Drug Discovery World

SEPTEMBER 16, 2022

A biologic therapy for very young children with moderate to severe eczema (or atopic dermatitis) has been shown to be safe and effective in an international trial. The therapy is already licensed in the UK for adults and children aged six to 18, and was approved by the FDA in June 2022 for use in younger children.

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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Drug Discovery World

SEPTEMBER 27, 2023

Seven years of trial data DLd is licensed and has been available for use in Europe since 2019. The positive Final Draft Guidance (FDG) follows a positive acceptance from the Scottish Medicines Consortium (SMC) for routine use in NHS Scotland this month.

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Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. The city is host to many innovative biotech companies, including relative newcomers Orexa, a company that recently launched its first Phase II clinical trial.

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Drug Discovery World

FEBRUARY 9, 2023

1 This authorisation by the MHRA has been issued under Project Orbis, an international programme coordinated by the US Food and Drug Administration (FDA), which provides a framework for the concurrent submission and review of oncology medicines among international partners. 4 Updated median OS was 12.9 months compared to 11.3

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The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov. chief executive officer of Gamida Cell.

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Drug Discovery World

FEBRUARY 28, 2024

Using IgE to treat cancer In the UK, a Cancer Research UK-funded clinical trial has shown, for the first time, that a new class of antibody could benefit cancer patients whose existing treatments have stopped working. “Cancer shredding could hold potential not only for glioblastoma, but possibly for other hypermutated tumours.”

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New Drug Approvals

SEPTEMBER 8, 2024

5] History The effectiveness of palopegteriparatide was evaluated in a 26-week, randomized, double-blind, placebo-controlled trial that enrolled 82 adults with hypoparathyroidism. [5] 8] Brand names Palopegteriparatide is the international nonproprietary name. [9] 48,000) consisting of 34 amino acid residues. 14 August 2024.

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Drug Discovery World

JULY 2, 2024

An internal study performed recently, highlighted how Basel is outstanding in scientific collaboration with industry, measured via joint publications and at the same time how the local industry excels globally in the number of patents filed.” Biopôle Lausanne has been created to provide a focus for life sciences activity in the region.

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The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. TOKYO and CAMBRIDGE, England , Dec.

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Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. Significantly, in January 2023, the FDA finalised a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds without running afoul of federal law 2.

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Drug Discovery World

JANUARY 31, 2023

But first, there is the urgency of getting the new drug application (NDA) or biologics license application (BLA) filing into the hands of the respective regulatory authorities. Over the last decade, many pharmaceutical companies have undertaken internal ‘harmonisation’ projects.

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New Drug Approvals

SEPTEMBER 6, 2024

2 History Efficacy was evaluated in MARIPOSA (NCT04487080), a randomized, active-controlled, multicenter trial of 1074 participants with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic non-small cell lung cancer and no prior systemic therapy for advanced disease. [2] 20 August 2024.

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The Pharma Data

DECEMBER 13, 2020

To access the live call, please dial 1 (833) 540-1168 (domestic) or 1 (929) 517-0359 (international) and refer to conference ID 8792127. RLY-1971 is currently being evaluated in a first-in-human trial designed to treat patients with advanced or metastatic solid tumors. ET to discuss the collaboration. About Relay Therapeutics.

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The Pharma Data

AUGUST 17, 2020

In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses.

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The Pharma Data

NOVEMBER 5, 2020

There was a handful of positive clinical trial 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. Pfizer’s Xeljanz.

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The Pharma Data

OCTOBER 19, 2020

manufacturer, Pharmaceutics International, Inc. (“Pii”), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable.

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Clinical Trials Trials Pharmaceuticals Treatment 52

The Pharma Data

APRIL 29, 2022

SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III clinical data.

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The Pharma Data

DECEMBER 14, 2020

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 Kratz et al.,

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Drug Discovery World

APRIL 20, 2023

Regulators are therefore used to seeing cognitive data as primary or secondary outcomes in clinical trials, and are familiar with the instruments and methodological nuances of such data. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact,” EClinicalMedicine, vol. S Bliddal et al., 2021.101019.

