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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pharmaphorum

APRIL 12, 2021

Sanofi has licensed a potential inflammatory diseases drug from Manchester University spin-off C4X Discovery Holdings in a deal worth up to €414 million ($492 million). While the headline figure looks significant the UK biotech will receive only €7 million up front, reflecting the fact that the drug has not yet begun clinical testing.

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Drugs In-Vivo Licensing Licensing 52

Worldwide Clinical Trials

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In June 2023, the U.S. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

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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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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) on Friday, December 11, 2020. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. chief executive officer of Gamida Cell. chief executive officer of Gamida Cell.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

Drug Discovery World

SEPTEMBER 14, 2023

Also in July 2023, Alexion, AstraZeneca Rare Disease (Alexion) and Pfizer entered into an agreement for Alexion to purchase and license the assets of Pfizer’s early-stage rare disease gene therapy portfolio for a total consideration of up to $1bn, plus tiered royalties on sales. billion, a decrease of $15.0 Vaccines were up 9.1%

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Drugs Vaccination Vaccine Medicine 59

Drug Discovery World

FEBRUARY 16, 2023

Challenges remain with current delivery approaches, and genetic medicines applications have been generally restricted to the liver and ex vivo settings. Aera’s technology also includes a licensed therapeutic enzyme platform based on the discovery of novel, compact, and programmable gene editing enzymes.

Genetics 52

Genetics Medicine Gene Editing In-Vivo 52

The Pharma Data

JUNE 7, 2023

Acuitas’ LNP technology will support Bayer’s in vivo gene editing and protein replacement programs by specifically delivering RNA payloads to the desired target organ, the liver. LNPs are spheric drug delivery bodies which can be equipped with therapeutic payloads for intracellular delivery. Source link: [link]

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The Pharma Data

JANUARY 17, 2021

Based in Seattle, Washington, Sana focuses on in vivo and ex vivo cell engineering platforms to develop therapies for cancer, diabetes, cardiovascular disease, CNS disorders, and genetic diseases. But that number doesn’t quite reflect the company’s likely market valuation , which is expected to be between $9 billion and $12 billion.

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In-Vivo Marketing Engineer Genetics 52

pharmaphorum

FEBRUARY 19, 2021

Snipping out this viral code with powerful CRISPR gene editing technology, which last year won Drs Emmanuelle Charpentier and Jennifer Doudna the Nobel Prize for chemistry, would in theory prevent the need for drugs to suppress the virus and the development of AIDS.

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pharmaphorum

OCTOBER 8, 2020

Its main platform – called X-editing – can generate CRISPR drugs with improved activity, specificity and deliverability compared to rivals, according to the start-up’s website. Scribe has designed, engineered and tested thousands of evolved CRISPR enzymes to build an advanced platform for creating breakthrough in vivo treatments,” said Oakes.

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Gene Editing Gene In-Vivo Clinical Trials 56

FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. Tobolowsky & Charles G. FDORA § 3209(a)(1). FDORA § 3209(a)(2). 42 U.S.C. § 42 U.S.C. §

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The Pharma Data

DECEMBER 9, 2020

Our focus on partnering to accelerate patient access to innovative medicines underscores our commitment to advancing breakthroughs in biomedicine such as antibody drug conjugates, cell therapy, RNAi and more, Ed Zhang, company co-founder, chief operating and business officer, said in a statement.

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In-Vivo In-Vitro Antibody Development 52

The Pharma Data

MARCH 8, 2021

Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related. This program included assays such as Big Blue and PIG-a designed to provide a robust measure of a drug or chemical’s ability to induce mutations in vivo.

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Trials In-Vivo Genotoxicity RNA 69

The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. Over the past four years our two companies have built a strong drug discovery relationship. population will have obesity.

In-Vivo 52

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The Pharma Data

APRIL 8, 2022

They also identified several drugs that reduced the production of inflammatory cytokines in infected Alveolus Chips, which could be useful in treating excessive inflammation in the lung. Based on these studies, one of those drugs was licensed to Cantex Pharmaceuticals for the treatment of COVID-19 and other inflammatory lung diseases.

