The Pharma Data

NOVEMBER 26, 2020

26, 2020 — In isolated areas of the United States, nurse practitioners are filling an important role in helping people access treatment for opioid addiction, according to a Washington State University (WSU) study. By late 2018, nurse practitioners were writing nearly 20% of buprenorphine prescriptions in rural Oregon, the study found.

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. Over-the-counter treatments fail due to the body’s natural protective system. 25% for dry eye disease treatment.

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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 Target Review

MARCH 3, 2025

The search for effective treatments for neurodegenerative diseases like Parkinson’s disease has long been hindered by the brain’s complexity and the absence of adequate models for drug discovery. This approach has the potential to revolutionise clinical trial design and lead to more effective, personalised treatments.

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FDA Law Blog: Drug Discovery

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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Drug Target Review

NOVEMBER 6, 2023

Advances in research and development and the utilisation of combination treatment strategies are revolutionising the haematology care landscape, but more must be done to address patients’ individual needs. Evolution of Cancer Pharmacological Treatments at the Turn of the Third Millennium. Published 2018 Nov 13.

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The Pharma Data

NOVEMBER 18, 2021

Eli Lilly and Company blazoned that registration is now open for the CHALLENGE-MIG clinical trial, the first and only head-to- head trial comparing twoanti-calcitonin gene- related peptide (CGRP) drugs for the preventative treatment of episodic migraine in grown-ups.1 gepants) may help people achieve the pretensions that count most to them.

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

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New Drug Approvals

OCTOBER 12, 2024

ALZ-801 is an advanced and markedly improved candidate for the treatment of alzheimer’s disease. 2018; 32(9): 849–861. [2]. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. 2018 Mar;57(3):315-333. 2007 ; Kocis et al.,

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The Pharma Data

DECEMBER 17, 2020

He’s been off insulin since August 2018 — more than two years. No treatments are approved for reversing type 1 diabetes. WEDNESDAY, Oct. 7, 2020 — After starting a drug that’s officially approved to treat a type of blood cancer, a young man with type 1 diabetes was able to stop using insulin.

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SugarCone Biotech

MARCH 24, 2025

Other mechanisms that cancer cells use to escape from TCE treatment are less expected. This provides ample flexibility to optimize the treatment modality to attack specific cancers. CD58 is a protein that interacts with the CD2 protein that is expressed on T cells to upregulate T cell activation. Lancet Haem 11: e693-e707. Shen et al.

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Drug Target Review

NOVEMBER 3, 2023

“Our findings provide crucial insights into the molecular mechanisms that govern cell fate decisions in the human gut, which is essential for understanding these conditions and ultimately developing treatments,” Lin said. 2018 February 8 [2023 November 1];172(4):650-65. The study was published in Science. Cell [Internet].

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The Pharma Data

MARCH 13, 2021

“Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity, with a proven efficacy and safety profile as a preventive treatment for HAE attacks. Subject to approval, we are looking forward to providing lanadelumab as a new treatment option for patients in Japan living with HAE.”.

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The Pharma Data

MARCH 30, 2021

2] – The atogepant application demonstrates AbbVie’s longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine. .

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Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Trends Immunol 39(6):446-459 (2018). Nat Commun 9(1):1760 (2018). A combined treatment regimen of MGMT-modified γδ T cells and temozolomide chemotherapy is effective against primary high grade gliomas. Fisher J, Anderson.

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Drug Target Review

AUGUST 24, 2023

We will explore how GDF-15 impacts the tumour microenvironment and hinders the infiltration of T cells into the tumour, as well as the implications of neutralising GDF-15 to reverse its inhibitory effects and sensitise tumours to anti-PD-1 treatment. T-cell infiltration is a prerequisite for responses to checkpoint inhibitors.

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Broad Institute

NOVEMBER 4, 2024

Back in 2018, Eric Lander, Aviv Regev, Melina Claussnitzer, and Jesse Engreitz, among others, launched the Variant to Function (V2F) initiative aimed at leveraging the genetic data Broad had been accumulating for years into a mechanistic understanding of disease. It was the right energy at the right time.

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Drug Target Review

JANUARY 17, 2024

This insight could lead to potential therapies to prevent treatment resistance. Furthermore, the stem cell-like characteristics promote resistance to treatment through upregulation of efflux transporters, promotion of glioblastoma stem cell proliferation in neurogenic zones, and immune suppression.

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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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Eye on FDA

AUGUST 27, 2023

But in fact, as can be seen in previous years such as 2019, 2018 and 2015, the mid-year tally (in red) is not always predictive of what we may see by year’s end (in blue). AdComms and Approval Votes Are Up – In addition to NME approvals, there have been an increased number of FDA Advisory committees held to discuss new treatments.

