FDA Law Blog

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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XTalks

NOVEMBER 5, 2024

Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D). Polyrizon’s focus on intranasal protection aligns with a rapidly expanding market in drug delivery innovation.

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XTalks

NOVEMBER 6, 2024

Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drug delivery, supporting prescription drugs, nutraceuticals, pet care and sports supplements. Priced at $4.0

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Camargo

NOVEMBER 24, 2020

Interest in the pulmonary route has also grown in recent years because delivering the drugs through the lungs allows direct systemic delivery and bypasses the first pass metabolism. Why is pulmonary drug delivery a complex challenge? How can we accomplish drug delivery to the lungs in nonclinical studies?

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Outsourcing Pharma

JANUARY 16, 2024

Clinical-stage drug delivery and development company DelSiTech has made the biggest single financing round in its history with the successful completion of a â10 million deal.

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BioPharma Reporter

FEBRUARY 16, 2022

From wearable injectors to nasal inhalation devices, experts expect to see many developments in drug delivery as the biologics industry grows.

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Fierce Pharma

AUGUST 28, 2024

Novartis has formed a strategic collaboration with drug delivery specialist Lindy Biosciences to develop self-administered versions of the Swiss pharma’s innovative drugs.

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Medical Xpress

MARCH 6, 2023

at Northwestern University—has developed novel technology with the potential to change the future of drug delivery. A team of scientists—led by Yamin Zhang, Ph.D., and Colin Franz, MD, Ph.D., at Shirley Ryan AbilityLab and John Rogers, Ph.D.,

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Fierce Pharma

APRIL 17, 2024

After proving the merits of its drug delivery platform last year with the approval of Teva’s long-acting schizophrenia drug Uzedy, France’s Medincell has hooked another big-name partner. Medincell and AbbVie inked a development and licensing pact to create up to six long-acting injectables, Medincell said Wednesday.

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XTalks

OCTOBER 27, 2021

Genentech’s ocular implant drug delivery system for treatment of macular degeneration has received approval from the US Food and Drug Administration (FDA). Susvimo delivers ranibizumab via a port delivery system into a surgically placed implant in the eye, allowing for continuous delivery of the drug.

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Pharmaceutical Technology

MAY 29, 2024

A team at King’s College London has developed a “drug delivery cage” that can be filled with chemotherapy drugs.

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Camargo

OCTOBER 14, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The FDA has also recently launched the Software Pre-Certification Pilot Program to provide an efficient regulatory framework for developers of SaMD products.

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pharmaphorum

FEBRUARY 25, 2021

Drug Delivery Devices Symposium. We have the distinct privilege of unveiling Oxford Global’s Drug Delivery Devices Symposium, taking place on the 10th of March, 2021. Discuss Combination Product Development & Engineering with leading experts such as Andrew Yum , United Therapeutics and Ning Yu , Biogen.

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Pharmaceutical Technology

APRIL 17, 2023

US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. We believe that STS101 will contribute to improving the quality of life of patients suffering from migraine.

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Roots Analysis

FEBRUARY 26, 2024

Biologics constitute a majority of the top selling drugs and represent one of the fastest growing segments of the overall pharmaceutical industry. Our Social Media Platform Web: [link] LinkedIn: [link] Twitter: [link] The post Subcutaneous Medications and Drug Delivery Systems appeared first on Blog.

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BioPharma Reporter

FEBRUARY 16, 2022

Lipid nanoparticle systems (LNPs) as a delivery mechanism for novel drug modalities are proving effective, but there are bioanalytical challenges associated with encapsulation, says an expert.

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pharmaphorum

AUGUST 5, 2020

SMi presents the 4 th Annual Ophthalmic Drugs Conference taking place on the 23 rd -24 th November 2020, in London. Workshop will be on ‘Ophthalmic Drug Delivery Development – Trials and Tribulations’. Understanding the pharmacological challenges for DD and development pathway including cost and timelines.

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pharmaphorum

NOVEMBER 17, 2021

SMi presents the Inaugural: Transdermal and Microneedle Drug Delivery Conference. Latest innovations in drug delivery beyond the needle. SMi is proud to present the Transdermal and Microneedle Drug Delivery Conference, taking place on the 24th to 25th January 2022, in London. pharmaphorum . pharmaphorum .

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Pharmaceutical Technology

AUGUST 12, 2022

Ceapro has extended a partnership underway to carry out a further research project with McMaster University for developing an inhalable immuno-therapeutic/-prophylactic for Covid-19-induced lung fibrosis. This project is intended to develop therapies for people suffering from Covid-19’s long-term effects.

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Roots Analysis

JANUARY 30, 2023

Hence, a precision therapy or we can say a target therapy (involving intracellular drug delivery) is much needed to all the patients suffering from cancer. Here is how the intracellular drug delivery comes into action for majority of the fatal diseases that requires target therapy. The answer is yes. The answer is yes.

