Drug Channels

JUNE 14, 2022

Their policy recommendations would therefore have a devastating impact on these patients and their hope for treatments and cures. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. As Nobel prize winner Ronald Coase observed: “If you torture the data long enough, it will confess to anything.” d/b/a Drug Channels Institute.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Clinical Trials Trials FDA Regulations 105

Drug Target Review

APRIL 4, 2024

Treatment with mesdopetam counteracted both these features of the psychosis model, ie, restored normal levels of synchronisation and reduced HFOs. In rodents, non-human primates, as well as humans, long-term treatment with levodopa has been associated with an increase in dopamine D3 receptor expression.

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Disease Treatment Licensing Licensing 105

The Pharma Data

JANUARY 11, 2021

-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB System received its first PMA approval in late 2018.

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Drug Channels

NOVEMBER 5, 2021

To learn more about the risk-based care approach, download the free whitepaper: Risk-Based Care Helps Cancer Treatment Adherence. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. Read on for Ashleigh’s insights. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

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Alta Sciences

MARCH 4, 2025

This was in 2006, at a time when the FDA guidances on these topics had not yet been published. Despite having a final FDA guidance issued in 2017 , evolving drug development and treatment modalities continue to prompt important dialogue to adapt existing methods.

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Clinical Trials FDA Drug Development Trials 52

National Institute on Drug Abuse: Nora's Blog

JULY 22, 2024

People with an opioid use disorder (OUD) urgently need treatment not just to protect them from overdosing but also to help them achieve recovery, but highly effective medications like buprenorphine and methadone remain underused. Almost all (99%) of those retained in treatment achieved remission.

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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FDA Approval Treatment FDA RNA 52

Drug Target Review

AUGUST 15, 2023

As the medical community continues to unravel the complexities of Myc , this study opens up new avenues for understanding both cancer and ageing, bringing hope for more effective and safer treatments in the future. Academic Press; 2006 [cited 2023 Jul 27]. References Chi V. Dang et al. The C-myc target gene network [Internet].

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Drug Target Review

OCTOBER 4, 2023

Antibody-drug conjugates (ADCs) have been a groundbreaking approach to cancer treatment with their ability to deliver cytotoxic drugs directly to diseased cells while sparing healthy tissues. Ultimately, flexibility in dual-payload ADC development means better treatments could reach patients sooner. Biomaterials 273 , 120817 (2021).

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Small Molecule Drugs Immune Response Targeted Protein Degradation 126

BMG Labtech

FEBRUARY 28, 2023

The first regulatory approval by the FDA for a HDAC inhibitor was in 2006 for Vorinostat – a cancer treatment for cutaneous T-cell lymphoma (fig. The discovery of an enzyme that removes acetyl groups from histone dates to 1969 when Inoue and Fujimoto discovered histone deacetylase (HDAC) activity in calf thymus extract.

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FDA Treatment Disease Marketing 52

Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. Can you provide a summary of the key findings and implications of the preclinical studies on ISM6331 for the treatment of advanced solid tumours?

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Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Previously, Mr Ho served as a Senior Equity Research Analyst at Bank of America from 2006 to 2009 and an Equity Research Analyst at Piper Jaffray & Co. from 2003 to 2006, covering the biotechnology and life-science tools sectors.

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Drug Target Review

JUNE 19, 2024

Our goal is to stand on the shoulders of giants and advance this exciting and new field of medicine, so that it can deliver valuable treatments to patients. How do you envision the future of cell therapy and its potential impact on medical treatments and healthcare? Could you give us an overview of the Lineage platform?

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Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

Drug Channels

NOVEMBER 13, 2020

Anndi also suffers from a rare disease and requires treatment with an orphan drug. Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. Today’s guest post comes from Anndi McAfee, a successful voice over artist. Check out her impressive IMDB credits. Your kids have definitely heard her voice. Read on for her disturbing story.

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Disease Treatment Drugs 52

Drug Target Review

JANUARY 24, 2024

2006 July 29 [2024 January 18]; 368(9533):387-403. 2006 July 29 [2024 January 18]; 368(9533):387-403. The cause of the sporadic form of the disease is unknown, probably because the disease is heterogeneous, caused by ageing in concert with a complex interaction of both genetic and environmental risk factors. Nat Communications.

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RNA Disease DNA Engineering 64

Drug Channels

JULY 29, 2020

In this issue: Pricing problems for diabetes treatments Controversy over Regeneron’s copay support Massachusetts concedes that coupons help some patients (but accumulators hurt) A 2020 update to my all-time favorite chart Plus, thoughtful perspectives on diversity from AmerisourceBergen CEO Steve Collis. d/b/a Drug Channels Institute.

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Drug Target Review

NOVEMBER 23, 2023

elegans applicable to larger brains, including those of fish, octopuses, mice, and humans, and if so, what implications does this have for neuroscience and potential treatments for neurological conditions? Are the principles governing the organisation of neuropeptide networks in C.

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New Drug Approvals

SEPTEMBER 8, 2024

5 On August 14, 2024, seladelpar was granted accelerated approval by the FDA for the treatment of primary biliary cholangitis, 6 which is a condition associated with aberrant bile acid metabolism. July 2024). “Seladelpar treatment reduces IL-31 and pruritus in patients with primary biliary cholangitis” Hepatology.

