MedCity News

APRIL 17, 2024

The post FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries appeared first on MedCity News. The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories.

FDA 263

FDA Manufacturing Marketing Physicians 263

World of DTC Marketing

JUNE 17, 2021

SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product. Medpage Today.

FDA 164

FDA Physicians Marketing Doctors 164

Nixon Gwilt Law

MARCH 6, 2025

On February 21, 2025 , the FDA officially determined that the shortage of semaglutide injection products has been resolved. When the FDA determines the drug shortage is resolved, the normal restrictions on compounding will apply once again. Those impacted must navigate critical regulatory changes now in play for compounded semaglutide.

FDA 52

FDA Physicians Distribution Medical 52

World of DTC Marketing

FEBRUARY 2, 2022

Never mind that physicians have turned against the drug Biogen wants to fight the decision because of their business needs. While some doctors have been eager to start prescribing the newly approved drug, others had criticized the FDA for clearing the drug before studies proved it works. Top researchers who advised the U.S.

Food and Drug Administration 239

Food and Drug Administration Physicians Side effects Doctors 239

World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. They research the drug online and ask their physician about it if they decide it’s a treatment option. Second, a physician is not going to prescribe a drug a patient doesn’t need. DTC ads raise awareness around health conditions. Again this is not true.

Marketing 285

Marketing Prescription Side effects Doctors 285

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. Of course, they should, but in the end, it’s going to come down to trust in their doctor and the FDA. Do patients care? Do patients care?

Patients 200

Patients FDA Doctors Physicians 200

World of DTC Marketing

MARCH 11, 2022

Trust, for example, in physicians is still relatively high. Most patients completely trusted their physicians “to put their needs above all other considerations” (69%). Physician trust in the U.S. Physician trust in the U.S. While this is an excellent general overview, it does not apply to all healthcare.

Physicians 212

Physicians Healthcare Healthcare Pharma 212

World of DTC Marketing

JUNE 2, 2021

Here are some basics: 1ne: Physicians receive a lot of emails and don’t have time to read every one. One of our tests, one of the most read emails, had a subject line of “new label information for prescribing just FDA approved.” Only send an email when you have something to say that will interest physicians.

Physicians 180

Physicians Doctors Marketing Sales 180

World of DTC Marketing

AUGUST 25, 2022

Pharma companies have access to some of the best physicians in the country, and they are underutilized when helping patients understand health issues. This also means you must have a content strategy based on listening to patients, nurses, and physicians. So what’s the ROI? The other key thing to remember is the reading level.

Doctors 227

Doctors Media Physicians Pharma 227

World of DTC Marketing

DECEMBER 29, 2021

The demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. There are also several physicians chiming in with their concerns over the long-term use of the drug. I reached out to some physicians to ask their opinion, and it varied. Unfortunately, the hype is going to exceed reality.

Side effects 191

Side effects Physicians Patients FDA 191

Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

Food and Drug Administration 105

Food and Drug Administration FDA Physicians Food 105

MedCity News

JULY 27, 2023

Current applications Today, there is an escalated appetite to address emerging procedures because they offer an opportunity for device makers – and physicians like me who are interested in cutting-edge technology – to influence new areas of medicine. It is akin to pioneering the untamed West in the 18th Century.

Specialization 241

Specialization Medical Medicine Leads 241

Legacy MEDSearch

SEPTEMBER 12, 2022

a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. Aerin Medical Inc., Aerin Medical is a privately held, venture-backed company, with U.S.

Medical 98

Medical Patients FDA Physicians 98

Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). The post US FDA approves Apellis’ geographic atrophy therapy Syfovre appeared first on Pharmaceutical Technology.

Food and Drug Administration 98

Food and Drug Administration FDA Physicians Food 98

Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1).

Food and Drug Administration 98

Food and Drug Administration FDA Transportation Physicians 98

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

Marketing 97

Marketing FDA Food and Drug Administration Pharmaceutical 97

World of DTC Marketing

DECEMBER 23, 2020

How do physicians feel about patients asking for a new drug via a telehealth visit, and can the prescriber evaluate whether a patient is a good candidate or a new drug? The FDA can be myopic when researching how consumers view and react to DTC. Is TV the best channel? Fair Balance in TV is a waste of time.

Prescription 249

Prescription Doctors Side effects Marketing 249

World of DTC Marketing

AUGUST 10, 2022

They’re using label and FDA-friendly language, which isn’t what patients want to hear. Use language that talks to patients as a physician would talk to them. While there is a segment that sees the drug as a “quick fix” to lose weight, others are skeptical and want to know more about side effects and costs.

Marketing 252

Marketing Media Side effects Pharma 252

World of DTC Marketing

NOVEMBER 5, 2021

.” One has to wonder if physicians are warning patients that Wegovy is NOT a miracle cure for obesity but must be taken with a strict diet and increased exercise. The FDA should have required that Novo mention the requirement of diet and exercise when taking the drug. Click to Tweet.

