XTalks

JULY 26, 2024

These issues primarily stem from patients and healthcare providers miscalculating or incorrectly administering the drug. Compounded semaglutide products, unlike the US Food and Drug Administration (FDA)-approved ones, can vary widely in strength and packaging, making it easy for mistakes to happen.

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Drug Delivery Systems FDA Approval Drug Delivery Containment 97

Pharmaceutical Technology

APRIL 17, 2023

SNBL chairman and president Dr Ryoichi Nagata said: “We are very pleased to announce that SNBL will be involved in the launch of this novel intranasal drug, which was developed based on SNBL’s novel intranasal drug delivery platform technology, pending potential FDA approval. “We

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Drugs Drug Delivery FDA Approval Licensing 147

Pharmaceutical Technology

FEBRUARY 13, 2023

Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility.

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Drug Delivery Systems FDA Approval Bioavailability Drug Delivery 130

XTalks

MARCH 21, 2025

The rankings are based on each companys ability to tackle critical challenges from drug delivery and diagnostics to personalized therapies using cutting-edge science. Following Neffys FDA approval , ARS Pharma reported $2.3 Here are 20 companies leading the way in 2025. million in fourth-quarter (Q4) 2024 net revenue.

Genome 59

Genome Genomics FDA Approval Trials 59

Outsourcing Pharma

AUGUST 13, 2024

Patients suffering from severe allergic reactions now have access to a new, needle-free treatment option, as the US Food and Drug Administration (FDA) has approved neffy, a 2 mg epinephrine nasal spray developed by ARS Pharmaceuticals, Inc.

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FDA Approval Drugs Development Drug Delivery 90

Scienmag

JUNE 3, 2022

The repurposing of FDA-approved drugs for alternative diseases is a faster way of bringing new treatments into the clinic. Researchers at Karolinska Institutet in Sweden have repurposed a cancer drug for treatment of neuroinflammatory diseases such as multiple sclerosis.

Drugs 73

Drugs Drug Delivery FDA Approval Clinical Research 73

XTalks

SEPTEMBER 16, 2024

Ocrevus Zunovo uses Halozyme Therapeutics’ Enhanze drug delivery technology , which enhances absorption by temporarily increasing the permeability of the subcutaneous tissue. The enzyme rHuPH20 enables rapid dispersion of the drug into the bloodstream.

FDA Approval 59

FDA Approval Antibody Drug Delivery Drugs 59

The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock.

FDA Approval 52

FDA Approval Drug Delivery Development Doctor 52

Outsourcing Pharma

JULY 23, 2024

Rusan Pharma Private Limited has announced that its active pharmaceutical ingredient (API) manufacturing facility in Ankleshwar, Gujarat, has been granted Good Manufacturing Practice (GMP) approval by the FDA.

Manufacturing 81

Manufacturing FDA Approval Drug Delivery Drugs 81

XTalks

AUGUST 14, 2024

XTALKS : Changes are Coming to Prefilled Injectable Drug Delivery Systems Live and On-Demand: Thursday, September 12, 2024, at 1pm EDT (10 am PDT) Register for this webinar today to learn more about the future of injectable drug delivery systems and the impact of blow-fill-seal technology.

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Drug Delivery Systems Dermatology Drug Delivery Antibody 111

XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. Following the announcement, Valnevas stock rose by 1.4%.

Immune Response 59

Immune Response Vaccine Vaccination Trials 59

XTalks

JANUARY 18, 2023

Ayesha also talked about the FDA approval of AstraZeneca’s asthma inhaler Airsupra, the first-in-class drug that contains both a beta agonist and corticosteroid. The inhaler is approved as a rescue medication for adults with asthma to help treat bronchoconstriction and asthma attacks.

Life Science 52

Life Science FDA Approval Containment Scientist 52

XTalks

JUNE 14, 2023

XTALKS WEBINAR: Drug Delivery — Evaluating Off-The-Shelf and Novel Drug Delivery Solutions Live and On-Demand: Tuesday, July 11, 2023, at 1pm EDT (10am PDT) Register for this free webinar to learn about important tradeoffs when considering an off-the-shelf (OTS) drug delivery platform vs. novel development.

