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Lyra Therapuetics initiates Phase 3 trial for chronic rhinosinusitis treatment

LYR-210 is an investigational product designed to provide six months of anti-inflammatory treatment from a single in-office administration(Image from Lyra Therapeutics)

Lyra Therapeutics (NSDQ:LYRA) announced today that it initiated the Phase 3 Enlighten I trial for its LYR-210 treatment.

Watertown, Massachusetts-based Lyra’s Phase 3 Enlighten I clinical trial will evaluate LYR-210, delivered through Lyra’s proprietary XTreo drug-eluting implant, in adult, surgically naïve chronic rhinosinusitis (CRS) patients. The company designed LYR-210 for delivery in a brief, non-invasive, in-office procedure with up to six months of continuous anti-inflammatory medication in the sinonasal passages.

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

Respironics recall, supply chain issues lead to Philips miss on Q4 projections

Royal Philips (NYSE:PHG) shares took a hit today on fourth-quarter results that came up shy of the consensus forecast.

The Amsterdam-based company posted profits of $183 million (€162 million), or 18¢ (€0.16) per share, on sales of $5.5 billion (€4.9 billion) for the three months ended Dec. 31, 2021, for a 75.2% bottom-line slide on a sales decline of 5.6%.

Adjusted to exclude one-time items, earnings per share were 64¢ (€0.57), 73¢ behind Wall Street, where analysts were looking for sales of $5.9 billion.

“In the fourth quarter, we recorded €4.9 billion sales, reflecting a 10% comparable sales decline, with an adjusted EBITA margin of 13.1%,” Philips CEO Frans van Houten said in a news release. “As we announced on January 12, 2022, sales were impacted by several headwinds, namely supply chain challenges, postponement of equipment installations in hospitals related to COVID-19, and the consequences of the Respironics field action.

Phil…

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 …

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…

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…

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.

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…

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…

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…

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…

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…

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…