ASPET

NOVEMBER 17, 2023

Benzodiazepine pharmacoresistance develops when treatment of status epilepticus (SE) is delayed. This response may result from gamma-aminobutyric acid A receptors (GABA A R) internalization that follows prolonged SE; this receptor trafficking results in fewer GABA A R in the synapse to restore inhibition.

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Treatment Therapies International Drugs 100

Codon

NOVEMBER 3, 2024

In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. These challenges have led to strategies such as directly observed therapy (DOT), in which nurses or physicians monitor patients to ensure they take their medicine every day.

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Vaccine Trials Therapies Clinical Trials 92

DrugBank

JUNE 13, 2024

These innovative technologies are changing how medications reach their targets within the body, leading to more effective treatments with fewer side effects.   Take cancer treatment, for example. Implantable insulin pumps equipped with continuous glucose monitoring (CGM) sensors can update old diabetes treatment options.

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Therapies Drugs DNA Treatment 74

Drug Patent Watch

DECEMBER 9, 2024

Taxol: From Pacific Yew to Cancer Treatment Taxol (paclitaxel), a widely used cancer drug, was originally isolated from the bark of the Pacific yew tree. Artemisinin: Nobel Prize-Winning Malaria Treatment Artemisinin, derived from the sweet wormwood plant, has become a crucial treatment for malaria.

Drugs 97

Drugs Drug Development Pharmaceuticals Production 97

PPD

DECEMBER 16, 2024

Rising costs have become a persistent challenge for drug developers, driven by a combination of internal and external pressures that have intensified in recent years. Each delay not only increases costs but also jeopardizes a treatments viability, underscoring the urgency for efficient timelines and streamlined processes.

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Common Sense for Drug Policy Blog

APRIL 21, 2024

Agonist Treatment for Cannabis Use Disorder "Cannabinoid agonist treatment is unlikely to be an approach relevant to all cannabis users seeking treatment, as evidenced by the large numbers of individuals who did not complete the study screening process, and the modest 12-week treatment retention rates. JAMA Intern Med.

Treatment 52

Treatment Clinical Trials International Therapies 52

SCIENMAG: Medicine & Health

JUNE 21, 2023

New research published in the Journal of Internal Medicine demonstrates that optogenetics—which uses light-sensitive proteins to control the activity of targeted cells—is a promising shock-free approach to treating atrial fibrillation (AF), or an irregular, often rapid heart rate, for immediate restoration of regular rhythm.

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Therapies International Treatment Research 64

Drug Target Review

DECEMBER 11, 2024

By employing advanced analytical techniques like high-resolution mass spectrometry (HRMS) and carefully calibrating systems with optimal internal standards (IS), we effectively mitigate matrix effects and provide reliable preclinical toxicology data. These solutions must contain analytes and internal standards at known concentrations.

International 52

International Laboratories Drugs Pharmacokinetics 52

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. 2 It is this complexity that necessitates powerful, targeted combination therapies.

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Small Molecule Therapies Treatment Disease 111

Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

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Clinical Research Research Clinical Trials Bioethics 52

Drug Target Review

SEPTEMBER 6, 2024

What trends are driving the increased use of in vivo delivery methods in gene therapy? This growth has been influenced by the increased use of lentiviral vectors for more prevalent diseases, earlier treatment lines and broader applications. How are new therapeutic areas emerging as potential targets for in vivo gene therapy?

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Therapies Vaccine Marketing Disease 59

KIF1A

JULY 8, 2023

Notably, last month the FDA granted accelerated approval to a gene therapy for Duchenne Muscular Dystrophy (DMD), a genetic muscle-wasting disorder that primarily impacts boys. The treatment, called Elevidys, consists of a miniature version of the dystrophin gene that is mutated in DMD, and is administered intravenously.

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Therapies Regulations FDA Treatment 98

Advarra

JUNE 13, 2023

Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. The accelerating gene therapy market is expected to grow globally by 16.6% Some of these treatments potentially make permanent changes to the humans they are introduced into.

Therapies 52

Therapies Research Clinical Trials Trials 52

The Pharma Data

JULY 23, 2021

(Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021. ADUHELM is indicated for the treatment of Alzheimer’s disease.

International 52

International Disease Clinical Trials Trials 52

The Pharma Data

DECEMBER 29, 2020

Primary Aldosteronism Testing Rare in Treatment-Resistant HTN. 29, 2020 — Patients with apparent treatment-resistant hypertension are rarely tested for primary aldosteronism, according to a study published online Dec. 29 in the Annals of Internal Medicine. Professional. TUESDAY, Dec. Cohen, M.D., Cohen, M.D.,

Treatment 52

Treatment International Therapies Research 52

PLOS: DNA Science

SEPTEMBER 5, 2024

Diagnosis began to shift from a body-part basis to a molecular one, which I wrote about in “Mutation and location important in cancer treatment” for The Lancet in 2015. The researchers tested the model on 19 types of cancers, and validated the findings among several international patient groups.

