Takeda pays $300M to license Protagonist drug for blood disorder
Bio Pharma Dive
FEBRUARY 1, 2024
The agreement gives Protagonist an experienced hand in Takeda, which can help the former commercialize its product.
Kite and Daiichi Sankyo update cell therapy licensing agreement
Pharmaceutical Technology
DECEMBER 8, 2022
The delivery of the product is anticipated to begin early next year. By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.
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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.
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uniQure signs license deal for Apic Bio’s gene therapy for SOD1-ALS
Pharmaceutical Technology
JANUARY 31, 2023
Gene therapy company uniQure has entered into a global licensing agreement with Apic Bio for APB-102 to treat patients with amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1). The post uniQure signs license deal for Apic Bio’s gene therapy for SOD1-ALS appeared first on Pharmaceutical Technology.
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Developing Drug Products with the Label’s Commercial Value in Mind
Camargo
AUGUST 5, 2020
Whether you plan to out-license or commercialize your product, getting the label right matters. The post Developing Drug Products with the Label’s Commercial Value in Mind appeared first on Camargo.
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Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa
Pharmaceutical Technology
APRIL 13, 2023
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. The now expanded agreement will enable Rubic to explore other therapeutic avenues in both the human and animal health product markets.
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TherapeuticsMD and Mayne sign product licensing agreements
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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Laurus Labs and IIT Kanpur partner for new gene therapy products
Pharmaceutical Technology
JUNE 19, 2023
Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. Laurus Labs will be responsible for launching these products in India and emerging markets.
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Pharmanovia signs licence deal for Aeterna Zentaris’ Ghryvelin
Pharmaceutical Technology
MARCH 17, 2023
Pharmanovia and Aeterna Zentaris have entered an exclusive licensing agreement for the latter’s medicine Ghryvelin (macimorelin). Under the deal, Pharmanovia will acquire the exclusive rights and license to commercialise Ghryvelin in the EEA and the UK from Consilient Health.
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Alteogen signs global license deal with Sandoz
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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Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development
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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Melinta and Cidara sign licensing deal for rezafungin
Pharmaceutical Technology
JULY 28, 2022
Rezafungin for injection received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) earlier, which gives the NDA priority review. The post Melinta and Cidara sign licensing deal for rezafungin appeared first on Pharmaceutical Technology.
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You Have a Product – Now What? Key Considerations for an Effective Commercial Strategy
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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NIH licenses COVID-19 technologies to WHO-backed program
Bio Pharma Dive
MAY 13, 2022
The agreement, which covers three experimental vaccines as well as several key patents, will be royalty free for products sold in 49 low-income countries.
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Shionogi and MPP enter Covid-19 antiviral licensing deal
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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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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Dr. August Wolff and Cantabria Labs enter into an exclusive commercialization agreement for Southern Europe for hyperhidrosis product
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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Gilead Sciences to exclusively license Nurix Therapeutics’ protein degrader
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. Additionally, Nurix will receive up to low double-digit tiered royalties on the net sales of the product.
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Sandoz plans new biologics production plant construction in Slovenia
Pharmaceutical Technology
MARCH 10, 2023
Sandoz, a division of Novartis , has signed a Memorandum of Understanding (MoU) for constructing a new biologics production plant in Lendava, Slovenia, to support the growing demand for biosimilar medicines worldwide. At Sandoz, we are determined to continue leading the way in driving access to these critical medicines.
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Sangamo’s cell therapy receives EC orphan medicinal product designation
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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Takeda signs licensing agreement with HUTCHMED for fruquintinib
Pharmaceutical Technology
JANUARY 23, 2023
The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. The post Takeda signs licensing agreement with HUTCHMED for fruquintinib appeared first on Pharmaceutical Technology. It was commercially launched in the country in the same year under ELUNATE brand name.
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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. It plans to seek regulatory approval from the European Medicines Agency, the China National Medical Products Administration and the US Food and Drug Administration.
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Stealth and Pharmanovia partner for commercialisation of elamipretide
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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Astellas licenses companion drug for Pompe gene therapy
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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Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review
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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TG shares tumble following licensing deal for MS drug
Bio Pharma Dive
AUGUST 1, 2023
Some on Wall Street believe the New York-based biotechnology company is now less likely to get acquired after agreeing to sell partial rights to its only marketed product.
