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Taro Pharmaceuticals announces Type I recall of Taro-zoledronic acid injection

The Canadian division of Taro Pharmaceuticals (NYSE:TARO) has announced a voluntary Type 1 recall on six lots of Taro-zoledronic Acid Injection.

Type 1 recalls, according to Health Canada, refer to products that could cause serious adverse health consequences or death.

It corresponds to Class 1 recalls from the FDA.

Taro Pharmaceutical‘s consumer-level recall covers 5 mg/100 mL in 100 mL vials.

Zoledronic acid is a bisphosphonate.

The drug is indicated to increase bone mineral density, treat and prevent osteoporosis and for Paget’s disease, a condition associated with bone deformities.

The Brampton, Ontario–based subsidiary is recalling certain lots of the product as it may contain particulate matter higher than requirements allow.

The company has informed Health Canada about the recall.

Taro Pharmaceuticals notes that the particulate matter in the affected lots could lead to adverse events, but it has received no…

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FDA’s breakthrough medical device designations tally nears 700

Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review of medical devices and combination products that facilitate more effective treatment or diagnosis of serious diseases.

According to recent metrics published by FDA, the agency has issued a total of 693 designations under its Breakthrough Devices Program, previously known as the Expedited Access Pathway (EAP). As of June 30, 2022, the bulk of these designations (687) have come through FDA’s Center for Devices and Radiological Health (CDRH), while the Center for Biologics Evaluation and Research (CBER) has granted another six such designations.

Although nearly 700 devices have been granted breakthrough designation, only 54 of these devices have obtained full US marketing authorizations.

Breakthrough designations gaining pace in recent years

FDA data shows that the …

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Lifecore Biomedical’s owner plans to go all-in on contract development and manufacturing

Jim Hall is the CEO of Landec Corp., which will soon rename itself as Lifecore Biomedical, the subsidiary that Hall previously led. [Photo courtesy of Landec Corp.

Lifecore Biomedical parent company Landec Corp. (Nasdaq:LNDC) plans to take the subsidiary’s name, leadership and headquarters as its own and sell off food businesses to focus on contract development and manufacturing.

Santa Maria, California-based Landec said it will rename itself as Lifecore Biomedical “in the near future” and change its Nasdaq ticker to LFCR.

Landec named Jim Hall as its new CEO effective yesterday. Hall served as president of Chaska, Minnesota-based Lifecor since 2017. Landec CFO John Morberg will remain with the company.

Lifecore manufactures sodium hyaluronate for medical applications and offers contract development and manufacturing organization services for injectable pharmaceuticals and medica…

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ResMed expects steady growth over the next year

ResMed (NYSE: RMD, ASX: RMD) today reported fourth-quarter results that beat the consensus forecast on Wall Street amid continued adoption of its next-gen AirSense 11 CPAP.

CEO Mick Farrell said in a news release that ResMed launched the fully cloud-connectable AirSense 11 into several new European countries. The AirSense 11 is also selling well in the U.S., the company said.

Farrell also detailed ResMed’s strategy to deal with the semiconductor shortage facing ResMed and many other medtech companies:

“We also introduced our newest device to meet the needs of an industry crisis in PAP supply, the AirSense 10 Card-to-Cloud solution, during the quarter. The card-to-cloud device was launched into the U.S. and many other markets and is designed to work without an embedded communications module. This redesign allowed us to increase deliveries to customers and ultimately to get many more patients onto life-saving sleep apnea and respiratory care th…

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Ambu is letting go of 200 employees

Ambu recently announced that it would cut 200 employees from its global workforce as part of a cost reduction program.

The Ballerup, Denmark–based company has reported trouble making headway with its single-use scope products.

Ambu has reported a total of 4,500 employees in the past. That means the layoffs would represent about 4% of Ambu’s workforce.

Ambu expects to save roughly DKK kr250 million ($40 million) a year from the cuts, with DKK kr150 million ($24 million) in one-time expenses.

“We have had great successes, but also challenges,” Ambu CEO Britt Meelby Jensen said in an Aug. 3 news release.

She went on: “I have assessed the situation with the leadership team, and it is clear that the single-use market remains very attractive, but also that it is taking longer than expected to penetrate certain segments like duodenoscopy. To strengthen our financial position and flexibility, we have decided to launch a cost…

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Merck forges Alzheimer’s pact with Cerevance

Merck & Co. (NYSE:MRK) could pay more than $1 billion to the Boston-based biotech startup Cerevance to develop potential drugs for Alzheimer’s disease.

