STAT

AUGUST 5, 2024

As documented in a recent commentary that I and several colleague published in the journal Frontiers in Research Metrics and Analytics, considerations of diversity, equity, and inclusion (DEI) have been introduced into federal science funding decisions. Each of the major U.S. Read the rest…

Documentation 363

Documentation 363

STAT

MARCH 18, 2024

CVS Caremark, the PBM owned by CVS Health that oversees the prescription drug benefits of 103 million people, told its employer clients that it anticipated “more lower-cost products (including specialty biosimilars) may become preferred products” on its lists of approved drugs for 2024, according to documents obtained by STAT.

Biosimilars 363

Biosimilars Drug Pricing Documentation Pharmaceutical Companies 363

STAT

MAY 20, 2024

A huge amount of those documents were released last week, and the numbers mirror what  we’ve been seeing over the past several months : Not all hospitals are in dire straits, and in fact, many continue to do quite well. Sign up to get it in your inbox every Monday. Continue to STAT+ to read the full story…

Hospitals 262

Hospitals Documentation 262

STAT

OCTOBER 23, 2023

Starting in the first quarter of 2024, Optum’s post-acute-care companies will be called Home & Community Care, according to internal documents obtained by STAT. However, Optum advised employees that “Home & Community Care should not be directly next to the Optum logo” in marketing materials.

Documentation 362

Documentation Hospitals 362

Express Pharma

JUNE 28, 2024

Indian Pharmaceutical Alliance (IPA) concluded the 9th edition of the Global Pharmaceutical Quality Summit 2024. The day concluded with insights into future data and documentation imperatives, highlighting meticulous record-keeping and data management for compliance and quality.

Biosimilars 91

Biosimilars Documentation 91

Express Pharma

OCTOBER 31, 2024

This relates to the cGMP inspection conducted by the agency between February 20-28, 2024 and pertains to the supply of rh-Insulin (rhI) drug substance to the United States.

Documentation 107

Documentation 107

Pharmaceutical Technology

MARCH 28, 2024

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

Documentation 113

Documentation Vaccines 113

Putting Patients First Blog

JULY 1, 2024

General Comments: The NHC commends CMS for its efforts in revising the MPPP model documents to enhance clarity, accessibility, and beneficiary engagement. Additionally, to further enhance the effectiveness of the documents, we recommend the formal establishment of a feedback loop and periodic reviews.

Documentation 52

Documentation Communication Payment Processing 52

Drug Channels

NOVEMBER 19, 2024

In Medicare Part D in 2025: Preferred Pharmacy Networks Fade in a Collapsing PDP Market , I documented the Inflation Reduction Act’s (IRA) disruption to Medicare Part D prescription drug plans (PDPs). As always, we provide you with a handy table for tallying each chain’s participation and changes from 2024 to 2025. Fein, Ph.D.,

Documentation 66

Documentation 66

Putting Patients First Blog

APRIL 29, 2024

Recognizing both the potential benefits and challenges of the MPPP rollout, the NHC views the introduction of these documents as crucial for educating beneficiaries on their options, easing transitions, and possibly lessening the financial impact of prescription costs.

Documentation 40

Documentation Insurance Coverage and Processing Communication Pharmacy Technician 40

Express Pharma

JUNE 6, 2024

Stakeholders are invited to provide feedback on CDSCO draft guidance within 15 days from the notice’s issuance On May 29, 2024 a draft of the revised “Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines” was released for public consultation by Central Drug Standard Control Organisation (CDSCO).

Vaccines 96

Vaccines Documentation 96

Safe Biologics

FEBRUARY 1, 2024

Comments may be submitted here until April 30, 2024. When the biosimilar demonstrates a high degree of similarity to the RMP at the analytical and functional level, it may be possible to justify the omission of dedicated CES. Read the concept paper here.

Biosimilars 100

Biosimilars Documentation 100

STAT

FEBRUARY 28, 2024

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022 , STAT writes. The … A much-anticipated inquiry by U.S.

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Documentation 290

The Happy PharmD

SEPTEMBER 15, 2024

The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue. The post State of Well-Being 2023-2024 appeared first on The Happy PharmD. A survey conducted in 2021 highlighted this concern, indicating that workforce issues are a common challenge.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Dosage Documentation Communication 52

Big Molecule Watch

AUGUST 20, 2024

On July 25, 2024, the FDA published a notice establishing a public docket for commenting to obtain information to assist the FDA in assessing how best to advance the development of new biosimilar products, as part of the Biosimilar Use Free Amendments of 2022 (“BsUFA III”).

Biosimilars 57

Biosimilars Documentation 57

Drug Channels

OCTOBER 3, 2024

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. For the fourther quarter of 2024, coinsurance rates for 51 drugs increased, while rates for only 19 drugs decreased. All rights reserved.

Documentation 52

Documentation 52

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. By Deborah L. 89 FR 74966 at 74968 (Sept.

Documentation 57

Documentation Packaging 57

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co. Internet} US FDA.

Documentation 98

Documentation Pharmaceutical Manufacturing 98

Drug Channels

MAY 14, 2024

As we document below, a growing share of Part B drugs have inflation-adjusted coinsurance rates that have been increasing , not declining. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Chalk off these coinsurance surprises to yet another unintended consequence of the IRA.

