Pharmacist Digest

STAT+: U.K. becomes the first country to release detailed data on sponsors that fail to register clinical trials

STAT

MARCH 28, 2024

Last week, the Health Research Authority posted complete registration information for 1,545 trials, including the name of the study, the sponsor, and registration number for the trial. And for almost all of the registered clinical trials, the sponsor had informed the HRA it was registered.

STAT+: In a rare move, FDA threatens to fine a company for failing to report clinical trial results

STAT

AUGUST 16, 2023

Food and Drug Administration recently threatened to fine a company or clinical trial investigator for failing to post study results on a federal government database. In a July 19 letter , the FDA warned Light Sciences Oncology about its failure to post study results about a prostate treatment to the database, ClinicalTrials.gov.

STAT+: U.K. trade group suspends Novo Nordisk for ‘serious breaches’ in promoting obesity drug

STAT

MARCH 16, 2023

The Association of the British Pharmaceutical Industry took this step after receiving a complaint alleging the company had sponsored courses on weight management on LinkedIn for health professionals, without making clear that it was involved in the sponsorship. Continue to STAT+ to read the full story…

ALiEM AIR Series | Respiratory 2023 Module

ALiEM - Pharm Pearls

OCTOBER 14, 2023

After carefully reviewing all relevant posts in the past 12 months from the top 50 sites of the Digital Impact Factor [1], the ALiEM AIR Team is proud to present the highest quality online content related to related to respiratory diseases in the Emergency Department. The other subset is for “Honorable Mention” posts. Ann Emerg Med.

Labelling

Labelling Hospitals

FDA’s New RWE Guidance Provides Recommendations for Sponsors Conducting Non-Interventional Real-World Studies and Describes the Potential to Use RWE for Initial Approvals in One Limited Circumstance

FDA Law Blog: Biosimilars

SEPTEMBER 10, 2023

Even though an IND is not required, this guidance is intended to provide recommendations for sponsors to follow for using RWE from such studies for regulatory decision-making. The guidance describes steps sponsors should take to evaluate the study’s feasibility for such purposes.

Documentation

Documentation Vaccines Drug Development

FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction

FDA Law Blog: Biosimilars

APRIL 30, 2024

It’s not clear, though, how SIR’s submitted after 60 days would be handled in the context of a post-100-day meeting interaction because some of those interactions would exceed 60 days, and per Table 1, FDA wouldn’t hold a meeting for 70 days after receiving such a request. design verification and validation).

Communication

Assessing the Accuracy of Pharmaceutical-Sponsored Health Information Online

Pharma Marketing Network

JULY 12, 2023

This is especially true when it comes to pharmaceutical-sponsored health information. Talk to your doctor: If you have any questions or concerns about pharmaceutical-sponsored health information, talk to your doctor. Look for citations: The information should be supported by scientific research. . ●

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies

ALiEM AIR Series | Procedures Module

ALiEM - Pharm Pearls

APRIL 14, 2023

After carefully reviewing all relevant posts in the past 12 months from the top 50 sites of the Social Media Index, the ALiEM AIR Team is proud to present the highest quality online content related to related to procedures in the Emergency Department. The other subset is for “Honorable Mention” posts. Please go to the above link.

Labelling

Roche shares data from phase 3 trial of Xolair as allergy treatment

Pharmafile

FEBRUARY 26, 2024

Roche has announced data from stage 1 of the National Institutes of Health (NIH)-sponsored phase 3 OUtMATCH trial, which assessed the safety and efficacy of Xolair (omalizumab) in patients allergic to peanuts and at least two other common foods.

Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices

FDA Law Blog: Biosimilars

MAY 6, 2024

FDA interprets the “ability to connect to the internet” to include devices that can connect to the internet by any means whether the sponsor intends the device to be connected or not. In addition, manufacturers need to submit plans for monitoring, identifying, and addressing post market cybersecurity vulnerabilities. are cybersecure.

