Pharmaceutical Technology

FEBRUARY 3, 2023

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective. As with any pharmaceutical manufacturing, challenges can be many, and processes are highly regulated.

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pharmaphorum

JANUARY 16, 2023

Rykindo has been approved for the treatment of schizophrenia and as monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults by the US regulator.

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Pharmaceutical Technology

MARCH 7, 2023

Frewitt also ensures that equipment conforms to required levels of ATEX or NEC (regulated) protection and can monitor temperature and amperes of processes, to ensure that the product flow and dosing of material remain stable and compatible with the set temperature and motor load. [i]

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FDA Law Blog

JULY 6, 2021

Nostrum noted that FDA regulations define a CRL as a determination that FDA “will not approve the application or abbreviated application in its present form.” Because Nostrum refused to make the changes required by the CRL, Nostrum argued, the Agency inherently has refused to approve that application.

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Delveinsight

AUGUST 10, 2020

Nintedanib is an orally bioavailable, small-molecule tyrosine kinase inhibitor (TKI) developed for the treatment of IPF and SSc-ILD. Boehringer Ingelheim is worth mentioning here, as it is presenting key posters and studies on Ofev’s SENSCIS Trial and INBUILD Trial. Ofev (Nintedanib) Facts. Esbriet (Pirfenidone) Facts.

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The Pharma Data

JANUARY 3, 2021

The information in the press release is information that Nanoform is obliged to make public pursuant to the EU Market Abuse Regulation. . +46 7686 650 11. 1 Good Manufacturing Practice. 2 Proof of Concept. 3 Active Pharmaceutical Ingredient. Finnish time. About Nanoform. Nanoform is an innovative nanoparticle medicine enabling company.

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The Pharma Data

NOVEMBER 26, 2020

The information in the press release is information that Nanoform is obliged to make public pursuant to the EU Market Abuse Regulation. For investor relations queries, please contact: Henri von Haartman , Director of Investor Relations hvh@nanoform.com / +46 7686 650 11. Finnish time. About Nanoform.

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The Pharma Data

MARCH 11, 2021

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). Session Date and Time: Monday, April 12, 2021 1:30 PM – 3:15 PM ET. Abstract Number: 1236. Session Title: Novel Antitumor Agents.

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The Pharma Data

JANUARY 27, 2021

Each study is planned to be carried out over an approximately two-week period as an open label, randomized, crossover, two-period, two-sequence, single dose pilot study to assess the relative bioavailability of each product. SOURCE: XPhyto Therapeutics Corp. View source version on accesswire.com: [link].

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XTalks

AUGUST 30, 2022

A major obstacle for CNS drug developers is the inability to target therapies to the CNS broadly (for instance, a therapy that is orally bioavailable as a pill and has difficulty crossing the blood-brain barrier) and certain CNS regions more specifically. The patients are waiting! Modern-Day Applications of Direct CNS Administration.

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Delveinsight

SEPTEMBER 8, 2021

Baricitinib, also known as LY3009104 or INCB028050 , is a novel orally bioavailable inhibitor of the tyrosine-protein kinase JAK1 or JAK2. Other attempts to modulate the immune response in SLE, with little success to date, have been made further downstream in the immune cascade, most notably in the regulation of B-cells.

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The Pharma Data

DECEMBER 3, 2020

Maribavir, an orally bioavailable anti-CMV compound, is the only antiviral agent presently in Phase 3 development for the treatment of post-transplant patients with CMV in SOT or HSCT. In transplant recipients, reactivation of CMV can lead to serious consequences including loss of the transplanted organ and, in extreme cases, can be fatal.

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The Pharma Data

DECEMBER 1, 2020

AXS-05 is also a sigma-1 receptor agonist; enhances brain levels of serotonin, noradrenaline, and dopamine, which are key neurotransmitters involved in the regulation of mood; and displays anti-inflammatory properties, which may be relevant to treating depression. AXS-05 is covered by more than 93 issued U.S.

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FDA Law Blog

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. For drugs, the relevant studies are any Phase 3 study or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies). 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). 355(z)(3) and 21 U.S.C.

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