Genezen to license CSL’s lentiviral vector production system
Pharmaceutical Technology
FEBRUARY 21, 2024
Contract development and manufacturing organisation Genezen has announced plans to license CSL’s Cytegrity lentivirus production system.
Sterling Pharma Solutions Granted MIA (IMP) License by MHRA for cGMP Antibody-Drug Conjugate Manufacturing at its Facility in Deeside, UK
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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Manufacturing challenges set back development progress of cell therapies in oncology
Pharmaceutical Technology
NOVEMBER 21, 2022
Manufacturing woes have affected both cell and gene-modified cell therapies in oncology recently, disadvantaging patients with multiple myeloma (MM) and melanoma. ITIL-168 is an autologous TIL therapy, meaning that patients need to undergo apheresis and wait for the product to be manufactured and reinfused.
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Kite and Daiichi Sankyo update cell therapy licensing agreement
Pharmaceutical Technology
DECEMBER 8, 2022
Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. Regulators in Japan have granted approval for the manufacturing plant of Kite in El Segundo, California, US, to produce Yescarta for the Japanese market.
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Synaffix and Amgen sign agreement for advanced ADCs development
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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Astellas to support development of Taysha’s gene therapy programmes
Pharmaceutical Technology
OCTOBER 25, 2022
Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.
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Shionogi and MPP enter Covid-19 antiviral licensing deal
Pharmaceutical Technology
OCTOBER 4, 2022
It will allow MPP to enable further manufacturing and supply of ensitrelvir following authorisation or approval from respective regulatory agencies. Under the deal, MPP granted sublicences to eligible generic manufacturers to produce and deliver ensitrelvir to 117 countries.
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Alvotech-Bioventure’s AVT02 approved in Saudi Arabia for manufacturing
Pharmaceutical Technology
JANUARY 25, 2023
The Saudi Food & Drug Authority (SFDA) has approved the manufacturing and distribution of Alvotech and Bioventure’s AVT02 (adalimumab). Previously, both companies signed license agreements for several biosimilars. The monoclonal antibody AVT02 is the approved biosimilar for AbbVie ’s Humira (adalimumab).
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Bio-Thera and Biomm enter licensing deal for ustekinumab biosimilar
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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Merck and Synplogen to develop viral vector gene therapies
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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GreenLight and US NIH partner to develop Covid-19 vaccine for variants
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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Xcell and aCGT Vector partner on cell and gene therapy development
Pharmaceutical Technology
OCTOBER 14, 2022
Pharmaceutical companies Xcell Biosciences (Xcellbio) and aCGT Vector have partnered to expedite the development of cell and gene therapies. The two companies will aim to improve the manufacturing and analytic procedures used to develop personalised cell and gene therapies to treat cancer patients.
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Evaxion and ExpreS²ion partner to develop new CMV vaccine
Pharmaceutical Technology
DECEMBER 6, 2022
Evaxion Biotech and ExpreS 2 ion Biotechnologies have entered a vaccine discovery collaboration agreement to co-develop a new cytomegalovirus (CMV) vaccine candidate. Using ExpreS 2 ion’s ExpreS2 platform, the company will manufacture the antigen constructs obtained from RAVEN.
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FDA gives Ferring go-ahead for Adstiladrin gene therapy manufacturing
Pharmaceutical Technology
JUNE 13, 2023
The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). The company aims to then increase supplies in 2024. This site will be used for Adstiladrin production.
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Biden may order compulsory licensing in drug pricing move
pharmaphorum
DECEMBER 7, 2023
The White House said today that it may take enforced ownership of patents on medicines developed with public funding if their manufacturers set their prices too high.
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Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa
Pharmaceutical Technology
APRIL 13, 2023
The expanded licence will include the development of vaccines and therapeutic proteins beyond Covid-19 for human and animal health markets in Africa. The initial agreement between Dyadic and Rubic involved discovery, development, manufacturing, and distribution of Covid-19 vaccines by transferring and licensing of C1 platform technology.