Documentation

Washington Representatives Summer Meeting

Putting Patients First Blog

JUNE 2, 2023

Who Should Attend The Washington Representatives Summer Meeting is open only to NHC nonprofit members – specifically policy and government relations staff – and the event’s sponsors. To become a sponsor, please contact Mary Crowther. The post Washington Representatives Summer Meeting appeared first on National Health Council.

Parexel and JFCR collaborate for cancer research

Express Pharma

JANUARY 16, 2024

Parexel will leverage JFCR’s expertise to help sponsors develop protocols that better align with Japan’s standard of care and regulatory approval processes — resulting in streamlined patient recruitment and study start-up. The post Parexel and JFCR collaborate for cancer research appeared first on Express Pharma.

Hospitals

JP Morgan 2023 – Day 1

pharmaphorum

JANUARY 9, 2023

Then in the evening, we’ll be at STAT@JPM for presentations by event sponsor GSK as well as the guest of honour: FDA Commissioner Robert Califf. The post JP Morgan 2023 – Day 1 appeared first on. Check below for updates throughout the day.

FDA Takes Additional Steps to Advance Decentralized Clinical Trials

LifeProNow

MAY 4, 2023

The agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research. The FDA is committed to working with sponsors to discuss how decentralized elements may fit into a clinical trial.

Packaging

Surprising Data on Employer-PBM Rebate Pass-Through Arrangements in 2023 (rerun)

Drug Channels

DECEMBER 12, 2023

This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. Click here to see the original post from August 2023. A serious effort exists to require greater transparency into PBMs’ activities and mandate full pass-through of rebates to plan sponsors.

Creating Synergy: Aligning Brand Values with High-Impact Healthcare Sponsorships in the Pharmaceutical Industry

Pharma Marketing Network

JULY 19, 2023

This could include sponsoring research into new drugs and treatments, providing educational resources about health conditions, or supporting patient care programs. For example, Pfizer, a leading pharmaceutical company, has a long history of sponsoring research into new drugs and treatments.

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies

Use of digital tools for clinical trials triples during pandemic; survey

pharmaphorum

OCTOBER 19, 2021

A new poll of clinical trial sponsors has found that around nine out of 10 of them are running decentralised trials with the help of digital technologies, a big increase on pre-COVID-19 levels. The post Use of digital tools for clinical trials triples during pandemic; survey appeared first on.

ALiEM AIR Series | Infectious Disease 2023 Module

ALiEM - Pharm Pearls

JULY 20, 2023

After carefully reviewing all relevant posts in the past 12 months from the top 50 sites of the Social Media Index, the ALiEM AIR Team is proud to present the highest quality online content related to related to infectious diseases in the Emergency Department. The other subset is for “Honorable Mention” posts.

Labelling

13th PM Society Digital Awards – celebrating creative innovation

pharmaphorum

SEPTEMBER 21, 2022

Decided by a panel of judges that included industry experts, healthcare professionals, agency leaders, and digital specialists, the PM Society Digital Awards 2022 went to the following companies: BRAND PROMOTION (sponsored by Initiative Health): Leukomed Sorbact NICE project, for Essity by Mole Digital.

Communication

Communication Vaccines

Psychedelic research: evaluating the fast-evolving regulatory roadmap

European Pharmaceutical Review

DECEMBER 21, 2022

Since then, there have been few breakthrough innovations in treating neuropsychiatric diseases such as anxiety, depression, substance use disorders (SUDs), and post-traumatic stress disorder (PTSD). Sponsors must understand this rapidly changing regulatory landscape and be able to pivot quickly to optimise their clinical trial strategies.

Compounding

Compounding Controlled Substances Drug Development

Improving trial predictability: leveraging AI-powered analytics to guide trial design, strategy, and operations

pharmaphorum

DECEMBER 2, 2022

This emphasises sponsors’ need for enrolment predictability. These problems are compounded with site-level concerns about protocol complexity, staffing shortages, low patient interest, and budgetary constraints — leaving sponsors to question how to plan trials that deliver against timeline commitments to support launch goals.

