The Pharma Data

DECEMBER 17, 2020

18, 2020 /PRNewswire/ — Camurus AB (NASDAQ STO: CAMX) announced today that the Swiss agency for therapeutic products, Swissmedic, has approved weekly and monthly Buvidal ® prolonged release buprenorphine for the treatment of opioid dependence in adults and adolescents from 16 years of age. LUND, Sweden , Dec. About Buvidal.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

A prescription not issued in the usual course of professional treatment or in legitimate, authorized research is not a prescription within the meaning of the CSA and the pharmacist knowingly filling it, along with the prescriber issuing it, is subject to penalties. 21 U.S.C. § 829; 21 C.F.R. Complaint ¶ 55. Complaint ¶ 58. Complaint ¶ 59.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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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. THURSDAY, Nov.

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Drug Target Review

OCTOBER 24, 2023

Live Bacterial Products (LBPs) will provide patients with a desirable, credible, safe and effective treatment option. The human microbiome, a complex ecosystem of microorganisms residing within our bodies, has emerged as a promising frontier in the quest for innovative medical treatments.

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The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. iii Current treatment options have limited efficacy in terms of weight loss or are often associated with adverse events. “We

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Conversations in Drug Development Trends

AUGUST 10, 2023

As one of the more recent fields to emerge in the clinical space, psychedelics have gained significant traction as a potential treatment for various neuropsychiatric diseases. Psychedelic Research at Worldwide Since 2017, Worldwide Clinical Trials have supported a myriad of sponsors leading the way in psychedelic research programs.

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Drug Target Review

AUGUST 16, 2023

Cancer remains a major global health concern, often diagnosed at advanced stages when treatment options and survival rates are limited. Suspicious findings can prompt further evaluation and definitive diagnosis, enabling timely treatment and improved patient outcomes. References 1. Jillian Phallen. DOI:10.1126/scitranslmed.aan2415

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The Pharma Data

FEBRUARY 22, 2021

Efanesoctocog alfa, a novel and investigational factor VIII therapy independent of von Willebrand Factor, is designed to provide near-normal factor activity levels for the majority of the week in a once-weekly prophylactic treatment regimen. Sanofi and Sobi collaborate on the development and commercialization of efanesoctocog alfa.

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Broad Institute

OCTOBER 4, 2023

AbbVie and Calico discovered the molecule, called ABBV-CLS-484 , after TIDE researchers at Broad identified the PTPN2 gene as a promising cancer immunotherapy target in 2017. It still sort of stuns me that we went from discovering a target in 2017 to testing drugs in patients starting in 2020,” Yates said.

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Common Sense for Drug Policy Blog

JANUARY 4, 2024

Cost Benefit Analysis of Opioid Treatment, Syringe Service Programs, and Test & Treat "Although model projections can only provide estimates of health benefits and costs, such analyses can provide intuition around critical mechanisms and assumptions to inform decision making. Published 2017 May 24. 2017;14(5):e1002312.

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The Pharma Data

APRIL 7, 2022

It may also limit coverage for any future approved treatment in the class. When additional data from this new class of treatments become available, Biogen urges CMS to reconsider today’s decision for all FDA-approved amyloid-beta targeting therapies. ADUHELM is indicated for the treatment of Alzheimer’s disease.

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New Drug Approvals

NOVEMBER 13, 2023

WO 2017/208267A1, WO 2020/250133 Al and WO 2022/024072A1, which are hereby incorporated by reference, disclose methods of use of the compound of Formula I for the treatment of Parkinson’s disease, synucleinopathies and Alzheimer’s disease (AD) respectively. amcrasto@amcrasto /////////// Ref [1].

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Alta Sciences

MARCH 4, 2025

Despite having a final FDA guidance issued in 2017 , evolving drug development and treatment modalities continue to prompt important dialogue to adapt existing methods. One example is the recent interest in psychedelics for the treatment of psychiatric disorders, including major depressive disorder.

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Alta Sciences

JUNE 27, 2023

Cancer Treatments, Clinical Trials, and the Motivation to Innovate nbartlett Tue, 06/27/2023 - 20:58 Getting to the Heart of Science with Michelle Newby At the heart of science are stories—stories of courage, challenges, successes, lessons, and people. Q: What was your cancer diagnosis and was treatment options were you given?

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Drug Target Review

OCTOBER 17, 2023

To improve its treatment, early diagnosis and appropriate therapeutic strategies are very important. Metabolic changes such as increased arginine levels could serve as biomarkers for detecting cancer at an early stage, which is essential for successful cancer treatment and patient survival. 2017 July [cited 2023 October 9]; 3(2):45-51.

