Fierce Pharma

JUNE 7, 2023

On Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug. . | As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval.

Documentation 122

Documentation FDA 122

Drug Topics

OCTOBER 5, 2022

Quality documentation ensures that pharmacies get paid for clinical services and offers a way to engage with patients.

Documentation 98

Documentation 98

STAT

SEPTEMBER 12, 2023

WASHINGTON — There’s a panel of 20 nutrition experts that has outsized influence on the American diet — and the food industry has worked hard to get friendly researchers into the group, new documents obtained by STAT show.

Documentation 145

Documentation 145

STAT

MAY 10, 2023

Reviewers at the Food and Drug Administration concluded that Sarepta Therapeutics did not show that its gene therapy for Duchenne muscular dystrophy will likely benefit patients and left key safety concerns, according to briefing documents released Wednesday.

Documentation 94

Documentation FDA 94

PioneerRx

MARCH 8, 2023

Save valuable time in your workflow with the Incoming Documents and Faxes tool, available in PioneerRx’s pharmacy software.…

Documentation 52

Documentation 52

Fierce Healthcare

SEPTEMBER 15, 2021

Industry Voices—Not all automation is created equally for clinical documentation improvement. Wed, 09/15/2021 - 15:26.

Documentation 145

Documentation 145

STAT

NOVEMBER 15, 2022

However, a STAT   review of documents detailing   the steps taken toward government approval found that regulators endorsed the vaccine, called Covaxin, despite discrepancies in the number of clinical trial participants.

Documentation 145

Documentation Vaccines 145

Fierce Healthcare

FEBRUARY 26, 2024

" However, it was unable to provide the most up-to-date financial documents with officials by a Friday deadline set by Gov. Maura Healey.

Documentation 57

Documentation 57

STAT

APRIL 12, 2023

The settlement, which includes California and New York, is the largest to date between Juul and state attorneys general, and will also require Juul to disclose a number of previously secret documents, which will be housed in an academic archive. Read the rest…

Documentation 86

Documentation 86

Pharmafile

APRIL 25, 2023

The National Institute for Health and Care Excellence (NICE) has submitted a Final Appraisal Document (FAD) for the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. read more

Documentation 59

Documentation Communication 59

pharmaphorum

NOVEMBER 13, 2020

Join us at our 2nd Clinical Document World Virtual event on January 19-21, 2021, alongside your TMF, clinical quality, document management, and clinical professionals to explore a strategic clinical process and ensure a complete Document Management Process. Focus on ensuring high quality documentation.

Documentation 52

Documentation 52

STAT

OCTOBER 6, 2022

In the run-up to an extremely unusual hearing later this month, newly released documents underscore highly contrasting views taken by the U.S. Food and Drug Administration and a manufacturer toward a controversial drug for reducing premature births, which the agency wants withdrawn from the market.

Documentation 90

Documentation FDA 90

STAT

JANUARY 29, 2024

LONDON — There was something odd about these Alzheimer’s cases. Part of it was the patients’ presentations: Some didn’t have the classic symptoms of the condition. But it was also that the patients were in their 40s and 50s, even their 30s, far younger than people who normally develop the disease.

Documentation 145

Documentation 145

Impact Pharmaceutical Services

SEPTEMBER 20, 2023

Challenge Syner-G was contracted by a US Pharmaceutical Company to help improve the quality of submission documentation generated during the manufacture of a Drug Substance intended for Phase II trials. Results Syner-G reviewed each documentation and provided suggestions/comments/guidance to the CDMO to bridge the gaps observed.

Documentation 40

Documentation Pharmaceutical Companies Pharmaceutical Companies Communication 40

Outsourcing Pharma

JANUARY 28, 2022

A representative from IQVIA discusses the particulars of the US agencyâs new draft document and shares what it might mean for clinical trial data evaluation.

Documentation 69

Documentation FDA 69

The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. After reviewing comments, FDA will revise and move questions and answers to the final document, as it deems appropriate. By Sophia R. Gaulkin — Last week, the U.S.

Documentation 59

Documentation Labelling FDA Packaging 59

BioPharm

MARCH 23, 2023

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

Documentation 59

Documentation FDA 59

STAT

MARCH 20, 2024

Johnson & Johnson has accused a long-standing employee of taking thousands of confidential files about commercial strategies as he left for a similar job at Pfizer, according to lawsuit filed in a federal court in New Jersey.

Documentation 112

Documentation 112

STAT

OCTOBER 27, 2023

The Food and Drug Administration said on Friday that it has some safety concerns about an experimental CRISPR-based treatment for sickle cell disease, citing the methods used by its makers to evaluate the risk of inadvertently making unwanted changes to patients’ DNA.