Insurance 271

Insurance Side effects Medical Prescription 271

World of DTC Marketing

SEPTEMBER 24, 2021

Physicians and insurers are rejecting Aduhelm because it should never have been approved in the first place. Then, against the advisory panel’s advice, Aduhelm was approved, but insiders within the industry criticized both the FDA and Biogen weren’t sold on the drug or its price tag. Biogen is in trouble.

Insurance 222

Insurance Pharma Doctors Physicians 222

Legacy MEDSearch

SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. This action is part of the FDA’s ongoing effort to ensure the safe and effective use of blood lancets in the home and health care settings. Tasso, Inc., For more information, please visit www.tassoinc.com. Press Release by: Tasso, Inc.

Medical 97

Medical FDA Food and Drug Administration Recruitment 97

Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Side effects 98

World of DTC Marketing

OCTOBER 19, 2020

We are already seeing a drop in the number of people who are willing to get a COVID-19 vaccination and until trust can be re-established with the FDA and the CDC I expect that number to remain high. Forward-thinking pharma marketers are thinking about ways to integrate DTC marketing into telehealth and at physician portals.

Pharma 180

Pharma Side effects FDA Marketing 180

Pharmaceutical Technology

APRIL 4, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Pharmaceutical 98

Legacy MEDSearch

NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. “We are pleased to receive another FDA clearance that extends our reach into the orthopedic device market with our ever-growing suite of cleared bone-fixation devices,” said Tyber Medical CEO and President Jeff Tyber.

Medical 98

Medical FDA Food and Drug Administration Engineering 98

Nixon Gwilt Law

JULY 23, 2024

In the recently released 2025 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”), the Centers for Medicare & Medicaid Services (CMS) created a new reimbursement pathway for “Digital Mental Health Treatment” (DMHT) devices and services.

Physicians 52

Physicians FDA Safety Management 52

pharmaphorum

JULY 7, 2022

Pfizer is still waiting for the green light to complete an acquisition of digital health company ResApp, a deal that looks even better now that its smartphone app for people with obstructive sleep apnoea (OSA) has been approved by the FDA. The post ResApp bags FDA okay for sleep apnoea app, after Pfizer takeover bid appeared first on.

FDA 105

FDA Prescription Healthcare Provider Patients 105

World of DTC Marketing

JANUARY 1, 2022

1ne: The value proposition of prescription drugs still outweighs potential side effects – Wegovy’s demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. Here are things I believe are more realistic. 3hree: Pharma will increase its spending in digital, but a lot of the money will be wasted.

Healthcare 244

Healthcare Healthcare Side effects Prescription 244

World of DTC Marketing

SEPTEMBER 22, 2021

Second, do people trust the FDA? ” 2wo: Physicians are still the gatekeepers of new Rx’s. First, there is confusion over treatments around COVID. Booster shots and misinformation have forced people to go online to try and get the facts. It’s an important question that needs to be explored via more research.

Doctors 43

Doctors Media Marketing Prescription 43

Pharma Marketing Network

MARCH 12, 2025

Regulatory Restrictions on Keyword Use Pharmaceutical ads must comply with regulations from organizations like the FDA (U.S.) , MHRA (UK) , and EMA (EU). Patients may search for best treatment for migraine, while a physician may look for clinical data on CGRP inhibitors. Understanding Pharma-Specific PPC Challenges 1.

Marketing 59

Marketing Pharma Prescription Competition 59

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for Pfizer and Myovant Sciences ’ Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) to manage moderate-to-severe pain linked with endometriosis in pre-menopausal women.

Food and Drug Administration 75

Food and Drug Administration FDA Management Physicians 75

Legacy MEDSearch

JUNE 17, 2022

Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company’s LOBO ® Vascular Occlusion System. The LOBO occluders integrate patented HD BRAID ® technology and an innovative design to provide interventional physicians with a One-and-Done solution for embolization.

Medical 90

Medical FDA Food and Drug Administration Recruitment 90

Legacy MEDSearch

DECEMBER 21, 2022

Food and Drug Administration (FDA) for 510(k) clearance. If FDA clearance is obtained, the ALICE device production line will be extended for Low-Rate Initial Production (LWRIP), which is an important operational stage in developing infrastructure to support serial manufacturing, quality control and shipping. Are you hiring?

Manufacturing 98

Manufacturing FDA Food and Drug Administration Medical 98

Nixon Gwilt Law

JULY 23, 2024

In the recently released 2025 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”), the Centers for Medicare & Medicaid Services (CMS) created a new reimbursement pathway for “Digital Mental Health Treatment” (DMHT) devices and services.

Physicians 52

Physicians FDA Safety Management 52

World of DTC Marketing

DECEMBER 22, 2020

Physicians are incorporating digital therapies into their patient encounters in increasing numbers. PWC polled consumers to ask them if they would be willing to use an FDA app or online tool to treat their medical condition. But at the same time, 93% of doctors believe mHealth apps can improve patients’ health.

Pharma 230

Pharma Doctors Patients Management 230

Legacy MEDSearch

JANUARY 18, 2023

Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. Press Release by: Cytovale. Are you hiring?

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Medical 98

Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

Food and Drug Administration 141

Food and Drug Administration Pharmacology Side effects Physicians 141