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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.
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.
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.
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 Phenomix Sciences, built on over a decade of clinical research at the Mayo Clinic, is disrupting this outdated approach.
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 clinicaltrials? Despite their potential, ADSC therapy faces several challenges in preclinical studies.
United Kingdom Medicines and Healthcare Products Regulatory Agency authorized ClinicalTrial Application.
With these important regulatory clearances for our first-in-human clinicaltrial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.
Sanofi and Translate Bio initiate Phase 1 clinicaltrial of mRNA influenza vaccine. Th e first clinicaltrial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. JUNE 22 , 2021.
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.
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.
Clinicaltrial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.
a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinicaltrials. LOS ANGELES , Jan.
(NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Company’s U.S.
About CNS Pharmaceuticals, Inc.
Phase III BRIDGE open-label, switch-over clinicaltrial met key objectives for safety and efficacy.
galactosidase-A product candidate under development for the treatment of Fabry disease. Twenty of twenty-two patients completed the 12-month treatment duration.
CARMIEL, Israel and BOSTON , Dec.
The 2022 winner, with the most overall votes across the ten finalist molecules , is BMS’ oral, deuterated allosteric TYK2 inhibitor, deucravacitinib, the first new treatment for plaque psoriasis in nearly a decade. MRTX1133 is currently in Ph I/II trials as an oral agent. #3: For more coverage, visit December 2022’s MOTM.
14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass.,
2] Medical uses Suzetrigine is indicated for the treatment of moderate to severe acute pain in adults. [1] The FDA has long supported development of non-opioid pain treatment. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo. Suzetrigine is taken by mouth. [1]
The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites. About GDA-201.
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.
Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.
.
NEW YORK , Jan.
MindMed Co-CEO J.R.
MindMed trades on the Canadian exchange NEO under the symbol MMED.
Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinicaltrials.
Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.
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.
Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company’s lead product candidate, PBGM01, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of infantile GM1 gangliosidosis (GM1). president and chief executive officer of Passage Bio. “Our
Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.
There was a handful of positive clinicaltrial news reported today. The Janssen Pharmaceutical Companies of Johnson & Johnson announced two Phase III trials, DISCOVER-1 and 2 demonstrated Tremfya (guselkumab) improved fatigue in adults with active psoriatic arthritis (PsA). Here’s a look. Janssen’s Tremfya.
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.
The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., If approved, Actemra/RoActemra would be the first U.S. today announced that the U.S.
Rapid and substantialimprovement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment.
points at Week 6 (primary timepoint), with AXS-05 treatment. points at Week 6 (primary timepoint), with AXS-05 treatment.
NEW YORK, Dec.
Reaching the end goal of delivering transformational new treatment options for patients can take a decade or more even when companies execute successfully and are well capitalized. Fortunately, AbbVie felt the same way, which is why we initiated discussions to in-license AbbVie’s most promising CF pipeline programs.
(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the long-term, open-label Phase 3 MOVEMENT trial of AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine in the acute treatment of migraine.
– 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.
However, this method isn’t universally applicable, as some matrices may not be compatible with charcoal treatment due to their specific composition or the nature of the analytes involved. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinicaltrials.
In addition, Dragonfly has an ongoing Phase 1/2 clinicaltrial for patients with advanced solid tumors, which began in July 2020. DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. Dragonfly received U.S.
26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About Cantargia.
This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] Treatment of phenol 143 with bromo epoxide 144 in the present of K2CO3 afforded ether 145 in 76% yield. 9] It is used as landiolol hydrochloride. IV -Blocker max.
The steady and rapid progress of this program is a testament to our strong collaboration with AstraZeneca, and we are hopeful that together we will bring a novel treatment option to this patient population with high unmet medical need.”. Additional details on the INTERLINK-1 clinicaltrial can be found here.
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.
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.
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. GvHD occurs when donor cells see the recipient’s healthy cells as foreign and attack them.
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). 9 Both the Pagoda and Pavilion trials are actively recruiting participants.
Eplontersen , sold under the brand name Wainua , is a medication used for the treatment of transthyretin-mediated amyloidosis. [1] 6] [7] [8] Medical uses Eplontersen is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. [1] twitter +919321316780 call whatsaapp EMAIL.
We are excited to partner with Relay Therapeutics, and we believe that the combination of KRAS G12C and SHP2 inhibitors together represents a promising approach that we hope could become a new treatment option for patients with KRAS G12C mutant tumors.”. To learn more about the first-in-human clinicaltrial of RLY-1971, please visit here.
Researchers at University College London conducted the two year clinicaltrial which showed that the progression of the disease could be halted for over two years. Researchers want to investigate this drug further and are hoping to collaborate with AstraZeneca on a larger clinicaltrial.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinicaltrials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.
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