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.

Development 242

Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

APRIL 13, 2023

Significant collaborative R&D programmes that are likely to be affected include Takeda’s partnership with Codexis for AAV-based gene therapy for Fabry disease and Takeda’s $3.6bn dollar deal with Poseida for the development of nonviral in vivo gene therapy programmes for the hereditary bleeding disorder haemophilia A.

Gene Therapy 243

Gene Therapy Marketing Gene In-Vivo 243

Pharmaceutical Technology

SEPTEMBER 14, 2022

As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. Tumour-infiltrating lymphocyte (TIL) therapy has been investigated as a treatment modality for melanoma for almost 20 years. months versus 3.1

Immune Response 246

Immune Response In-Vivo Production Manufacturing 246

BioSpace

JUNE 6, 2022

Sernova shared positive Phase I/II data from an ongoing clinical study of its implantable Cell Pouch device that showed evidence of in vivo active insulin production.

Insulin 100

Insulin In-Vivo Production 100

Pharmaceutical Technology

FEBRUARY 23, 2023

Moderna has entered a strategic research and development partnership with ElevateBio’s Life Edit Therapeutics to discover and develop new in-vivo mRNA gene editing therapies. The company will also receive tiered royalties on the worldwide net sales of products developed from the collaboration.

Gene Editing 147

Gene Editing Gene In-Vivo Gene Therapy 147

Pharmaceutical Technology

MAY 24, 2023

Autologous therapies are characterized as a circular supply chain; the patient’s own sample starts the supply chain, and it is then subjected to ex-vivo modifications with the resulting therapy administered back to that same patient. CGT trials operate with much lower volumes of manufactured final product.

Clinical Trials 246

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

Worldwide Clinical Trials

NOVEMBER 27, 2023

Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow. In June 2023, the U.S.

Gene Editing 189

Gene Editing Gene Gene Therapy In-Vivo 189

XTalks

OCTOBER 20, 2023

Intellia said NTLA-2001 is the first investigational in vivo CRISPR-based gene editing therapy cleared to enter late-stage clinical development. As an in vivo therapy, it can edit genes inside the body rather than in cells extracted from patients. ATTR amyloidosis is a rare, progressive and fatal disease.

In-Vivo 52

In-Vivo Gene Editing Trials Gene 52

Pharmaceutical Technology

AUGUST 21, 2022

The China National Medical Products Administration (NMPA) has granted clearance for Ascletis Pharma’s Investigational New Drug (IND) application of its drug candidate, ASC10, for Covid-19. D-N4-hydroxycytidine (NHC) in vivo. An RNA-dependent RNA polymerase (RdRp) inhibitor, ASC10 is an oral double prodrug.

In-Vivo 162

In-Vivo RNA Clinical Development Drugs 162

XTalks

APRIL 14, 2022

Conventional in vitro and in vivo studies are used in the drug development pipeline. However, could there be another way for developing biomedical products using in silico technology? Therefore, companies can evaluate their drug candidates or medical device products in “virtual patients” before assessing them in humans.

Trials 98

Trials In-Vivo In-Vitro Clinical Trials 98

Pharmaceutical Technology

MAY 31, 2023

In vivo and in vitro pre-clinical studies demonstrated that CFT8919 provides wider coverage of on-target resistant mutations and intracranial activity, indicating its potential to be effective against brain metastases. C4T will hold the exclusive rights to develop and commercialise the product in all regions except greater China.

In-Vivo 130

In-Vivo Bioavailability In-Vitro Licensing 130

Camargo

DECEMBER 22, 2021

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Each product is unique, and so is the associated development strategy. Why Conduct a Portfolio Analysis?

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

Pharmaceutical Technology

JULY 20, 2022

Roche will also make further payments to Avista during the collaboration’s research phase and clinical, sales-based milestone and royalty payments for resulting products. Avista's computationally steered, in vivo scAAVengr platform uses a high-throughput method with the integrated quantitative validation of new cell-specific AAVs.

