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GSK and Vir aim to ramp up sotrovimab supply during omicron surge

In early December 2021, GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) announced that their COVID-19 antibody therapy sotrovimab appeared to retain efficacy against the omicron variant. 

Now, demand for sotrovimab is eclipsing supplies of the drug as omicron has fueled a record number of infections in the U.S. and elsewhere.  

According to the Wall Street Journal, Glaxo and Vir are moving to get another manufacturing plant on line to ramp up the production of the drug, which is currently produced in a single facility.  

The U.S. has ordered 600,000 doses of the drug for $945.1 million for the first quarter of the year. 

Other countries, including Australia and Canada, are also seeking to procure more of the drug. 

GSK and Vir expect to sell 1.7 million doses internationally through binding agreements. 

This week, WHO revised their COVID-19 therapeutics guidelines, adding sotrovimab to a list of “conditionally …

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FDA extends approval of remdesivir to encompass non-hospitalized high-risk

Gilead Sciences’ (NSDQ:GILD) Veklury (remdesivir) became the first FDA-approved COVID-19 drug when it was approved in October 2020.

Now, the company has announced that the FDA has granted expedited approval of a supplemental new drug application (sNDA) for the drug to treat non-hospitalized adult and adolescent patients with a high risk of progression to severe COVID-19, including hospitalization or death.

The drug was formerly approved for hospitalized adults and children in a hospital or healthcare setting capable of offering similar care. Now, it can be administered in some outpatient settings.

FDA also expanded the emergency use authorization of the drug for non-hospitalized children younger than 12 with a high risk of disease progression.

Demand has surged for COVID-19 therapies, including remdesivir that retain efficacy against the omicron variant of SARS-CoV-2.

Gilead first discovered and developed remdesivir in 2009 as a investigati…

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FDA approves second indication of AbbVie’s Skyrizi for adults with active psoriatic arthritis

FDA first approved AbbVie’s (NYSE:ABBV) interleukin-23 inhibitor Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis in 2019. Now, the agency has extended the approval to include adults with active psoriatic arthritis (PsA), which affects almost one out of three people with psoriasis.

To win the new indication, AbbVie provided data from the KEEPsAKE-1 and KEEPsAKE-2 pivotal studies. Those studies tested Skyrizi in adults with active PsA, including refractory patients.

In the placebo-controlled KEEPsAKE trials, Skyrizi met the primary endpoint of ACR20 at week 24. ACR20 is a composite measure from the American College of Rheumatology that refers to 20% improvement across several variables, including swollen, tender and painful joints.

“In the pivotal KEEPsAKE trials, Skyrizi demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis,” said Dr. Alan J. Kivitz, KEEPsAKE clinical…

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Medtronic’s recall of HawkOne system is Class I

The FDA today issued a notice confirming that the recall of Medtronic’s (NYSE:MDT) HawkOne system is Class I, the most serious kind.

So far in 2022, the FDA has classified three Medtronic-related recalls as Class I, with the Covidien (part of Medtronic) Puritan Bennett 980 series ventilator and the Synergy Cranial and StealthStation S7 Cranial software receiving the same classification earlier this month. All recalls confirmed by the FDA this month were initiated by Medtronic in 2021.

Get the full story at our sister site, MassDevice.

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Medtronic’s recall of HawkOne system is Class I

The FDA today issued a notice confirming that the recall of Medtronic’s (NYSE:MDT) HawkOne system is Class I, the most serious kind.

So far in 2022, the FDA has classified three Medtronic-related recalls as Class I, with the Covidien (part of Medtronic) Puritan Bennett 980 series ventilator and the Synergy Cranial and StealthStation S7 Cranial software receiving the same classification earlier this month. All recalls confirmed by the FDA this month were initiated by Medtronic in 2021.

The latest recall covers 95,110 HawkOne directional atherectomy systems in the U.S. that were distributed between Jan. 22, 2018, and Oct. 4, 2021. Medtronic initiated the recall on Dec. 6, 2021, having received 163 complaints and 55 reports of injuries with no deaths reported related to the issue.

Medtronic designed HawkOne with a catheter and a cutter driver for use during procedures intended to remove blockage from peripheral arteries and improve blood flow. The rec…

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Patient groups voice disapproval for CMS proposal to limit coverage of aducanumab 

Image by Gerd Altmann from Pixabay

Biogen’s (NSDQ:BIIB) Alzheimer’s drug Aduhelm (aducanumab) continues to be a source of contention. Advocates cite the need for a new therapy for the memory-robbing disease while skeptics remain unconvinced about the benefit-risk profile of the drug. 

