Drug Discovery World

JUNE 5, 2023

Ariceum Therapeutics, a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, has acquired Theragnostics, a UK-based private biopharmaceutical company engaged in the development of radio-labelled PARP inhibitors for the diagnosis and treatment of tumours.

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Drug Discovery World

FEBRUARY 14, 2024

AlphaMedix is a targeted alpha therapy currently in Phase II clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles. In the Phase I study, treatment was well-tolerated, with a response rate of 62.5%

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The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. million treatment courses of PAXLOVID have been prescribed in the U.S. “Today marks a monumental milestone as PAXLOVID became the first COVID-19 oral treatment to be approved by the U.S.

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Drug Discovery World

JUNE 1, 2023

According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. Chief Medical Officer and Head of Global Product Development. Basel, 17 August 2020.

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The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Chief Medical Officer and Head of Global Product Development, Roche. “The Chief Medical Officer and Head of Global Product Development, Roche. A decision on U.S. Actemra/RoActemra is not U.S.

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Drug Discovery World

MAY 3, 2023

The study Vicore is conducting a randomised, double-blind, placebo-controlled, cross-over trial evaluating the effect of ATRAGs on endothelial dysfunction (reflecting blood vessel health) in patients with type-2-diabetes-mellitus (T2DM )1, a condition where endothelial dysfunction is central in the development of organ damage. The trial will (..)

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Drug Discovery World

NOVEMBER 23, 2023

As part of CALYX, Minoryx is conducting an extensive pre-screening MRI-based campaign aimed at identifying eligible adult X-linked Adrenoleukodystrophy (X-ALD) patients with cALD. In June 2023, the US Food and Drug Administration (FDA) approved CALYX’s trial of leriglitazone to treat adult male X-ALD patients with cALD.

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The Pharma Data

MARCH 28, 2022

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a 2.0 mg dose of Ozempic ® (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analogue for the treatment of adults with type 2 diabetes. Ozempic ® is now approved in the US at 0.5 mg and 2.0

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

JULY 12, 2021

Food and Drug Administration (FDA) has approved finerenone, the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist, under the brand name Kerendia ®. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development.

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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 received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019. Drug Enforcement Administration.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif.,

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The Pharma Data

AUGUST 24, 2020

It will investigate the safety, measure key biomarkers and assess surrogate markers of efficacy in its AGT103-T treatment. The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases.

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Drug Target Review

MAY 1, 2024

How have advancements in antibody-drug conjugates (ADCs) expanded treatment options for different types of cancer? The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development.

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Drug Discovery World

MARCH 7, 2023

She has managed multinational projects for charities and not-for-profits to find new treatments for Malaria and led Innovate UK grants through to successful completion. On the completion of the company’s seed funding, she said: “Whilst life expectancy has increased over recent years, our healthy lifespan has not kept up.

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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Kimberly Smith, M.D., About the long-acting regimen of cabotegravir and rilpivirine.

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The Pharma Data

OCTOBER 31, 2020

Food and Drug Administration (“FDA”) has approved the Investigation New Drug (IND) application for TG-1000, a novel treatment for influenza A and B. TAIPEI, Taiwan , Nov. 1, 2020 /PRNewswire/ — TaiGen Biotechnology Company, Limited (“TaiGen”) ( Taiwan : 4157) announced today that U.S. SOURCE TaiGen.

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The Pharma Data

MAY 31, 2022

The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment.

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Drug Discovery World

OCTOBER 4, 2022

Oligomerix’s portfolio of compounds is expected to provide a potentially lower-cost treatment alternative and/or complement to the newly emerging high-cost therapeutic options such as the monoclonal antibody products. Diseases such as PSP and FTD have no licensed and available treatments. With its recent award of $3.35

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). ADUHELM is indicated for the treatment of Alzheimer’s disease. ADUHELM is indicated for the treatment of Alzheimer’s disease.

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Drug Discovery World

SEPTEMBER 14, 2023

joined Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla. Regulatory developments There were several noteworthy developments across Pfizer’s pipeline, which were covered by DDW. Chris Boshoff, M.D.,

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The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. One step closer to a novel treatment.

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The Pharma Data

NOVEMBER 18, 2021

KEYTRUDA Is Now Approved for the Adjuvant Treatment of Patients With RCC at Intermediate-High or High Risk of Recurrence Following Nephrectomy, or Following Nephrectomy and Resection of Metastatic Lesions. KEYTRUDA Is the First Immunotherapy Approved for the Adjuvant Treatment of These Patients With RCC.

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The Pharma Data

DECEMBER 16, 2020

OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system.

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. “I

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The Pharma Data

JANUARY 6, 2021

As the compound was already approved by the FDA for its original indication, the companies are expecting significant savings in cost and time associated with its pre- or clinical development for the new indication. This patent is just the beginning of many results expected from our extended collaboration. Source link.

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The Pharma Data

APRIL 14, 2021

Xolair for self-injection offers healthcare providers and appr opriate patients another administration option for more flexibility in managing their treatment. Roche’s Chief Medical Officer and Head of Global Product Development. with Xolair since its initial approval in 2003. today announced that the U.S. indications.

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Drug Target Review

JANUARY 8, 2024

Following that work, it was discovered by Dr David Sinclair’s lab at Harvard that turning on only three of the four factors (OSK; Oct4, Sox2, Klf4) is the sweet spot for developing therapeutics where you can partially reprogram cells and restore cells to a more youthful state, while maintaining cell identity.

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Drug Discovery World

JULY 2, 2024

In 2005, Glycart was acquired by the Roche Group and integrated in Roche Pharma Research and Early Development (pRED). The centre currently has 58 pharma/biotech assets that are in pre-clinical development, alongside 29 that are being tested in clinical trials. References [link] [link].

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The Pharma Data

SEPTEMBER 29, 2020

Treatment becomes first and only biologic for HES in the US. GlaxoSmithKline’s Nucala has been approved by the US Food and Drug Administration (FDA) for the treatment of hypereosinophilic syndrome (HES), making it the first biologic approved in this indication. Source link.

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Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

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Drug Discovery World

NOVEMBER 24, 2022

The US Food and Drug Administration (FDA) has approved HEMGENIX (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with haemophilia B. . We are thrilled to witness this milestone in haemophilia B treatment,” said Kim Phelan, Chief Operating Officer of The Coalition for Hemophilia B.

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The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. The Company plans to initiate a Phase 2 trial within the next several months. “We

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The Pharma Data

APRIL 28, 2023

Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

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The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C. ,

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