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Pfizer and Touchlight agree to patent license for Pfizer to utilise rapid, scalable, enzymatic doggybone DNA (dbDNA) in Pfizer’s clinical and commercial manufacture of its mRNA vaccines, therapeutics, and gene therapiesAgreement includes upfront payment, potential development and commercial milestone payments, and royalties upon commercializationAccess (..)
.– December 10, 2019 — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced that it has completed clinical production of Bridge Therapeutics Inc.’s
Additionally, for illustrative reasons this is geared towards a single target / product focus vs. broader platform diligence, though many of these mental models will apply for selecting targets and indications for a platform. with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., in liver, in CNS)?
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
What key findings about stem cell behaviour, differentiation and integration within host tissues impact the development of stem cell therapies? Despite their potential, ADSC therapy faces several challenges in preclinical studies. Is there a certain disease or condition that you believe stem cell therapy holds the most promise for?
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).
Novartis today announced a license option agreement with Voyager Therapeutics, a gene therapy company focused on next-generation adeno-associated virus (AAV) technologies, for three capsids to use in potential gene therapies for neurological diseases, with options to access capsids for two other targets.
This article incorporates text from this source, which is in the public domain. ^ “Qfitlia approved as the first therapy in the US to treat hemophilia A or B with or without inhibitors” Sanofi (Press release). Food and Drug Administration. 28 March 2025. Retrieved 29 March 2025. 28 March 2025. Retrieved 29 March 2025.
13, 2021 /PRNewswire/ — EVOQ Therapeutics today announced a license and collaboration agreement with Amgen for the discovery and development of novel drugs for autoimmune disorders. EVOQ Therapeutics today announced a license and collaboration agreement with Amgen. ANN ARBOR, Mich. ,
NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. About Teva.
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.
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. Biogen 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.
Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the U.S. About Omidubicel.
Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target.
05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. .
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).
(Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system (CNS) disorders, today announced that U.S. GM1 is a rare and often life-threatening CNS disorder with no approved disease-modifying therapies available. About PBGM01.
. (“Dragonfly”), today announced that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted the global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002. About Bristol Myers Squibb.
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
About Juyou Bio – Technology Co.
Juyou Bio-Technology Co.,
. (“Biolojic”), a biotechnology company that computationally designs functional antibodies, today announced a research collaboration and license agreement that will leverage Biolojic’s AI-based multibody platform to discover and develop a potential novel antibody-based therapy for the treatment of diabetes.
This approach not only boosts our clients’ ability to achieve high accuracy and meet regulatory requirements but also supports the seamless transition of innovative therapies from the lab to the clinic with confidence. Purity and radioactive enrichment are key factors in ensuring the IS aligns with product specifications.
With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. The drug product is packaged and shipped as a solid powder. Is this a drug product or drug-device combination product?
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.
The application received Breakthrough Therapy , Fast Track and Priority Review designations by the FDA. Upon completion, the mixture was quenched by addition of aqueous sodium bicarbonate solution and the aqueous layer extracted with DCM, dried (MgSO) and concentrated in vacuo to give the desired product in a 5:1 mixture of diastereomers.
Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow. What Does the Future of Gene Editing Hold?
With our oncology strategy, we are dedicated to accelerating the research and development of novel cancer therapies that have the potential to make a meaningful difference in the lives of patients.” “We look forward to progressing Cedilla’s programs and continuing to focus on assets that allow better patient selection.
– Second Product Candidate Expected to Enter Clinic in First Half of 2021. Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. PHILADELPHIA, Jan.
These structures are particularly relevant in dealing with uncertainty about the future commercial potential of the target's products. 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.
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. Vlad Coric , M.D., About Sosei Heptares.
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.
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.
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).
– 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-. Abrocitinib is licensed in Great Britain in recommended doses of 100mg and 200mg. Source link: [link].
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Relay Therapeutics will receive $75 million upfront and is eligible to receive an additional $25 million in near-term payments and $695 million in additional potential milestones, plus royalties on global net product sales.
Relay Therapeutics to host conference call at 8:00 a.m.
CAMBRIDGE, Mass.,
Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. . This includes therapies against the nuclear receptor ROR?t,
Targeting 4-1BB remained of interest to the immuno-oncology field as cell culture experiments and tumor models in mice suggested that robust anti-tumor immune responses could be triggered by anti-4-1BB antibody therapies. Immunologically, what immune responses are you really activating in patients receiving the BiAb therapies?
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.
Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. Lisa Placanica, Senior Managing Director Center for Technology Licensing at Weill Cornell Medicine. Noria) and PSMA Therapeutics Inc.
It ensures that a production process consistently yields products of predetermined quality and safety. In the case of urgent or immediate public interest, process validation may be conducted concurrently with manufacturing the commercial small molecule or biologic product to expedite product availability for patients.
Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. Kate Krav-Rude/Shutterstock.
E&C lawmakers grill directors of FDA medical product centers Wednesday’s House E&C Health Subcommittee Hearing featured an extensive grilling of the leaders of FDA’s three medical products centers: CDER, CBER and CDRH. House of Representatives’ Energy and Commerce (E&C) Committee on Thursday, May 22.
Foundational cell therapy platform builds upon seminal work from co-founders, leveraging a T Cell Receptor (TCR) discovery engine and suite of synthetic biology components intending to develop potentially best-in-class therapies targeting oncogenic driver mutations like KRAS and p53. Aude Chapuis, M.D., and Tom Schmitt, Ph.D.,
is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. About Jounce Therapeutics
Jounce Therapeutics, Inc.
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