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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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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XTalks

JUNE 14, 2023

percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. Attendees will understand best practices for novel drug delivery design and development. Attendees will understand best practices for novel drug delivery design and development. What Is Dry Eye Disease?

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Gene Silencing Drug Delivery FDA Approval RNA 97

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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XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) granted approval to AstraZeneca’s Airsupra (albuterol/budesonide), formerly known as PT027, for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in individuals aged 18 years and older who have asthma.

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FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately.

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pharmaphorum

NOVEMBER 7, 2022

SAE Media Group reports: Mitchell de Long, Vice President, Chemistry from Aerie Pharmaceuticals and Naj Sharif, Vice President, Ophthalmology Innovation Center from Santen Inc USA cordially invite industry experts to speak at the 5th Annual Ophthalmic Drugs Conference. Ophthalmic Drugs. This event is less than four weeks away.

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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

AUGUST 30, 2022

According to an analysis of the 2013 Medical Expenditure Panel Survey, one in six US adults reported taking a psychiatric drug at least once in 2013. CNS drugs treat a range of neurologic and psychiatric disorders, such as psychosis, depression, Parkinson’s disease, multiple sclerosis and epilepsy.

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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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Roots Analysis

FEBRUARY 22, 2022

Further, in order to improve the quality of life in these patients, companies have developed novel devices capable of delivering a variety of formulations of different drugs / therapies, in an efficient and relatively simple manner. Autoinjector As Emerging Drug Delivery Device.

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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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FDA Approval Generic Drugs Marketing Drug Delivery 59

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

” XTALKS WEBINAR: Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems Live and On-Demand: Thursday, June 15, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn about the differences and similarities between the US and EU regulatory frameworks for co-packaged combination products.

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Drug Discovery World

OCTOBER 18, 2023

Promising therapies are stumbling in clinical trials AAV vector-based gene therapies use modified viruses as drug delivery vehicles to effectively introduce DNA sequences into cells via transduction. Food & Drug Administration (2017) FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss.

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Gene Therapy Gene Clinical Trials Clinical Trials 64

FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. Of course, the statute says that only drug formulation, composition, or method of use patents are listable, but FDA has not defined the scope of the “drug” that must be covered by the patent.

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The FDA approved EYSUVIS based on the positive results from one Phase II and three Phase III trials.

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FDA Approval Immune Response Drug Delivery Drugs 52

Pharma Mirror

FEBRUARY 18, 2021

Maculus plans to raise USD3 million on a USD8 million valuation for a 12-18 month period, including initial in-vivo animal studies and completion of in-vitro / in-vivo drug elution studies. Capable of delivering any FDA approved.

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Drug Discovery World

MARCH 16, 2023

2 EP0042’s ongoing clinical-stage study follows earlier drug discovery and development work led by The Institute of Cancer Research, London, which was funded by organisations including The Institute of Cancer Research, Breast Cancer Now and Cancer Research UK. International Journal of Molecular Science, 21(4): 1537. and Wang, H-G.

Drugs 52

Drugs FDA Approval Development Research 52

Delveinsight

NOVEMBER 26, 2020

Retinal vein occlusion drug market. The treatment options such as Intravitreal injection of anti-vascular endothelial growth factor (VEGF) drugs, and Intravitreal injection of corticosteroid drugs. Intraocular injections of steroids are another potential treatment for eyes that don’t respond to anti-VEGF drugs.

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FDA Approval Marketing Drug Delivery Systems Drugs 63

Drug Discovery World

JUNE 23, 2023

The US Food and Drug Administration (FDA) has given approval to Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection with Enhanze for subcutaneous (SC) use for the treatment of generalised myasthenia gravis (gMG).

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FDA Approval Drug Delivery Antibody Drugs 52

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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Marketing Pharma Companies Drug Delivery Clinical Trials 52

Camargo

OCTOBER 14, 2020

The second guidance, “ ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs ,” deals with the not uncommon situation wherein an ANDA application has received tentative approval because of a Paragraph III patent certification in the original application.

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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. So far, all the other antibodies are also delivered by intravenous infusion.

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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]. DRUG INTERACTIONS.

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Drug Delivery Systems Drug Delivery Trials Drugs 52

The Pharma Data

JANUARY 17, 2021

a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, today announced dose administration for the first patient in a Phase 2a clinical study of the company’s lead drug candidate, STP705, for the treatment of cutaneous basal cell carcinoma. GAITHERSBURG, Md.

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The Pharma Data

JANUARY 6, 2021

The approach used to turn botulinum toxin into a kind of Trojan horse that delivers a cargo into neurons has enormous potential for future drug development,” noted Thomas C. “This is a landmark study in converting the power of lethal botulinum neurotoxins into therapies. Südhof, M.D.,

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Medicine Antibody Protein In-Vitro 52

Pharmaceutical Technology

APRIL 24, 2023

Researchers may develop nanodrugs due to their smaller surface area to allows drugs to dissolve faster, or nanoparticles may encapsulate drugs, so they last longer in the body. Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages.

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The Pharma Data

MAY 5, 2021

Lilly hit by staff accusations, FDA scrutiny at COVID drug factories ( Reuters ). Pharma showers Menendez with rare, off-cycle burst of campaign cash as Democrats eye drug pricing reforms ( STAT ). New Scottish Agency Would Ensure Supply Of Cost-Effective Drugs ( Pink Sheet ).

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Vaccination Vaccine Gene Therapy Contract Packaging 52