Drug Discovery World

OCTOBER 31, 2023

Currently, 15 trials of the new potential therapies for ALS have included NfL as an endpoint 8. The UK’s regulator, the MHRA, has indicated support in its early-stage advice, but suggests more clinical data is also needed. These factors have made regulators reluctant to rely on NfL in benefit-risk assessments of new therapies.

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The Pharma Data

APRIL 19, 2022

Kite’s Global CAR T-Cell Therapy Manufacturing Network Increasing Capacity by 50% to Meet Patient Demand for New Cancer Therapies. — Scalable and Adaptable Facility Provides Flexibility for Current and Future Cell Therapy Innovation. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.

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Drug Discovery World

MAY 15, 2024

Dr Catherine Beech , CEO at Exonate and Dr Pete Adamson , CSO at Breye Therapeutics discuss the need for better therapies to treat diabetic retinal disease and current progress in the field. Selective targeting would enable the therapy to treat the disease whilst not impacting the natural processes of VEGF. In 2019 there were >14.2

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The Pharma Data

OCTOBER 26, 2020

The agreement covers the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein. The agreement covers the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein. Mutations in OTOF lead to severe or profound congenital hearing loss. About Sensorion.

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Drug Discovery World

MAY 6, 2024

Amsterdam: The centre of European life sciences As a result of the UK withdrawing from the EU, in 2019 the EMA headquarters was moved from London to Amsterdam. The company is now investigating a promising gene therapy for Huntingdon’s disease in a Phase I/II trial, with patients already showing signs of preserved neurological function.

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Drug Discovery World

AUGUST 10, 2022

But decades of research led to improvements in cancer therapy, centred around the idea that one’s immune system could aid in treatment. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic.

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Elrig

APRIL 11, 2024

From 2015 to 2019, he was a postdoctoral researcher in Juergen Knoblich’s lab at the Institute of Molecular Biotechnology (IMBA), Vienna, Austria where he designed advanced human brain organoids aiming to recapitulate the architecture and function of the developing brain. He is an outdoor aficionado and loves to climb the highest summits.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

2018 ; Llewellyn and Tober 2010; Denham 2019 ). 2019 ), who found that their sample’s consumption ‘transcended IPEDs to encompass a much broader cocktail of substances’ (Salinas et al. 2019 : 49) including recreational drugs like cannabis and cocaine (see also Turnock 2021b ). 2014 ; Begley et al. Fincoeur et al.

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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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Advarra

DECEMBER 15, 2022

As the research community continues to seek clinical trial efficiencies designed to bring therapies to patients faster, more governing bodies are pushing for single institutional review board (single IRB) review as one way to streamline efforts. Policies and Regulations Affecting Single IRB Review. Nonexempt human subjects research.

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Drug Target Review

SEPTEMBER 4, 2023

7,9 Dihydrofolate reductase-thymidylate synthase (DHFR) have been successfully exploited for the therapy of bacterial infections and other parasitic diseases such as malaria. 2019): CRISPR in Parasitology: Not Exactly Cut and Dried! 2019): Biological plasticity rescues target activity in CRISPR knockouts, Nature Methods.

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Drug Discovery World

NOVEMBER 29, 2022

The new Clinical Pharmacology degree was launched in 2019 by Professors Emma Baker and Iain Greenwood and aims to take a holistic view of the development of drugs and create graduates that will stand out in the job market. Providing a broad view.

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

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Drug Target Review

AUGUST 24, 2023

Neutralising GDF-15 with CatalYm’s anti-GDF-15 antibody visugromab was shown to reverse its inhibitory effects and to re-sensitise tumours to anti-PD-1 treatment, achieving commensurate survival benefit of anti-GDF-15-anti-PD-1 combination therapy in vivo. 2019 May 22;10:1078. Cancer Immunology Research. 2021 Dec 1;9(12):1425-38.

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The Pharma Data

NOVEMBER 2, 2020

Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders. The communication of this press release in certain countries may constitute a violation of local laws and regulations. About Sensorion.

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The Pharma Data

JANUARY 12, 2021

million for the fourth quarter of 2019. million for the full year 2019. Due to COVID-19, we saw customer demand increase significantly in both new and existing accounts, resulting in increased awareness of our high velocity therapy for treating patients with respiratory distress. 2020 was a transformational year for Vapotherm.

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Drug Discovery World

MARCH 29, 2023

The commission is proposing the introduction of temporary emergency marketing authorisations 1. Extra foreign inspections Since July 2019, the MRA (Mutual Recognition Agreement) between the EU and the US FDA has been fully in force. She also does not believe that the problems with Europe’s medicines can be solved with regulation.