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Gene Silencing Drug Delivery FDA Approval RNA 97

XTalks

JANUARY 17, 2023

Airsupra is being jointly developed by AstraZeneca and Avillion, also a UK-based drug development company that received funding from. Related: Lung Disease Diagnostic Xenoview Gets FDA Approval for Use with MRI. The FDA approval was based on results from the MANDALA, DENALI and TYREE Phase III studies.

FDA Approval 97

FDA Approval Containment Allergies Drugs 97

pharmaphorum

NOVEMBER 4, 2020

That includes include France’s Inotrem, which is developing nangibotide in phase 2 testing for septic shock, and Dublin-based Priothera, which is developing immuno-oncology drug mocravimod in phase 2b/3 for acute myeloid leukaemia (AML) in partnership with Kyowa Kirin.

Life Science 96

Life Science Drug Delivery FDA Approval Drugs 96

Camargo

OCTOBER 14, 2020

In this situation, the timing and content of amendments following tentative approval can be complicated; Camargo can help sponsors navigate the process. Approval of the Month: FDA Approves First Closed-Loop Monitoring and Drug Delivery Device.

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Development Insulin Drug Delivery Production 196

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.

FDA Approval 52

FDA Approval Production Research Development 52

XTalks

NOVEMBER 3, 2021

The team also learned about the FDA approval of Genentech’s new ocular implant drug delivery system, called Susvimo, for the treatment of neovascular, or wet, age-related macular degeneration (nAMD). Read the full articles here: FDA Authorizes Pfizer/BioNTech COVID-19 Vaccine for Kids 5 to 11.

Life Science 52

Life Science Drug Delivery Systems Vaccine Vaccination 52

XTalks

AUGUST 30, 2022

One of the biggest challenges with developing therapies to treat CNS disorders is the delivery of systemically administered investigational products (IPs) to the brain, which is limited by the blood-brain barrier. Some methods of direct CNS administration include intrathecal, intraparenchymal and intracerebroventricular (ICV) delivery.

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Trials Drug Delivery Drugs Gene 83

XTalks

MAY 18, 2023

In addition, Resonant Link can charge implants that are as small as 3 mm in diameter and implanted up to 6 cm deep, all while meeting the US Food and Drug Administration (FDA)-mandated temperature limits for implants that prevent surrounding tissues from burning. Our wireless charging for titanium cans changes all of that.”

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Development Packaging Packaging Manufacturing 96

FDA Law Blog

JUNE 13, 2024

FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug.

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Drug Delivery Systems Drugs Production Drug Delivery 116

pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now.

FDA Approval 59

FDA Approval Generic Drugs Marketing Drug Delivery 59

Roots Analysis

FEBRUARY 22, 2022

Autoinjector As Emerging Drug Delivery Device. The generic version of EpiPen received the FDA approval in 2018. Further, given the multidisciplinary requirements of this class of drug delivery devices, several companies have entered into product co-development and co-commercialization agreements as well.

Drug Delivery 52

Drug Delivery Production Marketing Development 52

The Pharma Data

OCTOBER 26, 2020

EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. Kala’s proprietary AMPPLIFY drug delivery technology is what gets EYSUVIS its backstage pass to penetrate the mucus barrier and delivering the loteprednol etabonate (LE) to the ocular tissue. INVELTYS launched in the U.S.

FDA Approval 52

FDA Approval Immune Response Drug Delivery Drugs 52

Delveinsight

NOVEMBER 26, 2020

Fortunately, there are FDA-approved products present in the Retinal vision occlusion drug market including Lucentis (ranibizumab), Eylea (aflibercept), and Ozurdex (dexamethasone intravitreal implant) with Avastin in use as an off-label therapy to help manage the condition and improve the vision.

