Pharmaceutical Technology

MAY 25, 2023

Pushing back an initial deadline, the US Food and Drug Administration (FDA) has proposed a new regulatory action date of 22 June, by which time the agency will assess the logistics of a possible approval for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy.

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FDA Food and Drug Administration Prescription Food 52

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. People don’t want to lose weight through diet and exercise if they can lose it through a prescription drug.

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Healthcare Healthcare Side effects Prescription 244

pharmaphorum

SEPTEMBER 26, 2022

Digital health company Better Therapeutics has submitted its lead prescription digital therapeutic (DTx) BT-001 to the FDA, seeking approval for use by adults with type 2 diabetes (T2D). Still to come, of course, will be the challenges of ensuring access and reimbursement for the DTx, if approved by the FDA.

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FDA Prescription Patients Medical 52

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The FDA’s action plan. The first AdCom was critical of the study’s robustness.

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FDA Food and Drug Administration Physicians Side effects 98

Legacy MEDSearch

APRIL 25, 2023

Food and Drug Administration (FDA). Potential benefits include: Reduction in Radiation: Removing the need for high-radiation intraoperative scans throughout the procedure can lead to a 10x reduction in radiation exposure. ABOUT PROPRIO Proprio is a leading medical technology company creating the new way of seeing in surgery.

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FDA Food and Drug Administration Recruitment Medical 52

pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic. Now at $6.79

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FDA Prescription Food Medical 44

World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). The FDA’s stamp of approval for the Fitbit sensor is a big deal. Not if it affects their bottom line.

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Healthcare Healthcare Food and Drug Administration FDA 227

World of DTC Marketing

NOVEMBER 18, 2021

prices on seven of the 10 costliest prescription drugs in 2020 without justification, increasing drug spending by $1.67 leading to an almost $1.4 AbbVie filed 55% of Imbruvica’s patent applications after FDA approval, the report said” So how do people who work for AbbVie feel? billion, a U.S. billion increase in U.S.

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Pharma Prescription Medicine Manufacturing 202

Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). This important milestone enables the world’s first prescription music platform, and is a remarkable day for our company, for music, for healthcare, and most importantly for stroke survivors.” ” InTandem is anticipated to be available soon in select market segments. .

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FDA Food and Drug Administration Recruitment Medical 52

World of DTC Marketing

MARCH 11, 2022

However, the public is aware that they may need prescription drugs to manage chronic health conditions. Even patients will still line up if a prescription drug shows promise. Even patients will still line up if a prescription drug shows promise.

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Physicians Healthcare Healthcare Prescription 212

Legacy MEDSearch

MARCH 15, 2023

The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring.

Food and Drug Administration 97

Food and Drug Administration FDA Recruitment Physicians 97

World of DTC Marketing

FEBRUARY 22, 2021

Jazz Pharmaceuticals has introduced a new prescription medication for patients with sleep apnea/narcolepsy that “helped adults get up to 9 hours of improved wakefulness in clinical studies at 12 weeks” and they’re using a flying pig on their DTC.

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Pharma Doctors Side effects Prescription 181

Pharmaceutical Technology

FEBRUARY 13, 2023

Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. Elyxyb is claimed to be the only FDA-approved first-line treatment, ready-to-use solution of celecoxib developed for the indication.

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World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. This leads to a question; “where does it end?” Wall Street wants growth, as do investors, but that may be impossible for pharmaceutical companies. ” Why are the costs so high? .”

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Pharma Food and Drug Administration Marketing Prescription 210

Pharmaceutical Technology

SEPTEMBER 23, 2022

Current treatment options for DES are dominated by a mix of prescription and over-the-counter (OTC) products. Artificial tears are also used extensively in conjunction with prescription therapies for symptomatic relief. Novaliq/ Bausch + Lomb’s NOV-3 (perfluorohexyloctane) is also currently at pre-registration stage with the FDA.

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Prescription Physicians FDA Marketing 59

PM360

SEPTEMBER 15, 2022

This leads 89% of those surveyed to believe some doctors will err on the side of their own legal safety when making decisions about patient care and the necessity of abortion. Patient Pages: Patients Refuse Prescription Use After Recalls. FDA Update. Qualio surveyed 2,002 U.S. Drug Approvals. 5 lineages of the omicron variant.

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Pharmaceutical Technology

APRIL 18, 2023

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics licence application for Abecma. This will lead to cytokine secretion, CAR T cell proliferation and subsequent cytolytic killing of BCMA-expressing cells.

Food and Drug Administration 52

Food and Drug Administration Prescription FDA Food 52

World of DTC Marketing

MARCH 8, 2021

The media have targeted pharmaceutical companies for a long time because sensational headlines lead to clicks. Forget the fact that prescription drugs only account for $.10 The FDA could require all pharma product websites to add general health prevention information and links to credible online health information.

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Healthcare Healthcare Insurance Media 310

Clarify Health

MAY 11, 2022

The study titled “Baseline Characteristics and Secondary Medication Adherence Patterns Among Patients Receiving Tafamidis Prescriptions: A Retrospective Analysis Using a National Specialty Pharmacy Dispensing Database” was published in Patient Preference and Adherence journal in April 2022.