Treatment 71

Treatment FDA Approval DNA Small Molecule 71

The Pharma Data

JULY 15, 2021

In a comparison of UPLIFT and MAPP survey findings (abstract ID: 35700), fewer people with psoriatic arthritis reported seeing a healthcare provider for their disease in the past year (50% in UPLIFT vs. 83% in MAPP) and a majority (74%) surveyed in UPLIFT perceived their disease as moderate-to-severe despite 83% receiving treatment.

International 52

International Disease Treatment Science 52

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 ¶ 58. Complaint ¶ 59.

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Pharmacy Government Treatment Compliance 139

PPD

OCTOBER 31, 2024

These internal issues are compounded by external pressures like inflation, the development of innovative therapies that require complex protocols and the need to comply with shifting regulatory requirements. This aims to ensure that treatments are effective across varied demographics and to address historical gaps in clinical research.

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Drug Development Clinical Trials Trials Drugs 52

The Pharma Data

AUGUST 30, 2021

Late-breaking abstract highlights a network meta-analysis on monthly migraine day reductions with AJOVY, Nurtec ® ODT (Rimegepant) and Atogepant in the preventive treatment of episodic migraine. Time Gained With Long-term Fremanezumab Treatment in Patients With Chronic and Episodic Migraine. TEL AVIV, Israel & PARSIPPANY, N.J.–(BUSINESS

International 52

International Clinical Trials Treatment Trials 52

FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

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Therapies FDA Production Regulations 59

The Pharma Data

SEPTEMBER 9, 2021

(NYSE and TASE: TEVA), today announced results from a network meta-analysis examining the efficacy of AJOVY (fremanezumab-vfrm), atogepant and Nurtec ® ODT (rimegepant) in the preventive treatment of episodic migraine (EM). 8-12, 2021. Atogepant 60 mg BID. a 1-12 weeks; 9-12 weeks for Rimegepant. b Exact value with 3 decimal places: ?0.004.

International 52

International Treatment Clinical Trials Trials 52

Drug Target Review

DECEMBER 6, 2024

In cases where control or treatment groups show large variability, this could reflect true biological responses to a treatment, and removing such data could reduce the accuracy of the analysis. It is crucial during this phase to strike a balance between removing erroneous data and preserving meaningful biological variability.

RNA 52

RNA Drugs Research Science 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

Disease 52

Disease Trials Treatment Clinical Trials 52

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.

FDA 52

FDA Treatment Therapies International 52

PPD

JUNE 7, 2023

The number of pediatric patients diagnosed with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) is on the rise, yet there are currently no approved therapies to treat NAFLD and NASH in adult or pediatric populations. As therapies for the treatment of NASH in adult patients go this year to the U.S.

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Trials Clinical Trials Clinical Research Disease 98

The Pharma Data

MAY 27, 2022

Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

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FDA Approval Therapies FDA Treatment 52

The Pharma Data

MARCH 24, 2021

of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment at Week 52 (p < 0.0001). of women who continued relugolix combination therapy remained responders through Week 104.

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Therapies Treatment Science FDA Approval 52

Drug Target Review

JULY 7, 2023

In pregnant individuals, maternal autoantibodies can even attack the organs and tissues of the foetus, 1-9 Many of these diseases are rare, with no safe, targeted, advanced and effective treatment options approved for patients in need. Targeted therapies are designed to interfere with, or target, molecules such as proteins within the body.

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Disease Immune Response Therapies Treatment 98

Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

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Clinical Research Therapies Research Vaccine 52

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.

FDA Approval 52

FDA Approval Treatment FDA Therapies 52

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.

Treatment 52

Treatment FDA Therapies Vaccine 52

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

Drug Target Review

OCTOBER 26, 2023

Genome engineering and gene therapies that manipulate DNA sequences in cells have driven a biotechnological revolution over the past decade. 1 Adeno-associated virus (AAV) vectors are the leading platform for in vivo gene delivery for the treatment of various human diseases. Molecular Therapy 20 , 1831-1832 (2012).

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Engineering Virus Therapies Immune Response 105

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.

FDA Approval 52

FDA Approval FDA Treatment Hospitals 52

The Pharma Data

MAY 6, 2021

INDIANAPOLIS , May 6, 2021 /PRNewswire/ — With a goal of integrating data and technology to help streamline diabetes management, Eli Lilly and Company (NYSE: LLY) signed strategic international agreements with four companies – DexCom, Inc., This creates a solid foundation enabling collaboration and confident treatment decisions.

International 52

International Therapies Disease Production 52

The Pharma Data

MARCH 9, 2021

. (“Biolojic”), a biotechnology company that computationally designs functional antibodies, today announced a research collaboration and license agreement that will leverage Biolojic’s AI-based multibody platform to discover and develop a potential novel antibody-based therapy for the treatment of diabetes.

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Therapies Research Licensing Licensing 52