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Hookipa partners with Roche for cancer immunotherapy development
Pharmaceutical Technology
OCTOBER 21, 2022
On concluding this trial, Roche will gain the right to develop and market the licenced products across various indications, contingent on approval. Roche also holds an option for licensing second arenaviral cancer immunotherapy. According to the agreement, Roche will make $25m in upfront payment to Hookipa. .
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C4XD and AstraZeneca enter $402m deal to develop respiratory disease therapy
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. on meeting clinical development and commercial milestones in the future, in addition to tiered royalty payments, upon the marketing of the product.
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EC announces EU pharma reform that cuts market exclusivity
Pharmaceutical Technology
APRIL 27, 2023
Companies would receive a patent extension of additional two years if their products are launched across all the EU’s member states, per the document. In addition to this, the EC document also states that companies can get a further year if their product targets an additional indication.
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Twist Bioscience and Astellas team up for antibody discovery
Pharmaceutical Technology
APRIL 21, 2023
Astellas will license a suite of single-domain antibody (VHH) libraries from Twist for five years to conduct research and development activities. The company is also expected to receive royalty payments on sales of the product.
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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing
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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GreenLight and US NIH partner to develop Covid-19 vaccine for variants
Pharmaceutical Technology
AUGUST 1, 2022
The human health product candidates of GreenLight are currently in the pre-clinical stage. In March, the company entered a licensing agreement with Serum Institute of India (SII) to expedite access to messenger RNA products in emerging markets worldwide.
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Sanofi and Innate Pharma extend cancer therapeutics partnership
Pharmaceutical Technology
DECEMBER 19, 2022
On choosing the candidate, the company will oversee the complete development, production and marketing. Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers.
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BARDA awards contract for Sabin’s Ebola Sudan and Marburg virus vaccines
Pharmaceutical Technology
JANUARY 13, 2023
BARDA, part of the Administration for Strategic Preparedness and Response (ASPR) of the US Department of Health and Human Services, will initially invest around $35m for the production of up to 100,000 doses of the Ebola Sudan virus (ChAd3-SUDV) vaccine. Currently, there are no licensed vaccines against these viruses.
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MHRA fast tracks ADvantage’s immunomodulator for Alzheimer’s disease
Pharmaceutical Technology
APRIL 6, 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease.
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Brii Bio acquires Vir’s antibody rights for Hepatitis B in Greater China
Pharmaceutical Technology
JULY 4, 2022
Following the option exercise, Vir will receive the option exercise fee, regulatory and commercial milestone payments as well as tiered royalties on net product sales from Brii Bio. A widely neutralising monoclonal antibody (mAb), VIR-3434 (BRII-877) acts on the hepatitis B virus (HBV).
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Zai Lab and argenx announce NMPA approval for sBLA for VYVGART Hytrulo
Pharmaceutical Technology
NOVEMBER 12, 2024
Zai Lab and argenx have announced receipt of approval from the National Medical Products Administration (NMPA) of China for the supplemental biologics license application (sBLA) for VYVGART Hytrulo 1,000mg vial for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
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In the News: October Regulatory and Development Updates
Camargo
NOVEMBER 11, 2020
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.
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Making new product planning for life science more effective with human-centred design
pharmaphorum
OCTOBER 28, 2022
The sooner a human-centred perspective is applied to the development of either a drug or device product, the more likely the product will be adopted and used because it’s been designed around what the end consumer wants and needs. This will ensure that you are developing a product these audiences will use.
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Sutro strengthens its immuno-oncology pipeline with two new ADCs
Pharmaceutical Technology
AUGUST 11, 2023
In June, Sutro received a $140m payment from Blackstone Life Sciences as part of the Vaxcyte product licensing agreement.
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Ayush ministry informs HC that it has instructed drug regulators against use of Unani label for Ayurveda drug
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 21, 2023
The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]
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EC approves Novartis’ Tabrecta for non-small cell lung cancer
Pharmaceutical Technology
JUNE 23, 2022
It was discovered by Incyte and licensed to Novartis in 2009. The latest development comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion in April this year. A kinase inhibitor, Tabrecta acts on MET.
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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. This is Synaffix’s 12th licensing agreement to date.
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Ablaze Pharmaceuticals to develop drug candidate for liver cancer
Pharmaceutical Technology
APRIL 3, 2023
The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio. It is based on RayzeBio’s specialisation in targeted radiotherapy (TRT) discovery and Ablaze’s know-how in therapeutic product clinical development, as well as on the radiopharmaceutical infrastructure in China.
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