Pharmaceutical Technology

SEPTEMBER 2, 2022

This is a result of intensive research efforts that have produced regimens that have prolonged patient survival, most of which are a combination of a proteasome inhibitor + an immunomodulatory drug (ie. lenalidomide) + a steroid ± an anti-CD38 antibody.

Food and Drug Administration 59

Food and Drug Administration FDA Sales Physicians 59

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. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

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

pharmaphorum

OCTOBER 13, 2022

In the last decade, there has also been rapid development and interest in CRISPR/Cas9 technology and other gene-editing tools that could offer transformative avenues to deliver gene therapies for patients and families affected by devastating diseases such as sickle cell disease and thalassemia. Bringing in the patient perspective.

Food and Drug Administration 52

Food and Drug Administration Side effects Patients FDA 52

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

PM360

AUGUST 9, 2022

Following the annual American Society of Clinical Oncology (ASCO) conference, oncologists were asked how the data presented would impact their care of patients. Another 17% recommended mandating patient recruitment requirements and 14% would like to see the development of a diverse pool of investigators and staff.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 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. The SavvyWire is the first and only Sensor-Guided TAVR solution, designed to support TAVR efficiency and lifetime patient management. OpSens Inc. ,

FDA 52

FDA Food and Drug Administration Recruitment Physicians 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

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. DELTA-1 is a Phase II single-arm trial in metastatic melanoma, evaluating the efficacy of ITIL-168 in patients who have progressed on previous therapy.

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Manufacturing Food and Drug Administration Medical science Patients 59

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. billion by 2030. How has the gene therapy landscape evolved over the last several years?

Pharmaceutical 75

Pharmaceutical Food and Drug Administration Medicine Manufacturing 75

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.

Manufacturing 98

Manufacturing FDA Food and Drug Administration Medical 98

PM360

AUGUST 9, 2022

Addressing the issue of medication adherence begins before a patient even fills their first prescription. According to a recent IQVIA analysis, only one in four patients who were new to a brand in 2021 successfully initiated therapy. “To The caveat: only 8% of patients have ever used these hubs, according to research from Phreesia. “As

Food and Drug Administration 105

Food and Drug Administration Prescription Patients Medical 105

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.

Food and Drug Administration 90

Food and Drug Administration Consulting Marketing Manufacturing 90

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. Most patients must use a wheelchair by the time they are in their teens.

Patients 52

Patients Food and Drug Administration Biopharma FDA 52

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.

Food and Drug Administration 52

Food and Drug Administration Recruitment Marketing Management 52

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.

FDA 52

FDA Medical 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. About Tyber Medical LLC.

Medical 98

Medical FDA Food and Drug Administration Engineering 98

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 1 Following in vitro production from T cells collected from a patient’s leukapheresis procedure, the CAR T cells are infused back into the patient’s blood, where they proliferate and expand. This is variable and to some extent unpredictable.

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Manufacturing Food and Drug Administration Patients Pharma 84

Pharmaceutical Technology

JUNE 30, 2022

The country also offers timely patient recruitment due to a population of nearly 4 million, many of whom are treatment-naïve. This will put up a barrier to the traditional system where the drugs are shipped on a direct-to-site basis straight away from the manufacturing facilities to a Georgia storage facility within the location.”.

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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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