Gene Therapy 147

Gene Therapy Gene Development In-Vivo 147

Drug Patent Watch

JANUARY 14, 2025

The Thyroid Association’s Concerns The American Thyroid Association (ATA) had raised concerns about the FDA’s methods for determining bioequivalence between levothyroxine products[2]. They recommended avoiding switching between levothyroxine products, leading to a preference for brand-name prescriptions.

Generic Drugs 87

Generic Drugs Development Drugs Manufacturing 87

Pharmaceutical Technology

FEBRUARY 13, 2023

Best practice is to also consider the ‘developability’ of the lead compounds in conjunction with any evidence of potential in-vivo activity, by taking a holistic approach. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?

Development 130

Development In-Vivo Drugs Clinical Trials 130

Pharmaceutical Technology

AUGUST 17, 2022

oRNA molecules have been demonstrated to possess increased stability in vivo compared to linear mRNA and can potentially create more quantities of therapeutic proteins within the body. . Merck will also make royalty payments on any approved products developed out of the partnership.

RNA 147

RNA Vaccine Vaccination In-Vivo 147

Pharmaceutical Technology

OCTOBER 14, 2022

The AVATAR AI technology will mimic the tumour microenvironment ex vivo and provide capabilities that support the therapeutic products’ development with improved potency and persistence, as well as reduced cell exhaustion. 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

Pharmaceutical Technology

SEPTEMBER 14, 2022

Currently, the company is making investments and obtaining crucial aspects of commercial-scale production and radioisotope supply. The company is also concluding more than 200 in vivo studies to gain insights and discover new drug candidates that could provide therapeutic radioisotopes for tumour-linked antigens.

In-Vivo 130

In-Vivo Clinical Trials Clinical Trials Engineer 130

Pharmaceutical Technology

MARCH 24, 2023

Generation Bio will also receive payments in future development, regulatory and commercial milestones, along with royalties on worldwide net sales of immune cell-targeted and liver-targeted products. Both companies will use the partnership for advancing in vivo immune cell targeting as a new class of genetic medicines.

Genetics 130

Genetics Medicine Development In-Vivo 130

Pharmaceutical Technology

SEPTEMBER 29, 2022

Sanofi will also make tiered royalty payments on net sales of products resulting from the collaboration in the future. Under the agreement, Sanofi will receive non-exclusive rights to Scribe’s CRISPR by Design platform of wholly-owned enzymes for developing ex vivo NK cell therapies.

Development 130

Development In-Vivo Genome Genomics 130

Pharmaceutical Technology

MAY 18, 2023

Other investors include Investissement Québec, Omega Funds, Cowen Healthcare Investments, CTI Life Sciences Fund III, Northleaf Capital Partners, BVF Partners and Vivo Capital. Net proceeds from the transaction are expected to be used to finance the clinical development of enGene’s lead product, intravesical detalimogene voraplasmid (EG-70).

Gene Therapy 130

Gene Therapy Gene In-Vivo Life Science 130

Pharmaceutical Technology

MAY 18, 2023

KSQ will receive future payments of up to $510m on achieving all milestones during the agreement period, along with potential net sales royalties on any commercial product that is the result of the partnership. Takeda will make an upfront payment and provide an investment in the double-digit millions of dollars to KSQ.

Gene Therapy 130

Gene Therapy In-Vivo Gene Genetics 130

Pharmaceutical Technology

JUNE 15, 2023

Verve Therapeutics and Eli Lilly and Company have entered an exclusive research partnership to advance the former’s preclinical stage in vivo gene editing programme targeting lipoprotein(a) (Lp(a)) to treat atherosclerotic cardiovascular disease (ASCVD). Lilly will provide funding for the Phase I clinical trials.

Gene Editing 130

Gene Editing Gene Gene Therapy In-Vivo 130

Drug Discovery Today

NOVEMBER 5, 2020

London, November 4th, 2020: NanoMab Technology Limited, a privately held biopharmaceutical company focussing on cancer precision therapies, today announced that it had received CTA Acceptance from the Medicines Healthcare products Regulatory Agency (MHRA) to carry out a Phase II clinical Study for its NM-01 product.

