Roche Diagnostics North America appoints new CEO

Brad Moore. [Image courtesy of Roche]Roche (OTCQX:RHHBY)  announced today that it appointed Brad Moore as president and CEO of Roche Diagnostics North America.

Indianapolis-based Roche Diagnostics North America said Moore’s appointment becomes effective Jan. 1, 2023. He currently serves as SVP of core lab and point of care within Roche Diagnostics North America. He succeeds and reports to Matt Sause, whom Basel, Switzerland-based Roche recently named CEO of its global diagnostics business.

“Brad has a proven reputation for delivering outstanding results and is a highly effective leader,” said Sause. “I’m confident his experience will be a tremendous asset for the North America team, our customers and patients.”

Moore joined the company in October 2016. He initially joined as head of the company’s North American diabetes care business. In 2019, his role expanded to include Europe and North America commercial operatio…

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Roche Diagnostics promotes from within to fill corner office

Roche (OTCQX:RHHBY) announced that it promoted Matt Sause to CEO of Roche Diagnostics.

Sause, 45, currently heads up Roche Diagnostics’ North America Region. His move to the corner office and to the company’s executive committee becomes effective Jan. 1, 2023.

The Basel, Switzerland-based company appointed current Roche Diagnostics CEO Thomas Schinecker to CEO, effective March 15, 2023.

“Matt Sause’s career at Roche has spanned twenty years in multiple countries across Asia, Latin America, Europe and North America in both the diagnostics and pharma divisions,” Schinecker said. “His combination of scientific knowledge with commercial experience makes him an excellent leader for the diagnostics division.”

The company’s board proposed the current CEO, Severin Schwan, as its new chair on March 14, 2023.

“Matt Sause has had an exceptional career with Roche and I am very pleased that we can once again internall…

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Two-year data show Roche’s Vabysmo improved vision in people with wet age-related macular degeneration

Roche (SIX:RO, ROG; OTCQX:RHHBY) has announced new positive two-year data from its TENAYA and LUCERNE studies of Vabysmo (faricimab) in neovascular or “wet” age-related macular degeneration (nAMD).

Based on the study results, Roche estimates that more than 60% of people taking the drug could receive an injection of facrimab once every four months while achieving similar vision gains compared to Eylea (aflibercept) administered every two months. In addition, almost 80% of patients taking faricimab could receive an injection of it every three months or longer.

Over two years, patients receiving faricimab had an average of 10 injections compared to those taking aflibercept, who received 15 injections.

Faricimab is a bispecific antibody that inhibits both angiopoietin-2 and vascular endothelial growth factor A.

“These longer-term results reinforce confidence in Vabysmo and support its continued use in people with neovascular AMD,” said Dr. Levi Garraw…

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Roche shares upbeat Phase 3 data for Hemlibra in hemophilia

Facing potential competition from Novo Nordisk’s (NYSE:NVO) investigational blood coagulation factor stimulants Mim8, Roche (SIX:RO, ROG; OTCQX:RHHBY) released positive new data from the Phase 3 HAVEN 6 study focused on the use of Hemlibra (emicizumab) in patients with mild or moderate hemophilia A.

Hemlibra won FDA approval in 2018 for hemophilia A without factor VIII inhibitors.

The drug raked in almost $2.8 billion in sales in 2021.

In the open-label, single-arm HAVEN 6 study, two-thirds of Hemlibra recipients with mild or moderate hemophilia A had no treated bleeds at 55.6 weeks median follow-up.

Basel, Switzerland–based Roche said the drug continued to have a favorable safety profile in patients without factor VIII inhibitors.

The company plans on presenting the data at the International Society on Thrombosis and Haemostasis (ISTH) Annual Congress on July 11, 2022 in London.

Roche intends to ask the European Medicines Agency to …

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Roche’s bispecific antibody Lunsumio wins priority review from FDA for non-Hodgkin lymphoma

Roche (SIX:RO, ROG; OTCQX:RHHBY) has announced that it has accepted the company’s Biologics License Application (BLA) and granted priority review for Lunsumio (mosunetuzumab), a CD20xCD3 T-cell engaging bispecific antibody developed by the company’s Genentech subsidiary.

In February, Biogen (Nasdaq:BIIB) said it would pay $30 million to exercise an option to participate in the development and commercialization of the drug candidate.

Basel, Switzerland-based Roche believes mosunetuzumab holds potential for adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two other systemic therapies.

Follicular lymphoma arises from B-lymphocytes and is a common slow-growing form of non-Hodgkin lymphoma (NHL).

Approximately one in five patients with follicular lymphoma relapse within two years of diagnosis, according to an article in the ASCO Post.

Lunsumio would be a fixed-duration treatment that could …

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Genentech’s crenezumab stumbles in Alzheimer’s trial

Roche (SIX:RO, ROG; OTCQX:RHHBY) subsidiary Genentech announced that a study of the amyloid beta-protein inhibitor crenezumab failed to show statistically significant clinical benefit in Alzheimer’s patients.

