Networking, Patients and Safety

Navigating the Regulatory Environment of Pharmaceutical Marketing: Balancing Patient Safety and Industry Innovation

Pharma Marketing Network

MAY 3, 2023

However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.

Safety

Safety Food and Drug Administration Pharmaceutical Marketing

Are timely access and robust safety mutually exclusive?

pharmaphorum

JULY 6, 2022

And how can regulators balance timely access with robust safety? Cancer patients in Europe wait an average of almost eight months longer for access to breakthrough medications than their American counterparts. The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better?

Safety

Safety FDA Medicine Patients

Cerner Enviza and FDA partner to develop AI drug safety tools

Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

Safety

Safety Food and Drug Administration FDA Side effects

Personalizing the Cancer Patient Journey

Pharma Marketing Network

JULY 27, 2022

The patient care team supplies an abundance of information, although sifting through brochures and online resources can be daunting for the patient and their caregiver. 1 The marketer’s goal is to design easy-to-follow patient guidelines while conforming to med-legal language. Meeting Patients Where They Are.

Patients

Patients Education Retail Pharma

ReCor Medical Announces Two Concurrent JAMA Network Publications of Study Results on the Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension

Legacy MEDSearch

FEBRUARY 28, 2023

In addition, pooled analysis results from the combined primary efficacy endpoint and safety data from RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II were concurrently published in JAMA Cardiology. Patients were to remain off antihypertensive medications throughout the two months of follow-up unless specified BP criteria were exceeded.

Networking

Networking Medical Physicians Safety

The Rise of Audio Social Networks – Where Pharma Can Make an Impact

Pharma Marketing Network

JUNE 8, 2021

Introducing new networks and features. What is unique about Clubhouse from other social networks, like Twitter and Facebook, is it is a ‘closed, hierarchical platform’ – a moderator oversees the discussion and possesses the ability to allow someone to either enter in conversation or boot out if appropriate.

Networking

Networking Pharma Media Marketing

Putting Patients First: Improving the Pharmaceutical Supply Chain

Impetus Digital

JANUARY 30, 2023

Medications and supplies must be handled with the utmost care, often needing to comply with strict temperature regulations and changing demands from patients and providers that vary depending on the country. Add this to infrastructure challenges like cold storage or delays, and it’s no wonder patient needs are not always put first.

Pharmaceutical

Pharmaceutical Patients Safety Distribution

Patient centricity and the changing pharmaceutical vista

pharmaphorum

JANUARY 27, 2023

Having previously spoken with Dr Mullen three years ago when she was country medical director for the UK & Ireland at GSK – on the topic of patient centricity and embedding that focus within the core of a pharmaceutical company – our recent interview provided some interesting insights into the changing landscape of the industry.

Patients

Patients Pharmaceutical Medical Physicians

Steps to building a more patient-centric industry

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

Patients

Patients Transportation Retail Recruitment

EU Medical Device Safety Monitoring & Reporting Conference | October 26-28, 2021 | Berlin, Germany and Virtual

Pharma Marketing Network

SEPTEMBER 15, 2021

Maximizing Patient Safety and Sustaining Long Term Quality Through Enhanced Device Surveillance while navigating the EU Regulatory Landscape. The post EU Medical Device Safety Monitoring & Reporting Conference | October 26-28, 2021 | Berlin, Germany and Virtual appeared first on Pharma Marketing Network.

Safety

Safety Medical Digital Media Marketing

Leading patient adherence pharmaceutical companies

Pharmaceutical Technology

SEPTEMBER 7, 2022

Failing to adhere to prescribed medication regimens is one of the prime reasons for poor patient health outcomes. Pharmaceutical and healthcare companies are working continuously to improve patient adherence, which also impacts disease control and pharmaceutical industry revenues directly. Patient adherence.

Leads

Leads Pharmaceutical Patients Pharmaceutical manufacturing

Using data analytics to better manage care transitions

Clarify Health

JANUARY 29, 2024

Care transitions are often critical periods where patients may be vulnerable to complications or relapses. Ensuring effective management of care transitions is not just a matter of patient convenience; it is pivotal to enhancing patient outcomes, improving population health, and reducing unnecessary medical spend.

