pharmaphorum

SEPTEMBER 7, 2022

GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug early next year. The safety data has one element, however, that might be expected to stimulate discussion at the advisory committee meeting.

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Legacy MEDSearch

SEPTEMBER 27, 2022

Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. See Full Press Release at the Source: Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia.

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FDA Food and Drug Administration Recruitment Medicine 98

Legacy MEDSearch

SEPTEMBER 26, 2023

Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke ® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop technology. The approval provides patients implanted with the Evoke ® System the ability to undergo 1.5 head and extremity and 1.5T

Medical 52

Medical FDA Food and Drug Administration Safety 52

Legacy MEDSearch

NOVEMBER 7, 2022

a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. “Surgeons are constantly learning new techniques, either robotics or laparoscopic, and safety is always front and center.

Medical 95

Medical FDA Safety Recruitment 95

Legacy MEDSearch

AUGUST 15, 2022

This first-generation anatomical segment analysis tool emerged over 10 years ago from research aimed at detecting subtle volumetric and shape abnormalities in patients with mild traumatic brain injury. More importantly, it provides point-based correspondence longitudinally and across patients. About ClearPoint Neuro.

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World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. Here are some myths around DTC marketing: 1ne: DTC ads result in patients asking for prescriptions they don’t need. Some DTC budgets are only released when certain sales targets are hit. Finally, patients won’t ask for a drug if the co-pay is too high.

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Marketing Prescription Side effects Doctors 285

MedReps

SEPTEMBER 19, 2022

There’s no shortage of challenges for those new to pharma, medical sales and even veterans. In case you weren’t aware, nothing in medical sales comes easy – at least not for long. Below are seven common challenges that pharmaceutical and other medical sales reps face. Physician Access. Insurance Coverage.

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Medical sales Medical sales reps Medical Sales 66

Legacy MEDSearch

SEPTEMBER 5, 2023

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO solution is not yet approved for sale or distribution in the USA and is limited by USA law to investigational use. VisAble.IO

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Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. This system fills that void for both surgeons and patients.” I’m excited that the study met its superiority composite endpoint, which included effectiveness and safety components.

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Legacy MEDSearch

OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe.

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pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. billion or more.

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pharmaphorum

SEPTEMBER 29, 2022

Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review. Here is a patient (*written consent obtained) I saw just 2 weeks ago with severe disease. — Brian S.

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FDA Patients Leads Safety 67

pharmaphorum

OCTOBER 17, 2022

The FDA is planning to take an additional three months to review Biogen’s experimental therapy for amyotrophic lateral sclerosis (ALS), setting back its decision date from January to April. There are around 31,000 patients with ALS in the US. The post FDA delays decision on Biogen’s ALS hope tofersen appeared first on.

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Legacy MEDSearch

JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration (FDA) for UroActive. .

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Food and Drug Administration Patients Safety Recruitment 52

pharmaphorum

SEPTEMBER 1, 2022

Sanofi now has approval on both sides of the Atlantic for Xenpozyme – its enzyme replacement therapy for rare disease acid sphingomyelinase deficiency (ASMD) – after getting a green light from the US FDA. Some patients may survive into adulthood, but tend to die prematurely from respiratory failure.

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FDA Safety Patients Marketing 52

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.

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FDA Recruitment Patients Medical 52

pharmaphorum

DECEMBER 20, 2022

Switzerland’s Idorsia has submitted a new drug application to the FDA for aprocitentan as a treatment for people whose blood pressure remains stubbornly high despite treatment and who are at increased risk of complications like kidney disease and stroke. The dual endothelin receptor antagonist (ERA) has been tipped as a potential $2.5

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Sales FDA Patients Safety 89

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. Itatani, MD, Ph.D., Cardio Flow Design Inc. Cardio Flow Design, Inc.

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FDA Food and Drug Administration Recruitment Physicians 52

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). . CereVasc, Inc., About CereVasc, Inc. Press Release by: CereVasc.

