pharmaphorum

MARCH 5, 2021

billion in annual sales it generated during its peak year in 2013. Copaxone (glatiramer) was once a mainstay of Teva’s portfolio with blockbuster sales that the Israel-based pharma fought hard to protect, including releasing a long-acting version to counter cheaper copycat drugs.

Documentation 98

Documentation Communication Hospitals 98

Med Ed 101

MARCH 10, 2021

There are a few important heart failure guideline updates in the works to the American College of Cardiology’s Heart Failure Guidelines, last published in 2013. This document […]. The post Heart Failure Guideline Updates in 2021 appeared first on Med Ed 101.

Documentation 40

Documentation 40

Pharma in Brief

JANUARY 20, 2021

Also on January 18, 2021, the FC issued a new Practice Direction outlining its Document Retention Schedule, including new plans for the destruction of certain archived documents. Service of Documents. Parties may serve their documents electronically pursuant to the Federal Courts Rules. Document Retention Schedule.

Documentation 52

Documentation 52

pharmaphorum

AUGUST 23, 2021

The debacle conjures up the spectre of the government’s last attempt to shake up patient data-sharing – 2013’s Care.data scheme – which suffered from a number of false starts and was eventually shut down in 2016. survey conducted in July. ” The post NHS data sharing scheme “on hold” as millions opt out appeared first on.

Medical Records 89

Medical Records Documentation Pharmaceutical Companies Pharmaceutical Companies 89

pharmaphorum

SEPTEMBER 16, 2021

Since their inception in 2013, Clinical Commissioning Groups (CCGs) have led medicines optimisation efforts at local level. The Royal Devon and Exeter NHS Trust has used electronic medical records to document and share medicines decisions with GP practices and community pharmacies. A changing healthcare landscape.

Biosimilars 113

Biosimilars Community Pharmacies Medical Records Documentation 113

European Pharmaceutical Review

SEPTEMBER 22, 2022

2013 Oct; 48(10): 943–953. Published online 2013 Jul 2. NICE DSU technical support document 18: methods for population-adjusted indirect comparisons in submissions to NICE. Mayer-Hamblett N, Rosenfeld M, Treggiari MM et al. Standard Care versus Protocol Based Therapy for New Onset Pseudomonas aeruginosa in Cystic Fibrosis.

Drug Development 122

Drug Development Pharmaceutical Companies Pharmaceutical Companies Documentation 122

pharmaphorum

OCTOBER 7, 2020

When I finally sought treatment in 2013, I learned how to turn my ADHD into a strength by better managing it. Done is here to combat these stereotypes, and is working to remove barriers to treatment such as requirements and expectations about frequency of visits, documentation, medication choice and choice of provider.

Pharmaceutical Manufacturing 76

Pharmaceutical Manufacturing Documentation 76

Pharma in Brief

OCTOBER 28, 2021

As we previously reported , the ATI Request concerned Health Canada submission documents for Fortekor, an Elanco Canada Limited ( Elanco ) veterinary drug product. In the judgment, “Records” had been defined to mean the entire third-party request, which included documents that Elanco conceded were not confidential and could be disclosed.

Documentation 52

Documentation 52

Safe Biologics

FEBRUARY 1, 2024

Beginning in 2013, all 50 states and Puerto Rico enacted legislation that allows for pharmacy-level, automatic substitution only for biosimilars given interchangeable status based on additional data provided to the FDA that demonstrates safe switching. Proposing to change this standard in the U.S.

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

pharmaphorum

DECEMBER 29, 2022

The FDA granted full approval to Par’s generic on 28 March, 2013. According to court documents cited by Reuters, annual sales of Exforge in the US were over $400 million before generic versions reached the market.

Specialty Pharmacies 52

Specialty Pharmacies Documentation 52

pharmaphorum

JULY 16, 2021

Advisory committee members were mainly concerned about the safety profile of roxadustat, an oral HIF-PHI drug, including its potential to cause serious thromboembolic events which were flagged by the FDA in a briefing document published ahead of the meeting.

Documentation 52

Documentation 52

pharmaphorum

SEPTEMBER 29, 2022

In the United States, the Food and Drug Administrator (FDA) has so far published three draft guidance documents on patient-focused drug development, with a fourth expected in the coming months. Previously, Mathieu worked for EURORDIS-Rare Diseases Europe since 2013, involved in activities to foster the access to innovation to patients.