Marketing 63

Marketing FDA Approval Drugs Drug Delivery Systems 63

XTalks

JUNE 11, 2024

Drug-eluting stents (DES): DES reduce the incidence of restenosis and are coated with drugs that inhibit scar tissue growth. DCBs: DCBs, such as the Agent DCB, combine mechanical widening of the artery with drug delivery to the vessel wall to prevent cell proliferation.

Drugs 52

Drugs Drug Delivery Cardiology Marketing 52

FDA Law Blog

SEPTEMBER 19, 2023

The FTC expressed concern that patent listings that do not meet the statutory criteria undermine the competitive process, may disincentivize investment in developing generic and follow-on products, and reduce patient access to more affordable drugs thereby increasing costs to the healthcare system.

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Drugs Branding Drug Delivery Systems Generic Drugs 105

pharmaphorum

NOVEMBER 7, 2022

The conference will explore advancements in ophthalmic treatments and variety of novel drugs, which are showing great clinical trial data. There will also be a specific focus on drug delivery along with advancements in novel technologies.

Drugs 52

Drugs Gene Therapy Clinical Trials Clinical Trials 52

XTalks

MAY 30, 2024

This innovative formulation uses Halozyme’s Enhanze drug delivery technology, facilitating the subcutaneous administration of biologics. New CIDP Treatments on the Market In January 2024, the FDA approved Takeda’s Gammagard Liquid for the treatment of CIDP in adults.

FDA Approval 40

FDA Approval Immune Response Trials Drug Delivery 40

Delveinsight

NOVEMBER 29, 2020

Looking at the potential of the pipeline therapies they hold once approved, pharmaceutical companies are charting out a seemingly exciting course in the market. Therapies such as dexamethasone drug delivery system and vascular endothelial growth factor inhibitors have already pierced deeper into the market.

Marketing 52

Marketing Drug Delivery Pharma Companies Clinical Trials 52

pharmaphorum

JUNE 22, 2021

GlaxoSmithKline (GSK) has reported encouraging data for its COVID-19 antibody sotrovimab, and an alliance with Halozyme to develop a new generation of long-acting HIV drugs, as it prepares to give a much-anticipated update to shareholders tomorrow.

Antibody 52

Antibody Protein Drug Delivery Drugs 52

The Pharma Data

JANUARY 17, 2021

“This marks another significant milestone as we continue to leverage our polypeptide nano-particle technology for siRNA drug delivery to advance our pipeline of oncology therapeutic candidates,” said Patrick Lu , Ph.D., the founder, President and CEO of Sirnaomics. Chief Medical Officer.

Gene Expression 52

Gene Expression Trials Development Production 52

FDA Law Blog

MARCH 12, 2024

It’s difficult to conclude from these statements, as FTC and Congress appear to have, that device patents categorically shouldn’t be listed in the Orange Book.

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Drugs Drug Delivery Systems Regulation Production 45

The Pharma Data

JANUARY 6, 2021

Standard antibodies cannot access toxin already inside neurons, and thus BAT® (Botulism AntiToxin, a product of Emergent BioSolutions), the only FDA-approved antitoxin, is only effective while the toxin remains in the circulation.

Medicine 52

Medicine Antibody Protein In-Vitro 52

The Pharma Data

AUGUST 31, 2021

Additionally, Janssen will present an update on the Phase 3 SunRISe-2 trial evaluating an investigational intravesical drug delivery system, TAR-200, in combination with the programmed cell death receptor-1 (PD-1) inhibitor cetrelimab in muscle-invasive urothelial carcinoma (Abstract # MP13-17). [1]. 2] ERLEADA ® received U.S.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs Trials 52

Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

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Drug Delivery Vaccine Vaccination Research 147

The Pharma Data

MAY 5, 2021

FDA approves 100th monoclonal antibody product ( Nature Reviews Drug Discovery ). Esker, a new biotech startup, launches with plans to make targeted immune drugs ( BioPharma Dive ). Microneedles are promising devices for painless drug delivery with minimal side effects ( EurekAlert ).

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Vaccine Vaccination Gene Therapy Contract Packaging 52