The Pharma Data

JANUARY 20, 2021

children and teens with type 2 diabetes increased by 30% between 2001 and 2009, with cases growing among youth aged 10 and older. Early screening can allow treatment to begin and prevent or delay diabetes-related problems. The number of U.S. But sometimes patients with type 2 diabetes don’t have any signs.

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Common Sense for Drug Policy Blog

DECEMBER 28, 2023

A 2001 study of alcohol abuse and dependence among US adults using the National Household Survey on Drug Abuse (NHSDA) — the precursor to the NSDUH — found that the prevalence of alcohol dependence was 7.4% among men and 7.3% among women who reported binge drinking (13). Prevalence of Alcohol Dependence Among US Adult Drinkers, 2009–2011.

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Conversations in Drug Development Trends

MAY 23, 2024

Regulatory Harmonization of Clinical Trials in the EU The EU-CTR repealed the Clinical Trial Directive 2001/20/EC (CTD) and national implementing legislation in the EU Member States on 31 January 2022. These therapies offer improved safety and high potency with fewer side effects than traditional treatments.

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Policy Prescription

MARCH 11, 2022

For the record, CanadaDrugs.com was never found or even accused of selling a counterfeit drug to its online pharmacy customers while it operated from about 2001 to 2018, but the pharmaceutical industry wanted people to believe otherwise. Kris Thorkelson never pled guilty to selling counterfeit drugs. clinics in 2011.

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Online Pharmacies Pharmacy FDA International 52

FDA Law Blog: Drug Discovery

APRIL 23, 2023

An “externally controlled trial” is described in the Draft Guidance as a study in which “outcomes in participants receiving the test treatment according to a protocol are compared to outcomes in a group of people external to the trial who had not received the same treatment.”

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FDA Law Blog: Biosimilars

MAY 23, 2023

Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021). the product label declares “tree nut” or “fish” but fails to declare the type of tree nut or species of fish in either the ingredient list or in a separate “Contains” statement).

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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. 2001 Sep;24(9):517–26. 26 Outside of drug safety, we also plan to adapt our model to anti-epileptic drug discovery. Adv Drug Deliv Rev. Rudy B, McBain CJ.

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The Pharma Data

DECEMBER 15, 2020

This cooperation intends to quickly provide to Chinese patients with this innovative diabetes treatment mechanism. However, significant clinical needs should be recognized due to the unsatisfied outcome using conventional treatments. in 19 provinces and regions in China. China has the largest number of diabetic patients in the world.

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Agency IQ

APRIL 12, 2024

Directive 2001/83/EC and Regulation (EC) No 726/2004. EURORDIS , a non-profit alliance of rare disease organizations, noted the amendments as a significant step towards “bridging the gap between rapid scientific progress and the slower advancement in patient care,” highlighting that 94% of rare diseases still lack treatment.

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Agency IQ

AUGUST 16, 2024

Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized. In the clinical studies, this consisted of a four-month course of treatment with three doses of MDMA administered in supervised therapy sessions.

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New Drug Approvals

JANUARY 13, 2023

Indications Forasartan is indicated for the treatment of hypertension [6] and, similar to other ARBs, it protects the kidneys from kidney blood vessel damage caused by increased kidney blood pressure by blocking renin–angiotensin system activation. [7] 41 (2): 137–52. doi : 10.2165/00003088-200241020-00005. PMID 11888333. S2CID 13185772.

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Agency IQ

MARCH 7, 2024

In the future regulations, IVDs would encompass software, physical or mental impairment and include assays that provide information on the predisposition to conditions or diseases and those that predict treatment responses, according to MHRA’s diagnostics head Burt. Keating did observe that the GSPRs will be tailored to U.K.

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Agency IQ

SEPTEMBER 29, 2023

GDPR) and “is without prejudice” to the laws on protection of intellectual property (2001/29/EC, 2004/48/EC and (EU) 2019/790). Data accessibility and sharing obligations may lead to safety concerns on the diagnosis and treatment of patients. Important definitions come both within the proposed law and from other Union legislation.

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PLOS: DNA Science

SEPTEMBER 5, 2024

The most groundbreaking cancer drug approval was for Gleevec , with a mere 3-month trajectory at FDA before its approval in 2001. 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.

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The Pharma Data

OCTOBER 19, 2020

Previous treatments could only hope to slow progression. Intellia has received approval to launch their Phase I trial of NTLA-2001 in hereditary ATTR. Their NTLA-2001 candidate uses their proprietary non-viral lipid nanoparticle platform, which will deliver this CRISPR/Cas9-based therapy.

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National Institute on Drug Abuse: Nora's Blog

AUGUST 28, 2024

Over the past two decades, substance use treatment admissions have increased among people aged 50 and over. Chronic pain is prevalent among older adults, and treatment for pain is less effective in this age group than it is in younger people; it negatively impacts quality of life and is a risk factor for cognitive decline and premature death.

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PLOS: DNA Science

MARCH 21, 2024

million price tag for the one-time infusion, and for the older siblings who contributed to developing the gene treatment, but were too sick to receive it. ” I wonder what families will actually end of paying for the one-and-done treatment. million, a lot less than the MLD treatment. Yes, the cost is horrifying.

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Common Sense for Drug Policy Blog

JULY 8, 2023

It has been criticized, for example, on the ground that there is a contradiction between the ideas of consent to treatment and the obligation to go to Commissions which, in turn, can apply sanctions (to people who do not have a substance use disorder) [ 6 ]. Nevertheless, it is undeniable that the system brought positive results.

