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.

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Pharmaceutical Technology

OCTOBER 7, 2022

The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk. Simultaneously, the companies have signed a securities purchase agreement under which Sanofi will procure $35m of Provention’s common stock on teplizumab, obtaining FDA approval. .

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Legacy MEDSearch

NOVEMBER 28, 2022

BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards. the healthcare subsidiary of Samsung Electronics Co., the healthcare subsidiary of Samsung Electronics Co., About NeuroLogica.

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FDA Food and Drug Administration Electronics Recruitment 92

Pharma Marketing Network

DECEMBER 4, 2024

As we approach 2025, emerging trends are reshaping how the industry engages with patients and healthcare providers. Virtual health consultations, mobile apps, and online portals have made it easier to engage patients and healthcare providers alike. Patient-Centric Marketing Patients want to feel heard.

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Legacy MEDSearch

DECEMBER 1, 2022

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. The FDA clearance of the QStat Cartridge expands the Quantra System’s indications for use to include trauma, and liver transplantation procedures. HemoSonics’ manufacturing, R&D, and Headquarters are based out of Durham, NC.

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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). Generic drug manufacturers, healthcare providers, and wellness brands often bid on similar terms. Understanding Pharma-Specific PPC Challenges 1.

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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.

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Food and Drug Administration FDA Healthcare Provider Medicine 59

Pharma Marketing Network

DECEMBER 31, 2024

Are you targeting healthcare providers (HCPs), patients, or payers? Follow FDA guidelines on advertising to ensure your messaging is accurate and ethical. Follow FDA guidelines, ensure accurate messaging, and work closely with legal and regulatory teams to review campaigns. Disclaimer: This content is not medical advice.

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Pharmaceutical Technology

NOVEMBER 7, 2023

Patients who have used the products should consult their healthcare provider and properly discard the product.

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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. million people in the UK and 2.7

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Infuse Medical

DECEMBER 17, 2024

Whether you are marketing a new medical product or creating animations for instructional reasons, you must satisfy regulatory criteria established by the FDA, EMA, or another health authority. Our repertoire includes patient education, surgical demonstrations, and pharmaceutical animation among other facets of healthcare.

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Legacy MEDSearch

JULY 31, 2023

Axial3D, a leader in medical segmentation and 3D solutions, today announced that it is the first to receive FDA clearance for an automated, AI-driven, cloud-based segmentation platform for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. Are you hiring?

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pharmaphorum

NOVEMBER 22, 2022

Stanza was made available to patients in September under the FDA’s Digital Health Enforcement Policy for Digital Health Devices, set up to facilitate access to remote therapies during the pandemic. It is available on prescription from healthcare providers. It is due to generate results next year.

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Pharmacology Patients Healthcare Provider Prescription 118

Legacy MEDSearch

AUGUST 16, 2023

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. per eligible Medicare patient case.

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FDA Food and Drug Administration Healthcare Provider Recruitment 52

Legacy MEDSearch

JULY 12, 2023

AccurKardia , a medical technology company delivering clinical-grade ECG interpretation software, announced today that its flagship product, the AccurECG Analysis System (“AccurECG” or the “System”), has been granted FDA 510(k) clearance. It is indicated for adults aged 22 and older.

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Pharmaceutical Technology

APRIL 28, 2023

Otsuka America Pharmaceutical and Lundbeck have received approval from the US Food and Drug Administration (FDA) for a new drug application for Abilify Asimtufii (aripiprazole) to treat schizophrenia or for maintenance monotherapy treatment of bipolar I disorder in adult patients.

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Food and Drug Administration FDA Healthcare Provider Food 52

Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.

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Legacy MEDSearch

JUNE 20, 2023

Food and Drug Administration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Innovation in the baby care space matters because some of the largest issues facing caregivers and healthcare providers have yet to be solved. BabySat will be available in the U.S.

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Prescription FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

MAY 24, 2023

In its 510(k) application to the FDA iHealthScreen has proposed the following indication for iPredict’s use: iPredict-AMD is indicated for use by health care providers to automatically detect more than early age-related macular degeneration (mteAMD) in adults above 50 years of age who have not been previously diagnosed with Late AMD (i.e.,

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Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. And, if there are concerns, the pharmacist can call their healthcare provider to develop a plan.

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Pharma Marketing Network

FEBRUARY 17, 2025

A pharmaceutical marketing company does more than run adsit builds connections between your brand, healthcare providers (HCPs), and patients. The Value of an Expert Partner: Industry-Specific Expertise: Pharmaceutical marketing companies know the ins and outs of marketing drugs, from branded drug launches to FDA regulations.

