pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

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FDA Food and Drug Administration Patients Food 108

PM360

SEPTEMBER 15, 2022

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety. Qualio surveyed 2,002 U.S.

Healthcare 52

Healthcare Healthcare Doctors Physicians 52

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions or survives.

Patients 52

Patients Food and Drug Administration FDA Safety 52

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.

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FDA Safety Recruitment Patients 98

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. Located in Massachusetts’ healthcare hub, CereVasc, Inc.,

Food and Drug Administration 52

Food and Drug Administration FDA Patients Recruitment 52

Rep-Lite

MAY 10, 2024

From groundbreaking advancements in technology to a growing emphasis on patient-centricity, the industry is constantly evolving. Technological Advancements in Healthcare Sales Technological advancements have been reshaping the landscape of healthcare sales, bringing forth a new era of innovation and efficiency.

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Medical sales Sales Medical Medical sales reps 52

European Pharmaceutical Review

APRIL 17, 2024

Roche’s twice-yearly, 10-minute subcutaneous injection of OCREVUS ® (ocrelizumab) has shown significant promise for patients with either with relapsing or primary progressive multiple sclerosis (RMS or PPMS). percent had no relapse) in patients through 48 weeks of the treatment. No new safety signals were identified for OCREVUS SC.

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Food and Drug Administration Safety Medicine Food 64

Pharmaceutical Technology

APRIL 20, 2023

The US Food and Drug Administration (FDA) has approved Roche ’s Polivy (polatuzumab vedotin-piiq), along with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP), to treat certain types of previously untreated diffuse large B-cell lymphoma (DLBCL) in adult patients.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. The device may be reassessed to ensure the performance and safety of the device is negatively impacted.

Medical 85

Medical Food and Drug Administration Manufacturing Safety 85

World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Patients should be scared. We need a 21st-century approach that puts patient safety first. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).

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Food and Drug Administration Prescription Pharma Manufacturing 187

Contrarian Sales Techniques

FEBRUARY 10, 2023

Non-invasive healthcare products refer to medical devices or technologies that do not require puncturing the skin or entering the body in any way to diagnose, treat, or monitor a health condition. They are designed to be safe and comfortable for patients, and typically have minimal side effects.

Healthcare 52

Healthcare Healthcare Manufacturing Medical 52

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?

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Patients Healthcare Healthcare Marketing 98

pharmaphorum

OCTOBER 12, 2018

Digital technology is transforming the way that healthcare is practiced and delivered, with areas like digital therapeutics forging ahead to complement traditional medical approaches and augment patient care. We’ll be looking at how digital and traditional approaches to medicine are being combined to improve patient outcomes.

Healthcare 52

Healthcare Healthcare Prescription Doctors 52

European Pharmaceutical Review

DECEMBER 7, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Comirnaty ® , the Pfizer/BioNTech COVID-19 vaccine for infants and children aged six months to four years in Great Britain. The acceptance was based on a randomised, placebo-controlled study that has enrolled approximately 4,700 children five to 11 years of age.

Food and Drug Administration 78

Food and Drug Administration Patients Side effects Medicine 78

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

Patients 52

Patients Food and Drug Administration FDA Safety 52

Pharmaceutical Technology

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. The post US FDA accepts Sandoz’s BLA for biosimilar denosumab appeared first on Pharmaceutical Technology.

Food and Drug Administration 52

Food and Drug Administration FDA Medicine Food 52

LEVO Health

OCTOBER 26, 2022

With seemingly countless treatment options on the table, how can your device cut through the clutter and get in front of the right patients at just the right time? You need to be a trusted partner for both patients and their providers alike. . Food & Drug Administration (FDA) classifies medical devices.

Medical 52

Medical Marketing Patients Food and Drug Administration 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. Dr. Itatani, MD, Ph.D., Itatani, MD, Ph.D., Cardio Flow Design Inc.

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

European Pharmaceutical Review

AUGUST 29, 2023

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. The safety and efficacy profile was consistent with the IV formulation.

