Conversations in Drug Development Trends

MARCH 7, 2024

Understanding the nuances of each pathway is crucial for small to midsize companies aiming to navigate the complexities of global clinical development successfully. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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The Pharma Data

DECEMBER 14, 2020

The IND covers the development of Rabeximod in Covid-19 and other indications, such as rheumatoid arthritis, and is a prerequisite for a future validation of the company’s five recent patent applications in the US market. “Filing an IND with the FDA is an important step in the clinical development of Rabeximod.

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The Pharma Data

DECEMBER 14, 2020

This grant will support Alume’s clinical development of its novel nerve illumination technology in surgery. Program grants are awarded to companies with promising technologies that have a strong potential for commercialization, to help translate life-saving innovations to consumer markets and create jobs in biotechnology.

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The Pharma Data

SEPTEMBER 11, 2020

The Covid-19 command center is customized to meet immediate needs related to research on the novel coronavirus, but can also be used more broadly for other infectious disease clinical development efforts now and in the future.”. Source link.

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The Pharma Data

DECEMBER 29, 2020

Stock Connect allows international and China Mainland investors to trade securities in each other’s markets through the trading and clearing platforms of their home exchange. Any of these intentions may alter in light of future development. View original content to download multimedia: [link]. SOURCE Ascentage Pharma.

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The Pharma Data

OCTOBER 14, 2020

The FDA’s Office of Orphan Drug Products grants orphan status to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States. Vice President, Business Development Apexigen 650-931-6236 mnevins@apexigen.com. About APX005M.

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The Pharma Data

OCTOBER 27, 2020

Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com. Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. Source link.

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The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. Innovent has built an international team with expertise in cutting-edge biological drug development and commercialization. SOURCE Innovent Biologics, Inc.

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The Pharma Data

JANUARY 27, 2021

ET ) to discuss the results and next steps in clinical development of BI-1206. technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.

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The Pharma Data

OCTOBER 26, 2020

AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus ( S. AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa ( P. View original content to download multimedia: [link].

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The Pharma Data

JANUARY 18, 2021

“The strong support of our syndicate reflects strong conviction in Vera’s clinical development experience and the potential of our lead asset to target the source of immune complexes in patients with IgAN and change the standard of care,” said founder and CEO Marshall Fordyce , MD. SOURCE Vera Therapeutics.

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The Pharma Data

NOVEMBER 23, 2020

View original content to download multimedia: [link]. . SOURCE Synthetic Biologics, Inc. . Source link.

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The Pharma Data

JANUARY 14, 2021

Market Access & Preparations for Commercialization in the USA. Head of North America Commercial, Andrew Udell, & Vice President Market Access, Christopher Ngai. Clinical Development – Pipeline Review. End.

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Codon

MARCH 24, 2024

Novo Nordisk’s market capitalization ($442B) is already larger than the GDP of Denmark ( $404B ), the country where the company is headquartered. The market for semaglutide-based products is projected to swell to $71B in less than a decade. market with Wegovy will, by 2030, require about one million liters of production capacity.

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The Pharma Data

OCTOBER 19, 2020

Caris Precision Oncology Alliance members also have access to the Caris Pharmatech oncology trial network, which can help reduce the time it takes to identify and connect appropriate patients with novel targeted cancer therapies in clinical development. Europe , Asia and other international markets. SOURCE Caris Life Sciences.

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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. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below.

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The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare. View original content to download multimedia: [link]. Media Contact: mindmed@150bond.com.

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Nvidia Developer: Drug Discovery

MARCH 21, 2023

Creating new drug candidates is a heroic endeavor, often taking over 10 years to bring a drug to market. Creating new drug candidates is a heroic endeavor, often taking over 10 years to bring a drug to market. Download proteins, molecules, and predicted 3D structures. New supercomputing-scale large language models (LLMs).

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Agency IQ

AUGUST 23, 2024

applications) on biopharmaceutical products to regulators for review and marketing authorization throughout the region via three routes. First, sponsors can opt to pursue marketing authorization in an EU member state by submitting their dossier to that state’s health authority (i.e., the “national competent authority,” or NCA).

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The Pharma Data

SEPTEMBER 16, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

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The Pharma Data

DECEMBER 15, 2020

Contribution of these robust data sets from industry led trials is critical to TOMI-T1D’s work in developing innovative and quantitative tools that can facilitate clinical development efforts and be endorsed by regulators for future use by the pharmaceutical industry to optimize the design of future clinical trials.

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The Pharma Data

JANUARY 17, 2021

“This result provides a foundation for a clinical development program using higher doses of setanaxib across a variety of orphan indications. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Significant improvement in fatigue was also achieved. About Genkyotex.

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The Pharma Data

SEPTEMBER 20, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

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Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

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The Pharma Data

JANUARY 4, 2021

Therapies granted ODDs by the FDA are qualified for various development incentives, including a tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, possible research grant awarded by the FDA, and most importantly, 7 years of US market exclusivity upon approval.

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The Pharma Data

OCTOBER 14, 2020

FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomized, controlled trials (HARMONY CTP and HARMONY 1) from the clinical development program for WAKIX. View original content to download multimedia: [link]. Harmony Biosciences Media Contact: Nancy Leone.

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The Pharma Data

OCTOBER 29, 2020

30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. vice president of immunology development at Lilly.

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The Pharma Data

JANUARY 25, 2021

million for the achievement of certain regulatory milestones including market approvals in Mainland China and Taiwan. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has cleared Armata’s IND to initiate a clinical trial of its lead therapeutic candidate, AP-PA02, in Pseudomonas aeruginosa infections. . View original content to download multimedia: [link]. . . .

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The Pharma Data

JANUARY 26, 2021

. “Multi-drug resistant bacterial infections are a serious and growing public health threat, and with two strong therapeutic candidates and a robust team to drive clinical development, we believe we are well positioned to be a leader in the innovative field of phage therapy,” said Todd R. .

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The Pharma Data

NOVEMBER 5, 2020

By a separate press release, the Company has today announced its intention to distribute the BUPI project to the shareholders of Moberg Pharma through a Lex Asea distribution with a subsequent listing on Nasdaq First North Growth Market during the Q1 of 2021. Other expenses for the Company’s operations.

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The Pharma Data

NOVEMBER 4, 2020

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”). View original content to download multimedia: [link]. .

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The Pharma Data

NOVEMBER 4, 2020

Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. License and research and development revenue. Research and development. .

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The Pharma Data

OCTOBER 26, 2020

Following the unauthorized download of all abstracts on the SITC website, Transgene is communicating the content of the late-breaking poster abstract that will be presented at the SITC 35th Anniversary Annual Meeting (SITC 2020), to be held virtually November 9-14, 2020.

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The Pharma Data

DECEMBER 2, 2020

The new plant will as a first priority produce recombinant GAD65, the active pharmaceutical ingredient in the therapeutic diabetes vaccine Diamyd ® currently in late-stage clinical development. Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. SOURCE Diamyd Medical AB.

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