CardioFocus wins Japan regulatory approval for HeartLight X3 system

CardioFocus today said its HeartLight X3 catheter ablation technology received approval from the Japanese Ministry of Health, Labor and Welfare.

Marlborough, Mass.-based CardioFocus designed the catheter ablation technology for controlled and consistent pulmonary vein isolation to treat atrial fibrillation (AFib).

Get the full story on our sister site, Medical Tubing + Extrusion.

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Accuray promotes exec Suzanne Winter to president

Accuray (NSDQ:ARAY) announced that it promoted executive Suzanne Winter to president, effective as of July 1, 2021.

Winter, who previously served as Sunnyvale, Calif.-based Accuray’s chief commercial officer and SVP of R&D & medical & scientific affairs, will continue to report to CEO Joshua Levine.

“Suzanne has had a significant impact on Accuray’s product portfolio and commercial momentum since joining the company. She is a leader who has a proven track record of building performance-oriented commercial organizations. We believe that her strategic leadership of Accuray’s commercial and R&D teams has successfully positioned the company for accelerated revenue growth,” Levine said in a news release. “In her expanded role, Suzanne will focus on the day-to-day business operations of the company, which will allow me to focus on growing Accuray’s external strategic collaborations and business development opportunities.

“I lo…

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BD home peritoneal catheter system wins expanded FDA clearance

BD (NYSE:BDX) today said it has received FDA 510(k) clearance for its PeritX peritoneal catheter system.

Franklin Lakes, N.J.-based BD designed the catheter system to drain symptomatic, recurrent non-malignant ascites, which causes a build-up of fluid in the abdomen.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Teva launches first U.S. generic Perforomist inhaled COPD treatment

Teva Pharmaceuticals (NYSE:TEVA) announced the U.S. launch of the first generic version of the twice-daily Perforomist inhalation solution.

Parsippany, N.J.-based Teva Pharmaceuticals — a U.S. affiliate of Tel Aviv, Israel-based Teva Pharmaceutical Industries Ltd. — launched the formoterol fumarate inhalation solution (20 mcg/2 mL) with an indication for treating bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

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

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Biotage debuts new automated platform to purify plasmid DNA

Biotage (STO:BIOT) has launched Biotage PhyPrep, an automated platform for plasmid DNA purification.

Featuring the company’s PhyTip columns’ dual flow chromatography technology, the technology provides supercoiled, endotoxin-free, transfection-grade plasmid DNA.

Drug developers commonly use plasmid DNA in biologic drug manufacturing to create vaccines and cell and gene therapies. Additionally, researchers use plasmids to clone, amplify and express specific genes, and to produce proteins and disease models.

The technology uses an automated process to purify plasmid DNA to limit the potential for human error and to maximize consistency.

The company boasts that the PhyPrep technology enables biopharmas that outsource plasmid purification to bring the process in-house. Biotage also says the technology is the first automated technology for plasmid purification that supports maxi-, mega- and giga-scale preparation.

“The launch of the Biotage PhyP…

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Europe orders another 150 million doses of Moderna’s COVID-19 vaccine

Moderna (NSDQ:MRNA) has announced that the European Commission has reserved an additional 150 million doses of its COVID-19 vaccine for delivery in 2022.

To date, the European Commission has reserved 460 million Moderna vaccine doses. 

The new deal gives the European Commission the ability to purchase new COVID-19 vaccines. 

The company is currently testing various booster options, including the use of its existing mRNA-1273 vaccine. In addition, it is developing a vaccine known as mRNA-1273.351 based on the B.1.351 variant that first emerged in South Africa. 

Interim data from a Phase 2 trial in the U.S. found that both mRNA-1273 and mRNA-1273.351 led to increased neutralizing antibody titer levels in response to the B.1.351 and P.1 variants. The mRNA-1273.351 appears to be more effective at generating an immune response to those viral lineages. The P.1 variant is also known as the “Gamma Variant.” 

Moderna also recently announced that the…

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6 pharma firms rank among Glassdoor’s 2021 Best Places to Work

Glassdoor has released its latest list of the top 100 best places to work in 2021, and six pharmaceutical companies made the cut. One thread running across the entries in the entire list is the employers’ ability to empower and inspire workers in a time of continued challenges.