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Marketing Pharmaceutical Pharma Prescription 52

Medgadget

AUGUST 8, 2023

Tom Ressemann: To diagnose ASD, healthcare providers currently rely on subjective methods like parent questionnaires and behavioral observations of social interaction and communication skills, to identify autistic symptoms and restricted and repetitive patterns of behavior which define the condition. How is this suboptimal?

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Evolve Your Success

OCTOBER 23, 2024

Meet the guest: Justin Ramsaran is an American digital health developer and entrepreneur who leverages cross-functional business strategies and digital transformation with artificial intelligence to empower individuals and advance healthcare systems.

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Pharmaceutical Technology

MAY 26, 2023

On 18 May 2023, the FDA announced the approval of Rinvoq (upadacitinib), AbbVie’s Janus kinase inhibitor (JAKi), to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) blockers.

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FDA Healthcare Provider Patients Safety 52

PM360

JANUARY 24, 2025

Applying AI to GVDs Amassing comprehensive productand market-related data, GVDs demonstrate the value of a pharmaceutical product to various stakeholders, including payers, healthcare providers, and regulatory bodies. These tools also improve overall dossier quality by flagging inconsistencies, inaccuracies, or missing information.

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PM360

DECEMBER 20, 2024

ACTO LAICA RepAssist by ACTO is the first GenAI Knowledge Assistant built specifically for Life Sciences and is designed to improve healthcare provider (HCP) interactions by providing pharma field reps with instant access to approved clinical and product information.

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Legacy MEDSearch

JULY 6, 2022

annalise.ai, the global radiology AI company with rapidly growing presence in Asia- Pacific, Europe and the United Kingdom, today announced the appointment of accomplished healthcare technology executives Lakshmi Gudapakkam as Chief Executive Officer and clinical strategist Dr Rick Abramson as Chief Medical Officer. The post annalise.ai

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Nixon Gwilt Law

JUNE 24, 2024

Strategic Mergers and Acquisitions —Mergers and acquisitions (M&As) may offer strategic advantages to both Digital Health and DTx companies, providing access to complementary sales channels, expanding product offerings and customer base, and accelerating market penetration.

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FDA Education Healthcare Healthcare 52

Rep-Lite

APRIL 4, 2024

Clinical Knowledge: Possessing a basic understanding of relevant medical conditions and procedures related to your devices will enhance your interactions with healthcare providers. Understanding relevant standards like FDA approvals demonstrates professionalism and ensures you promote your products ethically and compliantly.

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Sales Medical Interpersonal Skills Healthcare Provider 52

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Pharma Marketing Network

MAY 3, 2023

The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs. The FDA has strict guidelines for what information can be included in drug advertisements and how it should be presented to the public.

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Safety Food and Drug Administration Pharmaceutical Marketing 52

Nixon Gwilt Law

JUNE 24, 2024

Strategic Mergers and Acquisitions —Mergers and acquisitions (M&As) may offer strategic advantages to both Digital Health and DTx companies, providing access to complementary sales channels, expanding product offerings and customer base, and accelerating market penetration.

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FDA Education Healthcare Provider Patients 52

Pharmaceutical Technology

JANUARY 16, 2023

Throughout the PATH-HOME trial, 92% of the patients, healthcare providers, and caregivers could successfully administer Tezspire in the clinic and at home. The company expects to receive the US Food and Drug Administration (FDA) decision on the new pre-filled pen and self-administration in the first half of this year.

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Food and Drug Administration Healthcare Provider Medicine Physicians 59

Pharma Marketing Network

JANUARY 7, 2025

Because that’s where the audience ispatients, healthcare providers, and stakeholders all spend significant time online. In 2025, delivering tailored messages to individual patients and healthcare providers is no longer a luxuryits a necessity. A significant focus for regulatory bodies has been on transparency.

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Pharma Marketing Network

OCTOBER 6, 2021

The FDA requires that pharmaceutical ads present the benefits and risks of a prescription drug in a balanced fashion, meaning a large portion of creative is dedicated to important safety information (ISI) rather than brand message. Premium Placement Quality Allows Creative to Shine.

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Impetus Digital

AUGUST 11, 2022

A: CognICA is effectively our flagship clinical product that has CE marking; we have FDA 510(K) registration in the US so it’s approved for use in clinical environments. What exactly is that software? How is it set up? What does it do and what does it help to diagnose? As you said, it’s delivered as software.

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Professional Services Healthcare Healthcare Healthcare Provider 85

Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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