Most recently, Alzheimer’s disease advocates have criticized Medicare’s proposal to constrain coverage for the drug to clinical trial participants. 

The patient groups the Alzheimer’s Association, UsAgainstAlzheimer’s and the Global Alzheimer’s Platform Foundation have vowed to help overturn that decision by reaching out to the U.S. Health Secretary, lawmakers and officials within the Biden administration. 

The proposal would also apply to similar monoclonal antibodies that target the peptide amyloid-β (Aβ) and the protein tau to target Alzheimer’s.  

The Centers for Medicare & Medicaid Services (CMS) p…

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Zimmer Biomet’s ZimVie spinnoff moves forward

Zimmer Biomet (NYSE: ZBH) announced today that it has filed a Form 10 registration statement with the SEC as it moves forward with the spinoff of its spine and dental businesses.

The new 2,600-employee company will be called ZimVie, with headquarters in Westminster, Colorado. There is no exact date of when the deal will close in the first quarter of 2022, but ZimVie is hosting a virtual investors day on February 7.

ZimVie has filed to have its shares traded on the Nasdaq under the symbol ZIMV.

As part of the deal, ZB will receive a $501 million cash payment from ZimVie, which means that the new company will have $561 million in debt.

Zimmer Biomet’s spine and dental business have seen the COVID-19 pandemic negatively affect procedure volumes and cause supply chain disruptions. The business saw a net loss of nearly $35 million off $753 million in sales for the nine months ended September 30, 2021, an improvement from the loss of nearly $216 m…

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Feinstein Institutes researchers develop tiny implantable neurostimulator for mouse studies

A second-generation version of the wireless neuromodulation implantable mouse stimulator developed at the Feinstein Institutes. (Image from Feinstein Institutes)

Researchers have developed a novel, fully implantable wireless bidirectional vagus nerve stimulation (VNS) and sensing device for mice.

Engineers and researchers at the Institute of Bioelectronic Medicine at The Feinstein Institutes for Medical Research published details about the device and its capabilities in Biosensors and Bioelectronics to emphasize the potential to transform how bioelectronic medicine research is conducted around the world, according to a news release.

The researchers say that early evidence from the use of neurostimulation technology in mice may lead to the discovery of alternative therapies for various chronic diseases, including Crohn’s, rheumatoid arthritis and heart failure.

Institute of Bioelectronic Medici…

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IBM to sell Watson Health assets

IBM (NYSE: IBM) announced today that it will sell healthcare data and analytics assets from its Watson Health business to Francisco Partners.

Financial terms were not disclosed for the deal, expected to close in the second quarter of this year subject to customary regulatory clearances. But Bloomberg cites people familiar with the plans saying that the deal size is close to $1 billion.

“Today’s agreement with Francisco Partners is a clear next step as IBM becomes even more focused on our platform-based hybrid cloud and AI strategy,” said Tom Rosamilia, SVP of IBM Software.

“IBM remains committed to Watson, our broader AI business, and to the clients and partners we support in healthcare IT. Through this transaction, Francisco Partners acquires data and analytics assets that will benefit from the enhanced investment and expertise of a healthcare-industry-focused portfolio,” Rosamilia said in a news release.

Current management will remain in s…

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Eurofins’ empowerDx launches at-home blood test in U.S.

Eurofins subsidiary empowerDx today launched its PFAS Exposure direct-to-consumer at-home test in the U.S.

Luxembourg-based Eurofins touts the per- and polyfluorinated alkyl substances (PFAS) test as the first direct-to-consumer, at-home test for determining the levels of PFAS in a person’s blood and measure 47 of the PFAS “forever chemical” compounds.

According to a news release, the CDC reports that exposure to such forever chemicals can cause adverse health effects including cancer, thyroid disease, immune suppression, elevated cholesterol, respiratory disease and decreased fertility.

Eurofins’ PFAS Exposure test, developed by Eurofins Environment Testing companies and their research partners, is a self-administered sampling kit that uses a simple finger prick rather than the blood draw process that has been required to date, the company said.