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FDA Food and Drug Administration Recruitment Physicians 52

pharmaphorum

AUGUST 24, 2022

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion’s blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The safety and immunogenicity profile of the biosimilar was also comparable to Alexion’s drug, said Amgen.

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Safety Sales Patients FDA 83

pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. The post FDA slaps partial hold on Biogen, InnoCare MS drug appeared first on.

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FDA Side effects Biopharma Prospecting 67

Legacy MEDSearch

AUGUST 25, 2022

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. Recruitment in the European study is expected to end this summer.

Medical 52

Medical FDA Recruitment Pharmacology 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

pharmaphorum

NOVEMBER 22, 2022

The company said it has started the processing for withdrawing the marketing authorisation for Blenrep (belantamab mafodotin) at the request of the FDA. Some patients will be able to continue to receive the drug via a compassionate use programme. The post GSK will pull Blenrep from US market after failed trial appeared first on.

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pharmaphorum

NOVEMBER 14, 2022

The EMA’s human medicines committee (CHMP) has recommended IL-4 and IL-13 inhibitor Dupixent (dupilumab) to treat adults with moderate to severe PN, a disease which causes hard lumps to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain.

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Sales Medicine Patients Leads 95

Legacy MEDSearch

MARCH 17, 2023

Prompt referral from a PCP to a dermatologist can help minimize patient mortality, morbidity and result in the saving of health care dollars.” The device was granted FDA Breakthrough Device designation and is currently under review by the FDA. “It There were no device-related safety issues reported in either study.

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FDA Physicians Recruitment Medical 52

pharmaphorum

AUGUST 19, 2022

The European Commission has approved Oncopeptides’ Pepaxti in combination with dexamethasone for multiple myeloma patients with so-called triple class refractory disease – in other words those who don’t respond to all three of the major classes of treatment for the blood cancer.

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FDA Safety Sales Marketing 52

Legacy MEDSearch

JULY 27, 2022

Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. The ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.

Medical 52

Medical FDA Recruitment Physicians 52

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.,

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Medical 52

pharmaphorum

AUGUST 31, 2022

As expected, the FDA has moved quickly to grant emergency use authorisation (EUA) to two new-generation COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna, both targeting the new Omicron subvariants BA.5 The FDA said in a statement that the BA.4 The post FDA clears bivalent Omicron shots from Pfizer, Moderna appeared first on.

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Pharmaceutical Technology

MARCH 14, 2023

The agreement is intended for providing commercial support for CTx-1301, after receiving the US Food and Drug Administration (FDA) approval. Recently, Cingulate commenced its first Phase III trial which has been designed for evaluating CTx-1301’s safety and efficacy.

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Food and Drug Administration Medical FDA Marketing 59

pharmaphorum

OCTOBER 27, 2022

The phase 3 clinical programme, named ContRAst, was the first in RA to include head-to-head comparisons of otilimab with current treatments, hoping to build a niche for otilimab among hard-to-treat patients who have an inadequate response to or cannot tolerate available drugs.

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Legacy MEDSearch

JUNE 28, 2023

2 The incidence of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, with a reported rate ranging from 1.1 2 The incidence of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, with a reported rate ranging from 1.1 ”, states board-certified cosmetic dermatologist, Roy G.

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Medical FDA Recruitment Side effects 52

Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment Medical 98

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 million U.S.

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Food and Drug Administration FDA Medical Recruitment 52

Contrarian Sales Techniques

FEBRUARY 25, 2023

A point of view from a Medical Sales Rep I strongly believe that the most effective insurance policy is not to get sick. During my pharmacology class, I learned that there are no safe drugs, only safe patients. This is before a drug can be approved for public use.

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Side effects Medical sales reps Insurance Pharmacology 52

Legacy MEDSearch

FEBRUARY 28, 2023

In addition, pooled analysis results from the combined primary efficacy endpoint and safety data from RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II were concurrently published in JAMA Cardiology. Patients were to remain off antihypertensive medications throughout the two months of follow-up unless specified BP criteria were exceeded.

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Networking Medical Physicians Safety 98