Otsuka Holdings Archives - Medical Design Sourcing

ReCor reports more positive ultrasound renal denervation results

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat.

ReCor Medical said its Paradise ultrasound renal denervation (uRDN) treatment showed consistent and significant blood pressure reductions in an analysis of pooled data from its ReCor’s three Radiance randomized hypertension studies.

“Pooling the data from the Radiance program demonstrates that treatment with the Paradise uRDN System results in a consistent reduction in blood pressure across differing severities of hypertension,” Dr. Ajay Kirtane, a co-principal investigator on the study, said in a news release. “The consistent and clinically meaningful BP reduction across multiple patient groups increases our interest in the use of uRDN as a potential the…

ReCor Medical, Otsuka say renal denervation system met primary endpoint in U.S. study

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat.

ReCor Medical and Otsuka Medical Devices today announced positive results from a trial of its renal denervation system for hypertension.

The Radiance II U.S. FDA investigational device exemption (IDE) pivotal trial evaluating the Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at two months.

ReCor Medical designed its Paradise platform as a device-based, minimally invasive procedure for treating high blood pressure. The procedure usually takes less than…

J&J and Roche named to Clarivate’s Top 100 Global Innovators list

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

FDA to review Akebia’s and Otsuka’s vadadustat for anemia resulting from chronic kidney disease

FDA has accepted a new drug application (NDA) for the oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor vadadustat from Akebia Therapeutics (NSDQ:AKBA) and its partner Otsuka Pharmaceutical Co. (TYO:4578).

The two companies are pursuing the use of the drug to treat anemia resulting from chronic kidney disease.

The oral drug would offer patients more flexibility than anemia treatments known as Erythropoiesis-stimulating agents, which are injectable drugs that stimulate the bone marrow to produce red blood cells.

FDA has assigned the application a standard review and has set a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022.

The agency is not intending on holding an Advisory Committee meeting for the application.

In a statement, Akebia CEO John P. Butler said the company looks “forward to working with the FDA” as it reviews the application. …

ReCor Medical has positive renal denervation study news

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat.

ReCor Medical‘s renal denervation significantly reduced blood pressure among people with drug-resistant hypertension, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session.

The study news, announced yesterday, could suggest a turnaround in fortunes for renal denervation technology. One considered the next big thing in the medical device industry, renal denervation took a hit in the middle of the 2010s when Medtronic announced a major clinical trial had failed to meet its efficacy endpoint.

Medtronic, though, has since sought trial designs that…

Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society.

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)

Get the full picture from our sister site, Drug Discovery & Development.

Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]

The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society.

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)

Pandemic forces Proteus into bankruptcy

Proteus Digital Health has filed for Chapter 11 bankruptcy protection, noting that its efforts to raise money or sell the company fell victim to the COVID-19 pandemic.

The Redwood City, Calif.-based company missed a $100 million funding target in December. Once valued at $1.5 billion, Proteus previously raised $420 million from investors including Novartis Venture Fund and Kaiser Permanente Ventures, according to an April report by Forbes.

Proteus’ products combine oral medications with an ingestible sensor. The sensor-embedded pill was approved by the FDA in November 2017. Otsuka Pharmaceutical (TYO:4578) and Proteus developed the Abilify MyCite pill to treat schizophrenia, manic and mixed episodes linked with bipolar I disorder and depression in adults. Otsuka and Proteus signed an $88 million deal in 2018 in which Proteus would help Otsuka develop more digital medicines while commercializing the smart pill technology.

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