Drug Development 98

Drug Development Documentation 98

Ramblings of a pharmacist

SEPTEMBER 26, 2023

First of all - the text of the law passed by Congress and signed into law on 11/27/2013 is available here, on page 562-595. As I’ve discussed before on this blog, counterfeit products DO exist and even have the apparently appropriate T3 documents to validate their legitimacy. .”

Communication 105

Communication Pharmaceutical Manufacturing Documentation 105

pharmaphorum

MAY 14, 2021

For example, its 2013 guide to the methods of technology appraisal is still a valid reference to understand the key principles of cost effectiveness within an HTA context, and NICE decision support unit documents are a useful resource for any health economist needing technical or educational support.

Drug Pricing 59

Drug Pricing Documentation Pharmaceutical Companies Pharmaceutical Companies 59

Pharmaceutical Technology

OCTOBER 5, 2022

These, along with other similar claims, meant Biogen owed potential damages of $1,036,900,151 to the US and the various States, as per court documents. Tecfidera was approved in 2013 to treat MS, and in August 2020, Mylan launched its first FDA-approved dimethyl fumarate generic to the market.

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies 59

Syner-G

AUGUST 9, 2022

In 2013, the IMPACT (now part of Syner-G BioPharma Group) management team decided that the company needed to build a Regulatory Operations department to support their existing and future client base. Hosted software to publish regulatory submissions in the electronic common technical document (eCTD) format was deployed.

Packaging 40

Packaging Documentation 40

FDA Law Blog: Biosimilars

MARCH 27, 2023

The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA. FDA has been implementing the UDI system with different compliance dates for different types of medical devices to ensure a smooth implementation. Most of the compliance dates have been passed.

Labelling 45

Labelling Packaging Documentation 45

RX Note

JUNE 4, 2023

Read and document refrigerator and freezer temperatures at least twice each workday (in the morning and before the end of the workday). External Links Guidelines on Good Distribution Practice, 2013 Guideline on Good Distribution Practice, 2018 Medline Plus - Storing Your Medicines

Drug Storage 52

Drug Storage Labelling Medication Labelling Documentation 52

The Digital Apothecary

MAY 11, 2018

I had started being an Assistant Professor in January of 2013. My Years as an Assitant Professor Luckily (sarcasm) part of going up for promotion includes creating a document a couple hundred of pages long detailing what you did. The First Year (January - June, 2013) So my first academic year started mid-cycle.

Hospitals 130

Hospitals Documentation 130

European Pharmaceutical Review

FEBRUARY 1, 2024

For at least a decade from 2013 until recently, LDL lowering treatments were stuck on a paradigm of just putting people on statins and not getting LDL levels down to certain goals” CETP inhibitors have been around for a while, but they have unfortunately been unsuccessful in getting onto the market commercially. “For

Documentation 97

Documentation Diabetes Pharmaceutical Companies Pharmaceutical Companies 97

pharmaphorum

JANUARY 12, 2023

From the period of 2013 until the present, a third wave of the crisis struck, which saw synthetic opioids, such as fentanyl, cause a greater number of deaths. As the crisis rumbles on, there is a risk of greater levels of drug diversion, which requires a counter strategy on the part of the healthcare care industry and regulators.

Hospitals 105

Hospitals Documentation 105

Pharmaceutical Technology

NOVEMBER 4, 2022

At the time of its publication, the document prioritised the finalisation of Brexit above all else. The SME R&D tax credit scheme allows tax relief of up to 33% on qualifying R&D expenditure, which the former PM David Cameron’s cabinet introduced in April 2013. says O’Meara.

Documentation 93

Documentation Pharmaceutical Companies Pharmaceutical Companies 93

The Thyroid Pharmacist

DECEMBER 7, 2022

The PBDEs consisted of several commercial mixtures known as octa-BDE, penta-BDE, and deca-BDE (all phased out by 2013 in the U.S.; Breast milk and in-utero transmission have also been documented as a means for exposure and concern. [13]. 2013 Aug;26(4):498-510; Chevrier J, Harley KG, Bradman A, et al. Curr Opin Pharmacol.

Health and Personal Care Stores 88

Health and Personal Care Stores Labelling Immunization Immunity 88

National Association of Boards of Pharmacy

JUNE 14, 2023

Since 2013, the Early Discussion and Resolution system has helped connect patients who experience harm with their health care providers to facilitate candid discussions about what occurred, work toward reconciliation, and contribute to safeguarding others from harm.

