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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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.

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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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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.

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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.

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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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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.

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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.

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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.

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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.

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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.

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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.

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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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Drug Discovery World

AUGUST 9, 2023

The new acquisition gives Biogen rights to Reata’s portfolio of products for neurological diseases, including the FDA-approved Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s ataxia (FA) in the United States.

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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.

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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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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.

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Drug Discovery World

OCTOBER 18, 2023

Such therapies have become an appealing drug modality for multiple conditions, including monogenic disorders, cancers, and infectious diseases. Food & Drug Administration (2017) FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss. She received a Ph.D. References 1: U.S.

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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.

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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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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.

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Drug Discovery World

MARCH 16, 2023

Ellipses Pharma, a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, has been granted Orphan Drug Designation (ODD) by the FDA for EP0042, a dual FLT-3 and Aurora kinase inhibitor, for the treatment of acute myeloid leukaemia (AML). In February (..)

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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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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.

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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.

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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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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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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.

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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.

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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.

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