In-Vivo 40

In-Vivo Production Medicine 40

pharmaphorum

OCTOBER 8, 2021

The cell therapy field is showing no signs of slowing down, with huge investment and excitement around next generation products and their clinical validation in solid tumour indications. This year, we’ll be specifically focusing on next generation cell therapies and discussing: Novel in vivo delivery.

In-Vivo 52

In-Vivo Gene Manufacturing Marketing 52

pharmaphorum

APRIL 25, 2022

The UNC and NCSU team, led by biomedical engineer Yevgeny Brudno, report in Nature Biotechnology how they have developed an implant that can generate the CAR-T cells in vivo. In some cases where the cancer is particularly aggressive, that timeframe may simply be too long to be a viable option for the patient.

Engineer 105

Engineer In-Vivo FDA Approval Manufacturing 105

pharmaphorum

JANUARY 25, 2022

For example, there is no need for in vivo animal or in vitro pre-clinical or non-clinical studies. The area of digital therapeutics is growing rapidly, and in this piece Ben Hargreaves examines why this is the case, how broadly these therapies can be applied and why investment in the area is mounting. This equated to $21.3

Medicine 111

Medicine In-Vivo In-Vitro Development 111

Roots Analysis

JANUARY 27, 2025

The development of cell therapy products requires a robust population of cells that can be subjected to genetic alterations, without being damaged in this process. The development of cell therapy products requires a robust population of cells that can be subjected to genetic alterations, without being damaged in this process.

Manufacturing 40

Manufacturing Contamination Production Gene Therapy 40

pharmaphorum

OCTOBER 6, 2022

Disease modelling Gulf War Illness. In the mid-to-late 1990s, an unexplained illness began to emerge in army bases across the US. Symptoms and their severity ranged across individuals, and included fatigue, musculoskeletal pain, skin rashes, headaches, and gastrointestinal issues. Tinker, tailor, soldier, therapy.

In-Vivo 98

In-Vivo Research Genetics Drugs 98

BioTech 365

SEPTEMBER 2, 2020

SAN DIEGO and BOSTON, Sept. 02, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc.

DNA 40

DNA In-Vivo Protein Gene 40

Pharmaceutical Technology

SEPTEMBER 10, 2008

IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo. Natalie Coomber: Can you provide a quick background on the history of Biotest and the main work it is currently undertaking?

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In-Vitro Genotoxicity In-Vivo Development 100

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. Early-stage companies are often years, often a decade or longer, from a marketable product.

In-Vivo 52

In-Vivo Marketing Engineer Genetics 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.

Filler 92

Filler FDA Approval Dermatology In-Vivo 92

pharmaphorum

FEBRUARY 23, 2021

Advance Cutting-Edge Research and Development with Next-Generation Cell Therapies, to Deliver Best-in-Class Products to Patients in Need. Implement logic and develop ‘decision-making’ cells: create robust, controllable activation in vivo with University of Pennsylvania and Ludwig Institute for Cancer Research Lausanne.

In-Vivo 52

In-Vivo Engineer Development Production 52

Camargo

APRIL 28, 2021

The first tasks in striking this balance are dose selection and dosing interval determination, and this blog post offers an overview on how PK modeling and simulation can be applied to optimize the safety and efficacy of a product for pediatric populations in clinical trials. First Steps Toward Initiating Pediatric Clinical Studies.

Clinical Trials 130

Clinical Trials Clinical Trials In-Vivo Drugs 130

FDA Law Blog

JUNE 25, 2024

For the last 14 years, an applicant could get approval of a biosimilar as a standard biosimilar or an interchangeable biosimilar, but the interchangeable biosimilar presented a higher hurdle to approval: Applicants needed to show that a patient could be switched from the Reference Product to the biosimilar and back without issue.

In-Vivo 52

In-Vivo Production Protein Drugs 52

pharmaphorum

MAY 27, 2021

Life sciences tools company Esco Lifesciences Group has scored $200m in a series A and crossover round co-led by Novo Holdings and Vivo Capital. “They want innovation, they want quality, and they want products that have a global standing and Esco fulfils all of that.

Life Science 59

Life Science In-Vivo Manufacturing Gene Therapy 59