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. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA).

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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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XTalks

NOVEMBER 4, 2021

Now, instead of reaching for reading glasses, AbbVie’s eyedrop formulation Vuity could offer help in correcting far-sightedness as the US Food and Drug Administration (FDA) granted approval to it late last week. With the approval, Vuity becomes the first eyedrop approved for presbyopia. Vuity is a 1.25

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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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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

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 Recursion Recursion launched the LOWE AI-driven drug discovery platform, reporting $51.1

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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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XTalks

AUGUST 14, 2024

The US Food and Drug Administration (FDA) has approved Galderma’s monoclonal antibody Nemluvio (nemolizumab) for the treatment of adult patients with the chronic skin condition prurigo nodularis. Monoclonal antibody therapy has been found to have fewer side effects when compared to immunosuppressant drugs.

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XTalks

SEPTEMBER 16, 2024

In a new regulatory milestone, the US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq), introducing the first-ever subcutaneous injection option for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). billion in 2024 to $38.94

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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%.

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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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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.

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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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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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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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FDA Law Blog

JUNE 13, 2024

Though some drug companies have been reluctant to delist certain patents from the Orange Book, the District Court of New Jersey just ordered Teva to delist 5 of its patents that it deemed improperly listed. The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable.

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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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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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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

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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XTalks

JUNE 11, 2024

The US Food and Drug Administration (FDA) recently approved Boston Scientific’s Agent drug-coated balloon (DCB) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease (CAD). Repeat PCI: For patients experiencing restenosis, a repeat PCI procedure can be performed.

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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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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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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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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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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 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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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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XTalks

MAY 30, 2024

Potential New CIDP Treatment: argenx’s Efgartigimod Alfa The US Food and Drug Administration (FDA) has accepted argenx’s supplemental Biologics License Application (sBLA) for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for priority review to treat CIDP.

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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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XTalks

NOVEMBER 5, 2024

Its lead candidate, PL-14, targets nasal allergies and is scheduled for US Food and Drug Administration (FDA) submission via the 510(k) pathway, with preclinical trials expected to start in the second quarter of 2025 and pivotal trials by the end of 2025.

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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

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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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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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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