Management

Management Healthcare Provider Safety Healthcare

Precision-based Targeting: A Better Way to Connect with Patients and Healthcare Professionals

LEVO Health

FEBRUARY 1, 2024

Traditionally, healthcare marketing relied on broad, generalized strategies that often missed the mark in addressing the unique needs of diverse patient populations and high-level healthcare professionals (HCPs). While the one-size-fits-all approach had a broad reach, it lacked the precision necessary for impactful engagement.

Healthcare

Healthcare Healthcare Patients Marketing

Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. As of October 2023, 62.93

Safety

Safety Medicine Competition Networking

How one pharma “family business” places patients first

pharmaphorum

OCTOBER 26, 2022

And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.

Patients

Patients Pharma Consulting Transportation

Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

JULY 5, 2022

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. New hope for stomach cancer patients.

Patients

Patients Food and Drug Administration Side effects Safety

UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration).

Food and Drug Administration

Food and Drug Administration Patients Safety Recruitment

Embedding the Patient Point of View in Everything You Do

PM360

SEPTEMBER 15, 2022

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

Patients

Patients Healthcare Healthcare Marketing

EC approves first-line ovarian cancer treatment

European Pharmaceutical Review

NOVEMBER 22, 2023

Prior to this new approval , rucaparib was previously approved as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.

Consulting

Consulting Patients Networking Safety

Activ Surgical Secures CE Mark Approval for ActivSight™ Intelligent Light

Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

Food and Drug Administration

Food and Drug Administration Safety Recruitment Medical

Transforming the Patient Experience: Leveraging Cloud Monitoring for Seamless Healthcare Service

Impetus Digital

JULY 5, 2023

Cloud technology in healthcare has become critical in improving patient care and revolutionizing healthcare systems. Patients are more willing than ever to seek out greater healthcare services if their expectations are not met. The Patient Experience: What Is It, and Why Is It Important? So what exactly is it?

Healthcare

Healthcare Healthcare Patients Healthcare Provider

Achieving pharmaceutical drug traceability compliance

European Pharmaceutical Review

SEPTEMBER 25, 2023

Kumar acknowledged that a comprehensive solution for drug serialisation in ERP systems allow drug manufacturers to monitor these metrics and maintain adherence, “due to its customisable interface, centralised networking capabilities, and automated solutions, which allow pharma businesses to keep up with the always changing standards and laws.”

Pharmaceutical

Pharmaceutical Pharmacology Safety Manufacturing

CereVasc Receives FDA IDE Approval to Expand its Clinical Study of Patients with Normal Pressure Hydrocephalus Utilizing the Generation 2 eShunt® System

Legacy MEDSearch

SEPTEMBER 18, 2023

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites. CereVasc, Inc., Carl Heilman, M.D., and Adel Malek, M.D., Carl Heilman, M.D.,

Food and Drug Administration

Food and Drug Administration FDA Patients Recruitment

Meeting rising demands of a new radiotheranostic era

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration

Food and Drug Administration Manufacturing Safety Transportation

Ancora Heart’s AccuCinch System Demonstrates Significant Improvement in Quality of Life, Cardiac Structure and Function in Heart Failure Patients

Legacy MEDSearch

MARCH 24, 2023

a company developing a completely transcatheter device-based therapy to address heart failure (HF), announced that patients treated with the investigational AccuCinch ® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart. Ancora Heart, Inc.,

Patients

Patients Recruitment Medical Medicine

Next-in-class combination treatment shows potential in cystic fibrosis

European Pharmaceutical Review

FEBRUARY 8, 2024

RIDGELINE 105, evaluated the safety and efficacy of the vanza triple in children with cystic fibrosis between six and 11 years old with at least one mutation responsive to triple combination CFTRm. A third Phase III study was also part of the programme.

Food and Drug Administration

Food and Drug Administration Medicine Medical Consulting

Navigating the Maze: 10 Common Challenges Faced by Healthcare Referral Coordinators

Referral MD

APRIL 19, 2024

The healthcare industry is a complex web of services, specializations, and patient needs. However, this critical role has challenges that can impede efficient patient care delivery. Referral coordinators are burdened with paperwork, which steals precious time that could be spent on more meaningful tasks such as patient engagement.

Healthcare

Healthcare Healthcare Patients Management

Medical Sales Strategies: How to Drive Doctors’ Recommendations

MaBiCo

JUNE 7, 2023

Whether you are in the pharmaceuticals, dermoceuticals, OTC, medical devices, or whatever business relates with patients and their health, you need to have a clearly defined strategy on how to approach physicians. The first rule is that a sales strategy should be focused on the patient.