The failure is typical. Historically, 99% of Alzheimer’s drug candidate studies fail to show improvement over placebo, according to Alzheimer’s Research & Therapy.

In the research, Genentech partnered with the Banner Alzheimer’s Institute, the University of Antioquia in Colombia and the National Institute on Aging.

The research did find slight differences favoring crenezumab across several endpoints, but they failed to reach statistical significance.

“We’re disappointed that the treatment did not demonstrate a statistically significant clinical benefit,” said Dr. Eric M. Reiman, Banner Alzheimer’s Institute executive director, in a news release. “At the same time, we’re proud of …

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New authorized Roche COVID-19 test can also detect viral loads

Roche announced today that it received FDA emergency use authorization (EUA) for its cobas SARS-CoV-2 Duo diagnostic.

Authorization covers the cobas SARS-CoV-2 Duo on the fully automated cobas 6800/8800 systems, expanding Roche’s COVID-19 portfolio and representing the first automated, RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens.

The assay performs quantitation of SARS-CoV-2 RNA levels in the connected specimen, while only the qualitative result of cobas SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider.

Basel, Switzerland-based Roche said in a news release that the potential benefits from reporting a standard viral load along with the qualitative result may help clinicians assess and monitor infected patients across laboratories over time.

The company plans t…

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Roche to donate more medicines and diagnostics to Ukraine

With the war in Ukraine on the verge of entering its second month, Roche (SIX:RO, ROG; OTCQX:RHHBY) has announced that it will donate additional medications and diagnostics to the country.

The company had announced its plans to aid the country in early March, which included 150,000 packs of the antibiotic Rocephin, an antibiotic WHO lists as an essential medicine.

Roche will donate an additional 4,600 packs of medicines for influenza, rheumatoid arthritis, spinal muscle atrophy and some cancers. Additionally, the company will provide reagents and consumables to support testing 120,000 blood donations and 31,000 units for diabetes management.

In addition to providing supplies to Ukraine, several pharma countries, including Lilly, GSK and Pfizer, have announced plans to curtail operations or realign their business focus in Russia.

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Roche says its research-only COVID-19 tests can detect a range of variants, subvariants

Roche announced today that its TIB Molbiol subsidiary has made available testing solutions that can identify a number of COVID-19 variants.

Basel, Switzerland-based Roche’s testing offerings can identify the SARS-CoV-2 (the virus causing COVID-19) B.1.1.529 variant and differentiate between the omicron subvariants BA.1, BA.1.1, BA.2, BA.2.2, BA.3 and delta, according to a news release.

VirSNiP SARS-CoV-2 Spike S371L S373P and VirSNiP SARS-CoV-2 Spike S371L S373P 452R are Roche’s research use-only tests now available, adding to the test kits previously developed by Roche and TIB Molbiol for detecting recent BA.1 and BA.2, as well as other mutations, present in the novel B.1.1.529 omicron SARS-CoV-2 variant.

The company said TIB Molbiol’s researchers work in collaboration with academic contacts to continually screen for new variants and emerging diseases.

“Roche is pleased to offer testing options addressing the ongoing COVID-19 he…

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How medtech and pharma are responding to Russia’s invasion of Ukraine

[Image from Pixabay]

Medtech and pharma companies continue to support Ukraine relief efforts following Russia’s invasion.

Previously, the World Health Organization announced that it was sending “essential medical supplies” to Ukraine — including its first shipment of 36 metric tons of supplies for trauma care and emergency surgery and other health supplies — to meet the needs of more than 150,000 patients. Medical device and pharmaceutical companies have taken various actions for support efforts, ranging from matching employee contributions and sending supplies to suspending operations in the region.

Get the full running list of life science companies and their efforts on Medical Design & Outsourcing.

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How medtech and pharma are responding to Russia’s invasion of Ukraine

[Image from Pixabay]Medtech and pharma companies continue to support Ukraine relief efforts following Russia’s invasion.

Previously, the World Health Organization announced that it was sending “essential medical supplies” to Ukraine — including its first shipment of 36 metric tons of supplies for trauma care and emergency surgery and other health supplies — to meet the needs of more than 150,000 patients. Medical device and pharmaceutical companies have taken various actions for support efforts, ranging from matching employee contributions and sending supplies to suspending operations in the region.

Get the full running list of life science companies and their efforts on Medical Design & Outsourcing.

Read more
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How medtech and pharma are responding to Russia’s invasion of Ukraine

[Image from Pixabay]

Medtech and pharma companies continue to support Ukraine relief efforts following Russia’s invasion.

Previously, the World Health Organization announced that it was sending “essential medical supplies” to Ukraine — including its first shipment of 36 metric tons of supplies for trauma care and emergency surgery and other health supplies — to meet the needs of more than 150,000 patients. Medical device and pharmaceutical companies have taken various actions for support efforts, ranging from matching employee contributions and sending supplies to suspending operations in the region.

Below is a running list of life science companies and their efforts. This is a developing story and will be updated as companies release information.

3M: Suspending all business in Russia.

Abbott: Donating $2 million to humanitarian organizations to support Ukraine and refugees; donating …

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