Drug Discovery World

JUNE 1, 2023

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. DDW’s Megan Thomas explores three trends in the market.

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Drug Discovery World

OCTOBER 18, 2023

Sara Donnelly, Director of Research Planning and Business Development at PhoenixBio USA explores why the right pre-clinical model is essential for teams wanting to advance adeno-associated virus vector-based gene therapies. Adeno-associated virus (AAV) vector-based gene therapies hold exceptional promise across a range of disease areas.

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Drug Discovery World

AUGUST 23, 2024

It’s been a busy week for medical regulatory agencies, with a number of key decisions made on therapies for graft-versus-host-disease, neuroendocrine carcinoma, haemophilia B, lymphoma and non-small cell lung cancer. News round-up for 19-23 August by DDW Senior Digital Content Editor Diana Spencer.

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Drug Discovery World

AUGUST 14, 2023

Lung-I Cheng, Vice President and Head of Cell & Gene Therapy Service Line at AmerisourceBergen, and Cori Gorman, Senior Director of CMC and Regulatory Affairs at Biopharma Excellence, offer advice on navigating the different and sometimes contradictory regulatory requirements in the US and EU. billion in 2020 to $15.5

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Drug Discovery World

FEBRUARY 15, 2024

DDW Editor Reece Armstrong speaks to Tracy M Woody , President and Chief Executive Officer of Cessation Therapeutics, about the company’s goal to develop an antibody therapy to prevent fentanyl overdoses. As it stands, there are no FDA-approved products designed to prevent a fentanyl overdose.

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Drug Discovery World

SEPTEMBER 12, 2024

Childhood cancers often have a different biology than those in adults, yet targeted treatment options are mostly based on adult therapies. In contrast, 14 new cancer medicines for adults received FDA approval in 2023 alone. The current pipeline of potential new medicines being developed for childhood cancers is sparse.

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Drug Discovery World

DECEMBER 8, 2023

Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector. The cell and gene therapy industry is no exception to this digital transformation. General AI tools such as ChatGPT have acted as a catalyst, igniting a wave of AI innovation akin to the early days of the internet era.

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Drug Discovery World

MARCH 16, 2023

The cell and gene therapy (CGT) market is rapidly expanding, and projections suggest it will reach over $90B by 2023. With a maturing clinical pipeline, many FDA-approved treatments are on the horizon. The post Can characterisation industrialise cell and gene therapy?

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SCIENMAG: Medicine & Health

JULY 26, 2023

July 26, 2023 – Octapharma USA today announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) has received U.S. PARAMUS, N.J.,

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Drug Discovery World

DECEMBER 21, 2023

In a record year for gene therapy approvals, it isn’t surprising that cell & gene therapy (CGT) has been a hot topic. Three trends in the antibody-drug conjugate (ADC) market Antibody-drug conjugates are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker.

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Fierce BioTech

OCTOBER 5, 2023

Discover Strategies for Combatting Disruptions in Gene Therapy Development Cell and gene therapy development has exploded, with Q4 2022 showing more FDA approvals than over the past five years combined.[1]

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Drug Discovery World

MARCH 18, 2024

In December 2023, Cresemba for injection was approved for paediatric patients one year of age and older and capsules for paediatric patients six years of age and older who weigh 16kg and greater. Cresemba is the only azole antifungal therapy FDA approved for the treatment of IA and IM in patients as young as one.

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Drug Discovery World

JUNE 16, 2023

Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s news highlights, including an FDA approval for Pfizer, a NICE recommendation for AstraZeneca UK, and an update to the HER2 Breast Cancer Testing Guidelines.

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Drug Discovery World

APRIL 4, 2023

Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. This made Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to be approved in the US.

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Drug Discovery World

MAY 1, 2024

Many of the best-selling drugs in 2023 were monoclonal antibody (mAB) therapies, including Keytruda (pembrolizumab), Humira (adalimumab), and Dupixent (dupilumab) 1. Hammond says: “Many of the most popular drugs in 2023 are mAb-based therapies, which we predict will continue in 2024.

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Drug Discovery World

JULY 7, 2023

It’s been a fascinating week in drug discovery, as AstraZeneca announced that its Phase III trial of datopotamab deruxtecan did not meet its second primary endpoint and saw an 8% drop in its stock market value as a result.