Documentation 132

Documentation FDA 132

PioneerRx

MARCH 1, 2023

As pharmacists explore ways to get reimbursed for their services through a value-based care model, PioneerRx is right by your side with the ability to provide…

Documentation 52

Documentation 52

Fierce Healthcare

JULY 27, 2023

Amazon Web Services announced Wednesday a new AI-powered service for healthcare software providers that will help clinicians with paperwork. | AWS HealthScribe uses generative AI and speech recognition to help doctors transcribe and analyze their conversations with patients and drafts clinical notes.

Documentation 98

Documentation 98

Pharmacy Times

JULY 25, 2022

Once the revisions to become approved, there will be a minimum grace period of 6 months for pharmacies to comply.

Documentation 122

Documentation 122

BioPharm

JANUARY 11, 2023

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

Documentation 40

Documentation FDA 40

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. The post UK gov’t defends NHS data sharing plans in strategy document appeared first on.

Documentation 52

Documentation Health and Personal Care Stores Medical Records Communication 52

BioPharm

SEPTEMBER 16, 2022

Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.

Documentation 40

Documentation 40

Drug Topics

JANUARY 10, 2024

The estimated efficacy of the vaccine against documented infection for children and adolescents during the Omicron wave was 74.3% and 85.5%, respectively.

Vaccines 219

Vaccines Documentation 219

Pharmafile

JANUARY 20, 2023

India-based manufacturer Intas Pharmaceuticals has been issued a Form 483 by the FDA after three investigators found a “cascade of failure” in a site inspection carried out at their manufacturing facility in Pharmez Special Economic Zone (SEZ) between late November and early December 2022. read more

Documentation 94

Documentation FDA 94

STAT

MAY 16, 2023

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine.

Vaccines 94

Vaccines Documentation FDA 94

STAT

APRIL 11, 2024

Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer have projected — according to a document obtained by STAT.

Documentation 142

Documentation 142

Drug Topics

MARCH 22, 2024

Researchers aimed to address the adverse effects of veterans with COVID-19 diagnoses 18 months after infections were documented.

Documentation 154

Documentation 154

PhRMA

MARCH 29, 2023

This series – including surveys of 5,000 Americans conducted with Ipsos, a leading research company in the United States — documents a consistent trend in reports of insurer- and middlemen-imposed practices that can keep patients from the medicines and treatments that they need.

Insurance 288

Insurance Documentation 288

STAT

FEBRUARY 15, 2024

WASHINGTON — A new trove of internal emails and other documents from the e-cigarette maker Juul reveals the company’s extensive behind-the-scenes efforts to promote its interests in Washington — a rare insight into the otherwise opaque methods corporations use to influence the government.

Documentation 140

Documentation 140

STAT

DECEMBER 16, 2022

My grandmother died in the hospital, alone, the day after she was “found down” at home by emergency medical services. I lived near my Nani, as I called her but, even though I am a physician, was not allowed to see her after she had been admitted to her local hospital because of the strict, Covid-related no-visitor policy.

Documentation 103

Documentation Hospitals 103

STAT

DECEMBER 28, 2023

Health insurance giant UnitedHealth Group used secret rules to restrict access to rehabilitation care requested by specific groups of seriously ill patients, including those who lived in nursing homes or suffered from cognitive impairment, according to internal documents obtained by STAT.

Nursing Homes 145

Nursing Homes Documentation Insurance 145

STAT

OCTOBER 14, 2022

In 2011, Walgreens executives were under pressure. Amid a growing addiction crisis, and with the country already awash in prescription painkillers, the federal government was demanding accountability from the pharmacy giant for filling thousands of opioid prescriptions written by doctors in suspiciously large quantities.  

Documentation 114

Documentation 114

Fierce Healthcare

OCTOBER 26, 2023

Abridge, a startup that developed artificial intelligence-based documentation solutions for healthcare, has seen rapid growth in the past year, propelled by a "tornado of tailwinds," according to c | Abridge, a startup that developed artificial intelligence-based documentation solutions for healthcare, has seen rapid growth in the past year, (..)

Mayo Clinic 138

Mayo Clinic Documentation 138

Fierce Pharma

FEBRUARY 27, 2024

BioMarin has provided documents to the U.S. BioMarin has provided documents to the U.S. Department of Justice in response to a subpoena which requested information on the company’s government-sponsored testing programs for enzyme replacement therapies Vimizim and Naglazyme.

Documentation 88

Documentation 88