Sales Strategy

Sales Strategy Medical sales Doctors Sales

Eli Lilly reveals plans for new high-tech parenteral manufacturing site

European Pharmaceutical Review

NOVEMBER 20, 2023

Supporting European parenteral manufacture and supply Alongside expanding the company’s global parenteral product and device manufacturing network, the new facility will support the higher demand for Eli Lilly’s medicines, including its diabetes and obesity portfolio. This includes automation and high-speed manufacturing lines.

Manufacturing

Manufacturing Medicine Biopharma Engineering

Lipid Nanoparticles Immunogenicity & Toxicity | December 6-8, 2022

pharmaphorum

AUGUST 16, 2022

Dosing considerations dependent on your disease indication, route of administration and patient group for improved safety. Hear the latest insights and case studies to optimize your prediction of PKPD, accurate dosing regime and immuno-modulation of LNP for long-term patient safety and potency. And much more!

Pharmacology

Pharmacology Safety Networking Patients

Drug repurposing, real world data and AI/ML: perspectives and opportunities

Clarivate

OCTOBER 19, 2023

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects). This process allows to impute/predict missing links.

Networking

Networking Consulting Safety Side effects

Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling

Legacy MEDSearch

SEPTEMBER 26, 2023

This approval applies to all commercially implanted Evoke ® System patients in the United States as well as patients formerly enrolled in the ECAP Study. The approval provides patients implanted with the Evoke ® System the ability to undergo 1.5 IDE study with 300 patients enrolled. head and extremity and 1.5T

Medical

Medical FDA Food and Drug Administration Safety

Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

Legacy MEDSearch

JANUARY 13, 2023

Hip Innovation Technology , LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics.

FDA

FDA Safety Recruitment Patients

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. This could help to improve the lives of patients and make a real difference in the world. This could help to ensure that everyone has access to the care they need.

Pharmaceutical

Pharmaceutical Healthcare Healthcare Education

How can evidence-based medicine (EBM) methodology support drug withdrawals?

European Pharmaceutical Review

JULY 20, 2022

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Six products were withdrawn or revoked for safety reasons during the study period.

Medicine

Medicine Safety Side effects Electronics

Benefits of blockchain in limiting counterfeit drug distribution

European Pharmaceutical Review

MAY 22, 2023

Additionally, real-time access to data is also available to patients to go through their clinical trials, as well as sponsors, which reduces the cost of trials. Blockchain offers the possibility of non-modifiable data uploading with traceability and low-cost data storage. In conclusion, Kordestani et al.

Distribution

Distribution Transportation Pharmaceutical Networking

Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

JULY 26, 2023

As new healthcare challenges arise and the pharmaceutical landscape evolves, the FDA may be allocating its resources to focus on other pressing issues, such as drug approvals, monitoring emerging health threats, and enhancing drug safety. appeared first on Pharma Marketing Network.

Marketing

Marketing FDA Food and Drug Administration Pharmaceutical

The erosion of trust in health information?

World of DTC Marketing

AUGUST 20, 2020

In addition, Avaaz discovered that”global health misinformation spreading networks” had generated roughly 3.8 Polls show that as the pandemic has continued, US citizens have become less confident about the safety of a vaccine. billion views for their content on Facebook. This is disturbing on too many levels.

Media

Media Pharma Government Consulting

ClearPoint Neuro Announces FDA Clearance for ClearPoint Maestro™ Brain Model

Legacy MEDSearch

AUGUST 15, 2022

This first-generation anatomical segment analysis tool emerged over 10 years ago from research aimed at detecting subtle volumetric and shape abnormalities in patients with mild traumatic brain injury. More importantly, it provides point-based correspondence longitudinally and across patients. About ClearPoint Neuro.

FDA

FDA Recruitment Safety Patients

Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia

Legacy MEDSearch

SEPTEMBER 27, 2022

Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. The clearance was based on clinical data from the Company’s IDE approved study for the treatment of sebaceous hyperplasia. “We

FDA

FDA Food and Drug Administration Recruitment Medicine

Allotrope Medical announces FDA Safer Technologies Program (STeP) designation for their surgical device StimSit

Legacy MEDSearch

NOVEMBER 7, 2022

a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. “Surgeons are constantly learning new techniques, either robotics or laparoscopic, and safety is always front and center.