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Drug Target Review

MARCH 5, 2024

The first true test of my commitment came with my PhD in Biophysics as a scholar at the International Max-Planck Research School, specifically when I became pregnant with my first child in 2006. Our vision for the near future is to see cancer treated as a manageable chronic condition, with minimal side effects for those affected.

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The Premier Consulting Blog

NOVEMBER 30, 2022

Virtual patients are then generated who can be randomized to one or more cohorts to allow researchers to select treatment options. Natalizumab is a disease-modifying treatment for RRMS and is used as first- or second-line therapy depending on a patient’s clinical history.

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Trials Clinical Research Treatment Disease 52

The Pharma Data

JANUARY 8, 2021

It found that nearly 40% of 6,500 HPV vaccine-related posts from 2006 to 2016 amplified a perceived risk. A vaccine to prevent it has been available since 2006, and the CDC has more than 12 years of data showing that it is safe and effective, according to the study. The data suggest the posts had momentum over time.

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Vaccine Doctors Virus Disease 52

Common Sense for Drug Policy Blog

SEPTEMBER 28, 2023

The policy encouraged the de facto depenalization of simple possession by restricting enforcement to circumstances where people are engaged in public drug use or other behaviour that the VPD believed may harm others [ 5 ], which would notably sustain roles for policing in the lives of PWUD.

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Drug Target Review

DECEMBER 14, 2023

Cancer treatment Dr Stroik also discovered that polymerases theta and delta are physically attached to each other, which may enable drug developers to create a new cancer treatment by drugging this interaction. 2006 August 8 [2023 November 16]; 40: 363-83. Polymerase delta also aids polymerase theta in finishing synthesis.

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DNA Clinical Trials Treatment Research 59

FDA Law Blog: Biosimilars

MARCH 15, 2023

It can help detect breast cancer in its earliest, most treatment stages, when it is too small to be felt or detected by an alternative method. See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006).

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Regulations FDA Doctors Government 59

Advarra

MARCH 19, 2024

The DMC’s independent viewpoint adds a layer of scrutiny crucial for maintaining trial integrity and protecting participants during the conduct of the trial – while sponsors, CROs, and investigators remain blinded to treatment arms or placebo controls. Bear in mind: The February 2024 guidance is draft only, and not yet finalized.

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Clinical Trials Trials FDA Regulations 52

Drug Target Review

JUNE 6, 2023

In this IO arena, we continue to search for additional treatments that can further benefit patients. Immune checkpoint inhibitors, a well-established class of IO treatments, are designed to improve the ability of T-cells to fight cancer by removing inhibitory or suppressive mechanisms that may dampen the anti-cancer functions of T cells.

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The Pharma Data

APRIL 7, 2021

TYSABRI is a well-established high-efficacy treatment that now provides two routes of administration enabling flexibility to meet patients’ individual preferences and needs. The subcutaneous option provides a shorter administration time and expands access to treatment for patients and physicians beyond the infusion setting.

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Clinical Trials Treatment Virus Pharmacokinetics 52

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. ENSPRYNG treatment is administered every four weeks after an initial loading dose. Basel, 17 August 2020.

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FDA Approval FDA Clinical Trials Treatment 52

Common Sense for Drug Policy Blog

SEPTEMBER 9, 2023

Even among calls for a public health approach to opioids in North America, definitions range from those narrowly focused on population-level prevention via surveillance and research ( Joranson & Gilson, 2006 ) to expansive ones that include a commitment to the principles of social justice, human rights, and equity ( Emerson & Haden, 2021 ).

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Treatment Research Drugs 40

The Pharma Data

SEPTEMBER 9, 2020

Basel, 10 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. Both treatments were administered subcutaneously at week 0, 2, and 4.

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Treatment Disease Therapies FDA 52

The Pharma Data

DECEMBER 18, 2020

Roxadustat is approved in China, Japan (under the name Evrenzo), and Chile for the treatment of anemia in CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients. 2006 May; 47(5): S1-S132. Roxadustat is also in clinical development for anemia associated with MDS and for chemotherapy-induced anemia.

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Disease FDA FDA Approval Treatment 52

The Pharma Data

DECEMBER 16, 2020

We are entering an area with significant unmet medical need since the current treatment paradigm for GBM remains bleak, as this aggressive and currently incurable form of brain cancer continues to claim high mortality rates. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006.

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FDA Approval FDA Pharmaceuticals Clinical Trials 52

The Pharma Data

FEBRUARY 22, 2022

He is co-founder and non-executive board member of the Hartwig Medical Foundation (large scale DNA analyses) and is a board member of the Center for Personalized Cancer Treatment and leads several innovative precision oncology clinical trials. He has founded and leads several innovative precision medicine initiatives in oncology.

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Clinical Trials DNA Science Clinical Development 52

The Pharma Data

OCTOBER 19, 2020

(NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Company’s U.S. About CNS Pharmaceuticals, Inc.

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Clinical Trials Trials Pharmaceuticals Treatment 52

The Pharma Data

JULY 15, 2021

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. UK Biobank recruited 500,000 people aged between 40-69 years in 2006-2010 from across the UK.

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Disease Biosimilars Government Treatment 52

Codon

AUGUST 27, 2024

Putting a sequencer in every port, hospital, water treatment plant, or subway station isn’t feasible just yet due to the expense. That price tag seems worthwhile if the sequencing data leads to earlier treatment, faster recovery to productivity, and ultimately lives saved.

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