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Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care).

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New Drug Approvals

DECEMBER 24, 2023

1] Society and culture Names Eplontersen is the international nonproprietary name. [9] 1] Society and culture Names Eplontersen is the international nonproprietary name. [9] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85” WHO Drug Information. 22 December 2023.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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The Pharma Data

NOVEMBER 25, 2020

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. BioInvent International AB (publ).

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The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — The members of the Nomination Committee for BioInvent International AB :s (publ) (“BioInvent) Annual General Meeting in 2021 have now been appointed. Proposals to the Nomination Committee can be sent to Stefan Ericsson , by mail: BioInvent International AB (publ).), BioInvent International AB (publ).

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The Pharma Data

DECEMBER 1, 2020

(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the open-label Phase 2 COMET-TRD trial of AXS-05 in patients with treatment resistant depression (TRD). AXS-05 was well tolerated in the COMET trial.

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New Drug Approvals

SEPTEMBER 10, 2024

5] Society and culture Names Deuruxolitinib is the international nonproprietary name [6] and the United States Adopted Name. [7] “Phase 2 randomized, dose-ranging trial of CTP-543, a selective Janus Kinase inhibitor, in moderate-to-severe alopecia areata” Journal of the American Academy of Dermatology. J Am Acad Dermatol.

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LifeSciVC

JULY 6, 2023

After years of steady progress and tens of millions of dollars invested, Sanofi Genzyme corporate strategy shifted, and eventually a strategic decision was made to suspend the program, focus resources on immunology/immuno-oncology, and out license these assets. I hope that others in our industry maintain a similar focus on innovation.

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Drug Discovery World

JULY 16, 2024

Here, regulatory affairs teams are able to pre-empt agency queries in their initial submissions and/or when trying to provide consistent replies to questions globally – thereby increasing their chances of new products or clinical trials, or changes thereto, being accepted quickly, and first time.

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The Pharma Data

JANUARY 19, 2021

BioInvent’s management team will also give an update on the ongoing Phase I/IIa trial of BI-1206 in combination with rituximab and BioInvent’s partner CASI Pharmaceuticals (NASDAQ: CASI) will provide an update on the development plan and potential for BI-1206 in China. BioInvent International AB (publ) Co.

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New Drug Approvals

SEPTEMBER 20, 2023

1] [2] Society and culture Names Motixafortide is the international nonproprietary name. [4] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82” WHO Drug Information. 1] Motixafortide is a hematopoietic stem cell mobilizer and a CXCR4 antagonist. [1] an autologous transplant).

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Drug Discovery World

OCTOBER 16, 2023

Dr Tralau-Stewart says: “Indeed, many academic institutions have established new ways of supporting the discovery pipeline, providing tech transfer offices to support licensing, and entrepreneurship and start-up support through fundraising, accelerators, and incubators.

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The Pharma Data

NOVEMBER 22, 2020

Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. Blum, Cytokinetics’ President and Chief Executive Officer.

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Clinical Trials Licensing Licensing Trials 52

The Pharma Data

NOVEMBER 23, 2020

“In the last months, Ultimovacs has strengthened its corporate and clinical development position having launched multiple mid-stage clinical trials and established a solid financial runway. Mr. Berkien is currently a board member of the Nordic Pharma Licensing Group.

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Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

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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LifeSciVC

JANUARY 16, 2024

The expectation that Pharma will continue buy-ups here is helping to fuel conviction for another strong year ahead for M&A, especially for those acquirers who will rely on inorganic acquisition to build in areas under-represented by internal R&D (e.g., Additional trials (e.g., Join the club.

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New Drug Approvals

OCTOBER 24, 2023

This approval was based on favorable results obtained from Pfizer’s Elevate UC Phase III registrational program, consisting of the Elevate UC 52 and Elevate UC 12 clinical trials, that investigates the efficacy of a 2-mg daily dose regimen of etrasimod, with a 32% and 26% remission rate observed in UC 52 and UC 12 trials respectively.

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