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BMS licenses TCR-T immunotherapy therapy from Immatics
Pharmaceutical Technology
MAY 2, 2023
In 2019, Immatics and BMS entered an alliance to develop T cell-redirecting cancer immunotherapies. As per the agreement, BMS could exercise opt-in rights for any of the four TCR-T product candidates being developed by Immatics. This deal was expanded to incorporate gamma delta T cell therapies in 2022. Immatics’ CEO and co-founder. “We
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OSE Immunotherapeutics and Veloxis Pharmaceuticals Enter Into Global License Agreement to Develop, Manufacture, and Commercialize FR104, a CD28 Antagonist, in the Organ Transplantation Market
BioTech 365
APRIL 26, 2021
OSE Immunotherapeutics and Veloxis Pharmaceuticals Enter Into Global License Agreement to Develop, Manufacture, and Commercialize FR104, a CD28 Antagonist, in the Organ Transplantation Market OSE Immunotherapeutics and Veloxis Pharmaceuticals Enter Into Global License Agreement to Develop, Manufacture, and Commercialize FR104, … Continue reading (..)
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Biogen and Ginkgo Bioworks team up to develop novel gene therapy manufacturing platform
BioPharma Reporter
MAY 24, 2021
Biogen and Ginkgo Bioworks say their collaboration and license agreement will develop a next-generation AAV production platform, aiming to âredefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectorsâ.
Advances in cell line development
Drug Discovery World
APRIL 25, 2024
Reece Armstrong offers an overview of cell line development and outlines the benefits the technology is bringing to biopharmaceutical developers. Cell line development is an essential underpinning of the drug development process, enabling teams to test, optimise and manufacture therapeutics at a commercial scale.
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Noxopharm in-licenses novel RNA tech for drug discovery and vaccines
BioPharma Reporter
DECEMBER 6, 2021
Australiaâs Noxopharm has in-licensed novel RNA tech developed by Hudson Institute of Medical Research: focusing on RNA drug discovery and mRNA vaccine manufacture via Noxopharmâs subsidiary Pharmorage.
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Cantex secures license to develop small molecule-drug for inflammatory lung diseases
pharmaphorum
FEBRUARY 24, 2022
Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19. said Cantex CEO Stephen Marcus.
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Ginkgo Bioworks to discover and develop novel vaccine adjuvants
Drug Discovery World
FEBRUARY 20, 2024
A five-year contract totalling up to $31 million including programme options has been awarded to Ginkgo Bioworks to discover and develop next-generation vaccine adjuvants. Licensing for human use Adjuvants are components of vaccines that help to enhance the magnitude, breadth, and duration of the immune response to vaccination.
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Janssen to develop next-gen CAR-T therapies via agreement with Cellular Biomedicine Group
BioPharma Reporter
MAY 2, 2023
Janssen Biotech has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies.
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Using analytics and bioassays to de-risk your mRNA LNP drug development programme
Pharmaceutical Technology
FEBRUARY 15, 2023
The swift development and deployment of messenger-RNA (mRNA) vaccines against the SARS-CoV-2 virus during the COVID-19 crisis has catapulted the pharmaceuticals industry into a new paradigm. But the mRNA technology is not yet mature and there are no standardised manufacturing protocols yet. weight abundance.
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SpectronRx Receives U.S. Nuclear Regulatory Commission Materials License for New Facility
pharmaphorum
MARCH 16, 2021
Indiana-based radiopharmaceutical Contract Development and Manufacturing Organization expands nuclear pharmacy capabilities with second location . SpectronRx , a leading radiopharmaceutical contract development and manufacturing organization (CDMO), announced today that the U.S. To learn more, visit SpectronRx.com.
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Touchlight boosts DNA manufacturing capacity with latest expansion
Pharmaceutical Technology
MAY 26, 2023
Tripling its production capacity, Touchlight can now manufacture 8kg plasmid DNA, a key component for mRNA gene therapies and vaccines. As per the company, dbDNA is suitable for rapid, scalable manufacture of GMP DNA and can incorporate gene sequences of sizes ranging from 500bp to 20kb, which are typically unstable as pDNA.
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Touchlight signs patent license agreement with Pfizer for the use of dbDNA for the manufacture of mRNA-based vaccines, therapeutics and gene therapies
Drug Discovery Today
JULY 7, 2022
Pfizer and Touchlight agree to patent license for Pfizer to utilise rapid, scalable, enzymatic doggybone DNA (dbDNA) in Pfizer’s clinical and commercial manufacture of its mRNA vaccines, therapeutics, and gene therapiesAgreement includes upfront payment, potential development and commercial milestone payments, and royalties upon commercializationAccess (..)
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In the News: July 2021 Regulatory and Development Updates
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.