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The Pharma Data

MARCH 16, 2021

Viela (Nasdaq: VIE), headquartered in Gaithersburg, Maryland, is a biotechnology company dedicated to the discovery, development and commercialisation of novel treatments for autoimmune and severe inflammatory diseases. AstraZeneca.

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The Pharma Data

NOVEMBER 1, 2020

billion in 2018, and it is expected to be up to US$48.9 BTK inhibitors have the potential to transform the treatment paradigm of autoimmune diseases including MS. According to the Multiple Sclerosis International Federation (MSIF), more than 2.8 million people around the world are affected by MS today 1. billion by 2030 2.

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The Pharma Data

JANUARY 14, 2021

The approval was based on data from Study ADVL0912, a multicenter, single-arm, open-label trial in 121 patients ranging in ages from one to 21, and included 26 patients with r/r/, systemic ALK-positive ALCL after at least one systemic treatment. For the full year of 2019, Xalkoria brought in $530 million, an increase of 1% from 2018. “We

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The Pharma Data

JANUARY 12, 2021

12, 2021 — You have probably seen the social media posts: Your good friend’s co-worker is raising money online to help pay for cancer treatments or another friend needs funds to pay medical bills after a car crash. We did a big survey of that group late in 2018. TUESDAY, Jan. “We know that health care in the U.S.

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New Drug Approvals

SEPTEMBER 13, 2024

2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7] 2] Aticaprant is taken by mouth. [1] nM vs. 24.0 13] [14] Occupancy was 35% for a 0.5 nM vs. 24.0

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Drug Target Review

APRIL 3, 2024

This multi-layered mechanism contributes to the development of immunoresistance against current standard-of-care treatments such as checkpoint inhibitors, chemotherapy, or antibody-drug conjugates (ADCs). Visugromab is a monoclonal antibody – a treatment modality that has been extensively studied and de-risked.

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The Pharma Data

NOVEMBER 2, 2020

Those taking Aimovig saw a 50 percent reduction in monthly migraine days and a lower rate of treatment discontinuation, Novartis said. Aimovig was approved by the FDA in May 2018 and received a marketing authorization from the European Medicines Agency in July 2018. Source link.

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The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. One step closer to a novel treatment.

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Conversations in Drug Development Trends

FEBRUARY 28, 2023

95% of rare diseases don’t have a treatment approved and won’t anytime soon. Miraculously, there was an approved treatment. This treatment only exists because a small charity in the ’70s donated the funds needed for the researcher to discover it. Uplifting Athletes (UA) is on a mission to change that. It saved my life.”

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The Pharma Data

DECEMBER 13, 2020

On December17 ,2018, Toripalimab obtained conditional approval from the NMPA, for the 2 nd line treatment of patients with unresectable or metastatic melanoma. SHANGHAI, China, Dec. Both supplemental NDAs received priority review status by the NMPA in July 2020.

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Broad Institute

JANUARY 22, 2024

Since 2018, the Cancer Dependency Map (DepMap) Consortium , an academic-industrial partnership launched by the Broad, has uncovered several potential drug targets by systematically screening cancer models in search of genetic dependencies. We don't often think hard enough about how to get to cures in cancer.

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The Pharma Data

DECEMBER 22, 2020

22, 2020 — Tagrisso ( osimertinib ) received approval as an adjuvant treatment for patients with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, the U.S. TUESDAY, Dec. Food and Drug Administration announced Friday.

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The Pharma Data

DECEMBER 4, 2020

from the Boston Medical Center, and colleagues used data from the Behavioral Risk Factor Surveillance System (2008 to 2018) to assess the impact of Medicaid expansion on linkage to care, self-maintenance, and treatment among low-income adults with diabetes. In the early period, Medicaid expansion led to a 5.3-percentage

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FDA Law Blog: Drug Discovery

DECEMBER 13, 2023

Sasinowski — On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”

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Drug Target Review

SEPTEMBER 26, 2023

This will be achieved by inducing a seizurogenic phenotype using a known seizurogenic compound, and then determining if these changes are reduced by application epilepsy treatments. 2018 Mar;17(3):167–81. 2018 Dec 11;94(10):390–411. 2018;(136):56573. Nat Rev Drug Discov. J Pharmacol Toxicol Methods. 2016;81:37–46.

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The Pharma Data

NOVEMBER 9, 2020

Talaris Chief Executive Officer Scott Requadt sees FCR001, the company’s investigational cell therapy, as a potential pipeline in a product (an experimental treatment that could have multiple uses across a number of indications). At the time, Requadt helmed the venture capital group Claris that backed the Series A.

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The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. The pre-IND program focuses on the treatment of prostate cancer, the second most commonly diagnosed cancer in men. Noria) and PSMA Therapeutics Inc.

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