Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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The Pharma Data

NOVEMBER 29, 2020

MDM2 is a key regulator of the tumor suppressor p53 and one of the most potent inhibitors of apoptosis discovered thus far. 1 Meanwhile, these MDM2 inhibitors present some challenges, including dose-limiting hematological toxicities, thus the urgent need to develop new generation of MDM2-targeting therapies in the treatment of cancer.

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The Pharma Data

DECEMBER 13, 2020

We are excited to partner with Relay Therapeutics, and we believe that the combination of KRAS G12C and SHP2 inhibitors together represents a promising approach that we hope could become a new treatment option for patients with KRAS G12C mutant tumors.”. About RLY-1971.

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The Pharma Data

DECEMBER 1, 2020

Rapid and substantialimprovement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. NEW YORK, Dec.

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. (OTCQB: QBIO), announced today that the U.S. billion by 2027. .

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SugarCone Biotech

JUNE 10, 2024

This is where things get interesting due to the complexity of the immune system and its regulation. PD-L1 expression in the TME is a surprisingly poor biomarker for the clinical efficacy of anti-PD-1 and anti-PD-L1 blocking antibodies, despite the use of PD-L1-directed assays in determining patient treatment protocols.

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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] Comenzo, M.D., Director, John C.

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The Pharma Data

DECEMBER 23, 2020

Algernon has filed new intellectual property rights globally for NP-120 (Ifenprodil) for the treatment of respiratory diseases and is working to develop a proprietary injectable and slow release formulation. Algernon specifically investigates compounds that have never been approved in the U.S. CONTACT INFORMATION. Christopher J.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Sponsors should plan to justify the inclusion of a psychotherapy component.”

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The Pharma Data

JANUARY 18, 2021

BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments in mental disorders and viral infections, is pleased to announce that Health Canada has confirmed that 2-bromo-LSD is not a controlled substance. VANCOUVER, Jan.

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The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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Drug Discovery World

JANUARY 2, 2024

However, she believes perhaps the biggest issue with treatment development is simply: it takes too long. She said: “The speed is not sustainable. Covid, she says, proved to us what could be done in a very short period of time, particularly in the case of the mRNA vaccine. He said: “We welcome the announcement today.

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The Pharma Data

MARCH 4, 2021

Our goal is to one day bring new treatment options that provide greater seizure control, tolerability and function to DS and LGS patients around the world.”. Advancing New Treatment Options for DS and LGS Patients. Lennox-Gastaut syndrome can be caused by a variety of underlying conditions, but in some cases no cause can be identified.

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The Pharma Data

DECEMBER 23, 2020

This patent application, filed with the United States Patent & Trademark Office (“U.S.P.T.O.”), is titled: “MEDICATED CBD COMPOSITIONS, METHODS OF MANUFACTURING, AND METHODS OF TREATMENT.” U.S. is Titled “MEDICATED CBD COMPOSITIONS, METHODS OF MANUFACTURING, AND METHODS OF TREATMENT”. 62/990,709.

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The Pharma Data

OCTOBER 15, 2020

We are excited to share this new clinical data for naxitamab, which we believe could be a very important new treatment for high-risk neuroblastoma patients, if approved. Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. About Y-mAbs. Contact: Y-mAbs Therapeutics, Inc.

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The Pharma Data

NOVEMBER 26, 2020

The first one relates to the development of a Pharmaceutical grade version of Tauri-Gum , for nausea regulation (specifically designed to help patients that are subjected to ongoing chemotherapy treatment). is Titled “MEDICATED CBD COMPOSITIONS, METHODS OF MANUFACTURING, AND METHODS OF TREATMENT”. Contact: .

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S.

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The Pharma Data

AUGUST 5, 2020

Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis 1 . Showed the annual rate of brain volume loss was not significantly different (MRI-related secondary endpoint) 1. 10% of patients 1,3.

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The Pharma Data

DECEMBER 20, 2020

It is our continual objective to broaden our product scope, and Transcend, with its experienced management team, is a perfect foothold for us in the fast-growing market for psychedelics molecules and complements our existing pipeline of treatments.

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The Pharma Data

OCTOBER 20, 2020

(NASDAQ: ARTL) , a clinical stage biopharmaceutical company focused on developing and commercializing treatments intended to modulate endogenous signaling pathways, including the endocannabinoid system, today announced that it has filed a method of use patent with the U.S. Gorgas, Artelo’s President and CEO. PTSD affects approximately 3.5

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The Pharma Data

AUGUST 30, 2021

We know that long-term exposure to persistently elevated LDL-C increases the risk of ASCVD, which may lead to cardiovascular events such as heart attack or stroke. Treatment-emergent serious adverse events (TESAEs) were reported more frequently in patients with PVD, which was likely due to their more advanced disease 2.

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Codon

JANUARY 21, 2024

yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Scientists studied black men infected with syphilis for several decades while withholding known treatments. You can do a challenge trial with deadly diseases, but you need a “rescue therapy.”

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The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. LONDON and BOSTON, Jan.

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The Pharma Data

JANUARY 10, 2021

for the treatment of plaque psoriasis, became the first drug based on MorphoSys’ antibody technology to receive regulatory approval. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., In July 2020, the U.S. View source version on accesswire.com: [link].

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The Pharma Data

AUGUST 29, 2020

Inclisiran is currently under review by the FDA and the EMA for the treatment of primary hyperlipidemia (including Heterozygous Familial Hypercholesterolemia) in adults who have elevated LDL-C while being on a maximally tolerated dose of statin therapy. 30% with a mean reduction of 54.1% from baseline (observed values) 2 .

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The Pharma Data

DECEMBER 14, 2020

BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech focused on the development and commercialization of cutting edge treatments, today announced the value proposition of its acquisition of Transcend Biodynamics, LLC ’s (“Transcend”) manufacturing patent “Process of synthesizing 2-Bromo-LSD.”.

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The Pharma Data

JANUARY 13, 2021

There remains a significant need for new treatments with improved activity and tolerability to prevent or treat organ transplant rejection and to treat autoimmune conditions, including systemic lupus erythematosus, rheumatoid arthritis and multiple sclerosis.”. 1 Lederman, S. Also, etanercept (Enbrel®) is a TNF?

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The Pharma Data

MARCH 22, 2021

The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants, based on the recently updated EUA guidance from the U.S. Number of patients with events. Serious adverse events (SAEs) were largely related to COVID-19 and occurred in 1.1% Patients with ?

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The Pharma Data

JULY 27, 2021

” The acquisition will also add TNB-585, a Phase 1 bispecific T cell-engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings. chief executive officer of Teneobio. ” In June 2021, AbbVie Inc.

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The Pharma Data

DECEMBER 12, 2020

The medicine is approved in many countries for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica spectrum disorder. 5% have US Food and Drug Administration -approved treatments. Morgan Cazenove) (“J.P.

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The Pharma Data

JANUARY 27, 2021

Entered an exclusive license and supply agreement with Accord Healthcare for ZUBSOLV® covering 29 European countries. Important events after the period. With the ongoing Covid-19 pandemic having significantly worsened this crisis, there is a pressing need increase access to treatment.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. Persons”, as such term is defined in Regulations under the U.S. PharmaDrug Inc.

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The Pharma Data

NOVEMBER 2, 2020

for the Treatment of Achondroplasia. This acceptance by the FDA marks the first marketing application accepted for a treatment for achondroplasia in the United States. The study will be followed by a subsequent open-label extension trial when all subjects receive active treatment. If approved, 1st Therapy in U.S.

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Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

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The Pharma Data

SEPTEMBER 8, 2020

About AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

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