a clinical-stage emerging biotechnology company developing novel gene therapy treatments for rare, inherited metabolic diseases. Vivet’s lead program, VTX-801, is currently under clinicaldevelopment.
The EC’s decision is based on results from the Phase 2 CheckMate -142 trial in which Opdivo plus Yervoy demonstrated a clinically meaningful improvement in objective response rate (ORR) in patients with MSI-H/dMMR mCRC who received prior treatment with fluoropyridine, oxaliplatin and irinotecan. achieving a complete response.
30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease.
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