Compounding

Compounding Drug Development

ICYMI: PhRMA COO Lori Reilly speaks about the health care agenda for the next Congress

PhRMA

DECEMBER 9, 2022

On December 7, 2022, PhRMA sponsored the Axios event, “ The Post-Midterm Health Care Agenda ,” where I participated in a View from the Top segment with Nicholas Johnston, publisher of Axios. With a divided Congress, bipartisan action will be necessary to move the needle on health care policy.

Key operational considerations to optimise decentralised clinical trials

pharmaphorum

OCTOBER 18, 2022

Now that the COVID-19 pandemic has provided the industry with a solid foundation of experience with decentralised trials, it is appropriate to reflect and ask whether DCT studies are truly helping to address long-standing issues in research and development for sponsors, study teams and, most importantly, patients.

Drug Development

Drug Development Communication Vaccines

International Patient Forum

Putting Patients First Blog

APRIL 26, 2023

ET Event Location: Virtual IPF Home Register Schedule (Coming Soon) Speakers (Coming Soon) Sponsors Event Policies CAE Credits The post International Patient Forum appeared first on National Health Council. International Patient Forum Event Time: 1:00 - 3:00 p.m.

Injectable opportunities for CMOs despite internal capacity of big pharma sponsors

Pharmaceutical Technology

AUGUST 16, 2022

Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Packaging Trends in the Bio/Pharma Industry (August 2022).

Packaging

Packaging Vaccines

Rethinking trial engagement and recruitment starts with patient perspectives: patient survey insights

pharmaphorum

SEPTEMBER 14, 2022

But post-pandemic, the industry needed to figure out how to sustain the heightened interest in research for many therapeutic foci, especially considering the decrease in diagnoses during the pandemic that is only now being identified. Recruitment for much-needed COVID-19 vaccine and treatment trials accelerated. Reasons for “no” to trials.

Vaccines

Vaccines Medical Records Documentation Communication

ALiEM AIR Series | Orthopedics Lower Extremity Module

ALiEM - Pharm Pearls

MARCH 1, 2023

After carefully reviewing all relevant posts in the past 12 months from the top 50 sites of the Social Media Index, the ALiEM AIR Team is proud to present the highest quality online content related to related to neurologic emergencies in the Emergency Department. The other subset is for “Honorable Mention” posts.

Labelling

Engaging Communities through High-Impact Healthcare Sponsorships in the Pharmaceutical Industry

Pharma Marketing Network

JULY 19, 2023

Here are some examples of how pharmaceutical companies can use sponsorships to engage communities: Sponsoring community health events: Pharmaceutical companies can sponsor health fairs, walkathons, and other community events to raise awareness about important health issues and promote healthy lifestyles.

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies Diabetes Vaccines

Choosing the Right Sponsorships for Maximum Impact in the Pharmaceutical Industry

Pharma Marketing Network

JULY 19, 2023

Be creative: There are many different ways to sponsor a healthcare organization. Here are some additional tips for choosing the right sponsorships in the pharmaceutical industry: Consider the size of the organization: If you’re a small business, you may want to focus on sponsoring smaller, local healthcare organizations.

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies

How Sponsorship Can Amplify Healthcare Awareness and Education

Pharma Marketing Network

JULY 25, 2023

Here are some examples of how sponsorships can be used to amplify healthcare awareness and education: Johnson & Johnson sponsors the Healthy Living Index. Pfizer sponsors the National Stroke Association. Komen sponsors the Pink Ribbon Girls. There are many different ways to sponsor a healthcare organization.

Drug Pricing

Informa Connect’s Life Sciences Pricing & Contracting USA

Drug Channels

MARCH 18, 2024

The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can publish a guest post on Drug Channels, please contact Paula Fein (paula@DrugChannels.net). Other restrictions may apply.

Drug Pricing

When Should a 510(k) Include Clinical Data?

FDA Law Blog: Biosimilars

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. These include: results of pre- and post-market clinical investigation(s) of the device (i.e., By Adrienne R.