Food and Drug Administration 79

Food and Drug Administration Safety Medicine Food 79

Pharmaceutical Technology

APRIL 6, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease. A recent wave of monoclonal antibodies, including the FDA-approved Eisai / Biogen ’s Leqembi (lecanemab), is expected to shake up the space. “We

Safety 105

Safety Healthcare Healthcare Manufacturing 105

Pharmaceutical Technology

APRIL 3, 2023

Eisai and the National Cancer Center have signed an agreement to partner on investigator-initiated clinical research for the anti-cancer agent, tazemetostat (Tazverik Tablets 200 mg), based on the Patient-Proposed Healthcare Services system.

Insurance 98

Insurance Government Safety Patients 98

Legacy MEDSearch

AUGUST 29, 2022

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt ® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). . Located in Massachusetts’ healthcare hub, CereVasc, Inc.,

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

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.

FDA 52

FDA Healthcare Provider Patients Safety 52

World of DTC Marketing

JANUARY 8, 2021

Moderna, maker of one of only two vaccines granted emergency authorizations to prevent COVID-19 in the US, has been shamed with a 2020 “Shkreli Award” by the Lown Institute, a healthcare think tank. Can the FDA really control the quality of vaccine orders this big? However, in vaccines, cut corners could compromise patient safety.

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Government Safety FDA Pharma 266

Legacy MEDSearch

MARCH 20, 2023

(NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery (PGS), announced that it has received 510(k) clearance from the FDA for an expanded indication to treat pediatric patients with the Senhance® System.

FDA 52

FDA Recruitment Patients Medical 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.

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Food and Drug Administration Transportation FDA Medical 84

European Pharmaceutical Review

AUGUST 11, 2023

Crizanlizumab is a once-a-month, humanised monoclonal antibody infusion, indicated for the prevention of recurrent vaso‑occlusive crises (pain crises) in sickle cell disease patients aged 16 years and above. However, the STAND results did not suggest new safety concerns with crizanlizumab.

Marketing 79

Marketing Food and Drug Administration Medicine FDA 79

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 75

Patients Pharma Consulting Transportation 75

Legacy MEDSearch

MARCH 21, 2023

Food and Drug Administration (FDA). Lumicell is committed to revolutionizing the way breast cancer surgery is performed and bringing the benefits of the Lumicell Direct Visualization System to breast cancer patients,” said Kevin Hershberger, president and chief executive officer of Lumicell. Lumicell, Inc., About Lumicell, Inc.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Medical 52

Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

FDA 52

FDA Prescription Medicine Biopharma 52

pharmaphorum

DECEMBER 5, 2022

It has been announced today that Novartis’ Pluvicto (lutetium vipivotide tetraxetan) has shown statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

Medicine 57

Medicine Safety FDA Healthcare 57

Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. Ancora Heart , Inc., An estimated 6.5 million U.S. An estimated 6.5

Food and Drug Administration 52

Food and Drug Administration FDA Medical Recruitment 52

pharmaphorum

DECEMBER 14, 2022

When patients experience intense emotion, either positive or negative, they are rendered unconscious. Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002.

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Competition FDA Pharmaceutical Marketing 90

Contrarian Sales Techniques

JANUARY 25, 2023

Regulatory requirements such as HIPAA and FDA regulations are put in place to protect patient's safety and ensure that all sales and marketing efforts are compliant. It's not just about selling a product, it's about ensuring that all sales and marketing efforts are compliant and patient's safety is kept as a top priority.

Pharmaceutical Sales 52

Pharmaceutical Sales Sales Pharmaceutical Safety 52

Pharmaceutical Technology

AUGUST 19, 2022

The European Commission (EC) has granted approval for Celltrion Healthcare ’s Vegzelma (CT-P16) to treat metastatic breast cancer, advanced and/or metastatic renal cell cancer, non-small cell lung cancer, ovarian cancer, metastatic carcinoma of the colon or rectum and cervical cancer.

Food and Drug Administration 52

Food and Drug Administration Safety Medicine Food 52

PM360

JUNE 11, 2022

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. But 71% also want publicly shared information about how patients’ perspectives were incorporated into the development of products and services. Noël Moossa.

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Patients Pharma Education Media 59