The kits offer an all-in-one solution with essentials for collection and trans…

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Medtronic Foundation to invest nearly $4 million in STEM education for underserved students

The Medtronic Foundation announced today that it will invest in STEM education for more than 60,000 underserved and underrepresented students.

Over a two year span, the Medtronic Foundation plans to invest nearly $4 million to collectively serve those students across Minnesota, Northern California and Puerto Rico through 13 new partnerships with leading organizations serving those K-12 students.

Key locations were prioritized based on evidence of racial and economic disparities where Medtronic employees have a strong footprint and the capability to drive social change through opportunities in science, technology, engineering and math (STEM) education.

Medtronic employee volunteers will also partner with each organization to deploy employee talent in the form of mentorship to students along with other skilled volunteerism.

“Long-lasting, community-driven changes start locally. Our partners have trust of communities, and the expertise to lead …

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Intuitive posts Street-beating Q4 despite COVID-19-related procedure disruptions

Intuitive (Nasdaq: ISRG) shares slid in pre-market trading today despite fourth-quarter results that topped the consensus forecast.

The Sunnyvale, California-based robotic surgery technology developer posted profits of $380.6 million, or $1.04 per share, on sales of $1.6 billion for the three months ended Dec. 31, 2021, narrowly increasing its bottom line by about $100,000 on sales growth of 10.5% year-over-year.

Adjusted to exclude one-time items, earnings per share were $1.30, 2¢ ahead of Wall Street, while sales beat analysts’ projections by approximately 0.8%.

Worldwide procedures performed with Intuitive’s da Vinci surgical robot increased approximately 19% compared to the fourth quarter of 2020, as last year was adversely affected by the COVID-19 pandemic. Intuitive said in a news release that the resurgence of COVID-19 late in the fourth quarter of 2021 also impacted procedures, though.

Intuitive did not provide financial guidan…

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BD boasts of a landmark advancement in flow cytometry

BD (NYSE:BDX) touted a study on innovation in flow cytometry that featured as the cover story of the journal Science.

Franklin Lakes, New Jersey-based BD’s study was conducted in collaboration with the European Molecular Biology Laboratory (EMBL). It evaluated BD’s flow cytometry efforts that add fluorescence imaging and image-based decision-making to sort individual cells at high speed based on the visual details of each cell and not solely on the type or quantity of the biomarkers that are.

The company said in a news release that the new technology — known as BD CellView image technology — has the potential to transform immunology, cell biology and genomics research while enabling new cell-based therapeutic discovery.

BD says CellView can capture multiple images of individual cells flowing through the system at a speed of 15,000 cells per second. It also adds a previously impossible capability of sorting cells based on detailed microscopic …

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Merck senior exec Frank Clyburn to depart

Merck & Co. (NYSE:MRK) has revealed that Frank Clyburn, executive vice president and president, Human Health, will depart the company on Feb. 1, 2022.

At Merck, Clyburn had P&L responsibility for almost 90% of Merck’s business. Clyburn will assume the CEO role at International Flavors & Fragrances (IFF/NYSE:IFF) on Feb. 14.

“I’m excited to join IFF, an industry leader with a bright future, and to lead IFF to continue to deliver outstanding customer experience and sustained long-term growth,” Clyburn wrote on LinkedIn.

At IFF, he will receive a base salary of $1.3 million.

Frank Clyburn

Clyburn joined Merck in 2008.

Clyburn was involved in launching Merck’s blockbuster drug Keytruda. In 2020, Keytruda racked up $14.4 billion in global sales, making it the second-best-selling drug of that year.

“Frank’s strategic and operational excellence helped establish Merck a…

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IntelGenx doses first patient in Phase 2a Alzheimer’s study

IntelGenx Corp. (TSX:IGX/OTCQB:IGXT) has dosed the first patient in a resumed Phase 2a clinical trial involving an oral film of montelukast for Alzheimer’s disease (AD). 

The COVID-19 pandemic previously interrupted the study for more than one year. 

In 2019, the company initially announced that the study would enroll roughly 70 individuals with mild-to-moderate AD and test a montelukast buccal film.

The company issued a temporary recruitment hold in the second quarter of 2020 and resumed patient screening in October 2021.

Intelgenx produces oral, oral-topical and transmucosal films as well as transdermal patches. 

Previously covered by U.S. Patent No. 5,565,473 that expired in 2012, montelukast (Singulair) from Merck & Co. first won FDA approval in 1998. 

