Drug Topics

JULY 7, 2025

The study cohort included 136 patients with a confirmed HAE type 1 or 2 diagnosis who had at least 2 documented HAE attacks within 3 months prior to screening. Patients received either 300 mg or 600 mg sebetralstat or placebo. The study found patients who received sebetralstat had a beginning of symptom relief of 1.61 hours for 300 mg and 1.79

FDA 315

FDA Vaccines Specialty Pharmacies Compounding 315

The FDA Law Blog

OCTOBER 13, 2024

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

Documentation 64

Documentation FDA 64

Drug Topics

JUNE 25, 2025

The properties of thimerosal were documented to contribute to the safe use of multidose vials and packaging of vaccines, such as seasonal and pandemic influenza vaccines. Thimerosal is a mercury-containing compound that has been widely used as a preservative in some biological and drug products since the 1930s. Thimerosal and Vaccines.

Vaccines 387

Vaccines Independent Pharmacies Immunization Compounding 387

Pharmacy Times

JULY 18, 2025

Compliance with FDA guidelines, including documenting clinical differences and avoiding investigational GLP-1s, is essential for compounders. It would also be expected that the reason would be documented in the patient’s chart. In other words, the pharmacist can take that determination verbally but must document it.

Compounding 73

Compounding Compounding Pharmacies Documentation FDA 73

Viseven

JUNE 4, 2025

And patients gladly take the opportunity to access their online medical records — 54% reviewed their records at least three times during 2022 , compared to 38% in 2020. Medical histories, test results, and treatment plans are now shared seamlessly, ensuring everyone is on the same page.

Communication 52

Communication Health and Personal Care Stores HIPAA Medical Records 52

Pharmaceutical Technology

JULY 16, 2025

Robert Barrie July 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Shares in London-listed GSK closed 1.19% down following the document release. Experts also identified poor tolerability of regimens and resulting uncertainty regarding proposed dose, as per a briefing document published on 15 July.

Documentation 52

Documentation FDA Communication Packaging 52

Pharmaceutical Technology

JULY 15, 2025

The net payment made by Sino to acquire LaNova will be approximately $500.9m, a figure that excludes the estimated cash and bank deposits, according to a company document outlining the terms of the transaction. At the time, Sino spent 142 million yuan ($19.80m) to initiate its ownership involvement with the biotech.

Packaging 75

Packaging Communication Hospitals Vaccines 75

Drug Topics

JUNE 25, 2025

from 2017 to 2020. image credit: syahrir / stock.adobe.com While data shows that obesity has been on the rise among children in recent history, the overall complications spurred on by childhood obesity have been well documented. . Dispensing of glucagon-like peptide-1 receptor agonists to adolescents and young adults, 2020-2023.

Compounding 315

Compounding Insurance Coverage Insurance Specialty Pharmacies 315

Pharmaceutical Technology

JULY 18, 2025

By GlobalData Learn more about Strategic Intelligence Blenrep was approved under the FDA accelerated approval process in 2020 to treat multiple myeloma (MM). The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July.

FDA 52

FDA Communication Packaging Hospitals 52

European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

Documentation 52

Documentation Packaging FDA 52

STAT

JULY 10, 2025

The agency only highlighted letters that went to drugmakers whose products were eventually approved, documents that have already been made public over the years. Some portions of the letters, which cover decisions made from 2020 to 2024, were redacted to safeguard private business details.  

Documentation 78

Documentation FDA 78

STAT

MAY 1, 2024

In March 2020, as Bauman was preparing to undergo the surgery at a Mount Sinai medical facility in midtown Manhattan, he said he was invited to participate in a research study — one only open to patients already committed to undergo DBS at Mount Sinai.

Documentation 145

Documentation FDA Nursing Homes 145

IDStewardship

OCTOBER 28, 2022

Since the news of virtual Midyear in 2020, many residency programs have created social media accounts, most often on the platform Twitter. Develop a manual or guidance document outlining the goals of the account. This type of document is especially helpful for account management transitions in resident managed accounts.

Documentation 246

Documentation 246

Drug Store News

MARCH 3, 2023

The company went bankrupt in 2020 after a $4.3 billion takeover offer failed, according to a Bloomberg Law report that cited court documents.

Documentation 94

Documentation 94

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA 105

FDA Documentation Packaging Labelling 105

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

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

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

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

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

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

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

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

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