Roche Archives - Page 3 of 6 - Medical Design Sourcing

WHO prequalifies aIL-6R therapy for patients with severe or critical COVID-19

Roche (SWX:ROG) has won World Health Organization (WHO) prequalification for Actemra/RoActemra.

Actemra/RoActemra is an anti-interleukin-6 receptor (aIL-6R) receptor antagonist with tocilizumab as an active substance.

The prequalification will assist in low- and middle-income countries in procuring the therapy for patients on systemic corticosteroids who require supplemental oxygen or mechanical ventilation.

Actemra/RoActemra is the twelfth medicine to win prequalification.

“We’ve partnered with WHO and others throughout the last year to ensure that our COVID-19 medicines and tests can potentially reach more than 100 low- and middle-income countries, and WHO’s prequalification of Actemra/RoActemra is just one of the paths taken together to achieve this,” said Bill Anderson, CEO of Roche Pharmaceuticals, in a news release.

Roche will provide Actemra/RoActemra to WHO and partners at cost.

The company also said it would not assert its p…

Roche launches its connected blood glucose meter in Europe

Roche announced today that it launched its Cobas Pulse system in select countries accepting CE mark approval in Europe.

Basel, Switzerland-based Roche designed its Cobas Pulse system to combine the form factor of a high-performance blood glucose meter with simple usability and expanded digital capabilities comparable to that of a smartphone. The platform joins Roche’s connected point-of-care solution portfolio.

Get the full story at our sister site, Drug Delivery Business News.

Glytec partners with Roche to enhance insulin dosing decision support software

Glytec announced today that it entered into a strategic partnership with Roche Diagnostics USA for a digital health collaboration.

Waltham, Massachusetts-based Glytec’s partnership combines its FDA-cleared Glucommander insulin dosing decision support software with Roche’s expertise in medical devices and IT solutions in an effort to address the challenges associated with inpatient blood sugar management at the hospital bedside.

Get the full story at our sister site, Drug Delivery Business News.

Flywheel working with Roche and Genentech to sift through medical imaging data

The research data platform Flywheel has announced that Roche (OTCMKTS:RHHBY) and its subsidiary Genentech are using its cloud-scale informatics platform to ingest, standardize and analyze medical imaging data to streamline drug discovery.

Minneapolis-based Flywheel says the process provides a swifter and more efficient means to curate data at the terabyte and petabyte scales. Specifically, Roche and Genentech are using the platform to assist in finding answers to core scientific questions related to patient care and outcomes.

“With our platform in place, Roche and Genentech researchers can access high-quality images for complex analysis and machine learning, ultimately speeding the development of innovative therapies,” said Jim Olson, CEO of Flywheel, in a press release. “Before using the platform, this level of collaboration and analysis was simply not possible.”

A number of prominent research institutions, including Stanford University, Columbia Univer…

Atea Pharmaceuticals and Roche end joint development of COVID-19 pill

Atea Pharmaceuticals (NSDQ:AVIR) has announced the termination of a joint venture with Roche involving the development of the COVID-19 antiviral AT-527.

In October, the two companies revealed that the Phase 2 MOONSONG trial focusing on AT-527 did not meet its primary endpoint.

Atea will retain rights to AT-527 after the strategic collaboration with Roche ends on February 10, 2022.

“We believe strongly in the potential of AT-527 with its unique dual mechanism of action, antiviral activity against the major variants of concern and its market potential given the need for additional therapeutic options for COVID-19,” said Jean-Pierre Sommadossi, CEO of Atea Pharmaceuticals, in a press release.

AVIR shares dropped 11.36% in after-hours trading. The shares are down 72.57% so far this year.

Medtech M&A: The industry’s biggest mergers and acquisitions of 2021

[Image from Jp Valery on Unsplash]Across 2021, medtech has seen a wide range of mergers and acquisitions covering several areas of devices, pharmaceuticals and more.

Some have gone off without a hitch, while others fell into serious scrutiny as mouthwatering financial figures were revealed and major technologies were acquired.