A 2017 article published in Open Neurology Journal found that the drug appeared to improve memory in a limited number of patients with cognitive impairment. In addition, …

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MIT team working on all-in-one diabetes management devices

MIT engineers are working on an app that that identifies and quantifies food content, which can aid in carbohydrate counting for people with diabetes. [Image from MIT News]

MIT researchers are touting a platform aimed at helping patients maintain healthy glucose levels by streamlining the diabetes management process.

The researchers say the steps of estimating the carbohydrate content of a meal, drawing blood to measure blood glucose levels, then calculating the proper insulin dose before injecting the insulin — which typically must be repeated for every meal — make it difficult to maintain a treatment regimen. Those researchers say they’ve developed a new approach that makes the process easier and more efficient while helping diabetes patients maintain their healthy glucose levels.

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

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MIT team working on all-in-one diabetes management devices

MIT engineers are working on an app that that identifies and quantifies food content, which can aid in carbohydrate counting for people with diabetes. [Image from MIT News]MIT researchers are touting a platform aimed at helping patients maintain healthy glucose levels by streamlining the diabetes management process.

The researchers say the steps of estimating the carbohydrate content of a meal, drawing blood to measure blood glucose levels, then calculating the proper insulin dose before injecting the insulin — which typically must be repeated for every meal — make it difficult to maintain a treatment regimen. Those researchers say they’ve developed a new approach that makes the process easier and more efficient while helping diabetes patients maintain their healthy glucose levels.

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

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Element expands life sciences testing business with pharma, biotech capabilities

Element Materials Technology recently announced that with the completed acquisition of JMI Laboratories in 2021, it has built out its life sciences testing capabilities for the pharmaceutical and biopharmaceutical industries.

The acquisition added more than 1,000 experts in 23 facilities in North America and Europe and marked a strategic shift for the London-based company to increase its global presence in life sciences and connected technologies.

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

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Element expands life sciences testing business with pharma, biotech capabilities

Element Materials Technology recently announced that with the completed acquisition of JMI Laboratories in 2021, it has built out its life sciences testing capabilities for the pharmaceutical and biopharmaceutical industries.

The acquisition added more than 1,000 experts in 23 facilities in North America and Europe and marked a strategic shift for the London-based company to increase its global presence in life sciences and connected technologies.

“Our expansion into life sciences and connected technologies over the last two years has seen us gain a leadership position in these strategically important end-markets. As we celebrate 10 years of being a standalone Element business, we see more and more opportunities to work closely with our customers throughout their product and testing lifecycles,” CEO Jo Wetz said in a news release.

North Liberty, Iowa-based JMI participates in antimicrobial resistance monitoring studies that are used for FDA regulat…

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Akoya Biosciences hires new chief people officer

The self-proclaimed “spatial biology company” Akoya Biosciences (NSDQ:AKYA) has appointed Marilee Moy as its chief people officer.

Moy has more than three decades of experience in human resources and has worked for several life science companies, including Questcor, Counsyl, Tails Biomedical, Genentech and Johnson & Johnson.

Akoya, which went public last year, had raised more than $83 million in funding.

The company was founded in 2015 to commercialize technology developed at Stanford University that enables ultra-high multiplexed analysis for biomarker discovery.

Marilee Moy

Akoya specializes in spatial phenotyping, which provides insights into cell-cell interactions within tissue.

The company says its PhenoCycler-Fusion system can map one million cells in 10 minutes.

“As a member of our senior leadership team, I am particularly interested in the development of the com…

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Team Technologies acquires consumable medical device manufacturer iiMed

Team Technologies recently announced that it acquired consumable medical device manufacturer iiMed Medical Solutions for an undisclosed amount.

The acquisition is the fourth purchase since Clearlake Capital Group invested in the company in 2018. It is the eighth transaction completed by the company since 2012.

Nearshore specialty manufacturer iiMed makes FDA Class I and Class II consumable medical devices and partners with healthcare OEMs. It designs and manufactures devices for patient monitoring, wound care and compression therapy treatments.

“We are thrilled to welcome iiMed’s customer partners and talented employees to the Team family. We have been impressed with iiMed’s rapid growth and deep expertise across an array of specialty manufacturing solutions, and we look forward to working with the iiMed team to grow our combined business to better serve our healthcare customers,” president and CEO Marshall White said in a news release. “As our communiti…

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