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Efficiently develop antibody-based therapeutics
Drug Discovery World
OCTOBER 12, 2022
In the Quality by Design (QbD) approach to antibody-based therapeutics development, stability characterisation —the probability of a protein unfolding or denaturing— is performed to ensure that structure and function are preserved throughout development and manufacturing. . Approaches for monoclonal antibody formulation .
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Teva, forging ahead with new strategy, inks biosimilar deal with Spain's mAbxience
Fierce Pharma
APRIL 4, 2024
Teva has unveiled a fresh in-licensing accord with Spain’s mAbxience to chip in on an investigational biosimilar spanning multiple oncology indications. As Teva advances its Pivot to Growth strategy under CEO Richard Francis, the company is making good on its pledge to beef up its biosimilar pipeline through outside deals.
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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis
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. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).
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JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited
BioTech 365
JANUARY 18, 2022
JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited IRVINE, Calif., JenaValve” or the “Company”), developer and manufacturer … Continue reading →
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Collaboration boosts development of novel in-situ CAR-T cell therapies
Drug Discovery World
JANUARY 5, 2024
AbbVie and Umoja Biopharma have entered into two exclusive option and license agreements to develop multiple in-situ generated CAR-T cell therapy candidates in oncology. The first agreement provides AbbVie an exclusive option to license Umoja’s CD19 directed in-situ generated CAR-T cell therapy candidates.
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ERS Genomics and Cellular Engineering Technologies Enter CRISPR/Cas9 License Agreement
BioTech 365
AUGUST 17, 2021
ERS Genomics and Cellular Engineering Technologies Enter CRISPR/Cas9 License Agreement ERS Genomics and Cellular Engineering Technologies Enter CRISPR/Cas9 License Agreement License allows Cellular Engineering Technologies to develop, manufacture and commercialize next generation stem cell lines using CRISPR/Cas9 technology DUBLIN & … Continue (..)
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Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing
FDA Law Blog
MARCH 4, 2024
Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.
New eBook: Efficiently develop antibody-based therapeutics
Drug Discovery World
OCTOBER 12, 2022
In the Quality by Design (QbD) approach to antibody-based therapeutics development, stability characterisation —the probability of a protein unfolding or denaturing— is performed to ensure that structure and function are preserved throughout development and manufacturing. . Approaches for monoclonal antibody formulation .
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Rentschler Biopharma and ATUM Announce Leap-In Transposase® Licensing Agreement for Development of Robust Manufacturing Processes for Complex Therapeutic Proteins
BioTech 365
OCTOBER 14, 2020
License agreement provides Rentschler Biopharma full access to ATUM’s Leap-In Transposase® cell line development (CLD) tools Technology will be integrated into Rentschler Biopharma’s in-house process with a fast, cost-effective, and stable platform to complement existing CLD offering LAUPHEIM, Germany & … Continue reading (..)
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Betta to commercialise C4 Therapeutics’ CFT8919 in greater China
Pharmaceutical Technology
MAY 31, 2023
C4 Therapeutics has entered an exclusive licensing agreement with Betta Pharmaceuticals to develop and commercialise CFT8919 across the greater China region. It is expected to accelerate the development of CFT8919 in important international markets.
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AvantGen Announces Licensing of Its Anti-SARS-CoV-2 Antibodies to IGM Biosciences for COVID-19 Therapy Development
The Pharma Data
JANUARY 11, 2021
a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.
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Sanofi and Innate Pharma extend cancer therapeutics partnership
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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Swiss company Lonza acquires Synaffix to boost ADC offering
Pharmaceutical Technology
JUNE 2, 2023
Synaffix is focused on the commercialisation of its clinical-stage technology platform to develop ADCs that offer a range of potential targeted treatments for cancer. The deal includes $107.17m (€100m) of initial financial consideration in cash and an additional $64.3m (€60m) in performance-based consideration.
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Spero Therapeutics Announces $40 Million Equity Investment from Pfizer Inc. and Licensing Agreement for SPR206
BioTech 365
JUNE 30, 2021
and Licensing Agreement for SPR206 Spero Therapeutics Announces $40 Million Equity Investment from Pfizer Inc. and Licensing Agreement for SPR206 Spero grants Pfizer rights to develop, manufacture, and commercialize SPR206 … Continue reading →
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BOEHRINGER INGELHEIM ENTERS GLOBAL LICENSING AGREEMENT TO DEVELOP AND COMMERCIALIZE INNOVATIVE ANTIBODIES FROM A*STAR FOR TARGETED CANCER THERAPIES
The Pharma Data
JUNE 2, 2022
Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.
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