pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

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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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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. 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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Fierce Pharma

JANUARY 9, 2024

But the Japanese company will have to clear up manufacturing issues first. The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility.

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Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

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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. ImmunityBio’s vaccine design drives both antibody and T-cells to the spike (S) protein and nucleocapsid (N) protein.

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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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pharmaphorum

APRIL 9, 2021

The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lilly entered into clinical trials.

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pharmaphorum

AUGUST 25, 2020

The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and prevent coronavirus infections. AZD7442 is a combination of antibodies derived from convalescent plasma, taken from patients who have been infected with SARS-CoV-2 but have recovered.

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The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About BioInvent.

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Pharmaceutical Technology

FEBRUARY 3, 2023

CAR T based therapies manufactured with lentiviral vectors are also on the rise, points out Clive Glover, PhD, General Manager, Pall Corporation. Rather, he believes adaptation to suspension-based systems will be an important evolution in AAV manufacturing. For example, researchers have developed a two-plasmid cotransfection system.

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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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XTalks

JANUARY 22, 2025

IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus. seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. The findings reveal a remarkable 98.3%

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Pharmaceutical Technology

JUNE 2, 2023

Switzerland-based company Lonza has boosted its antibody-drug conjugates (ADCs) offering with the acquisition of Dutch biotechnology company Synaffix for a total consideration of $172m (€160m). 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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Pharmaceutical Technology

DECEMBER 6, 2022

In the partnership’s discovery phase, RAVEN, an artificial intelligence (AI) platform of Evaxion will be leveraged for designing a next-generation vaccine candidate that induces cellular as well as humoral/antibody responses. Using ExpreS 2 ion’s ExpreS2 platform, the company will manufacture the antigen constructs obtained from RAVEN.

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Pharmaceutical Technology

JANUARY 19, 2023

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. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

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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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Delveinsight

JANUARY 12, 2021

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant. Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. AvantGen Enters into a Licensing Agreement for its Anti-SARS-CoV-2 Antibodies with IGM Biosciences.

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Pharmaceutical Technology

AUGUST 26, 2008

As understanding of biological systems has forged ahead, pharmaceutical companies have made increasing use of biotechnology in discovering and manufacturing new medicines. ” Today most big pharmaceutical companies are pursuing biotechnology either in house or by using an in-licensing strategy.

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BioPharma Reporter

APRIL 20, 2023

CDMO Sterling Pharma Solutions has been granted a Manufacturerâs Authorisation for Investigational Medicinal Products from the UKâs Medicines and Healthcare products Regulatory Agency (MHRA).

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Pharmaceutical Technology

AUGUST 23, 2022

The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, 1-adapted vaccine. On obtaining the FDA EUA, the Omicron BA.4/BA.5-adapted

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BioTech 365

AUGUST 12, 2020

Cytovia developing novel CAR NK cell therapy and NK engager antibodies for cancer NEW YORK and LEIDEN, the Netherlands, Aug. 12, 2020 (GLOBE NEWSWIRE) — Cytovia Therapeutics, Inc (Cytovia), an emerging biopharmaceutical company developing CAR NK cell therapy and NK … Continue reading →

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Camargo

DECEMBER 13, 2021

A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account.

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pharmaphorum

JANUARY 7, 2021

The partnership covers up to five oncology targets identified by OBT using its discovery platform, and the UK firm will try to develop antibodies against them. Kite and Gilead will then develop and commercialise therapies based on these targets or antibodies.

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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. An advanced preclinical asset, LAVA-1223 is a bispecific T cell engager. It can act on and activate V?9V?2

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pharmaphorum

FEBRUARY 24, 2022

Monoclonal antibodies have made an important contribution to the treatment of COVID-19. However, their efficacy is limited, and they can be challenging to manufacture, store, distribute and administer.” The post Cantex secures license to develop small molecule-drug for inflammatory lung diseases appeared first on.

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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. It is still not known whether having antibodies will protect people from a second infection. Coronavirus infection triggers the immune system to produce antibodies.

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Delveinsight

AUGUST 18, 2020

The acquisition will help Sanofi transform its R & D and accelerate the discovery and manufacturing of novel medications in areas with significant unmet needs. . Administered orally, Enspryng is a humanized monoclonal antibody. USD 475 Million Deal: BMS Inks An A Global License Deal With Dragonfly For Immunotherapy Program .

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XTalks

OCTOBER 22, 2024

Vyloy is a first-in-class monoclonal antibody that targets the CLDN18.2 The FDA had rejected Vyloy in January due to “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility” for the drug. targeting antibody-drug conjugate. On the other hand, Merck & Co.

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The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S.

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pharmaphorum

JUNE 18, 2021

Japan’s Eisai has hit the jackpot with its first ever antibody-drug conjugate (ADC) drug candidate, attracting a licensing deal from Bristol-Myers Squibb that could top out at more than $3.1 antibody with cell-killing drug eribulin – sold on its own by Eisai as Halaven.

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. This product complements Cellectis’ portfolio of technologies involved in manufacturing allogeneic CAR T-cells.

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Pharmaceutical Technology

NOVEMBER 9, 2022

CSL Behring has a commercialisation and license agreement to develop EtranaDez. On November 7, the company announced that the FDA has scheduled a pre-licensure inspection of BioMarin’s manufacturing facility, and required the company to submit three-year Phase III Roctavian data in the approval application.

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The Pharma Data

SEPTEMBER 6, 2021

Takeda today announced that the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) will purchase 150 million doses of Novavax’ vaccine candidate (TAK-019 in Japan) manufactured in Japan by Takeda subject to licensing and approval. The details of the terms and conditions of the agreement are confidential.

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pharmaphorum

JULY 6, 2021

The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy.

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The Pharma Data

APRIL 9, 2021

Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab). 2 Biogen will gain exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan).

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The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. LOS ANGELES , Jan. 7, 2021 /PRNewswire/ — ImaginAb Inc. , No other terms were disclosed.

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