The collaboration will center around Cerevance’s Nuclear Enriched Transcript Sort sequencing (NETSseq) technology platform.

The platform’s origins trace back to research at the Howard Hughes Medical Institute.

Under the terms of the deal with Merck, Cerevance will license its preclinical Alzheimer’s drug program to Merck.

Merck will now pay Cerevance $25 million and could pay an additional $1.1 billion in milestone-based payments plus potential royalties.

Although there are a handful of FDA-approved drugs for Alzheimer’s, most focus on treating the symptoms rather than the cause of the condition.

One exception is Biogen’s aducanumab, which reduces amyloid deposits in the brain. It is not yet clear, however, if the drug has a cognitive benefit for patients.

Conversely, Cerev…

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The most common monkeypox vaccine side effects

Photo by Artem Podrez from Pexels

Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA), the most widely used vaccine to protect against monkeypox, tends to have generally mild side effects according to clinical trial data.

It is also clear that the Jynneos vaccine can help reduce the severity of monkeypox infections. Researchers are uncertain, however, about how the vaccine’s potential to reduce transmission, how strong its protective effect is, or how long it lasts.

A small study in Africa from 1988 found that an older smallpox vaccine was 85% effective in protecting against monkeypox.

CDC notes that there are no data about the effectiveness of the Jynneos or the ACAM2000 vaccine from Emergent Biosolutions (NYSE: EBS) in the current outbreak. The latter vaccine has not found widespread use in the monkeypox outbreak and generally is not as well tolerated as the Jynneos vaccine.

The …

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Medtronic has Class I recall for low-shock risk in ICDs

Medtronic Cobalt and Crome ICDs [Image from Medtronic]Medtronic (NYSE: MDT) is recalling 22,110 Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) in the U.S.

The Class I recall — the most serious classification from the FDA — is due to the potential for reduced shock energy during high-voltage therapy for Cobalt and Crome ICDs and CRT-Ds, according to FDA data.

Some devices have been found to deliver only around 79% of the programmed energy, which Medtronic estimates has a 1% reduction on efficacy.

Medtronic said there have been no reports of permanent harm or deaths due to the issue.

In June, Medtronic issued an urgent field safety notice in Europe warning of the same problem.

Medtronic is not recommending replacement of implanted devices. A software update is expected to fix the problem in new and existing implantations. Medtronic is asking hospitals to return certai…

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Cardinal Health’s CFO to move up to corner office

Cardinal Health CFO and soon-to-be CEO Jason Hollar [Image courtesy of Cardinal Health]

Cardinal Health (NYSE: CAH) announced today that its board has elected CFO Jason Hollar to become the pharma and medtech giant’s new chief executive officer, effective Sept. 1.

Hollar will succeed Mike Kaufmann, who has been Dublin, Ohio–based Cardinal Health’s CEO for the past five years. The CEO transition comes as Cardinal Health continues efforts to refocus its Medical business after the $1 billion sale of its Cordis business last year.

“This is a transformational period at Cardinal Health, and I am humbled to have the opportunity to lead a business that plays such a vital role in the healthcare ecosystem,” Hollar said in a news release.

Cardinal Health independent board chairperson Gregory Kenny described Kaufmann as a “tremendous leader during his tenure at Cardinal Health, helping the company navigate a p…

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Titan Medical to start manufacturing Enos systems later this year

Titan Medical’s Enos robotic-assisted surgery (RAS) system is meant to benefit hospitals through a smaller footprint, easy mobility and lower operating costs. [Images courtesy of Titan Medical]Titan Medical (Nasdaq: TMDI; TSX: TMD) expects manufactured units of the Enos robotic-assisted surgery system will be available later this year.

The goal is to commercially launch Enos in early 2025 after securing a De Novo market authorization from the FDA, the Toronto-based robotic surgery company said during its second-quarter earnings report today.

Titan Medical officials said they have an ongoing dialogue with FDA through the agency’s Q-Submission program. Its regulatory timeline includes filing an application for an investigational device exemption (IDE) in mid-year 2023 for its initial target indication for benign gynecologic surgical procedures, followed by an FDA response in the second half of 2023. After the IDE approval, the next step would be to compl…

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Cardinal Health’s CFO to move up to corner office

Cardinal Health CFO and soon-to-be CEO Jason Hollar [Image courtesy of Cardinal Health]Cardinal Health (NYSE: CAH) announced today that its board has elected CFO Jason Hollar to become the pharma and medtech giant’s new chief executive officer, effective Sept. 1.

