Drug Patent Watch

DECEMBER 10, 2024

Quality Documentation and Manufacturing Expertise CDMOs are experienced in generating high-quality documentation required for regulatory submissions and have extensive expertise in drug development and manufacturing. 2021, May 2). Key Pillar of a Successful CDMO: Exceptional Regulatory Compliance. Societal CDMO. LGM Pharma.

Documentation 98

Documentation Drug Development Pharmaceutical Manufacturing Pharmaceutical Companies 98

pharmaphorum

DECEMBER 22, 2021

As part of our 2021 in Review series, we look back over some of these developments. The document also states the importance of real-world data in understanding how currently available pharmaceutical products work in different populations. Education and empowerment allow for equal access to care. Looking ahead.

Documentation 105

Documentation 105

pharmaphorum

JANUARY 12, 2021

2020 was a big year for market access initiatives in the UK, many of which are only just starting, and their impact will come through in 2021 and beyond. It’ll also reveal just what the Target Development Profile (TDP) living document will cover and how it can evolve over time. That makes it a target for June 2021.

Documentation 82

Documentation 82

RX Note

OCTOBER 9, 2023

Since we don't even remember what we eat this morning, it is vital to make proper medical documentation. The amendments should be documented on the prescription and endorsed with “prescriber contacted” (PC), dated and initialled by the pharmacist/person dispensing.

Documentation 52

Documentation Medical Records 52

FDA Law Blog: Biosimilars

APRIL 8, 2025

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

Documentation 52

Documentation Labelling Drug Development 52

Drug Channels

OCTOBER 5, 2021

I am pleased to announce our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. The notable new material in this 2021-22 edition includes three new sections: Section 4.2.5. Copyright © 2006-2021 Pembroke Consulting, Inc. Section 4.4.

Biosimilars 75

Biosimilars Pharmaceutical Manufacturing Hospitals Documentation 75

National Association of Boards of Pharmacy

MARCH 22, 2024

Food and Drug Administration (FDA) has released a final guidance document offering recommendations to sponsors on developing monoclonal antibody products targeting SARS-CoV-2 intended to prevent or treat COVID-19. Additionally, the guidance document lists the criteria needed for FDA to issue emergency use authorizations.

Documentation 52

Documentation 52

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

Documentation 52

Documentation Inpatient 52

pharmaphorum

JUNE 22, 2021

The UK’s Department of Health and Social Care has published a document setting out its strategy on handling patient data – and defending its plan to transfer millions of GP records into a centralised database. — Matt Hancock (@MattHancock) June 22, 2021. — medConfidential (@medConfidential) June 22, 2021.

Documentation 52

Documentation Health and Personal Care Stores Medical Records Communication 52

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world.

Diabetes 246

Diabetes Biosimilars Documentation Compounding 246

European Pharmaceutical Review

JANUARY 17, 2023

The figures confirmed that in 2022, the UK remained a global leader in clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022. The number of Phase II/III trials increased from three trials in 2021 to seven trials in 2022. Over 80 percent, increasing from 131 trials in 2021 to 145 in 2022.

Documentation 119

Documentation 119

ALiEM - Pharm Pearls

JANUARY 26, 2024

Ciprofloxacin has been documented as a cause of IgA vasculitis. 2021 Jan;34(1):e14591. Case Question: What are common triggers for this diagnosis? Common triggers include infection, drugs, and autoimmune. Case Discussion Take-Home Points Consider IgA vasculitis, even in an older patient. Ann Pharmacother. 1995 Jan;29(1):84.

Nursing Homes 183

Nursing Homes Documentation Hospitals 183

Drug Channels

MARCH 16, 2021

I am pleased to announce our new 2021 Economic Report on U.S. Drug Pricing, Reimbursement, and Patient Costs (press release) We’re offering special discounted pricing if you order before March 28, 2021. The 2021 Economic Report on U.S. The full document clocks in at 412 pages. d/b/a Drug Channels Institute.

Drug Pricing 52

Drug Pricing Documentation 52

Pharma in Brief

JANUARY 9, 2022

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. The courts also had a busy year in 2021. Introduction. c) Other policy developments.

Documentation 52

Documentation Labelling Vaccines Packaging 52

Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

Communication 64

Communication Documentation Labelling Pharmaceutical Companies 64

pharmaphorum

OCTOBER 18, 2021

2 And, as of September 2021, there are 22 COVID-19 vaccines in use globally 3 , and over 2.3 And advances in digitalisation could facilitate a move from document-based submissions to data-based submissions, through a cloud platform like the one being developed by Accumulus Synergy. Last accessed: October 2021. Perspect Clin Res.

Vaccines 143

Vaccines Clinical Pharmacology Pharmaceutical Companies Pharmaceutical Companies 143

pharmaphorum

JULY 6, 2021

Oxford Nanopore is also building up to an initial public offering (IPO) later this year that could reinforce 2021’s position as the best-ever year for UK financing, well ahead of last year’s total tally of £2.81 Source: BIA, Clarivate.

Documentation 141

Documentation Vaccines 141

Drug Channels

DECEMBER 14, 2021

Click here to see the original post and comments from July 2021. I document this disappointing state of affairs below. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2022.

Documentation 98

Documentation 98

Express Pharma

DECEMBER 5, 2023

Under the agreement, Cyprium completed the transfer of its worldwide proprietary rights and US FDA documents pertaining to CUTX-101, the copper histidinate product candidate for the treatment of Menkes disease, to Sentynl. Sentynl now assumes full responsibility for the development and commercialisation of CUTX-101.

