Pharmaceutical Technology

NOVEMBER 28, 2022

C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. The deal has been signed to develop the C4X NRF2 Activator programme for these ailments. This includes an upfront payment of $2m from AstraZeneca.

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Pharmaceutical Technology

DECEMBER 5, 2022

Women’s healthcare company TherapeuticsMD has sign ed agreements for licensing its products to the Mayne Pharma affiliate in the US. Additionally, TherapeuticsMD will grant Mayne the exclusive license to market Annovera in the US. TherapeuticsMD will also get a 20-year royalty stream linked to Mayne’s net product sales.

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Drug Patent Watch

DECEMBER 12, 2024

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.

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Pharmaceutical Technology

AUGUST 1, 2022

GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. They intend to develop vaccines that provide lasting immune responses compared to existing vaccines.

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Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. Natural history data becomes critical for product development when there is no concurrent control.

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Pharmaceutical Technology

APRIL 3, 2023

Ablaze Pharmaceuticals is set to develop a new GPC3-targeted peptide drug candidate for the treatment of liver cancer in China. The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio. The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China.

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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. of hyponatremia, or low blood sodium levels.

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Pharmaceutical Technology

FEBRUARY 9, 2023

ReviR Therapeutics has signed a research collaboration and option-to-license agreement with Asieris Pharmaceuticals to discover new oncology therapeutics. Its initial focus is to develop therapeutics in oncology, CNS, and genetically defined disease indications.

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Pharmaceutical Technology

JANUARY 2, 2023

South Korean biotechnology company Alteogen has signed an exclusive license agreement with Swiss company Sandoz to develop and market biosimilar products that are enabled by the former’s Hybrozyme technology. Additionally, the company will have an option to license Alteogen’s Hybrozyme technology for two more products.

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Camargo

AUGUST 5, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. This prospectively developed comparative evidence was used to great advantage by Astellas as RWE in its submission for this new approval. Stay tuned.

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Pharmaceutical Technology

JANUARY 5, 2023

Capsida Biotherapeutics and Eli Lilly and Company ’s wholly owned subsidiary Prevail Therapeutics have announced a partnership for the development of non-invasive gene therapies for central nervous system (CNS) diseases. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Drug Patent Watch

OCTOBER 12, 2021

International License Abstract Development of generic drug product…. The post Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review appeared first on DrugPatentWatch - Make Better Decisions. This paper was originally published by Md.

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Camargo

DECEMBER 15, 2020

Whether a sponsor develops a new product or plans to license an exciting new asset developed somewhere else, commercial success or failure will depend on its understanding of the market and ability to develop an effective commercial strategy. What are they already prescribing for the product’s indication?

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Pharmaceutical Technology

JULY 28, 2022

Rezafungin is a new, once-weekly echinocandin antifungal being developed by Cidara to treat and prevent serious fungal infections such as candidemia and invasive candidiasis in adults. It is also being developed for invasive fungal infection prophylaxis in adults who undergo allogeneic blood and marrow transplantation.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Pharmaceutical Technology

JANUARY 6, 2023

Dutch biotechnology company Synaffix and Amgen have entered a licensing agreement for the development of next-generation antibody-drug conjugates (ADCs). For four future programmes, Amgen will also have an option for exercising exclusive licenses for research and commercialisation.

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Pharma Mirror

APRIL 18, 2023

Dudley, UK, April 18th 2023: Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced that it has been granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).

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Pharmaceutical Technology

MAY 31, 2023

Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. The investigational product candidate has concluded Phase III development as a treatment option for Barth syndrome.

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Pharmaceutical Technology

OCTOBER 4, 2022

Shionogi will waive royalty payments on product sales in all countries under this deal as long as Covid-19 is listed by the World Health Organization as a Public Health Emergency of International Concern. The post Shionogi and MPP enter Covid-19 antiviral licensing deal appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

AUGUST 2, 2022

Sosei Heptares , a corporate brand of Sosei Group Corporation, has signed a new drug discovery partnership and option-to-license agreement with AbbVie for discovering, developing and marketing new therapies for neurological ailments. Additionally, AbbVie will make tiered royalty payments based on global product sales to Sosei Heptares.