Medical Records

Clinical research in 2021: A new era of collaboration and innovation

pharmaphorum

JANUARY 25, 2021

Hopefully, this increased transparency and accountability will translate into more collaboration among sponsors, regulators and other stakeholders — including patients — earlier in the drug development process. Sponsors will want to capitalise on the heightened public interest during 2021 and beyond by building trust.

Communication

Communication Drug Development

Five Surprising Facts About GoodRx and the Discount Card Market (rerun)

Drug Channels

DECEMBER 15, 2022

This week, I’m rerunning some popular posts while I prepare for tomorrow’s live video webinar: Drug Channels Outlook 2023. Click here to see the original post and comments from October 2022. The research was sponsored by the Association for Accessible Medicines (AAM). Link below.)

Texas Shows Us Where PBMs’ Rebates Go (rerun)

Drug Channels

DECEMBER 13, 2022

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2023. Click here to see the original post and comments from August 2022. Over the weekend, the U.S. Senate passed a massive overhaul of the Medicare Part D program.

Overcoming the challenges of developing vaccines in an accelerated timeframe

pharmaphorum

NOVEMBER 20, 2022

Engaging with expert stakeholders from the inception of the vaccine discovery process and throughout clinical trial phases can enable sponsors to optimise their investment and stay ahead of competitors. These aspects will help sponsors to ensure programmes are streamlined for success.

Vaccines

Vaccines Immunity Immunization

What CVS Pharmacy’s New Cost-Plus Reimbursement Approach Means for PBMs, Pharmacies, Plan Sponsors, and Prescription Prices (rerun)

Drug Channels

APRIL 2, 2024

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: Drug Channel Implications of the Inflation Reduction Act. Click here to see the original post from December 2023. For more on acquisition cost reimbursement for pharmacies, see Sections 8.4. and 12.3.4. of our new 2024 Economic Report on U.S.

Documentation

Schizophrenia trials continue to test drug candidates as Covid-19 pandemic continues

Pharmaceutical Technology

JULY 29, 2022

A total of 127 planned schizophrenia trials are upcoming, with Cerevel Therapeutics and Newron Pharmaceuticals being the sponsors with the most planned schizophrenia clinical trials (five). The other top sponsors can be seen in Figure 1. This trend could indicate more research and development (R&D) expenditure on the disease.

Engaging change: Connecting patients and regulators can move the dial on drug development

pharmaphorum

JULY 19, 2022

“It’s important that the patient experience and patient voice is appropriately elevated, and that regulators, sponsors, and researchers are meaningfully engaging patient stakeholders in order to define the most high-value areas of impact.”. About the author.

Drug Development

Drug Development Communication

CCP Improvements Allow Industry to Track Pre-submissions

FDA Law Blog: Biosimilars

JUNE 5, 2023

Readers of the blog will know that I am a HUGE fan of the CCP (see our earlier posts here and here ). The most recent updates to the CCP allow sponsors of Pre-submissions to track their status just as they are able to do for 510(k)s. Mullen — FDA recently released further updates to the Customer Collaboration Portal (“CCP”).

Medicare Part D in 2024: Mapping Large Chains' Position in 2024’s Preferred Pharmacy Networks

Drug Channels

NOVEMBER 15, 2023

Today, I examine the seven largest retail chains’ participation in the 20 major 2024 Part D networks that the eight largest plan sponsors will offer. In an upcoming post, I’ll delve into how smaller pharmacies will participate in the 2024 Part D plans, by examining the pharmacy services administrative organizations (PSAOs).

Documentation

Cell and gene manufacturers benefit from surge in FDA drug approvals: GlobalData

Express Pharma

MAY 8, 2024

These innovative products have a limited pool of production staff and qualified facilities; large CMOs have been acquiring these capabilities in recent years and even larger sponsors will require these production services.”