Hollar will succeed Mike Kaufmann, who has been Dublin, Ohio–based Cardinal Health’s CEO for the past five years. The CEO transition comes as Cardinal Health continues efforts to refocus its Medical business after the $1 billion sale of its Cordis business last year.

“This is a transformational period at Cardinal Health, and I am humbled to have the opportunity to lead a business that plays such a vital role in the healthcare ecosystem,” Hollar said in a news release.

Cardinal Health independent board chairperson Gregory Kenny described Kaufmann as a “tremendous leader during his tenure at Cardinal Health, helping the company navigate a period of unprecedented challeng…

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Levita Magnetics raises $26M for Magnetic-Assisted Robotic Surgery platform

Levita’s Magnetic-Assisted Robotic Surgery (MARS) platform [Photo courtesy of Levita]Levita Magnetics said today it has raised $26 million to fund regulatory and commercial progress on its Magnetic-Assisted Robotic Surgery (MARS) platform.

The Menlo Park, California-based robotic surgery system developer also appointed Maria Sainz as chair of its board of directors.

The MARS platform is designed to help surgeons perform more high-volume abdominal procedures using fewer incisions and fewer personnel.

Levita won FDA de novo classification for its Levita Magnetic Surgical System in 2015. That handheld device uses a magnet placed outside of a patient’s abdomen to control a magnetic grasper inside the body during surgery, requiring only one incision instead of two.

The device requires someone to hold the external magnet while the surgeon is operating, but the new MARS platform assists with the external magnet and gives the surgeon more control…

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Making diversity in clinical research more than a talking point

Image courtesy of Pixabay

Not long ago, diversity in clinical research seemed like an obscure topic. Ben Enejo, a partner at Arthur D. Little, recalls mentioning the theme in the past and getting blank stares.

But the pandemic and the murder of George Floyd helped highlight the importance of diversity on multiple fronts, including in clinical research. As a result, there are growing collaborations between academia and the industry dedicated to the theme. The FDA has also released guidance on race and ethnicity.

In the U.S., about 75% of clinical trial participants were white in 2020, according to the FDA.

“Now, if you go back 20 years, I would say between 80% and 90% of clinical trials were not diverse,” Enejo said. “You could say we’re going in the right direction now.”

But while discussions on diversity in clinical research have escalated, “thereR…

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ZimVie sales down more than 11% in Q2 as it streamlines after spinoff

ZimVie (Nasdaq: ZIMV) saw declining revenue and widening losses during its first full quarter independent of Zimmer Biomet, the company reported today. It’s also reducing full-year guidance.

CEO Vafa Jamali told MassDevice and Medical Design & Outsourcing on March 1 — ZimVie’s first day of public trading — that initial tasks in the company’s spine tech business included pulling out of countries that had proved unprofitable. There were also some spine product discontinuations.

Coupled with a strong U.S. dollar causing headwinds for the dental tech side of the business, ZimVie’s losses roughly doubled year-over-year to $8.7 million, or 33¢ per share, for the quarter ended June 30, 2022. Sales were down 11.5% year-over-year to $233.4 million.

ZimVie reported adjusted EPS of 67¢. Yahoo Finance presently lists one analyst revenue prediction for the quarter who expected $238.3 million in sales.

“We continue to make progress t…

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Data supports use of Channel Medsystems Cerene cryotherapy

Channel Medsystems announced today that long-term clinical outcomes support its Cerene cryotherapy for treating heavy menstrual bleeding (HMB).

Long-term outcomes from the Clarity clinical study evaluating the safety and effectiveness of Cerene cryotherapy were published in the International Journal of Women’s Health.

Emeryville, California-based Channel Medsystems designed Cerene as a proprietary, hand-held technology for delivering cryotherapy to the lining of the uterus, freezing the tissue and significantly reducing future menstrual bleeding. The company received FDA approval for the platform in 2020.

The in-office endometrial cryoablation treatment safely and effectively reduces heavy menstrual bleeding while naturally minimizing pain without requiring general anesthesia, the company said in a news release.

In the study, Cerene is presented as a well-tolerated endometrial ablation that provides a significant reduction in HMB symptoms an…

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COVID-19 immunity test developers at MIT seek diagnostic manufacturer

A COVID-19 immunity detection test developed by MIT could help people determine their risk of infection. [Image courtesy of MIT]

MIT researchers have developed a device for predicting an individual’s COVID-19 immunity and are looking for a diagnostic company to get it manufactured in large numbers and approved by the FDA.