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Pharmaceutical Technology

MARCH 21, 2023

Gilead Sciences has exercised its option to exclusively license the investigational targeted protein degrader development candidate, NX‑0479, from clinical-stage biopharmaceutical company Nurix Therapeutics. GS-6791 is the first development candidate from the previous collaboration between Gilead Sciences and Nurix in 2019.

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Pharmaceutical Technology

DECEMBER 19, 2022

With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. On choosing the candidate, the company will oversee the complete development, production and marketing.

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Pharma Mirror

APRIL 13, 2021

Wolff”) and the Spanish pharmaceutical company Cantabria Labs (“Cantabria Labs”) concluded a strategic partnership on March 12th 2021 by entering into an exclusive licensing agreement for a newly developed medicinal product for the treatment of hyperhidrosis.

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Pharmaceutical Technology

JULY 1, 2022

Twist's VHH libraries, used for discovering and developing antibodies for use in immuno-oncology, will be licensed by Ildong for three years for research and development works. . The post Twist and Ildong to develop antibodies for immuno-oncology applications appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

DECEMBER 26, 2022

LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). As per the terms of the agreement, LegoChem will receive up to $1.25bn in upfront, development and commercial milestone payments from Amgen.

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Pharmaceutical Technology

AUGUST 4, 2022

Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies. Roche and Poseida will also partner in a research programme for creating and developing next-generation features and enhancements for allogeneic CAR-T therapies.

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Pharmaceutical Technology

JANUARY 23, 2023

Takeda has signed an exclusive licence agreement with HUTCHMED (China) and its subsidiary HUTCHMED to develop and market the latter’s fruquintinib. The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. The submission is planned to be completed in the first half of this year.

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Pharmaceutical Technology

APRIL 21, 2023

In May 2022, they signed a research partnership and exclusive option licence agreement for the development of antibodies to reduce tumour microenvironment-mediated immunosuppression. Astellas will license a suite of single-domain antibody (VHH) libraries from Twist for five years to conduct research and development activities.

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Pharmaceutical Technology

JULY 22, 2022

Sangamo Therapeutics has received orphan medicinal product designation (OMPD) from the European Commission (EC) for its Investigational autologous Chimeric Antigen Receptor Regulatory T Cell (CAR-Treg) cell therapy, TX200, for solid organ transplantation.

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Pharmaceutical Technology

JULY 4, 2022

Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement. The mAb is presently in the Phase II development stage.

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Pharmaceutical Technology

MAY 8, 2023

Shanghai Junshi Biosciences and Dr. Reddy’s Laboratories have partnered for the development and commercialisation of the anti-PD-1 monoclonal antibody, toripalimab, in 21 countries. The company may also choose to expand the scope to license toripalimab in New Zealand, Australia, and in nine other countries.

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Pharmaceutical Technology

JUNE 15, 2023

Japan-based Astellas Pharma has entered a partnership with Cullgen to discover and develop multiple targeted protein degraders through the latter’s proprietary uSMITE targeted protein degradation platform, in a deal potentially worth $1.9bn. Astellas could pay Cullgen up to $85m upon using its license option regarding the deal.

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Pharmaceutical Technology

DECEMBER 14, 2022

Merck and Synplogen have signed a non-binding Memorandum of Understanding (MoU) to expedite the development and manufacturing of viral vector-based gene therapy applications. The firms intend to merge their expertise to provide simplified viral vector gene therapy development, production and testing in Japan.

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Camargo

MAY 10, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Drug Product. The requirements of ClinicalTrials.gov often come as a surprise to those unfamiliar with the particulars of drug development.

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pharmaphorum

JANUARY 10, 2023

Astellas has licensed rights to a drug developed by Selecta Biosciences that could make more patients eligible for treatment with its gene therapy for inherited neuromuscular disorder Pompe disease. The post Astellas licenses companion drug for Pompe gene therapy appeared first on.

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Pharmaceutical Technology

JANUARY 13, 2023

The Biomedical Advanced Research and Development Authority (BARDA) has awarded a multi-year contract to the Sabin Vaccine Institute for developing and producing single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases. Currently, there are no licensed vaccines against these viruses.

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Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. Bio-Thera will handle BAT2206’s global development and commercial supply out of its manufacturing plants in Guangzhou, China.

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