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Drugs International Treatment Disease 52

The Pharma Data

OCTOBER 21, 2020

22 in the New England Journal of Medicine , could lead to an effective — and chemo-free — treatment for the cancer. Those drugs belong to a class called tyrosine kinase inhibitors (TKIs), and include Gleevec — the first TKI approved, back in 2001 — as well as newer ones like Sprycel and Bosulif.

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The Pharma Data

OCTOBER 21, 2020

22 in the New England Journal of Medicine , could lead to an effective — and chemo-free — treatment for the cancer. Those drugs belong to a class called tyrosine kinase inhibitors (TKIs), and include Gleevec — the first TKI approved, back in 2001 — as well as newer ones like Sprycel and Bosulif.

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PLOS: DNA Science

APRIL 13, 2023

received treatment, according to the National Institute on Drug Abuse (NIDA). So scrutinizing genomes for genes that control drug dependency could inspire treatments. The first SNP map was published in 2001 and the first GWAS in 2005. Drug addiction is prevalent and deadly. That’s the goal of the new report.

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DNA Drugs Treatment Science 52

Agency IQ

NOVEMBER 3, 2023

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. no available alternative treatments, 2. The Pharmaceutical Strategy document notes that Covid-19 just compounded medicines shortages that had already impacted patient health and the E.U. healthcare systems for years.

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Agency IQ

JULY 12, 2024

The EC’s assessment of the risk to the supply chain included the number of actual shortages for each medicine, as well as a public health impact assessment conducted by Member States (based on EMA’s guideline using two criteria: the therapeutic indication and availability of alternative treatment options). from a tablet to a capsule).

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Broad Institute

JULY 28, 2023

Postbiotics for the Treatment of Post-Traumatic Stress Disorder The gut microbiome is increasingly recognized as an important player within physiological homeostasis of the body but also in pathophysiological derailments.

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National Institute on Drug Abuse: Nora's Blog

NOVEMBER 25, 2024

Contrary to worries that syringe services programs (SSPs) will encourage or promote drug use, evidence shows that they more often do the opposite, linking people with addiction to effective treatment and even helping prevent overdose deaths. Unfortunately, prejudices against harm-reduction continue to impede the reach of SSPs.

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Agency IQ

DECEMBER 15, 2023

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. Additionally, medicines that treat a potentially fatal condition, require immediate administration, for which an interruption of treatment would jeopardize outcomes, or are part of a national disease control program (e.g.,

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The Pharma Data

JANUARY 13, 2021

There remains a significant need for new treatments with improved activity and tolerability to prevent or treat organ transplant rejection and to treat autoimmune conditions, including systemic lupus erythematosus, rheumatoid arthritis and multiple sclerosis.”. 1 Lederman, S. 175:1091-1101 (1992) 2 Karpusas, M et al., Structure.

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Codon

JULY 21, 2024

As the biotechnologist Alex Telford writes , “Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.” Another part of providing research animals with a good life is granting them a good death.

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National Drug & Alcohol Research Centre Blog

DECEMBER 17, 2020

Last year researchers at NDARC explored linked administrative data for the Opioid Agonist Treatment and Safety Study (OATS). The aim of the study is to quantify the risk of adverse events for people with a history of Opioid Agonist Treatment (OAT), the most effective treatment for opioid use disorder. Lancet 2020.

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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. Nevertheless, the costs of DNA sequencing have dropped since 2001 , and since 2008 have decreased at a pace more rapid than that which Moore’s Law predicts for computing power.

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PLOS: DNA Science

JULY 27, 2023

These patterns can foretell which treatments will likely work and which won’t, how likely and quickly the cancer will spread, and its path in the body. which spit out information guiding the trimming of tumors in real time, a bit reminiscent of its ancestor Hal the computer from 2001: A Space Odyssey. And then in 2001 came us.

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Common Sense for Drug Policy Blog

JUNE 4, 2023

Data between 2001-2018 evidences a substantial increase in drug poisonings over time for people who use opioids, with risk increasing particularly between the years of 2010-2018, an effect which was not entirely explained by the ageing of this cohort ( Lewer et al., 2022 ; ONS, 2019a , 2019b ; Public Health England, 2018 ). 2023.104025

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Codon

DECEMBER 12, 2024

Clarke — the British writer most famous for 2001: A Space Odyssey — published a little-known story called Technical Error , in which a power plant employee is transformed into his mirror image after an accidental short-circuit. In 2001, in an outbreak that had nothing to do with a lab leak, foot-and-mouth disease in the U.K.

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Agency IQ

JUNE 16, 2023

Proposed Rule Stage Restoration of Inadvertently Removed Exemption From the Requirements of FIFRA 2070-AK25 August 2023 In 2001, EPA inadvertently removed an exemption from the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

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Agency IQ

DECEMBER 15, 2023

The allowance or “variance” to the prohibition on the open burning of hazardous waste was established at a time when there were no alternatives to the safe treatment of waste explosives.

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Regulations Compliance Production Government 40

Agency IQ

MARCH 29, 2024

Specifically, the NPRM proposed changes to manifest regulations for shipments of hazardous waste that are exported for treatment, storage, and disposal. Additional revisions that would impact permitting, for example, changes to definitions or references, may also be proposed for other RCRA regulatory sections.

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New Drug Approvals

APRIL 23, 2025

Experimental Properties Property Value Source melting point (C) 195 C PhysProp water solubility 27.1 mg/L Not Available logP 3.21 HANSCH,C ET AL. 1995) pKa 3.4 In addition, the waste water that contains chromium or manganese is difficult to dispose, and these have all seriously restricted further developing of this technique. . 438 (7064): 6.

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