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The licensing deal with China’s Chimagen Biosciences is the latest example of drugmaker interest in exploring the potential of “T cell engagers” in autoimmune disease.
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
The gene editing company will focus on “in vivo” medicines, while seeking to license out or find a development partner for its clinical-stage treatment reni-cel.
The drug tecovirimat is currently in use for the treatment of mpox -- the disease caused by monkeypox virus -- that spread worldwide in 2022. Tecovirimat is an anti-poxviral drug, and its use is driving the emergence of drug-resistant variants of the monkeypox virus.
Neuropsychiatric treatment is on the verge of a major transformation. Historically, treatment options have been limited, with patients relying on daily medications that have minimal efficacy and troublesome side effects. “Zelquistinel is a positive modulator of NMDA receptors,” Donello explains.
As the CEO of iOnctura, an innovative oncology biopharmaceutical company she co-founded in 2017, Catherine has played a key role in advancing the development of highly targeted small molecules aimed at revolutionising cancer treatment. This is exciting because often resistance builds up to these other treatments.
"The Secret to Unlocking the Pharmaceutical Industry's Hidden Goldmine As a seasoned pharma professional, I've seen it time and time again: a promising new treatment, stifled by patent restrictions and licensing agreements that seem to favor the big players. But what if I told you that there's a way to level the playing field?
A treatmentlicensed from the NIH and in clinical testing for lupus is the startup’s lead program, while its founding “Treg” cell therapy research matures, according to CEO Peter Maag.
2] The label also has a warning about liver toxicity and the need to monitor liver blood tests at baseline and then monthly for at least six months after initiating treatment with fitusiran or after a dose increase of fitusiran. [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1] 26 March 2025.
s (Bridge) opioid addiction development therapeutic product, BT-219, and executed an Exclusive Licensing Agreement to use Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology. Bridge currently intends to seek approval from the U.S.
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.
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. ,
Drug development faces significant challenges: long timelines, high costs , complex processes and low probabilities of success (PoS), exacerbated by the shift towards more complex molecules, biologics and cell and gene therapies, hindering patient access to vital treatments. Highly accurate protein structure prediction for the human proteome.
Fosun Pharma is granted an exclusive license to develop, manufacture, and commercialize TEV-56278 in Chinese mainland, Hong Kong Special Administrative Region (SAR), Macau SAR, Taiwan, and select Southeast Asian countries. This collaborative framework specifies the respective responsibilities for each party.
Obesity treatment is undergoing a major shift, much like the advances seen in cancer care. Phenomix Sciences , led by CEO Mark Bagnall, is using precision medicine to make treatments more targeted and effective. Phenomix Sciences, built on over a decade of clinical research at the Mayo Clinic, is disrupting this outdated approach.
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.
Tofersen , sold under the brand name Qalsody , is a medication used for the treatment of amyotrophic lateral sclerosis (ALS). [3] Jump up to: a b c d e f g h i j k l “FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene” (Press release). 25 April 2023. Retrieved 10 June 2023.
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. LOS ANGELES , Jan. 7, 2021 /PRNewswire/ — ImaginAb Inc. ,
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. In June 2023, the U.S.
4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4]
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.
The data, which encompass up to 3 years of follow-up after a single infusion of the treatment, were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held from June 13–16 in Glasgow, United Kingdom. President and Chief Executive Officer of Intellia Therapeutics.
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.
AL01811 is a preclinical selective GBA2 inhibitor with first-in-class potential as an oral disease modifying treatment for Parkinson’s Disease Alectos to receive a $15 million upfront payment and is eligible to receive potential future development and commercial milestone payments. Biogen Inc. Source link: [link].
Randomization was stratified based on whether the ESR1 mutation was detected or not, prior treatment with fulvestrant, and presence of visceral metastasis. [2] Randomization was stratified based on whether the ESR1 mutation was detected or not, prior treatment with fulvestrant, and presence of visceral metastasis. [2] 8 February 2023.
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.
This outcome suggests sibeprenlimab’s potential to not only delay disease advancement but also improve long-term renal outcomes, addressing a critical unmet need for patients with IgAN, many of whom currently face limited treatment options. Treatment-emergent adverse events (TEAEs) occurred in 76.3% in the placebo group.
Department of Health and Human Services’ (HHS) decision to effectively remove the “X-waiver” requirement for physicians, expanding their ability to utilize medication-assisted treatment (MAT) for patients struggling with opioid use disorder (OUD). Added Dr. Rosenberg, “This is a great day for our patients.
Its sodium salt is used for the treatment of generalised myasthenia gravis (a disease that leads to muscle weakness and tiredness) in adults whose immune system produces antibodies against acetylcholine receptors. . 6] [9] [10] It is a complement inhibitor that is injected subcutaneously (under the skin). [6] April 2018). 90 (15 Supplement).
From mergers and acquisitions to licensing agreements and pricing discussions, these complex interactions demand a unique blend of scientific knowledge, business acumen, and interpersonal skills. The stakes are higher than ever, with billions of dollars and potentially life-saving treatments on the line.
Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA Koblitz & Jeffrey N. FDA once estimated that OTC hearing aids would save patients over $3000.)
The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. About GDA-201.
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 are the current challenges and limitations surrounding stem cell therapy in preclinical studies, and how are these issues addressed to ensure the safety and efficacy of potential treatments before advancing to clinical trials? Despite their potential, ADSC therapy faces several challenges in preclinical studies.
Consider using a variety of claim types, including: Compound claims Method of treatment claims Formulation claims Dosage regimen claims Each type of claim offers different protections and can be valuable in different scenarios. Be prepared to enforce your patents through licensing agreements or litigation if necessary.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine.
FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.
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 DF6002. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies.
Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. iii Current treatment options have limited efficacy in terms of weight loss or are often associated with adverse events. “We
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.
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