Licensing and Marketing - Clinical Research Informer

Kite and Daiichi Sankyo update cell therapy licensing agreement

Pharmaceutical Technology

DECEMBER 8, 2022

According to the revised deal, Daiichi Sankyo and Kite will transfer the Marketing Authorization for Yescarta to Gilead’s Japan subsidiary, Gilead Sciences K.K., The therapy’s sales and promotion works in Japan following the transfer of marketing authorisation will be carried out by the Kite Cell Therapy Business Unit at Gilead Sciences K.K.

Licensing

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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.

Gene Therapy

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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. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies.

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Rebounding from setbacks, Sanofi reveals promising data for hemophilia drug

Bio Pharma Dive

DECEMBER 14, 2021

Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.

Gene Therapy

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Centralisation of drug licensing may not be the right path to improve quality of drugs: SPIC

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2023

Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)

Licensing

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Pfizer takes on haemophilia B gene therapy market with new FDA application

Pharmaceutical Technology

JUNE 27, 2023

The FDA has accepted a biologics license application (BLA) for Pfizer's fidanacogene elaparvovec to treat adults with haemophilia B.

Gene Therapy

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Cristália signs licensing deal for Formosa’s APP13007

Pharmaceutical Technology

JANUARY 29, 2024

Cristália has signed an agreement to license exclusive rights to market Formosa Pharmaceuticals’ APP13007 in Brazil.

Licensing

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Generics expected to improve access for patients with idiopathic pulmonary fibrosis

Pharmaceutical Technology

SEPTEMBER 27, 2023

The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments approved by the FDA in 2014.

Licensing

Licensing Licensing Marketing

EC announces EU pharma reform that cuts market exclusivity

Pharmaceutical Technology

APRIL 27, 2023

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity.

Marketing

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Juvisé licenses J&J’s MS drug Ponvory for marketing outside North America

Pharmaceutical Technology

MARCH 27, 2024

The market for multiple sclerosis therapies is expected to be worth over $41bn by 2030, according to GlobalData.

Marketing

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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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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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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.

Hormones

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Intas licenses Helnius’s antibody for marketing in Europe and India

Pharmaceutical Technology

OCTOBER 30, 2023

Helinus will receive €42m upfront and will be in line to receive up to €143m in regulatory and sales-based milestone payments.

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Roche licenses Innovent ADC that could challenge Amgen drug

pharmaphorum

JANUARY 2, 2025

Roche licenses rights to a DLL3-targeted ADC from China's Innovent, hoping to bring a competitor to Amgen's lung cancer therapy Imdelltra to market

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Melinta and Cidara sign licensing deal for rezafungin

Pharmaceutical Technology

JULY 28, 2022

Melinta Therapeutics has signed a licence agreement with Cidara Therapeutics to facilitate a strategic collaboration for marketing the latter’s rezafungin in the US. The post Melinta and Cidara sign licensing deal for rezafungin appeared first on Pharmaceutical Technology.

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Searchlight licenses Mithra’s menopause drug Donesta for Canadian market

Pharmaceutical Technology

JULY 31, 2023

Mithra Pharmaceuticals is in line to receive €17.05m ($18.8m) in licencing fees, and milestone-based payments.

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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. Biomm will gain exclusive rights for the distribution and marketing in Brazil of the proposed biosimilar to Janssen’s Stelara.

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AbbVie enters obesity space with $2.3bn Gubra deal

Pharmaceutical Technology

MARCH 3, 2025

AbbVie is entering the obesity treatment market with a $2.3bn licensing agreement to acquire rights to a long-acting amylin analogue by Gubra.

Licensing

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Takeda signs licensing agreement with HUTCHMED for fruquintinib

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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Jupiter Neurosciences Makes Way in CNS Treatments with $11M IPO

XTalks

DECEMBER 4, 2024

Jupiter Neurosciences, a clinical-stage pharma company specializing in neuroinflammation, made its public market debut with an initial public offering (IPO) on the Nasdaq Capital Market under the symbol “JUNS.” ” The company priced 2,750,000 shares of common stock at $4.00

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Imugene licenses potential first-to-market allogeneic CAR T for blood cancers

Pharmaceutical Technology

AUGUST 18, 2023

Imugene's azercabtagene zarpreleucel (azer-cel) allo-CAR T cell therapy has shown a 58% ORR and 41% CR rate across all doses.

