pharmaphorum

MAY 18, 2022

Brand new UK startup RQ Biotechnology has been thrust into the spotlight after signing a $157 million licensing deal with AstraZeneca for monoclonal antibodies intended to protect vulnerable and immunosuppressed people from COVID-19. ” The post AstraZeneca buys into startup RQ Bio’s COVID antibodies appeared first on.

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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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The Pharma Data

MARCH 31, 2023

AstraZeneca has completed an exclusive global license agreement with KYM Biosciences Inc. i for CMG901, a potential first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, Notes CMG901 CMG901 is a novel antibody drug conjugate targeting Claudin 18.2, a promising therapeutic target in gastric cancers.

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Drug Discovery World

FEBRUARY 19, 2024

Dr Julie Warner is Vice President of Regulatory Affairs at drug development consultancy, Boyds. In this article, she provides her expert insights into the key trends and developments expected to shape the global drug development industry this year. antibody-drug conjugate [ADC] pipelines in some oncology settings).

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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. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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pharmaphorum

MARCH 24, 2022

GlaxoSmithKline has thrown its financial and drug development weight behind LifeMine Therapeutics, a US startup that aims to find new therapeutics from fungi – widely regarded as an underexplored resource of biologically-active compounds. The post GSK partners LifeMine on fungi-derived medicines appeared first on.

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The Pharma Data

APRIL 12, 2023

Program uses Denali’s Antibody Transport Vehicle (ATV) technology to cross the blood-brain barrier (BBB) and aims to increase target engagement Biogen Inc. Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ).

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The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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Pharmaceutical Technology

OCTOBER 31, 2022

The European Medicines Agency (EMA) has validated AbbVie ’s marketing authorization application (MAA) for epcoritamab (DuoBody-CD3xCD20) to treat relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients following two or more lines of systemic therapy. It also induces T-cell-mediated killing of CD20+ cells.

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pharmaphorum

JULY 8, 2022

Swedish rare disease specialist Sobi is paying $55 million upfront to license rights to ADC Therapeutics’ lymphoma therapy Zynlonta – approved in the US last year – in Europe and other international markets. The post Sobi bolsters blood division via $435m ADC licensing deal appeared first on.

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Pharmaceutical Technology

AUGUST 25, 2022

The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5). The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial.

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XTalks

JULY 25, 2022

Byondis announced that the US Food and Drug Administration (FDA) accepted their Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), an investigational therapy being studied to treat HER2-positive unresectable locally advanced or metastatic breast cancer. Vic-]Trastuzumab Duocarmazine Mechanism of Action.

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Pharmaceutical Technology

DECEMBER 28, 2022

Gilead Sciences and Jounce Therapeutics have amended their current license agreement for first-in-class immunotherapy, GS-1811 (formerly JTX-1811). The initial license agreement was signed in 2020. Now, the company will be solely responsible for all further research, development, and commercialisation of GS-1811 across the world.

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Pharmaceutical Technology

AUGUST 8, 2022

A HER2-directed antibody-drug conjugate (ADC), Enhertu is co-developed and marketed by AstraZeneca and Daiichi Sankyo. In July, the companies received Priority Review for their supplemental Biologics License Application (BLA) from the US FDA for Enhertu to treat unresectable or metastatic HER2-low breast cancer.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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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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Drug Discovery World

JANUARY 10, 2024

The acquisition includes Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter Phase II clinical development for asthma, with potential for additional indications.

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The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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Drug Discovery World

JANUARY 5, 2023

Synaffix and Hummingbird Bioscience have entered into a licensing agreement that it is hoped will enable Hummingbird Bio to develop an antibody drug conjugate (ADC) programme using Synaffix technology. .

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Delveinsight

AUGUST 17, 2021

Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use.

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The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 2 subvariant, now the dominant strain in Europe. 1-3 Evusheld was generally well-tolerated in the trial.

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Pharmaceutical Technology

MARCH 9, 2023

In-vitro T-cell activation is a key innovation area in immuno-oncology T cells can be activated and differentiated in vitro by crosslinking the TCR with CD3 antibodies and PMA treatment. Immatics is a biopharmaceutical company focused on the development of T-cell immunotherapies to fight against cancer.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

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XTalks

MARCH 1, 2021

The study is part of a broad development plan to assess the durability of the immunogenic responses elicited by its vaccine and the emergence of new SARS-CoV-2 variants. The third dose will be administered to the participants regardless of antibody titer levels. The study will be a part of current Phase I, II and III trials.

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pharmaphorum

NOVEMBER 22, 2022

The company says it will focus its energies on developing drugs for oncology, central nervous system and immunological diseases, and also make greater efforts to source R&D programmes from external developers. It also says it will focus on technological areas where it has strength, such as antibody-drug conjugates.

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pharmaphorum

JANUARY 4, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). This reduces the timeframe for the MAA to be reviewed.

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The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 TARRYTOWN, N.Y. , 12, 2021 /PRNewswire/ — . million doses.

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XTalks

APRIL 17, 2023

Monoclonal antibodies are gaining attention as alternative or additive treatments for atopic dermatitis. Lebrikizumab is a new and investigational monoclonal antibody designed to selectively inhibit IL-13. “In Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab outside of Europe.

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The Pharma Data

MARCH 22, 2021

Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days. The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants, based on the recently updated EUA guidance from the U.S.

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The Pharma Data

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology. Transaction Terms.

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Pharmaceutical Technology

AUGUST 23, 2022

According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, The companies have also commenced rolling submission for conditional marketing authorization from the European Medicines Agency (EMA) for this Omicron BA.4/BA.5-adapted

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The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

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Pharmaceutical Technology

FEBRUARY 14, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin 1, which are now well established in the industry.

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XTalks

FEBRUARY 29, 2024

In a statement , the company said it will discontinue Aduhelm to focus efforts on its other amyloid beta-directed antibody Leqembi (lecanemab) for Alzheimer’s and focus on developing other new treatments. Two years after its approval in 2021 , Biogen has decided to pull the plug on its Alzheimer’s drug Aduhelm (aducanumab).

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Drug Discovery World

MAY 31, 2023

Eisai has submitted a marketing authorisation application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody to the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. We look forward to working with the MHRA over the coming months to support the review of our clinical evidence.”

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Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Clinical Trials Clinical Trials Trials Licensing 52

pharmaphorum

DECEMBER 22, 2020

GlaxoSmithKline has closed the year with a flurry of deals, leaving its development pipeline bulging like Santa’s sack as chief scientific officer Hal Barron pursues a strategy to develop “transformational medicines”. million on the table if certain development, regulatory and sales goals are achieved.

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