Pharmaceutical Technology

MAY 22, 2023

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody that will be used to treat mild cognitive impairment caused due to AD and mild AD dementia in people with the confirmed presence of amyloid pathology in the brain. The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).

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BioPharma Reporter

JANUARY 5, 2023

AstraZeneca and Sanofi said their Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA).

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pharmaphorum

APRIL 14, 2022

billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). The post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on.

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pharmaphorum

MARCH 29, 2021

The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting. . The EU’s medicines regulator is also reviewing COVID-19 antibodies from AstraZeneca , GlaxoSmithKline/Vir Biotechnology, and Brii Biosciences.

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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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Pharmaceutical Technology

OCTOBER 25, 2022

Astellas chief strategy officer Naoki Okamura said: “Gene therapy is the cornerstone of Astellas’ Primary Focus, Genetic Regulation; our goal is to bring new transformative treatment options to patients living with serious genetic diseases and limited treatment options.

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BioPharma Reporter

AUGUST 1, 2023

Renaissance Pharma, a company focused on the development of life changing therapies in pediatric rare disease, has entered into an exclusive license agreement with St. Jude Childrenâs Research Hospital for Hu14.18, a humanised antibody in development by the hospital for the treatment of newly diagnosed high-risk neuroblastoma.

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BioPharma Reporter

DECEMBER 15, 2022

The French National Agency for the Safety of Health Products (ANSM) has granted a pharmaceutical establishment license to Axploraâs Le Mans site.

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Pharmaceutical Technology

AUGUST 16, 2022

antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling. On Horizon exercising the option, Q32 could be entitled to further receive up to another $645m in closing and milestone payments. Q32 will also receive tiered royalty payments on net sales. A fully human anti-IL-7R?

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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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BioPharma Reporter

OCTOBER 16, 2023

Synaffix, a Lonza company commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs), has entered a licensing agreement with SOTIO, a clinical stage immuno-oncology company owned by PPF Group.

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BioPharma Reporter

JULY 25, 2023

ImmunoGen, a biotech company focused on the development of antibody-drug conjugate (ADC) technology to treat cancer, has announced a multi-target license and option agreement to research novel, first-in-class ADCs with ImmunoBiochem, a biopharma firm developing novel biological therapeutics.

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BioPharma Reporter

SEPTEMBER 8, 2020

AbbVie has boosted its immunotherapy pipeline in a global licensing deal with Chinese biotech, I-Mab, for its anti-CD47 monoclonal antibody, lemzoparlimab.

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Drug Discovery World

JUNE 22, 2023

By providing evidence of its therapeutic relevance, it reveals insights into the importance of the RGMb/PD-L2 pathway in immunotherapy resistance and further strengthens the significance of IOME Bio’s bispecific antibody therapy approach, which targets RGMb (Repulsive Guidance Molecule b).

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BioPharma Reporter

MARCH 27, 2023

The biotech is launched with an antibody-based protein degradation platform, with technology licensed from UCSF.

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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. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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BioPharma Reporter

OCTOBER 18, 2022

Antibody-drug conjugate developer, Synaffix, has signed a licensing agreement with Cristal Therapeutics to gain access to its CliCr metal-free click chemistry.

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BioPharma Reporter

JANUARY 2, 2023

As the new year begins, we look at recent agreements in the global antibody drug conjugate (ADC) technology licensing space.

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Drug Discovery World

FEBRUARY 19, 2024

antibody-drug conjugate [ADC] pipelines in some oncology settings). A collaborative learning process between regulators and developers is required to build a pragmatic framework for AI’s use in drug development; 2023 saw the start of these efforts but it is expected to continue at pace in 2024.

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BioPharma Reporter

FEBRUARY 14, 2022

Biogen Inc and Xbrane Biopharma AB have entered into a commercialization and licensing agreement on Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA.

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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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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. Activation of T-cell proliferation specifically in a tumour is crucial for reducing the autoimmune side effects of antitumour immunotherapy.

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pharmaphorum

AUGUST 16, 2022

The deal gives it worldwide ownership of Trodelvy (sacituzumab govitecan), a first-in-class TROP2 antibody-drug conjugate drug it acquired as part of its $21 billion takeover of Immunomedics in 2020. The new deal means that the licensing deal has been terminated, and the Chinese pharma is no longer on the hook for any remaining payments.

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Pharma in Brief

JANUARY 10, 2024

However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. The Guidance was last updated in 2005.

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The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. “Following the successful delivery of more than 170 million doses to the U.S. CEO and Co-founder of BioNTech. “We

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Drug Discovery World

NOVEMBER 25, 2022

Gene therapies have made the headlines over the last few days, with treatments for rare AADC deficiency, lung cancer and haemophilia B given the go ahead from regulators. News round-up for 21-25 November by DDW Digital Content Editor Diana Spencer . FDA approves first disease-modifying therapy for T1D .

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pharmaphorum

DECEMBER 21, 2021

The Swiss pharma group is paying BeiGene $300 million upfront for an option on ociperlimab, a TIGIT antibody in phase 3 testing for non-small cell lung cancer (NSCLC), with another $700 million on offer if that option is exercised before 2023. Novartis licensed rights to tislelizumab for $650 million upfront and up to $1.55

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pharmaphorum

APRIL 28, 2022

billion licensing deal with Biohaven for rights to oral migraine drug rimegepant is approaching a payoff after the European Commission approved the drug. Pfizer’s $1.2

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pharmaphorum

APRIL 19, 2022

The US regulator has kicked off a priority review of Enhertu (trastuzumab deruxtecan) as a treatment for NSCLC with HER2 mutations after prior systemic therapy, setting up a decision in the third quarter of this year. billion licensing deal for the drug in 2019. That was more than double the amount made in the previous year.

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pharmaphorum

JULY 25, 2022

AstraZeneca and Daiichi Sankyo will hear back from the FDA before the end of 2022 on their license application for Enhertu in HER2-low breast cancer – an indication which could drive the drug into multibillion-dollar sales territory. That translated to an extra six months of life – from 16.8 months to 23.4

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pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. Antibodies like Ocrevus also struggle to penetrate the CNS and hit MS at the site of the problem.

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pharmaphorum

APRIL 6, 2022

The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of an FDA decision on the drug due in July. billion in milestones, shortly after its own PD-1 drug candidate spartalizumab failed a phase 3 trial in melanoma.

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pharmaphorum

DECEMBER 23, 2021

The US regulator issued Novartis with a complete response letter (CRL) for inclisiran a year ago, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy. It will be launched in the US in January, said Novartis. It has a long way to go.

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pharmaphorum

OCTOBER 1, 2021

KY1005 – now renamed amlitelimab – is one of a handful of new drugs targeting OX40 ligand, an immune system regulator delivered by intravenous infusion once every 28 days. Now, it says the drug has delivered “exciting” results in a proof-of-concept trial. It is also being developed in a subcutaneous formulation.

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The Pharma Data

JANUARY 13, 2021

The patent application is titled “Anti-CD154 Antibodies and Uses Thereof” and published under International Publication No. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.

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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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pharmaphorum

FEBRUARY 11, 2021

The accelerated development assumes that regulators are prepared to accept immunogenicity data from smaller trials, Pangalos said in the briefing to announce the firm’s quarterly results. The company also indicated the potential of its long-acting antibody combination in the fight against the pandemic. Is it perfect?

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