Medical

Medical FDA Safety Recruitment

MHRA approves Pluvicto® and Locametz® for prostate cancer

European Pharmaceutical Review

AUGUST 17, 2022

The MHRA has also issued a licence in Great Britain for Locametz ® (gozetotide) which, after radiolabelling with gallium-68, is a radioactive diagnostic agent indicated for the identification of PSMA-positive lesions by positron emission tomography (PET) in adult patients with prostate cancer. percent), dry mouth (38.8 percent), nausea (35.3

Medicine

Medicine Patients Consulting Marketing

Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

SEPTEMBER 2, 2022

To ensure the safety of medicines post-regulatory approval, a risk management plan (RMP) is established. However, the importance of rigorous documentation of the sampling strategy has also been underlined in recent guidelines related to another research field, patient preference studies. What are risk minimisation methods?

Food and Drug Administration

Food and Drug Administration Medicine Safety Food

Streamlining healthcare with AI for drug development

Pharmaceutical Technology

JUNE 15, 2023

AI for drug development is rapidly streamlining R&D processes, speeding up time to market and providing a better experience for patients and providers. With the power of AI, healthcare organizations are streamlining pharma R&D , revolutionizing patient care and improving business operations.

Healthcare

Healthcare Healthcare Safety Ethics

Navigating the Regulatory Environment of Pharmaceutical Marketing: Balancing Patient Safety and Industry Innovation

Are timely access and robust safety mutually exclusive?

Trending Sources

Cerner Enviza and FDA partner to develop AI drug safety tools

Personalizing the Cancer Patient Journey

ReCor Medical Announces Two Concurrent JAMA Network Publications of Study Results on the Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension

The Rise of Audio Social Networks – Where Pharma Can Make an Impact

Putting Patients First: Improving the Pharmaceutical Supply Chain

Patient centricity and the changing pharmaceutical vista

Steps to building a more patient-centric industry

EU Medical Device Safety Monitoring & Reporting Conference | October 26-28, 2021 | Berlin, Germany and Virtual

Leading patient adherence pharmaceutical companies

Using data analytics to better manage care transitions

Precision-based Targeting: A Better Way to Connect with Patients and Healthcare Professionals

Understanding the evidence used in drug product withdrawals

How one pharma “family business” places patients first

Novel oral chemotherapeutic holds potential for stomach cancer patients

UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Embedding the Patient Point of View in Everything You Do

EC approves first-line ovarian cancer treatment

Activ Surgical Secures CE Mark Approval for ActivSight™ Intelligent Light

Transforming the Patient Experience: Leveraging Cloud Monitoring for Seamless Healthcare Service

Achieving pharmaceutical drug traceability compliance

CereVasc Receives FDA IDE Approval to Expand its Clinical Study of Patients with Normal Pressure Hydrocephalus Utilizing the Generation 2 eShunt® System

Meeting rising demands of a new radiotheranostic era

Ancora Heart’s AccuCinch System Demonstrates Significant Improvement in Quality of Life, Cardiac Structure and Function in Heart Failure Patients

Next-in-class combination treatment shows potential in cystic fibrosis

Navigating the Maze: 10 Common Challenges Faced by Healthcare Referral Coordinators

Medical Sales Strategies: How to Drive Doctors’ Recommendations

Eli Lilly reveals plans for new high-tech parenteral manufacturing site

Lipid Nanoparticles Immunogenicity & Toxicity | December 6-8, 2022

Drug repurposing, real world data and AI/ML: perspectives and opportunities

Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling

Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

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

How can evidence-based medicine (EBM) methodology support drug withdrawals?

Benefits of blockchain in limiting counterfeit drug distribution

Why Is FDA Issuing Fewer Marketing Violation Letters?

The erosion of trust in health information?

ClearPoint Neuro Announces FDA Clearance for ClearPoint Maestro™ Brain Model

Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia

Allotrope Medical announces FDA Safer Technologies Program (STeP) designation for their surgical device StimSit

MHRA approves Pluvicto® and Locametz® for prostate cancer

Pharmacovigilance deep dive: risk minimisation measures

Streamlining healthcare with AI for drug development

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