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AriBio licenses Alzheimer’s pill in China for up to $770m

Pharmaceutical Technology

MARCH 25, 2024

An unnamed Chinese partner takes on AR1001 in an APAC Alzheimer’s market predicted to be worth $2.6bn by 2030

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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.

Development

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Biocon Biologics signs agreement with Janssen to market Bmab 1200

Pharmaceutical Technology

AUGUST 29, 2024

Biocon has reached a settlement and license agreement with Janssen for the commercialisation of Bmab 1200, a proposed biosimilar to Stelara.

Licensing

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Lava fires up a $700m cancer licensing deal with Seagen

pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The post Lava fires up a $700m cancer licensing deal with Seagen appeared first on.

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LianBio to shut down, return cash to investors

Bio Pharma Dive

FEBRUARY 14, 2024

The biotech is planning to dissolve less than four years after launching with plans to license drugs and market them in China and other Asian countries.

Licensing

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Sandoz partners with Samsung Bioepis to license Stelara biosimilar

Pharmaceutical Technology

SEPTEMBER 11, 2023

The agreement allows Sandoz exclusive marketing rights for the inflammatory bowel disease therapy in Europe and North America.

Licensing

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Advanz Pharma to license Dimerix’s DMX-200 drug candidate

Pharmaceutical Technology

OCTOBER 5, 2023

Advanz Pharma has signed an agreement to licence Dimerix’s DMX-200 for marketing in the UK, Australia and New Zealand among others.

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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.

Licensing

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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. .

Development

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Santhera and Catalyst to market DMD drug vamorolone in North America

Pharmaceutical Technology

JULY 19, 2023

The agreement covers licensing rights in North America for Duchenne muscular dystrophy and other future indications.

Licensing

Licensing Licensing Marketing Drugs

Halozyme, doubling down on a licensing strategy, buys a drug delivery biotech for nearly $1B

Bio Pharma Dive

APRIL 13, 2022

Antares Pharma's auto-injector technology is of particular interest to Halozyme, which believes that the various markets to which it could be applied represent billions of dollars in potential sales.

Drug Delivery

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ESMO 2022: shrinking market for Trodelvy, with fierce ADC competition

Pharmaceutical Technology

SEPTEMBER 13, 2022

Trodelvy has already received regulatory approval for previously treated triple-negative breast cancer (TNBC) across the eight major markets (8MM – US, France, Germany, Italy, Spain, UK, Japan and China). The post ESMO 2022: shrinking market for Trodelvy, with fierce ADC competition appeared first on Pharmaceutical Technology.

HR

HR Marketing Hormones FDA Approval

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.

Production

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Chinese tech giant Baidu licenses mRNA algorithm to Sanofi

pharmaphorum

NOVEMBER 23, 2021

Sanofi has bolstered its push into mRNA-based therapies with a new licensing deal – but not as might be expected with some up-and-coming biotech company. The post Chinese tech giant Baidu licenses mRNA algorithm to Sanofi appeared first on.

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Y-mAbs’ Danyelza injection receives marketing approval in Brazil

Pharmaceutical Technology

MAY 24, 2023

Y-mAbs Therapeutics has received marketing authorisation for Danyelza (naxitamab-gqgk) 40mg/10mL injection from the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária, to treat high-risk neuroblastoma. The therapy is given three times a week and repeated every four weeks.

Marketing

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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.

Development

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Manufacturing issues delay lebrikizumab’s entry to the atopic dermatitis market

Pharmaceutical Technology

OCTOBER 23, 2023

On 2 October, Eli Lilly announced that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the biologic license application (BLA) for its anti-interleukin (IL)-13 biologic lebrikizumab for the treatment of adults and adolescents (12 and older) with moderate-to-severe atopic dermatitis (AD).

Manufacturing

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Aurinia’s Lupkynis receives marketing authorisation from Swissmedic

Pharmaceutical Technology

MAY 3, 2023

Aurinia Pharmaceuticals has received marketing authorisation from the Swiss Agency for Therapeutic Products (Swissmedic) for Lupkynis (voclosporin), along with a background immunosuppressive therapy. They also maintained a stable estimated glomerular filtration rate (eGFR) over three years.

