Clarivate

OCTOBER 10, 2022

Based on the TROPICS-02 trial results, Gilead has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion for TRODELVY in the much larger setting of metastatic HR+/HER2-negative breast cancer. Key ESMO findings. months; HR: 0.321, P<0.001). Key ESMO findings. months vs. 20.3 months vs. 20.0

Marketing 52

Marketing Safety Patients Competition 52

Clarivate

MAY 24, 2022

The company has ramped up its patient access efforts through a partnership with the Chinese Red Cross Foundation, established in June 2021 and aimed at providing physician education and patient awareness programs for rare diseases. 3] Rare Diseases at FDA [online]. [4] Chinese Journal of Evidence-based Pediatrics. 2011; 6:81-82. [3]

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

pharmaphorum

SEPTEMBER 12, 2022

Dr Prasanth Reddy, head of oncology at LabCorp, tells us how the company works with cancer care teams, biopharma partners, and patients as an integral part of the patient journey from testing to treatment. They offer the only diagnostic kit cleared by the US FDA for pan-solid cancer comprehensive tumour profiling using a 500+ gene panel.

Patients 101

Patients Medicine FDA Healthcare 101

Clarivate

MAY 24, 2023

A narrow FDA AdComm vote in favor of accelerated approval for Sarepta’s first-in-class gene transfer therapy illustrates challenges faced by regulators, payers and developers as a wave of innovative genetic treatments for rare diseases comes to market.

Patients 52

Patients Food and Drug Administration Biopharma FDA 52

Legacy MEDSearch

MAY 19, 2023

PaceMate ® announced today its collaboration with AliveCor ® , the global leader in FDA-cleared personal electrocardiogram technology and remote patient management solutions for the cardiovascular industry. The FDA-cleared KardiaMobile device is the most clinically validated personal ECG solution in the world.

Healthcare Provider 52

Healthcare Provider Management Healthcare Healthcare 52

Medgadget

FEBRUARY 17, 2023

Currently, the awkwardness of conventional laparoscopic tools keeps many physicians from using them in a variety of cases. Interestingly, due to FDA’s regulatory methodology, surgical robots have to be approved for specific indications by the agency. are still done in an open fashion.

Physicians 80

Physicians Engineering Side effects Leads 80

Clarivate

OCTOBER 7, 2021

Based on the KEYNOTE-716 data, it is anticipated that Keytruda will gain a label expansion in this patient setting, with FDA priority review status and a PDUFA date set for December 2021. Kisqali plus letrozole demonstrated a significant OS benefit, but is that enough to displace physician favorite Ibrance?

Patients 91

Patients Safety Marketing Physicians 91

Medgadget

MARCH 2, 2023

To make implantation of the Alpha DaRT sources easy and precise, the company developed dedicated applicators andadapted existing biopsy devices, that physicians are already acquainted with, to deliver the radioactive sources. The FDA looked at the data, saw it promising, and asked for a small feasibility study in the U.S.

Manufacturing 83

Manufacturing Leads Patients Medicine 83

Clarivate

DECEMBER 14, 2023

The weight loss drug conundrum PBMs may rethink their coverage policies for GLP-1 receptor agonists after the November 2023 approval of Eli Lilly’s Zepbound whose active ingredient was already available as diabetes drug Mounjaro ® and which joins Novo Nordisk’s Wegovy ® among the latest class of FDA-approved options.

Marketing 52

Marketing Healthcare Healthcare Insurance 52