Here are the 10 biggest mergers and acquisitions in medtech in 2021:

Next>

Medtech M&A: The industry’s biggest mergers and acquisitions of 2021

[Image from Jp Valery on Unsplash]

Across 2021, medtech has seen a wide range of mergers and acquisitions covering several areas of devices, pharmaceuticals and more.

Some have gone off without a hitch, while others fell into serious scrutiny as mouthwatering financial figures were revealed and major technologies were acquired.

Here are the 10 biggest mergers and acquisitions in medtech in 2021:

Next>>

FDA approves Genentech’s Susvimo drug-eluting eye implant

Genentech’s Susvimo implant. [Image from Genentech]Genentech announced today that it received FDA approval for its Susvimo injection for treating macular degeneration (AMD).

South San Francisco-based Genentech, a member of the Roche Group, designed its Susvimo ranibizumab injection (100 mg/mL) for intravitreal use via ocular implant for treating people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.

Get the full story at our sister site, Drug Delivery Business News.

Roche and Atea’s COVID-19 pill disappoints in Phase 2 trial

Interest in oral antivirals has surged in recent weeks. Merck (NYSE:MRK) announced on October 1 that the investigational antiviral molnupiravir appeared to halve the risk of hospitalization from COVID-19.

Roche (SWX:ROG) and Atea (NSDQ:AVIR) are having less luck with the oral, direct-acting antiviral drug candidate AT-527.

The two companies announced that the Phase 2 MOONSONG trial failed to meet its primary endpoint related to reducing the level of SARS-CoV-2 in patients with mild-to-moderate COVID-19 relative to placebo.

The drug appeared to be more effective in high-risk patients with underlying health conditions.

Roche and Atea are mulling whether they can modify the international Phase 3 MORNINGSKY study to increase the risk of achieving a statistically significant benefit. The companies expect data from that trial in the second half of 2022.

Both companies saw their stock price decline in the aftermath of the announcement. AVIR shares…

Roche’s amyloid-targeting gantenerumab wins breakthrough therapy designation for Azheimer’s

Roche (OTCQX: RHHBY) has announced that its investigational anti-amyloid beta antibody gantenerumab for Alzheimer’s disease received breakthrough therapy designation from FDA.

The agency has granted the status to a range of investigational Alzheimer’s, including lecanemab from Eisai and Biogen and donanemab from Eli Lilly. Biogen’s aducanumab had also received the designation before FDA approved it in June.

Clinical trial data has shown that gantenerumab significantly reduced brain amyloid plaque, which accumulates in the brains of people with Alzheimer’s.

The so-called amyloid hypothesis has led to the development of scores of failed experimental Alzheimer’s therapies. Biogen‘s (NSDQ:BIIB) aducanumab was the first to win FDA approval based on amyloid clearing.

Showing convincing evidence of cognitive improvement, however, has remained more elusive for drug developers. A Phase 3 trial of gantenerumab did no…

REGEN-COV cuts viral load within 7 days in COVID-19 patients

Regeneron Pharmaceuticals (NSDQ:REGN) and Roche (OTCQX: RHHBY) are touting positive results from a Phase 2/3 study investigating the potential of REGEN-COV (casirivimab and imdevimab) antibody cocktail in hospitalized COVID-19 patients. The study met its primary endpoint of reducing viral load within one week in seronegative patients needing low-flow or no supplemental oxygen.

REGEN-COV, known as Ronapreve outside of the U.S., led to a 36% reduced risk of death by day 29 in the overall treatment population.

“These new results, combined with the nearly 10,000-patient RECOVERY trial, further validate how REGEN-COV can change the course of illness for patients even after they are hospitalized with COVID-19,” said Dr. George D. Yancopoulos, president and chief scientific officer at Regeneron, in a statement.

Roche has partnered with Regeneron (NSDQ: REGN) to help manufacture and distribute REGN-COV2, which Regeneron first developed.

Roche’s chief medi…

34 of the most innovative pharmaceutical products

Photo by Myriam Zilles on Unsplash

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to make its selections.

The organization will announce final winers in the competition at ceremony in New York City on October 28, 2021.

In terms of pharmaceutical agents, the organization selected the following 34 nominees:

Company Drug name

AbbVie Inc.

Rinvoq (upadacitinib)

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma

Adhansia XR (methylp…