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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CODA Biotherapeutics appoints new chief scientific officer

CODA Biotherapeutics, Inc.

South San Francisco, California–based biopharma CODA Biotherapeutics names Susan Catalano as chief scientific officer.

Founded in 2014, CODA Biotherapeutics is working on a gene therapy-mediated chemogenetic platform for intractable neurological disorders.

Catalano aims to help advance the company’s platform to find treatments for unmet neurological needs. “CODA’s combination of deep expertise in gene therapy and small molecule discovery and development, combined with its foundational technology in small molecule-tunable ion channels, is truly unique and holds the promise of shifting the paradigm of how we treat neurological diseases,” Catalano said in a press release. “I look forward to leading the effort to unlock the potential of this technology and develop therapeutics that can make a real difference in the lives of people who are desperate for treatment options.”

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Roche to donate essential medicines to Ukraine

Roche (SIX:RO, ROG; OTCQX:RHHBY) announced that it would ship 150,000 packages of the antibiotic Rocephin to Ukraine, among other medical supplies, including diagnostics.

Rocephin is a broad-spectrum cephalosporin antibiotic.

The World Health Organization cites it as an essential medicine.

Basel, Switzerland–headquartered Roche noted in a statement that it is working with various international and local partners to ensure delivery to the war-torn country. It also vowed to continue delivering medical supplies to Russia and Belarus “within the scope of the available possibilities.”

The Ukrainian government estimated that approximately 2,000 civilians had died in the attacks to date, although Ukraine’s emergency services agency underscored that the number was “approximate.”

Roche noted that it had enrolled Ukrainian patients in ongoing clinical trials and said it would work to ensure continued access to treatment to those individuals.

O…

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World Health Organization sending 36 metric tons of medical supplies to Ukraine

Photo by Yehor Milohrodskyi on Unsplash

The World Health Organization today said that it is sending more than 36 metric tons of medical supplies to support the humanitarian emergency in Ukraine following Russia’s invasion last week.

WHO Director-General Tedros Adhanom Ghebreyesus said the organization is 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.

“Prior to the conflict, WHO distributed emergency supplies to 23 hospitals, although our prepositioned supplies in Kyiv are currently inaccessible,” Ghebreyesus said in a press briefing. “There is an urgent need to establish a corridor to ensure humanitarian workers and supplies have safe and continuous access to reach people in need.”

Get the full story on our sister site, Medical Design & Outsourcing.

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World Health Organization sending 36 metric tons of medical supplies to Ukraine

Photo by Yehor Milohrodskyi on Unsplash

The World Health Organization today said that it is sending more than 36 metric tons of medical supplies to support the humanitarian emergency in Ukraine following Russia’s invasion last week.

WHO Director-General Tedros Adhanom Ghebreyesus said the organization is 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.

“Prior to the conflict, WHO distributed emergency supplies to 23 hospitals, although our prepositioned supplies in Kyiv are currently inaccessible,” Ghebreyesus said in a press briefing. “There is an urgent need to establish a corridor to ensure humanitarian workers and supplies have safe and continuous access to reach people in need.”

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How pharma firms stack up in terms of innovation

Photo by Edward Jenner from Pexels

Tthe pharma industry has ramped up its ability to innovate in the past couple of years. Many firms in the sector have retooled operations, rethought clinical trials and accelerated the ability to commercialize new drugs.

Clarivate’s Top 100 Global Innovators 2022 report, however, cited only two pharma companies. Clarivate also projects that the level of innovation of the pharma sector will fall relative to other notable industries from 2020 to 2025.

Part of the reason for that prediction is the trend of increased collaboration in the sector makes it more difficult for individual pharma companies to stand out from the pack, according to Ed White, chief analyst and VP of IP and innovation research at Clarivate.

The pharma research ecosystem is considerably more fragmented now than it was 10 to 20 years ago.

“It’s difficult for us to say …

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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…

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