Legacy MEDSearch

DECEMBER 16, 2022

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the TruLift Lateral Expandable Spacer System and Lateral Plate System.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Manufacturing 52

European Pharmaceutical Review

JULY 13, 2023

In many European countries physicians can now prescribe medical cannabis for an array of chronic health conditions, including chronic pain, mental health disorders and neurological conditions. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.

Medical 84

Medical Food and Drug Administration Pharmacology Medicine 84

Legacy MEDSearch

OCTOBER 9, 2023

HistoSonics ® , ( www.histosonics.com ), the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. was achieved indicating that physicians can precisely target and destroy liver tissue and unresectable liver tumors.

FDA 52

FDA Food and Drug Administration Physicians Safety 52

pharmaphorum

OCTOBER 13, 2022

Several manufacturers are developing novel treatments for the disease, including Vertex, which has partnered with CRISPR Therapeutics to develop a gene-editing treatment for beta-thalassemia and sickle cell. Beta-thalassemia is a rare blood disorder caused by a genetic defect in hemoglobin.

Food and Drug Administration 52

Food and Drug Administration Side effects Patients FDA 52

European Pharmaceutical Review

APRIL 21, 2023

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Therefore, another question is how we can obtain reliable, transparent information on older drugs. C-limit and be applied to the whole supply chain.

Pharma 80

Pharma Food and Drug Administration Medicine Pharmaceutical 80

PM360

AUGUST 9, 2022

Sermo , a physician-first online community, found the tracks at ASCO that oncologists felt were the most transformative to be breast cancer (58%), lung cancer (34%), and developmental therapeutics—molecularly targeted agents and tumor biology (32%). EPA Administrator Michael Regan said the agency will take more aggressive action against PFAS.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

Legacy MEDSearch

APRIL 12, 2023

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery.

FDA 52

FDA Food and Drug Administration Recruitment Manufacturing 52

Legacy MEDSearch

SEPTEMBER 20, 2022

Food & Drug Administration (“FDA”) for the SavvyWire (“SavvyWire”), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. OpSens is also involved in industrial activities in developing, manufacturing, and installing innovative fiber optic sensing solutions for critical applications.

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

Pharmaceutical Technology

NOVEMBER 21, 2022

Manufacturing woes have affected both cell and gene-modified cell therapies in oncology recently, disadvantaging patients with multiple myeloma (MM) and melanoma. ITIL-168 is an autologous TIL therapy, meaning that patients need to undergo apheresis and wait for the product to be manufactured and reinfused.

Manufacturing 59

Manufacturing Food and Drug Administration Medical science Patients 59

Infuse Medical

JANUARY 9, 2020

Medical device products require approval by the Food and Drug Administration (FDA) before they go to market. If your target audience is physicians, they care more about how it will improve their day-to-day work activities and MOA. Plan Ahead Before FDA Approval.

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Food and Drug Administration Training Sales Marketing 52

Legacy MEDSearch

DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. and Israel. Are you hiring?

Manufacturing 98

Manufacturing FDA Food and Drug Administration Medical 98

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

Pharmaceutical 73

Pharmaceutical Food and Drug Administration Medicine Manufacturing 73

pharmaphorum

OCTOBER 3, 2022

This typically sees higher-priced drugs, even in oncology, being sidelined in favour of biosimilars, off-patent branded drugs, or locally manufactured alternatives, unless manufacturers offer significant discounting to gain access to national essential medicines lists. However, even then, challenges could remain.

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Food and Drug Administration Consulting Marketing Manufacturing 93

Legacy MEDSearch

SEPTEMBER 21, 2023

Food and Drug Administration (FDA) to market the Blackhawk ® Ti 3D Printed Cervical Spacer System with standalone clearance. Altus Capital Partners is a private equity firm that controls investments in middle-market manufacturing businesses. For more information, please visit www.choicespine.com.

Food and Drug Administration 52

Food and Drug Administration Recruitment Marketing Management 52

PM360

AUGUST 9, 2022

“To put this into perspective: if all of the patients were 100% adherent, then at most the brand would achieve 25% of the TRx volume that their sales team successfully had physicians write,” explains Josh Richardson, Chief Commercial Officer, Prescryptive Health. Eli Phillips, Jr.,

Food and Drug Administration 105

Food and Drug Administration Prescription Patients Medical 105

Nixon Gwilt Law

OCTOBER 11, 2022

Food and Drug Administration (“FDA”) released the final version of its guidance to industry stakeholders for Clinical Decision Support software (“CDS Guidance”). On September 27, 2022, the U.S. These RTM codes require use of a device, which of course includes SaMD, but does NOT include Non-Device CDS software.

Medical 52

Medical FDA Food and Drug Administration Food 52

Legacy MEDSearch

NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. According to Tyber Medical’s Senior Project Engineer Abe Perryman, physicians have responded favorably to the company’s new staple system.

Medical 98

Medical FDA Food and Drug Administration Engineering 98

Clarivate

MAY 24, 2023

Food and Drug Administration advisory committee’s narrow 8-6 vote in favor of recommending accelerated approval for a first-in-class gene transfer therapy was welcomed by Duchenne muscular dystrophy (DMD) patients and caregivers.

Patients 52

Patients Food and Drug Administration Biopharma FDA 52

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 2,3 Clinical implementation of CAR T-cell technology requires a reproducible T-cell manufacturing platform, which necessitates effective gene-transfer tools and T-cell culture conditions.

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Manufacturing Food and Drug Administration Patients Pharma 82

Pharmaceutical Technology

JUNE 30, 2022

Another factor driving Georgia’s growth in the clinical trial space is the recent significant investment in the country’s health system, creating several new facilities and programmes, as well as increasing the number of experienced physicians.

Food and Drug Administration 52

Food and Drug Administration Distribution Recruitment Transportation 52

Pharma Marketing Network

JUNE 11, 2020

I was at Physicians Online at the time. You know, in November 2009, the FDA held a public hearing about the promotion of Food and Drug Administrative Related Regulated Medical Products, using the internet and social media tools. They would write up the presentations by physicians about drugs.

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