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

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

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

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

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

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

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

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

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

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

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

pharmaphorum

MAY 4, 2021

In 2020, life science firms accounted for a third of the SEC’s enforcement actions. That puts your firm in legal jeopardy, even if the distributor signed some pro-forma legal documents and you didn’t know the agent was acting on your behalf.

Documentation 111

Documentation Pharmaceutical Companies Pharmaceutical Companies Hospitals 111

Omnicell

SEPTEMBER 5, 2022

Today at Omnicell-Illuminate 2020, the first-ever digital conference focused on technology-driven medication management, I had the pleasure to reveal a comprehensive look at Omnicell’s product roadmap and strategic vision for supporting customer success in achieving zero-error medication management.

Omnicell 52

Omnicell Documentation Patient Care 52

pharmaphorum

SEPTEMBER 21, 2020

Fantatic news for the FCS Community – NICE has issued a positive Final Evaluation Document (FED) for Volanesorsen. — Action FCS (@ActionFCS) September 18, 2020. Read more about it here [link] #actionfcs #lpld @GeneticAll_UK @rarediseaseuk @findacure_fdn @livingwithfcs @MikeWM @manchester_cv @lipiddoc.

Documentation 80

Documentation FDA 80

pharmaphorum

APRIL 27, 2021

Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.

FDA 90

FDA Chemotherapy Documentation 90

pharmaphorum

SEPTEMBER 28, 2022

“For example, in early 2020, we enrolled somewhere between 3,000 to 3,500 participants each week. In March 2020, when the pandemic hit, we had to pause in-person recruitment. Martin is also the primary author of the pivotal FDA guidance document Collection of Race and Ethnicity Data in Clinical Trials. About the author.

FDA 98

FDA Documentation Dosage Pharmaceutical Companies 98

pharmaphorum

FEBRUARY 12, 2021

If 2020 was the year that cemented the role of virtual advisory boards and virtual engagement in many forms, then we believe that 2021 will be the year of ‘virtual co-creation’. The benefits of virtual advisory boards (VABs) in replacing face-to-face advisory discussion with KOLs and HCPs are now clear and established.

Documentation 59

Documentation 59

pharmaphorum

FEBRUARY 8, 2022

In briefing documents released by the FDA reviewer, the agency has made it clear that the Chinese clinical results filed in support of the PD-1 inhibitor do not meet the criteria for foreign data fled in support of a marketing application in the US. .”

FDA 52

FDA Documentation Chemotherapy 52

Omnicell

SEPTEMBER 5, 2022

To put that figure in perspective, its cost would be almost 50% more than the Coronavirus Aid, Relief, and Economic Security (CARES) Act passed in March 2020; the spend on such a bill would be equivalent to about 70% of the entire non-COVID-19-related annual federal budget for 2020.

Vaccines 52

Vaccines Omnicell Documentation Immunization 52

ISPE

SEPTEMBER 8, 2023

We have 19 committees, councils, and working groups that are doing incredible work bringing visibility to the industry’s regulatory challenges and developing solutions that are delivered through ISPE content outlets: webinars, PE magazine articles, iSpeak blog posts, training materials, conference sessions, and ISPE Guidance Documents.

Documentation 91

Documentation 91

The deprescribing.org Blog

APRIL 14, 2021

From October 2020 to January 2021, Amy worked with Dr. Barbara Farrell in the Bruyère Continuing Care Geriatric Day Hospital and with her Deprescribing Research Team as part of her postgraduate PharmD training. Document, document, document. Today we have another blog post for you. Discharge medication reviews.

Community Pharmacies 52

Community Pharmacies Documentation Hospitals Communication 52