FDA Law Blog

JULY 23, 2024

FDA recently released a much-anticipated draft guidance to address these frequent questions: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. Drug delivery includes successful product preparation and the initiation, progression, and completion of dose delivery.

Drug Delivery 105

Drug Delivery Drugs Bioequivalency Production 105

XTalks

JANUARY 29, 2025

Highlights include expansion of biotech operations in Philadelphia, acquisition of a new pharma-device facility near Dublin, Ireland, and a new Center of Excellence for advanced drug delivery and drug-device combination product assembly in Rockford, Illinois.

Drug Delivery 52

Drug Delivery Production Packaging Packaging 52

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.

Drug Delivery 91

Drug Delivery Drugs Development 91

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.

Drug Delivery 93

Drug Delivery Drugs Development 93

Camargo

NOVEMBER 24, 2020

Why is pulmonary drug delivery a complex challenge? Pulmonary delivery is highly specialized, and despite our vast and growing understanding of respiratory diseases and aerosol technologies, developing new and improved inhaled medicines still presents a number of challenges, particularly in getting the drug delivered to its target.

Drug Delivery 130

Drug Delivery Drugs Allergies Medicine 130

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.,

Drug Delivery Systems 74

Drug Delivery Systems Drug Delivery Drugs Research 74

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.

Development 196

Development Insulin Drug Delivery Production 196

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).

Drug Delivery 96

Drug Delivery Development Drugs 96

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.

Drug Delivery Systems 97

Drug Delivery Systems Drug Delivery Scientist Engineer 97

pharmaphorum

MARCH 24, 2025

Researchers in the US have devised a new depot system that could provide months or even years of delivery from a single subcutaneous injection.

Drug Delivery 66

Drug Delivery Development Drugs Research 66

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.

Drug Delivery 130

Drug Delivery Protein Drugs Development 130

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.

Development 130

Development Drug Delivery Systems Drug Delivery Clinical Trials 130

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.

Drug Delivery 52

Drug Delivery Drugs Engineer Production 52

pharmaphorum

AUGUST 5, 2020

Workshop will be on ‘Ophthalmic Drug Delivery Development – Trials and Tribulations’. Ophthalmic Drug Delivery is compelling for many reasons, including the major issue of patient compliance and tolerability of therapies. Hosted by Brian Levy, CEO, Ocunexus Therapeutics. About the workshop leader.

Drug Delivery 52

Drug Delivery Development Trials Drugs 52

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.

Drug Delivery Systems 104

Drug Delivery Systems Drug Delivery FDA Approval Drugs 104

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.

Development 130

Development Gene Therapy Drug Delivery Gene 130

pharmaphorum

SEPTEMBER 23, 2020

Programmable Oligonucleotide Delivery System (PODS), developed by Sixfold Bioscience, is a versatile system which delivers short interfering RNA (siRNA) gene silencing cargo to specific cancer cells.

Drug Delivery Systems 141

Drug Delivery Systems Gene Silencing Drug Delivery Medicine 141

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.

Drug Delivery 98

Drug Delivery Drugs Development 98

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.

Development 81

Development Drug Delivery Licensing Licensing 81

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.

Drug Delivery 52

Drug Delivery Drug Delivery Systems Drugs Marketing 52

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.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs Pharmacy 52

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.

Drug Delivery 85

Drug Delivery Drugs Development 85

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.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs Bioavailability 52

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.

Drug Delivery 92

Drug Delivery Drugs Development 92

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.

Drug Delivery 98

Drug Delivery Development Drugs Research 98

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, (..)

Drug Delivery Systems 40

Drug Delivery Systems Drug Delivery Marketing Development 40

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 […].

Drug Delivery 97

Drug Delivery Engineer Medicine Drugs 97

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.

Drug Delivery 147

Drug Delivery Compliance Development Drugs 147

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.

Drugs 147

Drugs Drug Delivery FDA Approval Licensing 147

BioTech 365

OCTOBER 11, 2021

Celsion GmbH Announces the Publication of an Article Reviewing the History of ThermoDox® Drug Development in Advanced Drug Delivery Reviews Celsion GmbH Announces the Publication of an Article Reviewing the History of ThermoDox® Drug Development in Advanced Drug Delivery Reviews … Continue reading →

Drug Delivery 40

Drug Delivery Development Drugs 40

BioPharma Reporter

JULY 30, 2024

In the rapidly evolving field of pharmaceuticals, the development of parenteral drugs and bioconjugates presents unique challenges and opportunities.

Development 95

Development Drugs Drug Delivery 95

BioPharma Reporter

NOVEMBER 21, 2022

Oramed Pharmaceuticals, a company focused on the development of oral drug delivery platforms, has signed an exclusive commercial distribution agreement for the Republic of Korea with local player, Medicox Co Ltd, in relation to its oral insulin candidate.

Insulin 95

Insulin Drug Delivery Development Drugs 95

Roots Analysis

SEPTEMBER 18, 2023

Therefore, medical technology is rapidly evolving, enabling more advanced and patient-friendly methods of drug delivery. In the pursuit of creating patient-centric healthcare solutions, the medical industry has witnessed a groundbreaking advancement in drug delivery with the emergence of large volume wearable injectors.

Drug Delivery 52

Drug Delivery Drugs Compliance Marketing 52

BioPharma Reporter

AUGUST 21, 2024

In a promising advancement, scientists from the University of North Carolina at Chapel Hill and Emory University have developed a novel drug delivery system using synthetic amyloid beta (AÎ) peptides.

Drug Delivery Systems 52

Drug Delivery Systems Development Drug Delivery Research 52

BioPharma Reporter

APRIL 26, 2021

Join us and our expert panel for our webinar, Innovations in Drug Delivery, next week.

Drug Delivery 52

Drug Delivery Medicine Drugs Development 52

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.

Development 91

Development Drugs Drug Delivery 91

BioTech 365

JUNE 22, 2021

ViiV Healthcare and Halozyme enter global collaboration and license agreement for ENHANZE® drug delivery technology to enable development of “ultra long-acting” medicines for HIV ViiV Healthcare and Halozyme enter global collaboration and license agreement for ENHANZE® drug delivery technology to … Continue reading →

Drug Delivery 40

Drug Delivery Licensing Licensing Medicine 40