Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. In October, the U.S.

Development 242

Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

MARCH 24, 2023

Under the terms of the deal, Moderna has purchased an option to license ctLNP and closed-ended DNA (ceDNA) technology from Generation Bio. Moderna will have an additional option to license a third programme targeting either immune cells or the liver.

Genetics 130

Genetics Medicine Development In-Vivo 130

Pharmaceutical Technology

JUNE 21, 2023

Coya Therapeutics has expanded its patent estate for COYA 301 by entering a licensing agreement with UNeMed, the University of Nebraska Medical Center’s technology transfer office. Coya secured exclusive patent rights and intellectual property rights related to COYA 301 and combinations to treat Parkinson’s disease (PD).

In-Vivo 130

In-Vivo Immune Response Clinical Trials Clinical Trials 130

pharmaphorum

JULY 5, 2022

The two partners will take an in vivo approach to the problem of so-called sensorineural hearing loss (SNHL) looking at ways to replace sound-detecting hair cells in the inner ear (cochlea) that become damaged in this type of deafness. An estimated 1.57 Astellas is already working on other approaches to treating hearing loss.

In-Vivo 110

In-Vivo Bioinformatics Genetics Licensing 110

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.

Gene Editing 189

Gene Editing Gene Gene Therapy In-Vivo 189

Pharmaceutical Technology

OCTOBER 14, 2022

aCGT Vector will offer its point-of-care, GMP-licensed manufacturing platform for validating Xcellbio's core next-generation manufacturing and analytical AVATAR AI technology for use in treating precision cancer. Xcellbio said that the AVATAR AI technology uses the tight environmental control of the AVATAR product family.

Gene Therapy 130

Gene Therapy Gene Development Manufacturing 130

pharmaphorum

JANUARY 10, 2022

The German group is paying $40 million upfront to kick off the alliance, which is focusing on the development of up to five CRISPR drugs that can be delivered in vivo for liver-targeted diseases. – are around one-third the size of the more commonly used Cas9.

In-Vivo 52

In-Vivo Gene Editing Gene Therapy Gene 52

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.

Antibody 52

Antibody Licensing Licensing Development 52

pharmaphorum

FEBRUARY 19, 2021

The company, which has licensed the CRISPR-based technology from Philadelphia’s Temple University, says it has already produced a functional cure for HIV that works in animals and wants to develop the technology in humans. We have proven the technology and candidate programs in vitro and in vivo in both small animal models and primate models.

Gene Editing 105

Gene Editing In-Vivo DNA In-Vitro 105

pharmaphorum

FEBRUARY 13, 2022

Quris’ BioAI safety prediction platform – which is based on human tissue samples on chips, nanosensors and machine learning – will be compared to traditional in vitro and in vivo laboratory techniques for spotting toxicity. The post Merck will assess Quris’ AI ‘patient-on-a-chip’ drug safety appeared first on.

Drugs 98

Drugs In-Vivo In-Vitro Pharma Companies 98

The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites. About Omidubicel.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

XTalks

DECEMBER 13, 2024

XTALKS WEBINAR: Enhance Early Biomarker Discovery: Translating In Vitro and In Vivo Multi-Omics Oncology Data Live and On-Demand: Thursday, January 16, 2025, at 11am EST (4pm GMT/UK) Register for this free webinar to learn how to harness the full potential of multi-omics data and advanced patient models to drive early biomarker discovery.

Antibody 99

Antibody In-Vivo Trials In-Vitro 99

pharmaphorum

OCTOBER 8, 2020

Scribe has designed, engineered and tested thousands of evolved CRISPR enzymes to build an advanced platform for creating breakthrough in vivo treatments,” said Oakes. The big biotech meanwhile has an antisense drug in trials for a subtype of inherited ALS, licensed from Ionis Pharma, in phase 3 clinical trials. Benjamin Oakes.

Gene Editing 69

Gene Editing Gene In-Vivo Clinical Trials 69

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). C4XD said it has developed a molecule small enough to be formulated into a pill, which has also been able to block IL-17 in vivo.

Drugs 52

Drugs In-Vivo Licensing Licensing 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. a biotechnology company specializing in the development of lipid nanoparticle (LNP) delivery systems for molecular therapeutics. Source link: [link]

Gene Therapy 40

Gene Therapy Gene Gene Editing In-Vivo 40

XTalks

MAY 22, 2023

According to Allergan Aesthetics, SkinVive is slated for commercial availability within the next six months, exclusively through licensed physicians and practitioners. It is an injectable gel indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21. mL to sustain the desired effect.