Pharmacy Technician 40

Pharmacy Technician Documentation 40

European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. 2011;29:7122–7124. Sharma D, Khamar S, Cullen A, et al.

Vaccines 111

Vaccines Communication Immunization Immunity 111

Putting Patients First Blog

SEPTEMBER 26, 2024

Disparities in clinical trial participation have been well-documented, with certain populations, particularly racial and ethnic minorities, women, pregnant and lactating people, older adults, and people with disabilities, often underrepresented in clinical research. Journal of the American College of Cardiology , 71(18), 1960–1969.

Communication 52

Communication Clinical Pharmacology Documentation Drug Development 52

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey as the Senior Principal Scientist in early phase drug development. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

Vaccines 128

Vaccines Research Laboratories Documentation Compounding 128

The Thyroid Pharmacist

JULY 29, 2022

Feel free to use my own health timeline as a guideline to document your health journey. As you add your symptoms to a health history timeline, reflect on what season it was when your allergy or thyroid symptoms worsened. Are your symptoms worse in the winter when the house is shut tight, but fine when windows are open? Published 2018 Jul 2.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

STAT

DECEMBER 30, 2024

Work by device manufacturers to improve the performance of pulse oximeters on people with darker skin has progressed little since the Food and Drug Administration asked manufacturers in 2013 to voluntarily test the devices on more diverse skin tones, according to a study published Monday in JAMA.

Documentation 350

Documentation 350

RX Note

MARCH 31, 2023

KKLIU 0213/2013). Advertisements of Medicines to be Approved As stated in Section 4B , advertisements for the purpose of treatment or prevention of diseases other than specified in the Schedule has to been approved by the Medicine Advertisements Board. Advertisement approval number must be displayed on every advertisement.

Documentation 52

Documentation Labelling Diabetes Hospitals 52

The Thyroid Pharmacist

DECEMBER 1, 2023

In fact, researchers behind a 2013 meta-analysis observed that, statistically, people with low vitamin D were at a much greater risk of depression. [6] Vitamin D deficiency has been documented in Hashimoto’s, Graves’ disease, thyroid cancer, as well as postpartum thyroiditis. [13]

Immunity 98

Immunity Immunization Diabetes Dosage 98

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.” To be clear, as we discussed in a blogpost back in 2013 , the Federal Food, Drug, and Cosmetic Act does not explicitly require companies to permit photographs to be taken.

Documentation 113

Documentation Labelling 113

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition. Sex Med Rev.

Dosage 98

Dosage Documentation Diabetes Labelling 98

European Pharmaceutical Review

MAY 8, 2025

The document outlines alternative approaches to animal testing, including Threshold of Toxicological Concern (TTC), Quantitative Structure Activity Relationship (Q)SAR), Read Across Approaches (RAX), and in vitro approaches. EMA/CHMP/ICH/83812/2013. EMA/CHMP/ICH/353369/2013. 18 July 2023. 2 May 2022. Toxicol.

Compounding 52

Compounding Documentation 52

The Thyroid Pharmacist

JANUARY 20, 2023

Holy Basil ( Ocimum sanctum ) The anti-inflammatory effects of holy basil (also known as tulsi) have been documented in many in vitro and in vivo studies. doi:10.1155/2013/934183 [28] Siberian Ginseng. doi:10.1155/2013/514049; Cropley M, Banks AP, Boyle J. Evid Based Complement Alternat Med. 2013;2013:934183. Anc Sci Life.

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 98

Putting Patients First Blog

FEBRUARY 11, 2025

CMS should also work directly with providers to minimize administrative burdens caused by risk adjustment changes, as increased documentation requirements could further strain providers, particularly those treating high-cost populations. 2 (2013): 223231. 1 (2013): e001570. ” Health Affairs 32, no. BMJ Open 3, no.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Communication Documentation Hospitals 52

pharmaphorum

JULY 8, 2022

” The document says that AbbVie booked 99% of its 2020 prescription drug sales income through its foreign subsidiaries, when 75% of it was made in the US. Now, it’s turning its attention to other big pharma groups, including Abbott Laboratories, Merck & Co and reportedly also Bristol-Myers Squibb.

Biosimilars 59

Biosimilars Documentation 59