SugarCone Biotech

JUNE 10, 2024

[link] Immunity is complex and can be dangerous when exploited clinically, as demonstrated by the lethal administration of TNF, or anti-CD40L antibody (Biogen) or CAR-T cells expressing the CD16 Fc-receptor (Unum), among many other examples. This observation may be important given the critical role of DC in tumor antigen presentation.

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The Pharma Data

MARCH 8, 2021

These preliminary findings were presented today during Science Spotlights TM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting. About Molnupiravir.

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The Pharma Data

JULY 12, 2021

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 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.

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PPD

MAY 7, 2024

However, it also presents challenges and uncertainties, particularly in relation to the Population, Intervention, Comparator(s) and Outcomes (PICO) framework underpinning the new Joint Clinical Assessments (JCAs). Despite these challenges, the new EU HTA regulation presents significant opportunities.

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The Pharma Data

NOVEMBER 23, 2020

(NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, today announced that on November 23, 2020 , the NYSE American LLC (“NYSE American”), the Company’s current listing exchange, notified (..)

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The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . NEW YORK, NY, Dec.

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The Pharma Data

JANUARY 19, 2021

The event will feature a presentation by renowned lymphoma expert Mats Jerkeman, MD, Lund University, who will discuss the current treatment landscape, and unmet medical need for patients with relapsed or refractory Non-Hodgkin’s Lymphoma for whom current treatment options are very limited. LUND, Sweden , Jan. Eastern Time ( 5:30 p.m.

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The Pharma Data

NOVEMBER 11, 2020

These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As Viruses work by infecting host cells and hijacking the cell’s replication machinery.

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The Pharma Data

OCTOBER 14, 2020

Live Webcast : accessible from the Company’s website at www.eloxxpharma.com under Events and Presentations or with this link: [link]. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis. International Dial-in Number: (210) 874-7715. Conference ID : 9467336. About Eloxx Pharmaceuticals.

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The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Presentation at J.P. Pipeline Updates.

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The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. Sosei Heptares will now conduct a full internal review to determine a strategy for the further development and re-partnering of the program. ” About the License Agreement. TOKYO and CAMBRIDGE, England , Jan.

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The Pharma Data

SEPTEMBER 16, 2020

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. Amgen will present new data for AMG 510 (proposed INN: sotorasib) and AMG 160 during two oral presentations.

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The Pharma Data

JULY 22, 2021

“Building on Pfizer’s established leadership position in breast cancer science and CDK 4/6 inhibition, we are excited to work with Arvinas to maximize ARV-471, the first PROTAC for breast cancer with encouraging early clinical data and a potential novel hormonal therapy backbone for HR+ breast cancer,” said Jeff Settleman, Ph.D.,

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The Pharma Data

NOVEMBER 3, 2020

Senior Vice President, Head of Clinical Development of LogicBio, said, “We are pleased the FDA has granted Fast Track designation to LB-001 in recognition of the importance of our efforts to bring a durable treatment to the children suffering from MMA. Commenting on the announcement, Daniel Gruskin, M.D., About LogicBio Therapeutics.

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The Pharma Data

JANUARY 31, 2021

Gilead will be responsible for conducting a Phase 1 study for the HIV-specific therapeutic vaccine and holds an exclusive option under the collaboration to obtain an exclusive license to develop and commercialize the HIV-specific therapeutic vaccine beyond Phase 1. This press release features multimedia.

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The Pharma Data

DECEMBER 23, 2020

Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX’s vaccine candidate, UB-612. Under the signed license agreement, Aurobindo Pharma has obtained the exclusive rights to commercialize in India and to UNICEF and non-exclusive rights in other select emerging and developing markets.

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The Pharma Data

JANUARY 27, 2021

The Company is in late-stage clinical development and has been working toward establishing commercial readiness. The meeting will consist of presentations from the Company’s management team, with additional commentary from board members and collaborators, and will include a question and answer session for analysts and attendees.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

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Clinical Trials Trials Treatment Pharmaceuticals 52

Drug Target Review

JUNE 3, 2024

By encapsulating specific self-antigens within our biodegradable nanoparticles, we enable the targeted delivery of the CNPs to antigen-presenting cells (APCs) primarily in the spleen and liver. This allows us to compress preclinical development and go directly into proof-of-concept Phase 2 studies.

