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The Countering Emerging Threats - Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) program within the JPM Medical is designed to rapidly tackle known, unknown, and emerging threats by utilizing late-stage or licensed therapeutics. Repurposing is one such method. CBRN MCMs).
This article was first published by Elinevan Overbeeke, Sissel Michelsen, Mondher Toumi, Hilde Stevens, Mark Trusheim, Isabelle Huys, and StevenSimoens in Drug Discovery Today under a Creative Commons License. Highlights….
CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.
Novartis Oncology continues to reimagine cancer care through development of robust radioligand therapy portfolio. We continue to invest in radioligand therapy as one of the four unique platforms of Novartis Oncology. Broad expression of FAP demonstrated in tumors or in tumor stroma across many solid tumors 1 ,2 ,3.
– Abrocitinib is a once-daily oral JAK1 inhibitor indicated in Great Britain for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and over, who are candidates for systemic therapy-. This is the first marketing authorization globally for abrocitinib-.
Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.
a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. is biotechnology company focused on developing radiopharmaceutical imaging and therapy agents.
Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab). Biosimilars have the potential to enable greater access to marketed biologic therapies while generating cost savings and healthcare sustainability.
a biotechnology company developing cell and gene therapy treatments for patients suffering from vascular disease, today announced that it raised up to $5.5M that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe. MIAMI, Jan. 25, 2021 (GLOBE NEWSWIRE) — Ambulero, Inc. ,
BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.
This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The high costs associated with bringing a new drug to market, estimated to be over $2.6
Corlieve’s lead program employs a novel AAV gene therapy approach for the treatment of refractory temporal lobe epilepsy (TLE), the most commonly diagnosed focal epilepsy in humans. Maryland , US), a leading gene therapy company. Maryland , US), a leading gene therapy company. PARIS , Nov.
Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.
today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA).
These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. recent announcements from Merck and Sanofi for obesity and broader metabolic disease). Join the club.
DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. About Dragonfly.
15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China. About Burning Rock.
Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”).
million and US$1.8
with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., Alternatively, are there potential existing assets that may be available for in-licensing, especially if the potential licensor has pivoted strategic directions (i.e., in liver, in CNS)? with antibodies), or correction (e.g., Consider Fig.
Bactiguard’s growth strategy for the coming five-year period up to 2025 is based on a continued roll-out of Bactiguard’s technology, with a focus on new license agreements and a broader product portfolio. We have several interesting licensing projects ongoing and see new, exciting business opportunities. unchanged).
1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). .
TOKYO and CAMBRIDGE, England , Dec. GPCR – G protein-coupled receptors.
Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. Bayer today announced that it has entered into an agreement to acquire Noria Therapeutics Inc. Noria) and PSMA Therapeutics Inc.
SK Biopharmaceuticals entered an exclusive licensing agreement with Arvelle to develop the treatment in Europe. In the double-blind placebo study, adult patients with drug-resistant focal onset seizures who were administered the drug as an adjunctive therapy have exceeded existing supportive care. .
Our presence at ERS this year reiterates our commitment to patients through the further development of first-in-class therapies like Enerzair Breezhaler, as well as by exploring the potential of digital health companions and the carbon footprint of our solutions,” said Dominic Brittain, Respiratory Global Program Head, Novartis Pharmaceuticals.
Crown Bioscience Director Mike Batey takes a closer look at pediatric cancer and how recent regulatory changes and additional research focus may deliver new therapies for kids. Unfortunately, children have limited access to novel therapies, and new drugs for adults are often only tested in children many years following approval.
This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. ii When appropriately applied, concurrent validation provides a powerful tool to address impractical limitations of bringing new drugs and biologics to market.
It’s important to recognize that for many large pharmaceutical and biotechnology companies, compounds that have the potential to treat a rare disease of significant unmet need might become lower strategic priority than those that have mass market potential.
The function of the adjuvant is to market the body’s immune reaction. a pioneering biotech company developing novel intranasal vaccines and therapies to assist patients defeat debilitating diseases, including COVID-19. Varadarajan is co-founder of AuraVax Therapeutics Inc., Varadarajan is co-founder of AuraVax Therapeutics Inc.,
2222514-07-8 ] Palopegteriparatide , sold under the brand name Yorvipath , is a hormone replacement therapy used for the treatment of hypoparathyroidism. [1] 5] Study drug and conventional therapy were subsequently adjusted according to the albumin-corrected serum calcium levels. [5] 48,000) consisting of 34 amino acid residues.
Whilst TGF-β is an attractive target for cancer therapy because of its critical role in promoting tumor aggressiveness, immune escape and resistance to therapy, activation of alternative resistance pathways has hindered drug development attempts in the past. Pancreatic cancer is a very difficult cancer to treat.
Novartis today announced the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies. The exact indication for Jakavi varies by country.
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A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies.
About BioInvent.
The Company’s validated, proprietary F.I.R.S.T
The product has received Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations from the FDA. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. To learn more about Y-mAbs Connect, visit ymabsconnect.com.
We look forward to successful commercialization and licensing of TLC’s programs across the globe under Mr. Bliss’s leadership, as well as to creating benefit and bringing value for all of TLC’s stakeholders.”. Earlier in his career, he ran business-development functions at Amgen and Baxter. About TLC.
BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.
Could you explain the development of CNP-108 for T cell immunogenicity in gene therapy, and how it induces the immune system to build a tolerance to gene therapy treatments? It was published by Pfizer and Sarepta that the T cell component is responsible for toxicity in humans within gene therapy trials.
Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. Cornering the untapped Chinese CNS market, SciNeuro launched with $100 million in their pocket. SciNeuro Pharmaceuticals .
“Because SLV213 inhibits a host protein to block viral entry, it has the potential to retain effectiveness against viral mutations to avoid resistance and could be a highly potent therapy against a number of viruses, either as a single oral agent or in combination with direct acting antivirals.”. About Selva Therapeutics.
Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S.
MultiStem ® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. 28, 2021 11:00 UTC. About MultiStem ®.
Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.
It continues from drug candidate screening and selection, prototype generation, preclinical validation, early clinical studies, to later clinical studies and post-market monitoring. 6 On a larger scale, advanced drug delivery systems are already offering more targeted, effective and convenient therapies. What is the API’s solubility?
The Pfizer-BioNTech COVID-19 Vaccine, developed with BioNTech SE (Nasdaq: BNTX) based on its proprietary mRNA technology, has been shipped to 91 countries and territories 1 around the world as part of an emergency use authorization or conditional marketing authorization. Procedures should be in place to avoid injury from fainting.
At Usona, Mr. Barrow was responsible for launching the Phase 2 clinical program for psilocybin in the treatment of Major Depressive Disorder and for obtaining Breakthrough Therapy Designation for the program at FDA.
MindMed Co-CEO J.R.
About MindMed.
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