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Immune Response In-Vivo Genetic Analysis Research 52

The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. The companies will work together on the in vivo proof of concept (POC). MUNICH, Germany, Jan. Nasdaq: BIIB, Cambridge, Mass.,

Gene Therapy 52

Gene Therapy Gene Development In-Vivo 52

XTalks

APRIL 24, 2023

According to Dr. Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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The Pharma Data

MARCH 29, 2022

There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1, 6,7 This study also showed Evusheld reduced viral burden and limited inflammation in the lungs (in vivo) across all Omicron variants.6. Christoph D.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

Drug Discovery World

OCTOBER 4, 2022

Using its proprietary compound screening platform, Oligomerix discovers and develops differentiated, oral, small molecule inhibitors of tau self-association that are easy to administer and cost-effective. . OLX-07010 has been well characterised through an extensive program of pre-clinical toxicology and metabolism testing. . million in 2022 to 12.7

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The Pharma Data

NOVEMBER 5, 2020

Drawing upon 50 years of expertise in clinical research, biopharmaceuticals, biotechnology and drug discovery, Dr. Van Kampen excels as the chief executive officer of The Van Kampen Group, which assists other companies in research and liaisons with government and industry regarding licensing products for commercial use.

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Research Vaccination Vaccine Doctors 52

Pharmaceutical Technology

MAY 16, 2023

Nuvectis Pharma has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for NXP900. Nuvectis has licensed the exclusive global rights to NXP900 from the University of Edinburgh in Scotland, UK.

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The Pharma Data

DECEMBER 9, 2020

Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc., The company plans to do this by developing drugs that eliminate protein aggregation by either reducing the production of toxic proteins or removing them after the fact through autophagy. which will remain a key shareholder.

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

Pharmaceutical Technology

SEPTEMBER 19, 2022

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients. The treatment is indicated for usage in boys aged four to 17 years with CALD. thalassemia.

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Drug Discovery World

SEPTEMBER 6, 2022

There’s no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. Among these include Zolgensma, Novartis’ gene therapy drug for spinal muscular atrophy (SMA), which made headlines in the UK for its £1.79 billion, compared to $19.9 million price point per dose. Cancer is king .

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Gene Therapy Gene Manufacturing Medicine 52

The Pharma Data

JANUARY 4, 2021

Kiromic chPD1 has shown in preclinical data to show a cytotoxic response in 9 different in vivo models with 100% long-term PFS with the induction of host memory responses. We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. “We believe Prof.

In-Vivo 40

In-Vivo Development Big Data Immune Response 40

Drug Discovery World

APRIL 25, 2024

Cell line development is an essential underpinning of the drug development process, enabling teams to test, optimise and manufacture therapeutics at a commercial scale. For drug discovery and development, cell lines allow researchers to test the efficacy of therapeutics before moving into in vivo studies.

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The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Drug Discovery World

OCTOBER 2, 2023

We were able share new data that describes an expansion process in Quantum Flex that produced high quality Tscm cells in a relatively short period. With fully closed and automated devices, therapy manufacturing will hopefully be able to break the next barrier in patient access to generate safe products in record time.

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In-Vivo Manufacturing Production Gene Therapy 105

Drug Discovery World

NOVEMBER 9, 2023

Peter O’Callaghan, PhD, Head of Expression System Sciences, Biologics and Licensing, Lonza, on: ‘Solve bispecific heavy-light chain mispairing with bYlok technology’. Croasdale-Wood will then participate in a keynote chat, interviewed by Miho.

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The Pharma Data

DECEMBER 23, 2020

In July, ViiV Healthcare, which is based in London, resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine to the U.S. In July, ViiV Healthcare, which is based in London, resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine to the U.S.

Drugs 52

Drugs Licensing Licensing Vaccination 52

XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness. mL to sustain the desired effect.

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Filler FDA Approval Dermatology Production 92

Drug Discovery World

DECEMBER 12, 2023

KRRO-110 is an RNA editing oligonucleotide delivered to liver cells using clinically validated lipid nanoparticle (LNP) technology licensed from Genevant. Korro’s RNA editing approach has the potential to be transformative for AATD patients and Korro is well-positioned to deliver a best-in-class therapeutic.

RNA 52

RNA In-Vivo Genotype Genetics 52

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies. “We

Clinical Trials 52

Clinical Trials Clinical Trials Gene Therapy Trials 52

Drug Discovery World

AUGUST 4, 2022

While the developability gap is not new, the level of uncertainty and risk associated with biopharmaceutical development has increased measurably in recent years as the pressure to bring only first-in-class or best-in-class drugs to market has risen. Even for regular mAbs there are challenges.

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Development Protein Manufacturing Drugs 52

Drug Discovery World

FEBRUARY 26, 2024

For example, Vertex Pharmaceuticals’ stem-cell treatment for sickle-cell disease and transfusion-dependent β-thalassemia was authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) in November 2023, making it the first licensed therapy that uses the gene-editing tool CRISPR to help treat patients.

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