Filler 92

Filler FDA Approval Dermatology In-Vivo 92

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. Senior Vice President and Global Head of Cardiometabolic Diseases Research, Boehringer Ingelheim. population will have obesity.

In-Vivo 52

In-Vivo Contract Manufacturing Bioinformatics Clinical Development 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

Rare diseases can often be progressive, chronic and fatal. Approximately 72 percent of rare diseases are genetic, and around 70 percent of rare genetic diseases emerge in childhood. Sadly, one-third of children with rare diseases die before their first birthday.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

OCTOBER 14, 2020

today announced a licensing agreement with MANA Therapeutics for use of its EDIFY platform for the development of an autologous multi-tumor antigen adoptive T cell therapy for the treatment of multiple myeloma and solid tumors, as an additional T cell focused immunotherapeutic for its product pipeline. 15, 2020 04:00 UTC.

Licensing 40

Licensing Licensing In-Vivo Clinical Trials 40

The Pharma Data

MARCH 25, 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, 7,8) This study also showed Evusheld reduced viral burden and limited inflammation in the lungs (in vivo) across all Omicron variants.(7).

Antibody 52

Antibody In-Vivo Medicine Vaccine 52

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 Vaccine Vaccination 52

The Pharma Data

APRIL 8, 2022

Based on these studies, one of those drugs was licensed to Cantex Pharmaceuticals for the treatment of COVID-19 and other inflammatory lung diseases. Every breath stretches the lungs’ tissues with each inhale and relaxes them with each exhale. a Wyss Technology Development Fellow at the Institute. During his Ph.D.

Immune Response 52

Immune Response In-Vivo Genetic Analysis Research 52

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.

Research 52

Research Vaccine Vaccination Doctor 52

FDA Law Blog

FEBRUARY 2, 2023

The law defines this term to mean “a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug.” Tobolowsky & Charles G. FDORA § 3209(a)(1). FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

Clinical Trials 64

Clinical Trials Clinical Trials In-Vivo In-Vitro 64

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

The Pharma Data

OCTOBER 15, 2020

He is currently a professor at the University of Copenhagen where his lab focuses on PNAs in regard to drug discovery, gene targeting, antisense principles, cellular and in vivo delivery and administration of biopharmaceuticals. The Advance awards recognize the work of remarkable global Australians making an extraordinary impact worldwide.

In-Vivo 52

In-Vivo Business Development Manufacturing Development 52

The Pharma Data

DECEMBER 9, 2020

Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc., Vigil’s $50 million Series A financing, completed this week, was powered by Atlas Ventures and Northpond Ventures, and includes participating investors Hatteras Partners and Alexandria Venture Investments. SciNeuro Pharmaceuticals.

Marketing 52

Marketing In-Vivo Protein In-Vitro 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 Immune Response Big Data 40

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.

Vaccine 40

Vaccine Vaccination Clinical Trials Clinical Trials 40

The Pharma Data

APRIL 27, 2021

Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% at CER driven by growth drivers Dupixent ® and Vaccines. Specialty Care sales grew 15.3%, due to strong Dupixent ® performance (+45.6% to €1,047 million) and oncology launches. General Medicines core assets grew 4.4%, while GBU sales were down 3.8%.

Sales 52

Sales Vaccine Vaccination Medicine 52

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.

Licensing 52

Licensing Licensing Antibody Gene Therapy 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. While disease progression is slower in patients with later-onset SMA, there are significant unmet needs. “We

Clinical Trials 52

Clinical Trials Clinical Trials Gene Therapy Gene 52

The Pharma Data

DECEMBER 9, 2020

The Chinese biopharmaceutical industry is growing in leaps and bounds, but there is still a huge unmet need when it comes to getting patients access to the breakthrough therapeutic modalities and platforms like RNAi, cell and gene therapy and others. A solution could be at hand with Overland Pharmaceuticals.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

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.

In-Vivo 52

In-Vivo Marketing Engineer Genetics 52

The Pharma Data

MARCH 8, 2021

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. The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We

Trials 69

Trials In-Vivo Genotoxicity RNA 69

The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. 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 Vaccine 52