Drug Discovery World

MAY 15, 2023

The US Food and Drug Administration (FDA) has given the go-ahead to CytoAgents to initiate a US Phase Ib/IIa clinical trial investigating CTO1681 for cytokine release syndrome (CRS) in lymphoma patients receiving CAR-T cell therapy. CytoAgents anticipates the clinical trial to launch at its first trial site in the summer of 2023.

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Drug Discovery World

AUGUST 14, 2023

Janssen’s Akeega (niraparib and abiraterone acetate) is now available in the US for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) following FDA approval. The European Commission (EC) granted marketing authorisation for Akeega in April 2023.

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Drug Discovery World

DECEMBER 27, 2023

In other news, the FDA approved a promising antibody-drug conjugate for bladder cancer and trial results demonstrated that psilocybin could reduce depression symptoms in cancer patients. The post DDW Highlights: 27 December 2023 appeared first on Drug Discovery World (DDW).

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Drug Discovery World

DECEMBER 27, 2023

In other news, the FDA approved a promising antibody-drug conjugate for bladder cancer and trial results demonstrated that psilocybin could reduce depression symptoms in cancer patients. The post New DDW Highlights podcast for 27 December 2023 appeared first on Drug Discovery World (DDW).

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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. The post DDW Highlights: 10 July 2023 appeared first on Drug Discovery World (DDW).

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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. The post New DDW Highlights podcast: 10 July 2023 appeared first on Drug Discovery World (DDW).

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Drug Discovery World

OCTOBER 10, 2023

A new class of antidepressants In July 2023, AlzeCure Pharma published the results of a preclinical study supporting the antidepressive effects ACD856, the first in a new class of antidepressants. Over recent months, there have been a number of ground-breaking discoveries in drug discovery for mental health conditions.

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Drug Discovery World

NOVEMBER 23, 2023

Minoryx has announced enrollment of first patients with cerebral Adrenoleukodystrophy (cALD) in the US Phase III clinical trial, CALYX. This will push the Phase III CALYX trial forward and bring leriglitazone to patients as quickly as possible,” said Sílvia Pascual, VP Clinical Development, Minoryx. “In

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Drug Discovery World

OCTOBER 11, 2023

In August 2023, the US Food and Drug Administration (FDA) approved complement C5 inhibitor Izervay , which is currently the only approved GA treatment with a statistically significant reduction in the rate of GA progression. More than five million people worldwide suffer from GA, of which more than 40% are legally blind.

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PLOS: DNA Science

MARCH 28, 2024

The New Drug Duvyzat (givinostat), a type of drug called an HDAC inhibitor, has been in clinical trials to treat cancers and other disorders of the blood, Crohn’s disease, and a form of juvenile arthritis. Results from the study that led to the FDA approval appeared in The Lancet Neurology in April 2024 with commentary.

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Drug Discovery World

SEPTEMBER 2, 2024

The US Food and Drug Administration (FDA) approved the combination treatment for adults with BRAFV600E mutant metastatic NSCLC in October 2023. “We The approval is based on results from the Phase II PHAROS trial in treatment-naïve and previously treated patients with BRAFV600E mutant metastatic NSCLC.

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Drug Discovery World

SEPTEMBER 12, 2024

In addition, small patient populations make clinical trials difficult and reduce incentives for investment. Only two drugs were approved exclusively for children and young people with cancer by the European Medicines Agency (EMA) and five by the US Food and Drug Administration (FDA) from 2007 to 2022.

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Drug Discovery World

FEBRUARY 22, 2024

trillion in 2023, according to data analysts GlobalData. The top 20 global biopharmaceutical companies experienced varied year-on-year (YoY) market capitalisation shifts in 2023 amid the macroeconomic headwinds, steep patent cliffs and the commencement of US drug price negotiations under the Inflation Reduction Act (IRA).

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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. This won’t come as a surprise when you look at industry milestones achieved in 2023 and looking ahead, this shows no signs of slowing down.

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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. A market research report published in late June 2018 by HTF market Intelligence Consulting suggested that the ADC market in China would grow exponentially by 2023 4.

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Drug Discovery World

MARCH 1, 2024

This is the first time the FDA has used the amended procedures for withdrawal of accelerated approval that were enacted in 2023, as part of the Food and Drug Omnibus Report Act of 2022 (FDORA). Oncopeptides was required to conduct the OCEAN trial as a post-approval requirement under the accelerated approval programme.

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The Pharma Data

JUNE 26, 2023

FDA approves Pfizer’s LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata Pfizer Inc. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. Source link: [link]

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Drug Discovery World

OCTOBER 18, 2023

We’re beginning to see their potential come to fruition, with the FDA having approved three treatments as of January 2023 — for retinal dystrophy 1 spinal muscular atrophy, 2 and haemophilia B.