Documentation 85

Documentation 85

European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

Documentation 98

Documentation Method Validation Packaging Labelling 98

Putting Patients First Blog

JANUARY 11, 2024

New NHC Project Looking at Chronic Kidney Disease Disparities January 11, 2024 By: Lillian Q. it is estimated that about 37 million adults live with chronic kidney disease (CKD). 1 Once diagnosed, the complexity of management and treatment of CKD can severely impact lifestyle of patients and have dire implications for family members.

Mayo Clinic 111

Mayo Clinic Documentation 111

Birth Control Pharmacist

AUGUST 7, 2024

On August 6, 2024, the CDC released the 2024 U.S. MEC) and the 2024 U.S. These documents provide current evidence-based contraception recommendations for health care providers. The 2024 U.S. The 2024 U.S. Get the 2024 Chart Download the updated app including updated recommendations from the 2024 U.S.

Documentation 52

Documentation 52

Proxsys Rx

APRIL 19, 2024

And that is why the one 340B prediction we can make for 2024, unequivocally, is repeated three times in this post’s headline. Which means we may see a lot more states putting manufacturers in their place, in 2024. How covered entities should prepare for 340B changes in 2024 Build a qualified 340B team. And More Change.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Drug Pricing Packaging 52

European Pharmaceutical Review

AUGUST 25, 2023

According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. The document highlights that the revision should also consider related changes in other GMP chapters and annexes as well as in other regulatory documents. What is included in the new revision?

Documentation 98

Documentation Pharmaceutical Manufacturing 98

Big Molecule Watch

NOVEMBER 18, 2024

On November 13, 2024, Amgen filed a BPCIA complaint in the District Court for the Eastern District of North Carolina against Accord Biopharma, Inc.; Amgen and Sandoz moved to dismiss litigation and entered into a settlement agreement in April 2024. Accord Healthcare, Inc.; and Intas Pharmaceuticals, Ltd.,

Biosimilars 62

Biosimilars Documentation 62

Drug Channels

AUGUST 6, 2024

I then document how five multi-billion-dollar, for-profit, publicly traded pharmacy chains and pharmacy benefit managers (PBMs)—Cigna (via Express Scripts), CVS Health, UnitedHealth Group (via OptumRx), and Walgreens, Walmart—continue to dominate the 340B contract pharmacy market. Click here if you can’t see the video below.

Drug Pricing 52

Drug Pricing Documentation Hospitals 52

Putting Patients First Blog

SEPTEMBER 13, 2024

In 2016, the National Health Council (NHC) launched its Value Classroom , which consists of eight documents, glossaries, and infographics intended to educate patient organizations about important topics in patient-centered value assessment.

Documentation 52

Documentation 52

Drug Channels

JUNE 18, 2024

Click here to see the original post from April 2024. Last week, we documented the substantial concentration of dispensing revenues for specialty drugs. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. All rights reserved. This Feed is for personal non-commercial use only.

Specialty Pharmacies 52

Specialty Pharmacies Drug Pricing Documentation 52

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. A rolling submission of the CUTX-101 New Drug Application (NDA) to the FDA is ongoing, with expected completion in 2024.

Documentation 88

Documentation 88

Express Pharma

AUGUST 16, 2024

FOPE and Pharma State Academy recently hosted, third session of their PULSE series on August 11, 2024, spotlighting “Quality Risk Management (QRM)” with a special focus on the Revised Schedule M. The panel also discussed the differences between ICH Q9 and the Revised Schedule M, and the importance of meticulous documentation.

Documentation 107

Documentation Communication 107

Putting Patients First Blog

AUGUST 15, 2024

Patient Experience Data and the Need for Patient Experience Dossiers August 15, 2024 By: Lillian L Witting, MPH, CAPM, Senior Coordinator, Research and Programs Patient experience data is information collected about the impact of a disease or condition on the quality of life, experiences, perspectives, needs, and priorities of patients.

Documentation 52

Documentation Drug Development 52

Big Molecule Watch

OCTOBER 14, 2024

On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar of Amgen’s PROLIA and XGEVA. Amgen and Sandoz moved to dismiss litigation and entered into a settlement agreement in April 2024.

Biosimilars 62

Biosimilars Documentation 62

Express Pharma

JUNE 12, 2024

The Indian Pharmaceutical Alliance (IPA) is set to host the ninth edition of the Global Pharmaceutical Quality Summit, on June 27 and 28, 2024 in Mumbai. The participants can gain deeper insights on recent focus areas such as Quality Management Maturity Models, Data and Documentation Imperative and Talent Capability Building.

Pharmaceutical Manufacturing 103

Pharmaceutical Manufacturing Documentation 103

Pharma Leaders

APRIL 7, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

FDA Law Blog: Biosimilars

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 62

Documentation Drug Development 62

Safe Biologics

OCTOBER 13, 2024

Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars FOR IMMEDIATE RELEASE – September 4, 2024 Arlington, VA- U.S. physicians. physicians.

Biosimilars 100

Biosimilars Documentation 100

Drug Channels

APRIL 24, 2024

Last week, we documented the substantial concentration of dispensing revenues for specialty drugs. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. See The Top 15 Specialty Pharmacies of 2023: Market Shares and Revenues at the Biggest PBMs, Health Plans, and Independents.

Specialty Pharmacies 52

Specialty Pharmacies Documentation 52