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The Pharma Data

MARCH 9, 2022

The key secondary endpoint was also met, demonstrating once-weekly efanesoctocog alfa was superior to prior prophylactic factor VIII replacement therapy, showing a statistically significant reduction in ABR based on intra-patient comparison. The median annualized bleeding rate (ABR) was 0 with a mean ABR of 0.71.

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Drug Discovery World

MARCH 13, 2023

The cell and gene therapy (CGT) landscape has grown significantly in the past year. Between the 24 therapies already approved by the FDA 1 and a marked increase in clinical trials, widespread accessibility to precision medicine feels within reach. One example: Zynteglo, a newly approved gene therapy priced at a record-breaking $2.8M

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The Pharma Data

JANUARY 6, 2021

Jefferies and Kempen join Chardan and Bryan Garnier & Co, whose analysts also initiated coverage on the company with a “Buy” rating in 2020 and 2019 respectively. The communication of this press release in certain countries may constitute a violation of local laws and regulations. About Sensorion. Source link.

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The Pharma Data

DECEMBER 12, 2020

It plays a crucial role in many inflammatory and autoimmune diseases across multiple therapy areas, including haematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. Alexion achieved impressive revenue growth over the last few years, with revenues of $5.0bn in 2019 (21% year-on-year growth).

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The Pharma Data

NOVEMBER 3, 2020

m (-), including US launch of the scientifically proven digital therapies deprexis® and vorvida®. 2019 Jul-Sep. 2019 Jan-Sep. 2019 Jan-Dec. 2019-2020 Jul-Sep ?. . m (90.9).

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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

OCTOBER 19, 2020

New Guidance: The FDA issued and implemented new guidance, Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Testing Therapies, Antivirals and Vaccines. Please read more here. . Please read more here. .

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The Pharma Data

SEPTEMBER 9, 2020

The patients treated with ENSPRYNG were also less likely to require rescue therapy for a relapse compared with placebo (OR 0.46; 95% CI, 0.25–0.86, Additional applications are under review with numerous regulators, including in the EU and China. Applications are under review with numerous regulators, including in the EU and China.

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The Pharma Data

SEPTEMBER 9, 2020

The announcement was made during the virtual European Society of Minimally Invasive Neurological Therapy (ESMINT). Good Trackability to MCA: (1) Competitive Test Report 103618595,October 2019 (2) Competitive Test Report 103628641, October 2019. [v] v] Variable Braid Density: (1) Competitive Test Report 103628641, October 2019.

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Treatment Production Science Disease 52

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

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The Pharma Data

JANUARY 18, 2021

Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders. The communication of this press release in certain countries may constitute a violation of local laws and regulations. About Sensorion.

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Therapies Regulations Marketing Production 52

The Pharma Data

NOVEMBER 19, 2020

Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders. The communication of this press release in certain countries may constitute a violation of local laws and regulations. About Sensorion.

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The Pharma Data

AUGUST 16, 2020

First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology. Having an approved therapy that can be administered subcutaneously in the home, and has demonstrated an impact on the frequency of relapses, is an important advancement for patients.”. “We

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The Pharma Data

NOVEMBER 8, 2020

Following the data releases in 2018 and 2019, this will be the third time that Ascentage Pharma has presented updated clinical data of HQP1351 at the ASH Annual Meeting. In July 2019 , HQP1351 was cleared by the US Food and Drug Administration (FDA) to enter a Phase Ib clinical study. SUZHOU, China and ROCKVILLE, Md. ,

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The Pharma Data

AUGUST 1, 2021

AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. 2,3 TULIP-2 demonstrated superiority across multiple efficacy endpoints versus placebo with both arms receiving standard therapy.

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Trials Therapies Disease Treatment 52

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.

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The Pharma Data

JANUARY 23, 2021

On a larger scale, the tool may greatly aid existing and future TNBC studies that are currently exploring new therapies for targeted treatments. Collagen density regulates the activity of tumor-infiltrating T cells Kuczek, D.E., immunotherapy cancer 7, 68 (2019). J Transl Med 17, 309 (2019). Larsen, A.M.H.,

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Cell Biology Hospitals Treatment Clinical Trials 52

The Pharma Data

DECEMBER 29, 2020

HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the company was officially included into the Shenzhen-Hong Kong Stock Connect program (the “Hong Kong Stock Connect”). Ascentage Pharma (6855.HK)

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The Pharma Data

APRIL 28, 2021

1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

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The Pharma Data

FEBRUARY 8, 2021

In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA ®. Based on these data, ADT alone should no longer be considered sufficient for patients with advanced, castration-sensitive disease.”. About ERLEADA ® (apalutamide).

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