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Drug Target Review

NOVEMBER 17, 2023

Only three of the CAR-NK studies were for the treatment of solid tumours. By themselves, the NK cells showed limited efficacy, but anti-tumour efficacy was observed with co-treatment regimens (eg, monoclonal antibodies, haematopoietic stem cell transplants, whole body irradiation) and multiple dosing (tolerated well by patients).

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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? SVRA) in April 2017. from May 2017 until December 2022.

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Drug Target Review

NOVEMBER 17, 2023

Only three of the CAR-NK studies were for the treatment of solid tumours. By themselves, the NK cells showed limited efficacy, but anti-tumour efficacy was observed with co-treatment regimens (eg, monoclonal antibodies, haematopoietic stem cell transplants, whole body irradiation) and multiple dosing (tolerated well by patients).

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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. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. Tramiprosate was reported to inhibit Aβ42 aggregation into toxic oligomers ( Gervais et al.,

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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

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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The Pharma Data

NOVEMBER 2, 2020

adults by using blood pressure (BP) thresholds from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) and the 2017 American College of Cardiology-American Heart Association (ACC-AHA) BP guidelines. adults) using the 2017 ACC-AHA guideline criteria.

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Drug Target Review

APRIL 19, 2024

And so, I have been the managerial co-founder and CEO of Sibylla since 2017. This innovation opens the door to novel treatments, especially for proteins considered ‘undruggable’ in their mature forms, marking a significant stride in the field of protein degradation and pharmaceutical development.

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Advarra

JUNE 12, 2023

An IBC may also advise the IRB in assessing potential risks to the study subjects and how best to explain the unique risks of gene therapy and other genetically engineered treatments in the informed consent form (ICF). What Does an IBC Review? The post IBC vs. IRB: What’s the Difference? appeared first on Advarra.

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The Pharma Data

DECEMBER 30, 2020

(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the long-term, open-label Phase 3 MOVEMENT trial of AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine in the acute treatment of migraine.

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The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., BOSTON, Jan.

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DrugBank

JUNE 27, 2023

The general notion is that patients should be viewed individually, rather than strictly as members of some larger general population, and that their specific genetic background, environment, and lifestyle choices should be considered throughout drug development to the point of treatment and continuing patient care.

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The Pharma Data

JANUARY 11, 2021

The agency previously granted the gene therapy Orphan Drug and Rare Pediatric Disease designations in 2017. Patients receiving the infusion did not achieve statistically significant muscle function following 48 weeks of treatment. Source link.

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The Pharma Data

SEPTEMBER 9, 2020

The company is testing higher doses of Ocrevus against both relapsing MS and primary progressive MS while also studying the treatment in minority populations. Roche is hoping to defend its franchise against MS treatments from its competitors. Conor Kavanagh. Source link.

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Drug Target Review

SEPTEMBER 22, 2023

8 Furthermore, the absence of immune, mesenchymal, or endothelial cells limits the applicability of organoids for the assessment of certain therapies, such as immuno-oncology treatments or drug metabolism studies where more complex models are needed. CRISPR engineering in organoids for gene repair and disease modelling. 95: 729–38

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Broad Institute

OCTOBER 15, 2024

He investigated using probiotic bacteria as a possible treatment for C. After completing his PhD in 2017, Brown joined Xavier’s lab as a postdoctoral researcher and has been at the Broad ever since, now as a staff scientist. difficile colitis, a severe bacterial infection in the colon that frequently resists antibiotics.

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The Pharma Data

OCTOBER 18, 2020

(Janssen) has announced it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the expanded use of Tremfya (R) (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) in the European Union (EU). In July 2020, the U.S.

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The Pharma Data

AUGUST 9, 2020

In the HIBISCUS I induction study, in people without prior anti-tumour necrosis factor (anti-TNF) treatment, etrolizumab met the primary endpoint. In contrast, the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, did not meet its primary endpoint.

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The Pharma Data

AUGUST 5, 2020

Kymriah was the first CAR-T therapy to be approved by the US Food and Drug Administration (FDA) in August 2017, and is currently approved for two indications – relapsed or refractory paediatric and young adult acute lymphoblastic leukaemia and relapsed or refractory adult diffuse large B-cell lymphoma.

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The Pharma Data

NOVEMBER 27, 2020

27, 2020 — Freezing their eggs or ovarian tissue before breast cancer treatment increases survivors’ chances of having children after recovery, a new study finds. Treatment often includes chemotherapy, which can damage ovarian tissue, and long-term hormone treatment, which can cause early menopause. FRIDAY, Nov.

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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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