PM360

OCTOBER 13, 2023

Doctor Docs: Targeting Trust Between Pharma and HCPs A new study shows the crucial link in pharma marketers’ digital engagement strategy with HCPs is in jeopardy—trust. doctors are calling two particular drugs “paradigm-shifting”—tirzepatide, sold as Mounjaro , and semaglutide, sold as the brands Ozempic , Wegovy , and Rybelsus.

Healthcare 59

Healthcare Healthcare Doctors Pharma 59

Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy. Thus, the biosimilar presented a similar efficacy to the reference product.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Insurance 52

Legacy MEDSearch

JUNE 19, 2023

The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc.

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

World of DTC Marketing

DECEMBER 23, 2020

The old belief is that patients who are interested in new treatments ask their doctor about them. The FDA can be myopic when researching how consumers view and react to DTC. They’re going to go online where they can read the safety warnings that too often than not scare them because they lack context.

Prescription 249

Prescription Doctors Side effects Marketing 249

European Pharmaceutical Review

SEPTEMBER 27, 2022

The US Food and Drug Administration (FDA) have published initial guidance deliberating how ethical it is for children to take part in research trials. Thus, numerous drugs and medical devices approved and licensed by the FDA are missing essential paediatric-specific information on their product labels.

Ethics 95

Ethics Food and Drug Administration FDA Medical 95

pharmaphorum

AUGUST 1, 2022

Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) in the next few months, with a view to making it available in sometime around the middle of 2023.

FDA 95

FDA Safety Patients Doctors 95

PM360

SEPTEMBER 15, 2022

Doctor Docs: Doctors Left Concerned After Roe v. Abortion bans have made it a felony to provide or attempt to provide an abortion, meaning doctors and clinics are the ones likely to be charged and tried, rather than individual patients. FDA Update. Wade Overturn. A recent Sermo study of 240 U.S.-based Drug Approvals.

Healthcare 52

Healthcare Healthcare Doctors Physicians 52

European Pharmaceutical Review

MARCH 4, 2024

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 The emergency use approval from the FDA of lipid nanoparticle- (LNP-) based mRNA vaccines during the COVID-19 pandemic attested the significance of LNPs.

Food and Drug Administration 95

Food and Drug Administration Transportation FDA Medical 95

PM360

APRIL 7, 2023

Med Device Department: Medicare Sets Precedent for Virtual Reality Therapeutic Payments In November 2021, the FDA approved a virtual reality (VR) therapy that provides an immersive experience for relieving chronic lower back pain. CMS factored in the efficacy of the device as well as its safety beyond the use of opioids. In the U.S.,

Healthcare 52

Healthcare Healthcare Insurance Physicians 52

World of DTC Marketing

FEBRUARY 9, 2021

Consistently we heard that they like images of real patients or a REAL doctor with one key message communicated. 6ix: Safety information needs context. They understand that patient content could be edited to meet FDA requirements, but they like reading others’ experiences managing their health issues.

Pharma 180

Pharma Side effects Medical FDA 180

Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

Competition 59

Competition Marketing FDA Physicians 59

pharmaphorum

OCTOBER 12, 2018

The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label.

Healthcare 52

Healthcare Healthcare Prescription Doctors 52

LEVO Health

OCTOBER 26, 2022

Food & Drug Administration (FDA) classifies medical devices. They have regulatory controls and marketing pathways you have to follow based on the risk of your device and its overall safety and effectiveness. How the FDA Classifies Medical Devices. They are not obligated to submit data or information to the FDA. .

Medical 52

Medical Marketing Patients Food and Drug Administration 52

pharmaphorum

DECEMBER 22, 2022

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept.

FDA 75

FDA Patients Electronics Medical 75

pharmaphorum

AUGUST 8, 2022

Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ($3.1 billion) blockbuster.

Sales 57

Sales Marketing Doctors Prospecting 57

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. References. Counterfeit medicines. Available from: [link].

Medicine 96

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 96

pharmaphorum

SEPTEMBER 30, 2022

Another key factor to consider is the safety profile of the drug, particularly with regard to amyloid-related imaging abnormalities (ARIA) that are always a risk with amyloid-targeting drugs, causing oedema (ARIA-E) and haemorrhages (ARIA-H). . “What we cannot know yet is whether that effect increases over time in an individual.

Doctors 52

Doctors Side effects Safety Sales 52

pharmaphorum

AUGUST 11, 2022

Next, pharmacists review the participant’s genetic results – along with health data such as drug, lifestyle, and food interactions – to customize a “Medication Action Plan” that members’ physicians can access to determine which drugs should be prescribed to increase safety and efficacy.

Side effects 81

Side effects Medical Prescription Patients 81

World of DTC Marketing

JUNE 3, 2022

The FDA defines digital health this way. From mobile medical apps and software that support the clinical decisions doctors make every day to artificial intelligence and machine learning, digital technology has been driving a revolution in health care. What is digital health? Hacking medical devices remotely.

Doctors 291

Doctors Insurance Medical Electronics 291

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? John Carroll, Endpoints.