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Drug Discovery World

JUNE 23, 2023

Advanced Therapy Medicinal Products (ATMPs) have been making the news this week. FDA approves first gene therapy for Duchenne muscular dystrophy Sarepta Therapeutics’ Elevidys has become the first gene therapy for Duchenne muscular dystrophy (DMD) to gain marketing authorisation in the US.

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Drug Discovery World

MARCH 12, 2024

Adoptive T-cell therapy (ACT), particularly T-cell-based transplantation, is attracting increasing attention and is advancing rapidly since the FDA approval of CAR-T therapy for the treatment of relapsed/refractory acute lymphoblastic leukaemia and B-cell malignancies.

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Drug Discovery World

MARCH 1, 2024

The first therapy was approved for allergic reactions to food, a drug for scleroderma secured Fast Track Designation, and the CHMP recommended an extension to the use of Carvykti in melanoma, but there was also bad news for Minerva Biosciences and Oncopeptides.

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Drug Target Review

AUGUST 29, 2024

What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies? MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs.

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Drug Target Review

FEBRUARY 21, 2024

Stem cell transplants have saved patients’ lives time and time again, which led us to launch our own Stem Cell Transplant and Cellular Therapy Program. Regarding CAR-T cell therapy, could you highlight the promising findings that have been identified in the early stages of drug discovery, as well as potential challenges?

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The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (FDA) has approved belimumab (Benlysta®), the first-ever treatment for adults with lupus nephritis (LN) who are currently receiving standard therapy. We at the LRA are thrilled to share this news about belimumab and look forward to future approvals of other lupus nephritis treatment options.”.

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The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company’s commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies. today announced U.S. A bout the VENTANA MMR RxDx Panel.

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Drug Discovery World

JULY 10, 2023

It’s been a fascinating week in drug discovery, as AstraZeneca announced that its Phase III trial of datopotamab deruxtecan did not meet its second primary endpoint and saw an 8% drop in its stock market value as a result.

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Drug Discovery World

JULY 10, 2023

It’s been a fascinating week in drug discovery, as AstraZeneca announced that its Phase III trial of datopotamab deruxtecan did not meet its second primary endpoint and saw an 8% drop in its stock market value as a result.

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Drug Discovery World

JULY 31, 2023

President and Chief Executive Officer Christopher Viehbacher said: “In the second quarter, Biogen continued to advance ground-breaking science with the FDA approval of two first-in-class therapies for Alzheimer’s disease and ALS, while also delivering on our base business expectations. Biogen’s business is in transition.

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Drug Discovery World

MAY 31, 2024

” The US schizophrenia market is projected to grow to $8.06 billion by 2030, according to a market research report by Market Research Future.

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Drug Discovery World

AUGUST 24, 2023

The European Commission (EC) has granted conditional marketing authorisation (CMA) for Janssen’s Talvey (talquetamab) as monotherapy for relapsed and refractory multiple myeloma (RRMM). The most common adverse event (AEs) observed in the study was cytokine release syndrome (77%, 1.5% Grade 3 or 4).

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The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) gave a greenlight for ViiV Healthcare ’s Cabenuva. Cabotegravir is a ViiV product marketed as Cabenuva, and rilpivirine is a Janssen product with a brand name Edurant. The once-a-month regimen was preferred by nine out of 10 patients over the daily oral therapy. clinical practices. “Not

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Drug Discovery World

NOVEMBER 14, 2023

Cancer Monoclonal antibodies (mAbs) are a type of targeted drug therapy, and as such are often used to treat cancer. Alongside surgery, radiation and chemotherapy, antibody-based immunotherapy is considered to be a main component of cancer therapy 1. The global arthritis monoclonal antibodies market grew from $49.44

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Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials.

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The Pharma Data

AUGUST 31, 2021

today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. Source link: [link].

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The Pharma Data

MAY 19, 2023

ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S. Unlike other catheters on the market, the TactiFlex catheter uses a tip design with a laser-cut pattern that flexes when in contact with the heart wall.

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The Pharma Data

JUNE 22, 2023

FDA approval Pfizer (NYSE: PFE) announced that the U.S. 3,4,5,6) “Despite treatment advancement in metastatic castration-resistant prostate cancer, the disease can progress quickly, and many patients may only receive one line of therapy. Pfizer’s TALZENNA® in combination with XTANDI® receives U.S.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. This indication is approved under accelerated approval based on overall response rate and duration of response.

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The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. BUFFALO, N.Y.,

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