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

APRIL 11, 2023

Endogena Therapeutics has completed the dose-escalation stage of its Phase I/IIa study of EA-2353 in retinitis pigmentosa (RP) with no clinically relevant or dose-limiting adverse events. This gene-independent treatment approach has significant advantages in RP, which has multiple genetic causes.

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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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Drug Discovery World

APRIL 26, 2023

However, the efficacy of currently available anti-anxiety drugs is low, with more than half of patients not achieving remission following treatment. In this study, scientists sought to identify the molecular events in the brain that underpin anxiety.

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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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The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. 1 Secondary endpoints included time to cytotoxic chemotherapy, time to pain progression, time to chronic opioid use, and time to skeletal-related events. [3] 10 months. [5]

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The Pharma Data

FEBRUARY 24, 2022

Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Norman Stockbridge, M.D., Despite therapies in multiple drug classes, mortality remains high and treatment options for a broader range of patients are needed. Source link: [link].

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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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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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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

MAY 13, 2021

Product Name: Treatment Plans That Worked. Click here to get Treatment Plans That Worked at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors. Order 576 Treatment Plans That Worked here.

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Agency IQ

MAY 31, 2024

What we expect the EPA to do in June 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. This is what OIRA is currently reviewing.

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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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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

JANUARY 10, 2024

These therapies, which exhibit substantial long-term side effects, including genotoxicity and an increased predisposition to secondary cancers, have significantly higher rates of subsequent malignancies than the rate reported for patients following CAR-T cell immunotherapies.

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Agency IQ

MAY 3, 2024

What we expect the EPA to do in May 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. TSCA new chemicals procedural regulations. TSCA risk management rules.

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Drug Discovery World

JULY 19, 2023

The primary endpoint of iADRS measures cognition and activities of daily living such as managing finances, driving, engaging in hobbies, and conversing about current events. Lilly will work with the FDA and other global regulators to achieve the fastest path to traditional approvals. of treated participants, with 6.1%

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The Pharma Data

NOVEMBER 11, 2021

Wegovy demonstrated a safe and well-tolerated profile across the programme, with the most common adverse events being gastrointestinal. In September 2021, Wegovy was approved by the UK Medicines and Health products Regulations Agency (MHRA). Wegovy was launched in the US in June 2021 following approval by the U.S.

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BMG Labtech

FEBRUARY 28, 2024

A better understanding of the receptor signaling properties of cannabinoid clinical candidates may open the door to the development of more effective and safer treatments. Epidiolex (a pure form of cannabidiol) is approved for the treatment of certain seizure disorders (Lennox-Gastaut syndrome and Dravet syndrome).

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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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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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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

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

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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The Premier Consulting Blog

OCTOBER 11, 2022

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. The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement.

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Agency IQ

JUNE 17, 2024

The courts are also heavily focused on the requirement of a causal link between a challenged action and the specific harm to a party, and will dismiss cases if the chain of causation between the events is too vague or attenuated. And even if not, the doctor must participate in the medical treatment that facilitates an abortion.

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The Pharma Data

DECEMBER 1, 2020

Rapid and substantialimprovement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. NEW YORK, Dec.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Advarra

FEBRUARY 24, 2023

But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? Sponsors need to carefully consider how they will prove safety and efficacy in a manner sufficient to satisfy the regulators.

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The Pharma Data

AUGUST 18, 2020

Johnson & Johnson statement on the launch of new CARE (Corona Accelerated R&D in Europe) consortium, Europe’s largest, multi-partner scientific research initiative dedicated to discovering and developing urgently needed treatment options for COVID-19. These statements are based on current expectations of future events.

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The Pharma Data

SEPTEMBER 15, 2020

Regulation in biotech can be both a barrier and a solution for innovating the drug discovery process as the pharma industry shifts from blockbuster products toward new individualized forms of medicine. Balance risk and innovation in regulation using new digital-therapy products. Add bookmark. Download Your Copy.

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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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The Pharma Data

OCTOBER 25, 2020

for the treatment of severe vernal keratoconjunctivitis (VKC) in patients ages 4-18. “We look forward to working with the FDA during the review process and are optimistic this treatment could provide much needed symptom relief for those affected so they may better engage in their daily activities.” Contact.

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Common Sense for Drug Policy Blog

JANUARY 1, 2024

Multiplying the lifetime costs of HIV treatment per person ($229,800) 25 by the average number of diagnoses averted annually in both cities yields an estimated annual saving of $243.4 million in 2014, 13 allowing for greater coverage of injection events and more opportunities for disease prevention. million for Philadelphia and $62.4

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Drug Discovery World

JUNE 16, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. DDW’s Megan Thomas heard from attendees about key trends in the sector.

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. (OTCQB: QBIO), announced today that the U.S. . Source link.

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