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Medical Xpress

JANUARY 3, 2023

Fear of needles, injection-associated infection and pain are responsible for patients skipping doses, which encourages the development of new delivery strategies that combine efficacy with limited side effects to treat patients adequately.

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pharmaphorum

SEPTEMBER 23, 2020

Sixfold Bioscience in partnership with Medicines Discovery Catapult, has been given the green light, through the award of an Innovate UK Smart Grant to test a pioneering system designed to deliver drugs directly to cancerous cells, without impacting the healthy cells around it.

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Pharmaceutical Technology

APRIL 21, 2023

Samyang has entered into a strategic partnership agreement with LG Chem to develop new cancer therapeutics using Samyang’s technology, NanoReady. LG Chem will use the technology for the development of innovative mRNA-based cancer therapeutics with maximised therapeutic efficacy.

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BioPharma Reporter

NOVEMBER 27, 2023

1nhaler, a Scotland-based drug delivery device developer, has raised Â2 million to develop its single-use dry powder inhaler (DPI).

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Roots Analysis

FEBRUARY 26, 2023

Over the last two decades, the pharmaceutical industry has observed a paradigm shift from conventional drug delivery strategies to the long-acting drug delivery (LADD) of products to treat several disease indications, such as ophthalmic disorders, oncological disorders, neurological disorders and infectious diseases.

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pharmaphorum

FEBRUARY 3, 2022

Innovations in Formulation and Device Design for Enhanced Subcutaneous Delivery. As Part of Europe’s leading Injectable conference series, we will assess innovations in drug product formulation and biologics, new technologies in device design and the use of long-release injectable compounds. reaching £915 billion by 2027.

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Pharmaceutical Technology

FEBRUARY 15, 2023

The swift development and deployment of messenger-RNA (mRNA) vaccines against the SARS-CoV-2 virus during the COVID-19 crisis has catapulted the pharmaceuticals industry into a new paradigm. Their capacity, which facilitates the delivery of larger mRNAs and the co-delivery of multiple RNAs, enables new therapeutic mechanisms.

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Pharma Tutor

JUNE 18, 2020

The purpose of writing this review on floating drug delivery systems (FDDS) was to The recent developments of FDDS including the physiological and formulation variables affecting gastric retention, approaches to design single-unit and multiple-unit floating systems, and their classification and formulation aspects are covered in detail.

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Roots Analysis

MARCH 1, 2022

Interestingly, over the past few years, drug developers focused on non-respiratory diseases have also shifted their attention towards intranasal drug formulations. This can be attributed to ease of delivery, increased bioavailability and by-pass of first-pass metabolism offered by this type of route of administration.

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Roots Analysis

AUGUST 8, 2023

Furthermore, a wide variety of drugs and macromolecules, including DNA , proteins, and imaging agents, can be encapsulated in liposomal vesicles due to their unique ability to entrap both lipophilic and hydrophilic substances. The various therapeutic applications of liposomes in drug delivery have been highlighted in the figure.

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Outsourcing Pharma

APRIL 16, 2024

has unveiled its Alternative Methods Advancement Project (AMAP), a strong initiative aimed at changing drug discovery and development by exploring alternatives to animal testing. Charles River Laboratories International, Inc.

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BioPharma Reporter

MAY 20, 2022

The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded a total of $577m to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.

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BioPharma Reporter

AUGUST 21, 2024

A team of scientists from the universities of Glasgow and Tel Aviv has developed a groundbreaking method to transform the brain parasite Toxoplasma gondii into a potential vehicle for delivering therapeutic treatments directly to brain cells.

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BioPharma Reporter

JUNE 17, 2021

Sorrento Technologies, a biotech firm developing novel treatments for COVID-19 and aggressive cancers such as melanoma, has received FDA clearance to start a research collaboration together with Mayo Clinic.

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Pharmaceutical Technology

FEBRUARY 16, 2023

Ophthalmic technology firm Eyenovia and Formosa Pharmaceuticals have entered a collaboration agreement to develop new ophthalmic therapeutics. The collaboration will combine the Optejet dispensing technology of Eyenovia with the APNT nanoparticle formulation platform of Formosa to develop topical therapeutics.

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BioTech 365

JANUARY 22, 2021

Global Biotechnology, Drug Development and Drug Delivery Systems Nanoparticles Markets, 2019-2020 & 2025 – ResearchAndMarkets.com Global Biotechnology, Drug Development and Drug Delivery Systems Nanoparticles Markets, 2019-2020 & 2025 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Nanoparticles in Biotechnology, (..)

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Scienmag

JUNE 2, 2021

Texas A&M associate professor Akhilesh Gaharwar and graduate student Patrick Lee are developing a new class of hydrogels that can leverage light for drug delivery and regenerative medicine treatments. However, once inside, they can be challenging […].

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