Documentation 103

Documentation 103

Med Ed 101

MARCH 10, 2021

This document […]. The post Heart Failure Guideline Updates in 2021 appeared first on Med Ed 101. Prior to the full guideline release, the organization recently printed their updated Expert Consensus Decision Pathway for treatment of patients with heart failure with reduced ejection fraction (HFrEF).

Documentation 40

Documentation 40

pharmaphorum

DECEMBER 4, 2020

In a separate announcement, rival vaccine firm Moderna said it expected to have between 100 and 125 million doses available globally in the first quarter of 2021. The company said it is still on course to manufacture between 500 million and up to a billion doses of the vaccine globally in 2021.

Vaccines 125

Vaccines Documentation 125

pharmaphorum

SEPTEMBER 2, 2020

The guidance published on the Medicines and Healthcare products Regulatory Agency (MHRA) website is broadly similar to arrangements laid out in a Brexit “no deal” document published last year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

Documentation 124

Documentation Labelling 124

Express Pharma

AUGUST 23, 2023

The researchers tracked infections among 15,444 residents of Connecticut correctional facilities between June 2021 and May 2022, when the state experienced two epidemic waves due to the emergence of the COVID-19 Delta and Omicron variants.

Vaccines 98

Vaccines Documentation Immunity Immunization 98

Drug Channels

DECEMBER 2, 2021

This book provides a comprehensive, well-written chronicle of the COVID-19 pandemic (as of mid-2021). Dr. Gottlieb documents—with great specificity—how and why our government’s public health infrastructure failed us during the pandemic. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. Amazon link). to 1:30 p.m.

Documentation 75

Documentation 75

European Pharmaceutical Review

NOVEMBER 21, 2022

Study data from Elsevier’s abstract and citation database Scopus, identified that 2,450 papers were published in 2021 on the pathogen WHO identified as most critical, Acinetobacter baumannii (carbapenem-resistant). Enterococcus faecium : 1,246 in 2021 versus 730 in 2017. Neisseria gonorrhoeae : 731 in 2021 versus 478 in 2017.

Documentation 98

Documentation 98

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are. Comments on the guidance are invited.

Documentation 105

Documentation Medical Records 105

European Pharmaceutical Review

MARCH 13, 2024

The data integrity violations API deviations in the microbiology lab The first deviation – failure to follow and document laboratory controls at the time of performance, and failure to document and explain any departures from laboratory procedures – relates to the lack of data integrity within the microbiology laboratory.

Documentation 98

Documentation Pharmaceutical Manufacturing 98

Pharma Pathway

DECEMBER 12, 2022

Passed out years: 2020/2021/ 2022. Kindly Carry the below Documents with you: . Division: OSD-Formulation. Qualification: ITI, Diploma, B.Sc, B.Com. Location: Hyderabad. Date: 14th Dec’ 2022. Time: 9:00 AM to 01:00 PM. Venue: Granules India Limited, Gagillapur , Dundigal- Gandimaisamma- Malkajgiri , Hyderabad , Telangana – 500 043.

Pharmaceutical Manufacturing 86

Pharmaceutical Manufacturing Documentation 86

Pharmaceutical Technology

SEPTEMBER 15, 2022

The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database. AbbVie reported a 22.7%

Vaccines 108

Vaccines Drug Pricing Biosimilars Documentation 108

Pharmaceutical Technology

JULY 19, 2022

Mentions of cloud computing within the filings of companies in the pharmaceutical industry rose 65% between the final quarter of 2021 and the first quarter of 2022. Of the 10 biggest employers in the pharmaceutical industry, IQVIA was the company which referred to cloud computing the most between April 2021 and March 2022.

Omnicell 98

Omnicell Pharmaceutical Companies Pharmaceutical Companies Documentation 98

Med Ed 101

JUNE 9, 2021

The post Preparing For The BCMTMS Exam in 2021-2022 appeared first on Med Ed 101. I’m happy with the testimonials that we have received that make me believe we provide the best resources on the market that […].

Documentation 40

Documentation 40

Pharma in Brief

JANUARY 18, 2021

The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021. Prior to the January 6, 2021 amendment, the list of jurisdictions included the European Union and its member countries, along with the United States, Australia, Switzerland, and Japan. There are also certain timing requirements.

Documentation 52

Documentation 52

pharmaphorum

MARCH 7, 2022

Last November, it was confirmed that both NHS Digital and NHSX are to be folded into NHS England’s new Transformation Directorate, set up earlier in 2021 with the aim of bringing together digital and operational improvement teams within the NHS. — medConfidential (@medConfidential) November 22, 2021.

Documentation 115

Documentation 115

BioPharma Dive

AUGUST 14, 2023

The regulator has asked for documents tied to the 2021 deal as well as to the conduct and compensation of Illumina and Grail management.

Documentation 52

Documentation 52

pharmaphorum

FEBRUARY 10, 2021

Pharmaceutical companies will need new standard operating procedures (SOP) to cover activities such as collaborative working, and new documentation to reflect changes in language. But while amending processes and documentation to suit the 2021 code won’t be easy, the task doesn’t have to be as overwhelming as it first appears, she said.

Documentation 111

Documentation Pharmaceutical Companies Pharmaceutical Companies 111

Quality Matters

NOVEMBER 5, 2024

API DMFs are documents containing information on APIs that are submitted to the U.S. This is an update to an analysis of API DMFs that we conducted in 2021. In 2021, China filed 134 API DMFs, and by 2023, this number surged to 219, marking an impressive 63% increase over just two years.

Pharmaceutical Manufacturing 78

Pharmaceutical Manufacturing Packaging Documentation 78

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96