pharmaphorum

MARCH 16, 2021

In a review of the documents, the BMJ said they showed concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. The documentation was not complete and the leaks did not show how the agency’s concerns were satisfied, the BMJ added.

Vaccines 138

Vaccines Documentation 138

pharmaphorum

DECEMBER 10, 2020

FDA reviewers have already concluded that the vaccine is safe and effective in a briefing document ahead of the Vaccines and Related Biological Products Advisory Committee’s meeting. Feature image copyright BioNTech SE 2020, all rights reserved.

Vaccines 103

Vaccines Documentation FDA 103

pharmaphorum

JANUARY 13, 2021

The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records. Since then the agency has been investigating the incident involving the theft of documents that formed part of BioNTech’s filing for the BNT-162b vaccine.

Vaccines 82

Vaccines Documentation 82

pharmaphorum

APRIL 16, 2021

IQVIA’s Sarah Rickwood reviews the launch of innovative medicines in 2020 and outlines three key pillars of activity for companies to focus on and address in 2021. It is undeniable that 2020 was a particularly challenging year to launch non-COVID innovative prescription medicines.

Pharmaceutical Companies 95

Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

pharmaphorum

JANUARY 28, 2022

But never mind, 2021 was a blockbuster even compared to 2020 or 2019, with many sources saying there was twice as much, or nearly twice as much money raised this past year compared with the year before. And exactly how much more was that than 2020? Startup Health had it at $44 billion, a true doubling from 2020. Was it $57.2

Documentation 141

Documentation 141

pharmaphorum

NOVEMBER 20, 2020

Based on current projections the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 It is one of 11 vaccines that are in phase 3 development, including contenders from Moderna, Novavax and AstraZeneca, according to the World Health Organization’s regularly updated tracker document.

Vaccines 96

Vaccines Documentation FDA 96

pharmaphorum

APRIL 15, 2021

It will also include a directory of healthcare professionals and a digital document vault to store records, with the entire suite operating within Microsoft’s Cloud for Healthcare platform.

Documentation 112

Documentation Insurance 112

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

pharmaphorum

SEPTEMBER 23, 2020

“The hub is looking to attract high-calibre groups active in areas aligned to AZ’s strategy, as well as biotech and medtech companies that could gain a competitive advantage by tapping into AZ’s expertise and infrastructure,” says the document, Sector Convergence: A significant growth opportunity. Innovation versus regulation.

Documentation 140

Documentation Communication Hospitals 140

Hospital Pharmacy Europe

AUGUST 17, 2023

8 The GoCART Coalition In 2020, the European Society of Blood and Marrow Transplantation and the European Hematology Association joined forces and launched GoCART – a multi-stakeholder coalition in the field of gene and cellular therapies manufactured from cells and tissues of haematopoietic origin. Cham (CH): Springer; 2022: Chapter 43.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

European Pharmaceutical Review

AUGUST 1, 2022

The HMA/EMA Big Data Steering Group, set up in May 2020 to advises both the EMA and HMA on the implementation of ten priority recommendations highlighted by the Big Data Task Force, reviews its workplan annually to cover any new emerging topics.

Documentation 105

Documentation 105

Pharmaceutical Technology

JULY 15, 2022

The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin. California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form.

Insurance 131

Insurance Documentation Packaging 131

pharmaphorum

OCTOBER 18, 2021

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. A Timeline of COVID-19 Developments in 2020. 3, 101 (2020). 3, 50 (2020). References. 1 The Economist. Available from: [link].

Vaccines 143

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 143

pharmaphorum

JULY 27, 2022

Of all products approved by the European Medicines Association (EMA) between 2017 and 2020, 68% are currently available in England, a figure that stands at 54% in Scotland. In addition, the median time between regulatory approval and the first patient receiving a first dose was 247 days in 2020 – an increase of 25 days since 2018.

Documentation 98

Documentation FDA 98

Druggist

MAY 6, 2021

The official guide on type-2 diabetes management: document produced by NICE for healthcare professionals in the UK, which recommends treatment for type-2 diabetes. . On the other hand, only 50% of patient with type 2 diabetes (8 years or longer) reached normal sugar levels with a calorie-restricted diet (Taylo, 2020). eMC (2020).

Documentation 98

Documentation 98

The Checkup by Singlecare

DECEMBER 13, 2022

Noor Ali, MD, founder at Dr. Noor Healthcare Advisor , says that it also includes “strong supportive documents, [like] medical evidence, clinical notes, professional statements,” and more. If you are including documents, include a list of what you are sending here. Write short, factual statements. Do not include emotional wording. .

Insurance 98

Insurance Documentation Insurance Coverage HIPAA 98

pharmaphorum

JUNE 3, 2021

An earlier consultation that closed on 18 December 2020, covered methods. And anyone interested in a game of policy bingo will be able to mark off all the important policy documents and every agency too. Read below for a preview: NICE has never stood still since it started its work in 1999.

Documentation 98

Documentation 98

pharmaphorum

MAY 16, 2022

In 2020, USAID launched two policy documents to guide how the agency invests in digital infrastructure as part of its development and humanitarian assistance programmes: Digital Strategy and Vision for Action in Digital Health (aka Digital Health Vision).