The lateral flow test uses the same technology as at-home rapid antigen COVID-19 tests to measure neutralizing antibodies for SARS-CoV-2 in a blood sample, the researchers said in a study published in Cell Reports Methods.

The researchers have filed for a patent on the technology, which could help people weigh their COVID-19 immunity against risk and determine necessary precautions such as boosters.

RELATED: Harvard researchers plan to sell at-home, PCR-grade COVID testing system

The development comes more than two years into the pandemic as the latest virus mutation…

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Nanopath raises $10M Series A for women’s health diagnostics

Nanopath announced that it closed a Series A funding round to support its biosensing platform for diagnostics.

Cambridge, Massachusetts–based Nanopath intends to use the funds to back the development and commercialization of its platform that aims to transform how women’s pelvic and gynecologic infections are diagnosed. The company designed its novel approach to simultaneously characterize multiple pathogens with one test for faster, more precise diagnosis and treatment.

Nanopath’s proprietary biosensing technology uses ultrasensitive optical detection to identify DNAs and RNAs without the need for nucleic acid amplification. The approach minimizes reagents, lowers costs and reduces user steps while requiring minimal training to operate, making them accessible at the point of care.

According to a news release, Norwest Venture Partners and the Medtech Convergence Fund, a SV Health Investors venture fund, led the financing round. Ging…

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5 headwinds and 5 tailwinds for psychedelic medicine

Psychedelics were featured at SXSW 2022. [Image courtesy of Wikimedia Commons]

Decades after compounds like LSD and psilocybin were made illegal , psychedelic medicine appears poised to go mainstream in the coming years, potentially treating conditions ranging from anxiety to PTSD.

In the interim, however, hurdles remain.

The American Psychiatry Association (APA) recently released a conservative position statement on psychedelics and empathogens such as MDMA. In essence, the organization concluded that psychedelic medicine remains at the clinical stage. At present, there is “inadequate scientific evidence for endorsing the use of psychedelics to treat any psychiatric disorder except within the context of approved investigational studies,” APA noted.

While the APA said it supports rigorous clinical research into the compounds, “clinical treatments should be determined by scientific…

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GE Healthcare picks AI imaging startups for inaugural Edison Accelerator

GE Healthcare has selected seven companies to test their AI imaging technologies with GE’s Edison Digital Health Platform. [Image courtesy of GE Healthcare]

GE Healthcare and Nex Cubed have selected seven companies focused on artificial-intelligence-augmented medical imaging for the first cohort of the Edison Accelerator in Canada.

The companies will be matched with mentors and test their technologies with GE’s new Edison Digital Health Platform over the next three months. The program will end with innovation showcase presentations to potential investors and customers, and some startups could have their products distributed through the GE Healthcare Marketplace.

The cohort’s six startups are:

16 Bit, a physician-founded startup that uses routine chest, spine, pelvis, knee or hand x-rays with computer-aided detection and notification software for low bone mineral density prescreenin…
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Biogen is scaling back space outside Boston

According to reports, Biogen has taken steps to scale back costs following the release of its Aduhelm Alzheimer’s disease drug.

The company has moved to sublease more than 260,000 square feet at multiple locations in Massachusetts as it looks to cut $1 billion in costs, The Boston Globe reported.

Across from its Cambridge, Massachusetts, headquarters, the company plans to sublease more than 183,000 square feet in its 300 Binney Street space, while it has also made plans to sublease two floors comprising 80,000 square feet at one of two properties at 133 Boston Pond Road in Weston, Massachusetts, The Globe report said.

The Globe report credited the Boston Business Journal with first reporting the sublease news, while also saying that Biogen has “long subleased” one of its two Weston buildings to Monster, the job search website.

Biogen’s cost-cutting efforts will…

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Avenda wins FDA IDE nod for AI-enabled prostate cancer therapy

Avenda Health announced that it received FDA investigational device exemption (IDE) for its FocalPoint ablation system power by iQuest.

The IDE will allow Avendra to combine the two technologies in a randomized, controlled trial to show superiority over the standard of care for the treatment of prostate cancer.

iQuest uses artificial intelligence (AI) and deep learning to map prostate cancer and provide physicians with a precise location of cancer within the gland, plus a better understanding of the extent of the disease to help with treatment planning.

According to a news release, a retrospective study of 50 patients demonstrated that iQuest improved tumor margin creation over conventional treatment planning from 56% to 80%.

California-based Avenda designed its FocalPoint laser ablation system to treat localized prostate cancer in-office while preserving quality of life. Avendra’s system received FDA breakthrough device designation last yea…

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