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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Licensing Licensing Manufacturing Medicine 147

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).

Manufacturing 147

Manufacturing Antibody Marketing Licensing 147

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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Development Licensing Licensing Antibody 130

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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Gene Therapy Gene Development Manufacturing 130

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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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.

Gene Therapy 130

Gene Therapy Gene Development Manufacturing 130

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.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

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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Vaccination Vaccine Development Immune Response 130

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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Development Production Immune Response Licensing 161

Pharmaceutical Technology

NOVEMBER 29, 2022

Neogene focuses on discovering, developing and producing next-generation T-cell receptor therapies (TCR-Ts) that provide a new cell therapy approach for fighting cancer. AstraZeneca has signed an agreement for the acquisition of all outstanding equity of clinical-stage biotechnology firm Neogene Therapeutics in a deal totalling up to $320m.

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Gene Therapy Gene Development Manufacturing 279

Pharmaceutical Technology

MARCH 2, 2023

resulted primarily from the development of the US dollar and the Chinese renminbi. Additionally, due to the acquisition of Exelead, a biopharmaceutical contract development and manufacturing company, sales increased by 0.4%. Organically, the company generated an increase of 6.4% in group sales in fiscal 2022.

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Sales Life Science Licensing Licensing 245

Pharma Times

JULY 27, 2021

Organon will license the global development, manufacturing and commercial rights to investigational treatment ebopiprant

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Licensing Licensing Manufacturing Development 123

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

Licensing 130

Licensing Licensing Gene Editing Development 130

Pharmaceutical Technology

DECEMBER 2, 2022

The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance (BIRAC), supported Bharat Biotech in developing the new intranasal vaccine for Covid-19. Under the Mission COVID Suraksha Program, DBT, the Indian Government and BIRAC provided funding for the development and clinical trials of the vaccine.

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pharmaphorum

JANUARY 12, 2021

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. This is particularly important in developing countries, where access to cold-chain is limited,” said Channon. There are other theoretical advantages as well.

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Licensing Licensing Vaccination Vaccine 119

Camargo

SEPTEMBER 15, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explore how those changes could impact your program. Fitbit developing algorithm COVID-19 early detection. CMC changes during product development result in CRL .

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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.

Manufacturing 52

Manufacturing Gene Therapy Development Gene 52

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.

In-Vivo 130

In-Vivo Bioavailability In-Vitro Licensing 130

BioSpace

NOVEMBER 19, 2020

Novartis inked an exclusive worldwide license and collaboration deal with Australia-based Mesoblast to develop, commercialize and manufacture remestemcel-L for acute respiratory distress syndrome (ARDS), including when it is linked to COVID-19.

Licensing 96

Licensing Licensing Manufacturing Development 96

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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Licensing Licensing Gene Therapy Clinical Trials 130

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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Licensing Licensing Manufacturing Pharmacy 52

Pharmaceutical Technology

FEBRUARY 3, 2023

Under the deal, Karuna will have an exclusive worldwide licence for the development, manufacturing, and commercialisation of multiple Goldfinch Bio’s TRPC4/5 candidates, including GFB-887, the lead clinical-stage candidate. Additionally, the company will receive a royalty on net sales of each licensed product.

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Licensing Licensing Sales Development 130

XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus.

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

Pharmaceutical Technology

JULY 20, 2022

Previously, only licensed and authorised physicians, advanced practice registered nurses, and physician assistants could prescribe the drug. . And, if there are concerns, the pharmacist can call their healthcare provider to develop a plan. Pfizer expects revenues to reach approximately $22 billion in the fiscal year.

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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.

RNA 52

RNA Licensing Licensing Vaccination 52

STAT News

MARCH 22, 2023

National Institutes of Health rejected a petition urging the agency to use a controversial provision of federal law to widen access to a cancer drug by forcing the manufacturers to license their patents. The medicine was developed at the University of California, Los Angeles, with help from U.S.

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Licensing Licensing Manufacturing Drugs 98

Pharmaceutical Technology

MAY 16, 2023

Emergent will also hand over San Diego, California-based research facilities (focused on the Chikungunya vaccine candidate), a Swiss-based biologics manufacturing facility, and the EU/US-based commercial operations. Following the completion of the deal, Bavarian Nordic now boasts the only oral vaccine licensed by the U.S.

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pharmaphorum

JULY 18, 2022

The whole package should be available, the Chinese package, for countries’ regulatory authorities to license the product in the last quarter of this year,” Morgon states. We’ve been inspected by the European Medicines Agency (EMA) and passed the Good Manufacturing Practice (GMP) inspection.

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Vaccination Vaccine Development Immune Response 138

BioSpace

AUGUST 4, 2020

Merck entered into an exclusive licensing deal with Hanmi Pharmaceutical for the development, manufacture and commercialization of efinopegdutide for nonalcoholic steatohepatitis (NASH).

Licensing 78

Licensing Licensing Manufacturing Development 78

Pharmaceutical Technology

JULY 18, 2022

Quoin Pharmaceuticals and Endo International subsidiary Endo Ventures have signed a licence and distribution agreement and a supply agreement to develop, register, supply, market and distribute the former’s QRX003 exclusively in Canada. Under the supply deal, Quoin is entitled for manufacturing and supplying QRX003 to Endo.

Production 162

Production Marketing Licensing Licensing 162

Pharmaceutical Technology

JANUARY 19, 2023

It has been developed using the company’s recombinant nanoparticle technology. The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial.

Vaccination 147

Vaccination Vaccine Immune Response Protein 147

Pharmaceutical Commerce

DECEMBER 3, 2024

The agreement provides PTC with $1 billion in cash once deal closes, and is centered around PTC518's development, manufacturing and commercialization.

Licensing 59

Licensing Licensing Manufacturing Development 59

pharmaphorum

NOVEMBER 29, 2021

The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) – unveiled with fanfare by the government in 2018 – is rumoured to be up for sale. It was billed at the time as a key tool to accelerate the development of new and innovative vaccines to combat some of the world’s most prevalent diseases, from discovery to licensed product.

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STAT News

JANUARY 11, 2023

… Merck plans to take legal action against several pharmaceutical companies in China after noticing that some manufacturers were supplying Covid-19 drugs to some provinces and cities saying the medicines were authorized by Merck , Reuters reports. Meanwhile, here is the latest menu of tidbits to help you on your way.

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Gene Therapy Licensing Licensing Gene 98

Pharmaceutical Technology

SEPTEMBER 28, 2022

Seagen and Lava Therapeutics have entered an exclusive licence agreement for the development, manufacturing and commercialisation of the latter’s LAVA-1223 for solid tumours. We look forward to working with Seagen to develop potential next-generation cancer treatments.”. It can act on and activate V?9V?2

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Development Licensing Licensing Production 130

Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). The post FDA accepts Outlook Therapeutics’ BLA for wet AMD treatment appeared first on Pharmaceutical Technology.

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XTalks

MARCH 17, 2025

Roche, a global leader in biotechnology and diagnostics, has entered into an exclusive collaboration and licensing agreement with Zealand Pharma, a specialist in innovative therapeutics, to co-develop and co-commercialize petrelintide as a potential foundational therapy for people with overweight and obesity. billion $1.4 billion $1.4

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Hormones Drugs Sales Insulin 59