Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Target Review

SEPTEMBER 25, 2024

BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example. Classically, rational drug combinations are designed to target two nodes in the same oncogenic signalling pathway.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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The Premier Consulting Blog

OCTOBER 11, 2022

Clinical trials for ultra-rare diseases can be particularly challenging to mount due to small, geographically-dispersed patient populations. In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases.

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Drug Discovery World

NOVEMBER 10, 2023

Although the study was not powered to primarily assess efficacy, the kinetic visual field (Goldmann perimetry) increased significantly from baseline at days seven and 14 post treatment. KIO-301 was safe and well tolerated with no ocular and non-ocular serious adverse events, nor any signs of retinal inflammation.

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Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

MAY 25, 2023

The event brought together organisations representing different aspects of drug discovery, including research institutes, academia and industry, emphasising the importance of partnership and collaboration in this dynamic sector. As one of four Cancer Research UK institutes, it was a founding member of Cancer Research Horizons.

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Drug Discovery World

AUGUST 21, 2023

Semaglutide manufacturer Novo Nordisk reported earlier this month that the drug reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity, as shown in the SELECT trial. The drugs are currently approved as treatments for type 2 diabetes and weight loss.

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Agency IQ

JUNE 26, 2023

FDA quietly kicks off process that could inform future rare disease regulatory reforms Reforms buried within the FY2023 omnibus spending bill require the development of a new report looking at the regulatory processes of the U.S. a disease or condition is defined as rare by the Orphan Drug Act (ODA) if it affects fewer than 200,000 people.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. In my case, my daughter Iris has GM1 gangliosidosis.

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The Pharma Data

MAY 27, 2022

The FDA’s decision is informed by the results of Pfizer’s nonclinical studies and a Phase 2a clinical study of ervogastat/clesacostat, which showed that treatment with ervogastat/clesacostat reduced liver fat with a favorable safety and tolerability profile. Pfizer Inc. NYSE: PFE) today announced the U.S.

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The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. Based on these data, ADT alone should no longer be considered sufficient for patients with advanced, castration-sensitive disease.”.

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The Pharma Data

FEBRUARY 24, 2022

Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction. Source link: [link].

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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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The Pharma Data

AUGUST 19, 2020

(Momenta), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 Nipocalimab recently received a rare pediatric disease designation from the U.S. Food and Drug Administration. An estimated 2.5

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

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BMG Labtech

FEBRUARY 28, 2024

Interest is growing in the use of cannabinoids as tools to treat a host of different diseases and conditions including cancer , neurodegenerative disorders , inflammation, autoimmune and other conditions. Marinol and Syndros (dronabinol) are approved and used for the treatment of nausea and vomiting associated with chemotherapy.

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The Pharma Data

NOVEMBER 11, 2021

27 kg/m 2 ) with at least one weight-related comorbidity such as high blood pressure, heart disease or type 2 diabetes. Wegovy demonstrated a safe and well-tolerated profile across the programme, with the most common adverse events being gastrointestinal. About obesity Obesity is a chronic disease that requires long-term management.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 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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The Pharma Data

MARCH 27, 2021

Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Saxenda ® is expanded for the treatment of obesity in adolescents aged 12–17 years. If approved, Saxenda ® will be the first EU-approved treatment for obesity in adolescents.

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Drug Target Review

FEBRUARY 26, 2024

What is the primary cause of resistance to mitogen-activated protein kinase (MAPK) inhibitors in patients with BRAF-mutant melanoma, and why does it occur mainly through non-mutational events? What outcome is noted when treating BRAF inhibitor (BRAFi)-resistant melanomas with corin?

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Drug Discovery World

SEPTEMBER 14, 2023

Total revenue from oncology medicines increased 22%, CVRM 20%, R&I8 10%, and rare disease 12%. Additionally, Abrysvo was approved for use at 32-36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth to six months of age.

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Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options. 3D rendering of Antibody Drug Conjugate Molecules.

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The Pharma Data

JUNE 25, 2021

We are committed to responding to questions from the Alzheimer’s disease community and providing more details about our plans. About ADUHELM treatment and the confirmatory trial. ADUHELM is indicated for the treatment of Alzheimer’s disease. Food and Drug Administration (FDA). About the Patient Population.

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The Pharma Data

AUGUST 19, 2020

(Momenta), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 Nipocalimab recently received a rare pediatric disease designation from the U.S. Food and Drug Administration. An estimated 2.5

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The Pharma Data

JANUARY 25, 2021

“The establishment of an Advisory Board focusing on Alzheimer’s disease, and the recruitment of such an impressive group of scientific and clinical leaders in this field is an extremely important step forward for the Company,” stated Paul Brennan, NervGen’s President & CEO. Dr.

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The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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The Pharma Data

SEPTEMBER 9, 2020

CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment. CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke. Stroke Research and Treatment, Hindawi, 27 Nov.

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Broad Institute

JANUARY 31, 2022

About us Latest Our community Join Broad We are a research organization dedicated to better understanding the roots of disease and narrowing the gap between new biological insights and impact for patients.

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The Pharma Data

MARCH 13, 2021

Further, prespecified exploratory analyses showed donanemab slowed the accumulation of tau across key brain regions in patients affected by Alzheimer’s disease. “This is the first late-stage study in Alzheimer’s disease to meet its primary endpoint at the primary analysis.

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Drug Discovery World

JULY 12, 2023

It delivers and administers medicines and medical items to about 200,000 patients with complex conditions including cancer, heart disease, diabetes, dementia and HIV. Sciensus is the UK’s biggest private provider of homecare medicine services.

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Drug Discovery World

SEPTEMBER 9, 2024

Vesper Bio has completed a Phase I study for its lead candidate, VES001, a potentially disease-modifying treatment for frontotemporal dementia patients with mutations in the progranulin gene (FTD(GRN)). Frontotemporal dementia is the most common cause of dementia in people under the age of 60.

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Drug Discovery World

JULY 11, 2023

In addition, the vast complexity of human disease often means we need a better understanding of all the variables involved in a specific process. These different fundamental approaches (rules-based versus pattern recognition) to building these systems provide multiple opportunities to interject them into disease diagnostics and treatments.

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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]

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The Pharma Data

NOVEMBER 24, 2020

25, 2020 /CNW/ – On August 21, 2020 , Health Canada approved Lynparza® (olaparib), for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM- mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent (NHA).

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The Pharma Data

MARCH 9, 2022

The most common treatment-emergent adverse events (>5% of participants overall) were headache, arthralgia, fall, and back pain. Dietmar Berger, MD, PhD Global Head of Development and Chief Medical Officer , Sanofi “While advances have been made in the treatment of hemophilia, unmet medical needs still exist.

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