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Drug Discovery World

NOVEMBER 14, 2023

Data highlights include results from Purple Biotech, which revealed positive new results in March 2023 from exploratory analyses conducted as part of a Phase I dose escalation study into CM24 plus nivolumab for advanced cancer. billion in 2023 at a compound annual growth rate (CAGR) of 8.8% billion in 2022 to $53.81

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Drugs.com

AUGUST 2, 2023

2, 2023 -- All eyes are on the U.S. Food and Drug Administration this week as the agency weighs approval of a new pill that may quickly treat and ease severe postpartum depression. Approval of the drug could help millions of women. WEDNESDAY, Aug.

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Drug Discovery World

MARCH 8, 2024

The US Food and Drug Administration (FDA) has revealed plans to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase III TRAILBLAZER-ALZ 2 trial. The trial evaluated the efficacy and safety of Eli Lilly’s donanemab in early symptomatic Alzheimer’s disease.

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EG Life Sciences

FEBRUARY 15, 2023

It is without a doubt that 2022 predicted change and opportunity in biopharma and biotech clinical trials in 2023. The US Food and Drug Administration (FDA) approved around 26 novel drugs in 2022. Approval processes were slow in comparison to 2020 and 2021, where 53 and 50 approvals were achieved respectively.

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Drugs.com

AUGUST 2, 2023

2, 2023 -- All eyes are on the U.S. Food and Drug Administration this week as the agency weighs approval of a new pill that may quickly treat and ease severe postpartum depression. Approval of the drug could help millions of women. WEDNESDAY, Aug.

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Drug Discovery World

MAY 3, 2023

Vicore Pharma, a Swedish clinical-stage pharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists (ATRAGs), has dosed its first patient with C21 in a clinical study of endothelial dysfunction. Vicore Pharma states that results from the trial are expected in Q4, 2023.

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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. NYSE: PFE) announced today that the U.S. ” COVID-19 continues to cause significant burden in the U.S. 11) At this time, the U.S. government will continue to oversee the distribution of PAXLOVID, and U.S.

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Drug Discovery World

APRIL 27, 2023

With the FDA approval of the humanised anti-CD3 mAb TZIELD (teplizumab-mzwv injection) and then its subsequent announced acquisition of Provention Bio by Sanofi for $2.9 Further Phase II trials are expected to start in the third quarter of 2023 in patients with non-active secondary progressive multiple sclerosis (SPMS).

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Drug Discovery World

SEPTEMBER 2, 2024

Emphasis on manufacturing Experts were unanimous in their view of how far the cell & gene therapy (CGT) sector has come and the milestones achieved in both 2023 and early 2024, most referencing the first FDA-approved CRISPR therapeutic and the impact this will have on in-progress CRISPR clinical trials.

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Drug Discovery World

SEPTEMBER 25, 2024

Enhertu is now one of 13 ADCs approved by the FDA, with hundreds of others in development, some of which have been snapped up by big pharma in substantial deals, as is evident in the figures below. billion buy of ProfoundBio in April, and Ipsen’s $900 million deal with Sutro for anticancer ADC STRO-003, also in April.

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New Drug Approvals

SEPTEMBER 10, 2024

Deuruxolitinib C 17 H 18 N 6 , 314.422 Fda approved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,

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Drug Discovery World

FEBRUARY 3, 2023

A marketing authorisation application for daprodustat is currently under review with the European Medicines Agency, with a regulatory decision anticipated in the first half of 2023. Daprodustat tablets (under the brand name Duvroq) are already approved in Japan for the treatment of patients with anaemia of CKD.

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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

SEPTEMBER 7, 2023

1 There are a number of challenges faced in paediatric R&D, including the fact that the overall group includes five different age groups, the need for specific biomarkers, the extra length of time needed for trials, and the ethical concerns of conducting clinical trials in children.

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New Drug Approvals

SEPTEMBER 8, 2024

1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 5] History The effectiveness of palopegteriparatide was evaluated in a 26-week, randomized, double-blind, placebo-controlled trial that enrolled 82 adults with hypoparathyroidism. [5]

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Drug Discovery World

SEPTEMBER 26, 2023

In addition to providing the latest statistics on cancer incidence, mortality, and survivorship, the AACR Cancer Progress Report 2023 offers detailed updates and important context regarding the latest research in cancer etiology, early detection, diagnosis, treatment, prevention, and survivorship. million cancer deaths avoided.

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The Pharma Data

APRIL 20, 2023

FDA approves Roche’s Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Approximately 31,000 people in the US are projected to be diagnosed with DLBCL in 2023.

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New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

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Drug Discovery World

MARCH 7, 2023

In 2023, the company revealed data from a Phase III trial which showed that its vaccine candidate DCVax-L more than doubled overall survival in glioblastoma patients. Dr Janette Thomas, CEO, Five Alarm Bio Five Alarm Bio is an anti-ageing therapeutics company, which completed a seed investment round in early 2023.

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