Medical 52

Medical Patients Prescription FDA 52

pharmaphorum

OCTOBER 3, 2022

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry. It can lead to progressive paralysis and death.

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Insurance Prescription FDA Patients 52

Pharmaceutical Technology

MARCH 3, 2023

Albireo’s pipeline includes its lead asset, Bylvay (odevixibat), a potent, once-a-day, oral, non-systemic, ileal bile acid transport inhibitor (IBATi). Last month, the US Food and Drug Administration (FDA) accepted Bylvay for Priority Review to treat Alagille syndrome (ALGS) in paediatric and adult patients.

Pharma 52

Pharma Food and Drug Administration Transportation Prescription 52

Clarify Health

MAY 11, 2022

The study titled “Baseline Characteristics and Secondary Medication Adherence Patterns Among Patients Receiving Tafamidis Prescriptions: A Retrospective Analysis Using a National Specialty Pharmacy Dispensing Database” was published in Patient Preference and Adherence journal in April 2022.

Medical 40

Medical Patients Prescription FDA 40

Clarify Health

MAY 11, 2022

The study titled “Baseline Characteristics and Secondary Medication Adherence Patterns Among Patients Receiving Tafamidis Prescriptions: A Retrospective Analysis Using a National Specialty Pharmacy Dispensing Database” was published in Patient Preference and Adherence journal in April 2022.

Medical 52

Medical Patients Prescription FDA 52

Legacy MEDSearch

OCTOBER 16, 2023

” Proprio’s Paradigm secured FDA 510(k) clearance and significant additional funding earlier this year and is being deployed into select leading hospitals across the US and abroad. ABOUT PROPRIO Proprio is a leading medical technology company creating the new way of seeing in surgery.

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Legacy MEDSearch

JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

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Patients Recruitment Pharmacology Side effects 98

pharmaphorum

DECEMBER 22, 2022

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. This will lead to more pre-protocol design discussions between sponsors and CROs and regulatory bodies seeking input on new and potentially acceptable approaches to, for example, measure digital endpoints.

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FDA Patients Electronics Medical 81

Clarivate

OCTOBER 30, 2022

What the apps have in common is that they provide virtual sessions that lead patients through several weeks of cognitive behavioral therapy designed to improve sleep, lessen depression or curb opioid abuse. As a result, few products have FDA clearance. What’s next?

Insurance 52

Insurance FDA Prescription Marketing 52

pharmaphorum

NOVEMBER 2, 2022

The struggle to manage pain for individuals has been one that goes back a long way in history, with one of the earliest recorded medical prescriptions being for opium. This leads to psychological harm becoming a significant factor in chronic pain, alongside the physical symptoms. The potential for a digital solution.

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Food and Drug Administration Food FDA Patients 129

pharmaphorum

AUGUST 11, 2022

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. Many FDA-cleared drugs have pharmacogenomics data on the label, which indicate the biomarker information to help guide decisions regarding the use of the therapeutic in individual patients.

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Side effects Medical Prescription Patients 86

Pharma Marketing Network

OCTOBER 6, 2021

Leveraging attention metrics, Adelaide has helped leading brands across all verticals understand true media quality to deliver better full-funnel outcomes. Adelaide, a leader in the evidence-based media quality measurement space, provides marketers with a way to navigate the consumer privacy movement responsibly.

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Pharma Media Digital Media Marketing 98

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” FDA, 2022. . About the authors.

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Manufacturing Pharma Food and Drug Administration Safety 84

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. In fact, 73% were White, 14% were Asian, 6% were Hispanic, and 5% were African American.

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Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

Legacy MEDSearch

OCTOBER 25, 2023

Dr. Andrea Synowiec, a neurologist and headache specialist who serves as System Vice Chair of the Department of Neurology at Allegheny Health Network in Pennsylvania is the lead author of the study.

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Side effects Recruitment Networking Management 52

PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. How can data itself play a larger role in addressing adherence? Jason Burum.

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Medical Electronics Patients Healthcare 105

Medgadget

AUGUST 8, 2023

This common neurodevelopmental condition is often overlooked in affected children, leading to a lack of early intervention and care. The FDA-cleared indication for EarliPoint Evaluation is for the diagnosis and assessment of ASD for children aged 16 to 30 months. Despite the prevalence of ASD, the median age for diagnosis in the U.S.

Healthcare Provider 88

Healthcare Provider Healthcare Healthcare Prescription 88

Silver Line CRM

NOVEMBER 11, 2020

Prescription lift. What the consumerization of the patient means in action is: Map out exactly what it looks like for a patient to go from symptoms to testing to prescription and beyond. . Specialty pharmacies coordinating prescriptions, refills, and shipments. FDA/FTC/HIPAA compliance. Things like: Media spend.

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Marketing Pharmaceutical Side effects Insurance 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. It can lead to other health problems, including high blood pressure, heart attack, stroke and diabetes.

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FDA Prescription Healthcare Provider Physicians 103