FDA 207

FDA Food and Drug Administration Patients Biopharma 207

Pharma Marketing Network

OCTOBER 11, 2021

Patients and doctors went from trying to make sense of the platform to full-blown adoption where practices continue to incorporate it as an integral part of the go-to-market model. Telehealth has brought positive change for both patients and doctors. Be sure to give your team the psychological safety they need to ask questions.

Healthcare 59

Healthcare Healthcare Marketing Insurance 59

MedReps

SEPTEMBER 19, 2022

If a rep takes a more practical view of how to sell their product, they can find accessible staff members play a vital role in the doctor’s decision-making process. . Of course, the FDA and other government agencies have the final say, but in-between organizations like PHRMA are continually changing their rules.

Medical sales 66

Medical sales Medical sales reps Medical Sales 66

Pharma Marketing Network

OCTOBER 11, 2021

Patients and doctors went from trying to make sense of the platform to full-blown adoption where practices continue to incorporate it as an integral part of the go-to-market model. Telehealth has brought positive change for both patients and doctors. Be sure to give your team the psychological safety they need to ask questions.

Healthcare 52

Healthcare Healthcare Marketing Insurance 52

pharmaphorum

JULY 6, 2022

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. Now, in addition to doctors and providers, the FDA announced pharmacists with your medical information can prescribe Paxlovid to patients.

FDA 95

FDA Doctors Side effects Patients 95

pharmaphorum

JANUARY 15, 2023

That is perhaps why UPLIZNA is the first and only targeted B-cell depleting monotherapy approved by the EMA and the FDA for this disease in adults who have NMOSD and who have the autoantibodies to Aquaporin-4. A physician’s first-hand knowledge. She resides in Philadelphia with her husband and son.

Patients 84

Patients Medicine Physicians Medical 84

Pharmaceutical Technology

APRIL 13, 2023

Lower DCT usage for Phase I studies may be accounted for due to the heavier focus on safety and efficacy, and increased monitoring of trial participants in-person. In the US, the FDA (Food and Drug Administration) granted accelerated approvals of medical devices with AI in 2022 [8] , and growing use is expected throughout 2023.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

PM360

AUGUST 9, 2022

Doctors, caregivers, life sciences companies, and even companies in other industries have attempted to answer this question for as long as medications have been available. Needles cause patients pain, anxiety, pose safety risks, and for some people receiving injection therapy is a traumatic experience. But it is not a simple answer.

Prescription 105

Prescription Medical Side effects Patients 105

pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021. Levy asked.

Food and Drug Administration 82

Food and Drug Administration Prescription Media FDA 82

Pharmaceutical Technology

FEBRUARY 3, 2023

The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above. Asthma control improvement and safety profile were consistent with previous clinical trials.

Food and Drug Administration 59

Food and Drug Administration FDA Healthcare Provider Doctors 59

pharmaphorum

SEPTEMBER 12, 2022

Across LabCorp , we innovate through science and technology, with access to approximately 2,500 [doctors] and PhDs and over 700 patients. This reach allows us to support 82% of the novel drugs and therapeutic products approved by the US FDA, including 63% of those specific to oncology,” Reddy states.

Patients 95

Patients Medicine FDA Healthcare 95

PM360

SEPTEMBER 15, 2022

While I like traditional blinded market research projects or online virtual panels, the participants tend to be the “engaged patients” and may not account for the doctor-dependent patients needed to reach to move the market. In April, the FDA released an updated draft guidance identifying steps to improve diversity in clinical trials.

Patients 98

Patients Healthcare Healthcare Marketing 98

Medico Reach

OCTOBER 17, 2022

From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

PM360

JUNE 11, 2022

For example, everyone must be steeped in both FDA and FTC guidelines. Then, the MRL team and the influencer must align on where there is flexibility within messaging while still abiding to brand safety guidelines, as you don’t want to lose the authenticity that the influencer brings. Different patients have unique needs. Anthony Yanni.

Patients 59

Patients Pharma Education Media 59

PM360

DECEMBER 14, 2022

As of yet, the FDA has only approved medical cannabis in the form of CBD products used for treating epilepsy seizures and nausea caused by chemotherapy, though it is prepared to review studies for several other indications currently in trials.

Manufacturing 52

Manufacturing Medical Healthcare Healthcare 52

Medico Reach

OCTOBER 17, 2022

From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Legacy MEDSearch

JULY 19, 2023

We are more confident than ever that this groundbreaking technology will ultimately become the first-line treatment of choice for men and their doctors.” ” The company anticipates using the one-year follow-up data from the VAPOR 2 study in support of an FDA submission for U.S. Francis Medical, Inc., clinical sites.

Medical 52

Medical Side effects Patients Recruitment 52

Cadensee

OCTOBER 19, 2021

After about three months, on Independence Eve, we went to the doctor and discovered that he has something called familial dysautonomia. We went to the doctor, the doctor told us, 'Well, there's nothing you can do about it. By the way, with a very attractive safety profile so far. He had an infection; he didn't swallow.

Patients 52

Patients Medical Networking Marketing 52