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The Pharma Data

JANUARY 18, 2021

In-licensed from Merck KGaA, Darmstadt, Germany , atacicept has been studied previously in autoimmune diseases and shown to reduce autoantibodies in a dose-dependent fashion with once-weekly subcutaneous dosing and has a well-established and acceptable clinical safety profile.

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The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6].

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The Pharma Data

DECEMBER 23, 2020

Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX’s vaccine candidate, UB-612. “During this global health crisis response, we must establish partners with the strongest capabilities, like Aurobindo, to prioritize the development and the delivery of our vaccine.

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The Pharma Data

JUNE 7, 2022

” AD, or atopic eczema, is a chronic, relapsing, heterogenous skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.1-2 With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Almirall S.A.’s ’s Chief Scientific Officer.

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The Pharma Data

JANUARY 7, 2021

The positive interim, non-invasive testing data presented, along with the improved metabolic profile, suggest that icosabutate is having a positive impact on both general metabolic health as well as liver health in a short period of time. (NST) A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH.

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The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Pneumococcal Disease.

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The Pharma Data

SEPTEMBER 20, 2020

20, 2020 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM). THOUSAND OAKS, Calif.

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Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.

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LifeSciVC

SEPTEMBER 15, 2022

During our planning cycle, each function presents its strategy to the leadership team where we collectively review, discuss and challenge ideas. Given the complex nature of global clinical development, the strong foothold of our strategic plans positioned our team to overcome these obstacles. What’s next?

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The Pharma Data

NOVEMBER 5, 2020

Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies.

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The Pharma Data

NOVEMBER 4, 2020

New CTP-543 Data Presented in Late-Breaking News Session at EADV 2020. Initial data from an ongoing long-term, open label extension study with CTP-543 were presented in the late-breaking news session at the European Academy of Dermatology and Venereology (EADV) Virtual Congress on October 29, 2020. 2019.

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Molecule Blog

MARCH 17, 2023

The process of transforming a therapeutic or technology from the research and development stage into a market-ready product or service is intricate and laden with obstacles. The university then licenses the IP to an existing pharmaceutical company or a biotech startup, which takes on Investigational New Drug (IND) enabling studies.

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The Pharma Data

DECEMBER 15, 2020

Motixafortide has now demonstrated clinical utility in two therapeutic areas through multiple mechanisms of action, supporting our belief that it can serve as the backbone of a number of promising combination therapies to treat a broad range of cancer types,” Mr. Serlin concluded. Interested parties can register for the webinar here.

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The Pharma Data

AUGUST 5, 2021

Presenting the company’s half-year financial report, he highlighted how “we have achieved major successes in developing and launching drugs, some of which have blockbuster potential. The platform already has potentially ground-breaking medical innovations in clinical development, such as a therapy for the treatment of Parkinson’s.

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Production Pharmaceuticals Science Therapies 52

The Pharma Data

OCTOBER 14, 2020

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Relative to vaccinia, horsepox has substantially decreased virulence in mice 1. 1 Noyce RS, et al. 2018) PLoS One.

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The Pharma Data

DECEMBER 5, 2020

The results were shared in an oral presentation at the virtual 2020 American Society of Hematology (ASH) Annual Meeting. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

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The Pharma Data

OCTOBER 28, 2020

Further detail from the first five patients will be presented at the Foundation for Angelman Syndrome Therapeutics (FAST) Global Summit in December 2020. GeneTx licensed the rights to antisense technology intellectual property from the Texas A&M University System in December 2017. About Angelman Syndrome. About Ultragenyx.

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Protein Expression Therapies Treatment Disease 40

The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. The FcRn extends the half-life and hence the availability of pathogenic immunoglobulin G (IgG) antibodies.

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