Documentation 118

Documentation Vaccines 118

European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

Documentation 98

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 98

IDStewardship

DECEMBER 13, 2024

It may be derived from work completed inthe microbiology lab, unitsdispensed from the pharmacy, administrations performed by nurses, expenditures produced from drug purchases, documentation within any area of the electronic medical record, extraction from supplemental tools or data warehouses, and so much more.

Communication 225

Communication Medical Records Documentation 225

pharmaphorum

FEBRUARY 10, 2021

The project is coordinated by the University of Bologna and funded by the European Union’s Horizon 2020 research and innovation programme that involves more than a dozen partner institutions, including Italian startup InSilicoTrials.

Packaging 76

Packaging Documentation Hospitals 76

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.

Vaccines 108

Vaccines Documentation Compounding FDA 108

The FDA Law Blog

FEBRUARY 7, 2024

In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. Thus, such persons are subject to identification, recordkeeping, and reporting requirements.

Controlled Substances 116

Controlled Substances Documentation 116

The FDA Law Blog

JANUARY 15, 2024

FDA complied with that order, later extended the deadline because of COVID, and eventually settled on a PMTA deadline of September 9, 2020. FDA originally set the PMTA deadline as August 8, 2022, but a district court in Maryland ordered FDA to shorten it. But administrative law does not turn on such infinitesimal possibilities.”

FDA 115

FDA Documentation 115

Hospital Pharmacy Europe

JANUARY 25, 2024

Professor Nicola Stoner, chair of the RPS Consultant Pharmacist Group, said: ‘This document sets out an ambitious and exciting vision for the role of the consultant pharmacist following our very successful consultant pharmacist summit last year.

Documentation 98

Documentation Hospitals 98

pharmaphorum

DECEMBER 8, 2022

Instead, there are hints from other documents that are published by the government about just what the LSC is there to do. The Life Sciences Industrial Strategy Update , published in January 2020, updating on the second Life Sciences Sector Deal from 2018, also mentions the LSC. Pandemic (November 2020). Terms of reference.

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. The UK joined two initiatives in October 2020 that should bear fruit in the future: Project Orbis and the Access Consortium. The promise of faster market access . More change at NICE.

Documentation 82

Documentation 82

pharmaphorum

FEBRUARY 28, 2022

The analysis also suggests that rare diseases impose a substantial economic burden that can be reduced with availability of new treatments – the lack of treatment was associated with a 21% increase in total costs PPPY, according to the document.

Documentation 98

Documentation Hospitals 98

ISPE

SEPTEMBER 15, 2022

12 of February 2020 again received 2,000 comments from public consultation. The first draft for comments from industry stakeholders was published in 2017 and generated 6000 comments.

Documentation 97

Documentation FDA 97

The FDA Law Blog

OCTOBER 3, 2022

HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. Today, these two documents are key in navigating speaker programs in the industry. See 42 U.S.C. 1320a-7b(b).

Documentation 105

Documentation 105

pharmaphorum

DECEMBER 16, 2020

The document has been published just after the US started the rollout of Pfizer and BioNTech’s vaccine after it got an emergency green light last week, and ahead of an expert panel due to consider Moderna’s shot on Thursday. — Eric Topol (@EricTopol) December 15, 2020. Very encouraging! pic.twitter.com/6IVSj8E3F0.

FDA 98

FDA Vaccines Documentation 98

European Pharmaceutical Review

NOVEMBER 9, 2022

An analysis performed at the end of 2019 concluded that demand for viral vectors would have surpassed CDMO capacity during 2020. Technology transfer of the process from development to manufacturing involves generating a wide variety of documentation, data and training.

Vaccines 115

Vaccines Documentation Communication Hospitals 115

pharmaphorum

AUGUST 10, 2021

In December 2020, the Scottish Government published a National Cancer Plan, and while it listed a total of 68 actions, four were described as “flagships”. This new spirit of partnership has the ability to improve patient outcomes and create efficiencies for the NHS.”. Recovery and redesign.

Documentation 105

Documentation 105

Pharmaceutical Technology

APRIL 6, 2023

Accord US BioPharma president Chrys Kokino said: “The promise of HLX02’s reference product — Herceptin1 — is well documented, and we’re thrilled to announce this regulatory milestone as we work to provide patients increased options and access for treatment of serious conditions in oncology, immunology and critical care.

FDA 52

FDA Documentation 52

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

FDA 105

FDA Documentation Communication 105

pharmaphorum

NOVEMBER 1, 2021

The document says that Sleepio shows promise as a treatment for insomnia in primary care that could be an alternative medicines and sleep hygiene advice, but it is uncertain whether it will be cost-saving for the NHS. The consultation document is open for comment until 29 November, with final recommendations schooled by 12 May next year.

Documentation 59

Documentation 59

European Pharmaceutical Review

FEBRUARY 2, 2023

Between 2000 and 2020, Asian companies outperformed European companies for new approvals of CEPs, increasing their number CEPs from 183 to 2,369. References European Commission Staff Working Document ‘Strategic Dependencies and Capabilities’, update to the 2020 New Industrial Strategy, 2021.

Generic Medicine 111

Generic Medicine Packaging Documentation Pharmaceutical Companies 111