Marketing

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PharmaEssentia picks Pint-Pharma to market BESREMi in Latin America

Pharmaceutical Technology

JUNE 5, 2023

Pint-Pharma will obtain and maintain all marketing authorisations and will commercialise BESREMi in the region. In 2019, the European Medicines Agency approved the therapy, which has also been licensed in Japan, Taiwan and South Korea. It holds orphan drug designation in the US to treat PV.

Marketing

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Provention and Sanofi enter deal to launch teplizumab for type 1 diabetes

Pharmaceutical Technology

OCTOBER 7, 2022

A decision on the approval of the Biologics License Application (BLA) is anticipated on 17 November. Additionally, the company granted Sanofi an exclusive right of first negotiation (ROFN) to attain international rights to market teplizumab for T1D indications for a one-time payment of $20m.

FDA Approval

FDA Approval Licensing Licensing Antibody

GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

AUGUST 1, 2022

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.

Vaccination

Vaccination Vaccine Development RNA

Junshi Biosciences, Dr. Reddy’s partner to develop and market toripalimab

Pharmaceutical Technology

MAY 8, 2023

Under the terms of the license and commercialisation deal, Dr. Reddy’s will get licence for the development and commercialisation of toripalimab in India, Panama, Peru, Colombia, South Africa, Brazil, Argentina, Chile, Uruguay, and Mexico.

Development

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Kite and Daiichi Sankyo update cell therapy licensing agreement

uniQure signs license deal for Apic Bio’s gene therapy for SOD1-ALS

Trending Sources

How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Rebounding from setbacks, Sanofi reveals promising data for hemophilia drug

Centralisation of drug licensing may not be the right path to improve quality of drugs: SPIC

Pfizer takes on haemophilia B gene therapy market with new FDA application

Cristália signs licensing deal for Formosa’s APP13007

Generics expected to improve access for patients with idiopathic pulmonary fibrosis

EC announces EU pharma reform that cuts market exclusivity

Juvisé licenses J&J’s MS drug Ponvory for marketing outside North America

TherapeuticsMD and Mayne sign product licensing agreements

Alteogen signs global license deal with Sandoz

Pharmanovia signs licence deal for Aeterna Zentaris’ Ghryvelin

Intas licenses Helnius’s antibody for marketing in Europe and India

Roche licenses Innovent ADC that could challenge Amgen drug

Melinta and Cidara sign licensing deal for rezafungin

Searchlight licenses Mithra’s menopause drug Donesta for Canadian market

Bio-Thera and Biomm enter licensing deal for ustekinumab biosimilar

AbbVie enters obesity space with $2.3bn Gubra deal

Takeda signs licensing agreement with HUTCHMED for fruquintinib

Jupiter Neurosciences Makes Way in CNS Treatments with $11M IPO

Imugene licenses potential first-to-market allogeneic CAR T for blood cancers

AriBio licenses Alzheimer’s pill in China for up to $770m

C4XD and AstraZeneca enter $402m deal to develop respiratory disease therapy

Biocon Biologics signs agreement with Janssen to market Bmab 1200

Lava fires up a $700m cancer licensing deal with Seagen

LianBio to shut down, return cash to investors

Sandoz partners with Samsung Bioepis to license Stelara biosimilar

Advanz Pharma to license Dimerix’s DMX-200 drug candidate

TG shares tumble following licensing deal for MS drug

Hookipa partners with Roche for cancer immunotherapy development

Santhera and Catalyst to market DMD drug vamorolone in North America

Halozyme, doubling down on a licensing strategy, buys a drug delivery biotech for nearly $1B

ESMO 2022: shrinking market for Trodelvy, with fierce ADC competition

Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa

Chinese tech giant Baidu licenses mRNA algorithm to Sanofi

Y-mAbs’ Danyelza injection receives marketing approval in Brazil

Sanofi and Innate Pharma extend cancer therapeutics partnership

Manufacturing issues delay lebrikizumab’s entry to the atopic dermatitis market

Aurinia’s Lupkynis receives marketing authorisation from Swissmedic

PharmaEssentia picks Pint-Pharma to market BESREMi in Latin America

Provention and Sanofi enter deal to launch teplizumab for type 1 diabetes

GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Junshi Biosciences, Dr. Reddy’s partner to develop and market toripalimab

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