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies

The State of Employers’ Pharmacy Benefits: A Review of 2022 and the 2023 Outlook for Copay Programs (rerun)

Drug Channels

JUNE 23, 2023

This week, I’m rerunning some popular posts while I prepare for today’s live video webinar: PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding. Click here to see the original post from January 2023.

What’s Behind CVS Health’s Novel Vertical Integration Strategy for Humira Biosimilars (rerun)

Drug Channels

DECEMBER 11, 2023

This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. Click here to see the original post from September 2023. Let’s see if plan sponsors, patients, and legislators will pay attention to the man behind the curtain. d/b/a Drug Channels Institute.

Biosimilars

Biosimilars Labelling

STAT+: U.K. becomes the first country to release detailed data on sponsors that fail to register clinical trials

STAT+: In a rare move, FDA threatens to fine a company for failing to report clinical trial results

Trending Sources

STAT+: U.K. trade group suspends Novo Nordisk for ‘serious breaches’ in promoting obesity drug

ALiEM AIR Series | Respiratory 2023 Module

FDA’s New RWE Guidance Provides Recommendations for Sponsors Conducting Non-Interventional Real-World Studies and Describes the Potential to Use RWE for Initial Approvals in One Limited Circumstance

FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction

Assessing the Accuracy of Pharmaceutical-Sponsored Health Information Online

ALiEM AIR Series | Procedures Module

Roche shares data from phase 3 trial of Xolair as allergy treatment

Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices

Washington Representatives Summer Meeting

Parexel and JFCR collaborate for cancer research

JP Morgan 2023 – Day 1

FDA Takes Additional Steps to Advance Decentralized Clinical Trials

Surprising Data on Employer-PBM Rebate Pass-Through Arrangements in 2023 (rerun)

Creating Synergy: Aligning Brand Values with High-Impact Healthcare Sponsorships in the Pharmaceutical Industry

Use of digital tools for clinical trials triples during pandemic; survey

ALiEM AIR Series | Infectious Disease 2023 Module

13th PM Society Digital Awards – celebrating creative innovation

Psychedelic research: evaluating the fast-evolving regulatory roadmap

Improving trial predictability: leveraging AI-powered analytics to guide trial design, strategy, and operations

ICYMI: PhRMA COO Lori Reilly speaks about the health care agenda for the next Congress

Key operational considerations to optimise decentralised clinical trials

International Patient Forum

Injectable opportunities for CMOs despite internal capacity of big pharma sponsors

Rethinking trial engagement and recruitment starts with patient perspectives: patient survey insights

ALiEM AIR Series | Orthopedics Lower Extremity Module

Engaging Communities through High-Impact Healthcare Sponsorships in the Pharmaceutical Industry

Choosing the Right Sponsorships for Maximum Impact in the Pharmaceutical Industry

How Sponsorship Can Amplify Healthcare Awareness and Education

Informa Connect’s Life Sciences Pricing & Contracting USA

When Should a 510(k) Include Clinical Data?

Clinical research in 2021: A new era of collaboration and innovation

Five Surprising Facts About GoodRx and the Discount Card Market (rerun)

Texas Shows Us Where PBMs’ Rebates Go (rerun)

Overcoming the challenges of developing vaccines in an accelerated timeframe

What CVS Pharmacy’s New Cost-Plus Reimbursement Approach Means for PBMs, Pharmacies, Plan Sponsors, and Prescription Prices (rerun)

Schizophrenia trials continue to test drug candidates as Covid-19 pandemic continues

Engaging change: Connecting patients and regulators can move the dial on drug development

CCP Improvements Allow Industry to Track Pre-submissions

Medicare Part D in 2024: Mapping Large Chains' Position in 2024’s Preferred Pharmacy Networks

Cell and gene manufacturers benefit from surge in FDA drug approvals: GlobalData

The State of Employers’ Pharmacy Benefits: A Review of 2022 and the 2023 Outlook for Copay Programs (rerun)

What’s Behind CVS Health’s Novel Vertical Integration Strategy for Humira Biosimilars (rerun)

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