In addition to the pharma companies, a handful of medical device companies were featured as well including Stryker (14/100) and Intuitive Surgical (41/100)

Johnson & Johnson: 24 out of 100

J&J (NYSE:JNJ) has come up in the ranks since we published our list of the top pharma companies to work for in May. Employees praised the opportunities with various departments, the overall work environment and the work-life balance their roles afforded.

Johnson & Johnson was also the top-ranked pharmaceutical company in Gartner’s most recent list of top 25 supply chain companies, coming in at slot three. “J&J remains unparalleled in the life science industry, possessing enduring…

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GS Plastic Optics boasts reduced turn-around times

GS Plastic Optics (Rochester, N.Y.) is touting how it has reduced lead times for its single-point diamond turning point operations.

The result, according to GS Plastic Optics, is that it is now capable of turn-around times as little as 4–6 weeks depending on material availability and design complexity. The company achieved reduced lead times through new hires and equipment purchases.

GSPO often diamond turns acrylic (PMMA), COP (Zeonex and Zeonor), Styrene, Polyester (OKP-1 and OKP-4) and other select materials into short-run or prototype plastic optics.

The company produces precision optics for the consumer, medical, instrument LED lighting, and biomedical and analytical instrument marketplaces.

 

 

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Danaher to acquire Aldevron for $9.6B

Danaher (NYSE:DHR) announced that it entered into a definitive agreement to acquire Aldevron for approximately $9.6 billion.

Fargo, N.D.-based Aldevron, which employs approximately 600 people, manufactures high-quality plasmid DNA, mRNA and proteins to serve biotechnology and pharmaceutical customers across research, clinical and commercial applications.

Get the full story at our sister site, Pharmaceutical Processing World.

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Danaher to acquire Aldevron for $9.6B

Danaher (NYSE:DHR) announced that it entered into a definitive agreement to acquire Aldevron for approximately $9.6 billion.

Fargo, N.D.-based Aldevron, which employs approximately 600 people, manufactures high-quality plasmid DNA, mRNA and proteins to serve biotechnology and pharmaceutical customers across research, clinical and commercial applications.

According to a news release, Aldevron will operate as a standalone operating company and brand within Danaher’s life sciences business segment.

“We are thrilled to have Aldevron join Danaher’s life sciences segment. For nearly 25 years, Aldevron has made tremendous contributions to the advancement of cell, gene and other novel therapies and vaccines,” Danaher president & CEO Rainer M. Blair said in the release. This acquisition will expand our capabilities into the important field of genomic medicine and help us support our customers and their critical mission to bring more li…

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Could the controversial drug ivermectin save lives?

[Photo by Fusion Medical Animation on Unsplash]

The antiparasitic drug ivermectin holds promise as a COVID-19 treatment, according to a new study published in the American Journal of Therapeutics. The study authors conclude that ivermectin could reduce the risk of COVID-19-related death with moderate-certainty evidence. “Using ivermectin early in the clinical course may reduce numbers progressing to severe disease,” they conclude, adding that the drug is “likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

The meta-analysis analyzed databases up to April 2021, drawing from 24 randomized controlled trials with 3,406 patients. 

Another study published in Lancet found a concentration-dependent antiviral activity of oral high-dose ivermectin in a trial involving 45 patients.  

Many experts, however, have voiced skepticism regarding the use of ivermectin as a COVID-19 treatment.…

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Philips CPAP recall could be an opportunity for ResMed, analysts say

Baird analysts say that the recall of certain sleep and respiratory devices by Royal Philips (NYSE:PHG) may benefit ResMed (NYSE:RMD).

Earlier this month, Amsterdam-based Philips provided an update on the April 26 recall for some bi-level PAP and CPAP ventilator devices with a foam component problem, with the company expecting revenue headwinds in its sleep and respiratory care business to be compensated by the performances of its other businesses. It elected not to change financial guidances provided with the initial recall announcement.

Analysts at Baird, however, noted that there is an opportunity for ResMed to get a jump on Philips amid the recall with its respiratory products, although there is a high degree of difficulty as far “meaningfully capitalizing on this disruption,” and few clear answers exist right now.

ResMed, one of the top-performing stocks of 2020, saw a 4.6% rise from market open to market close on June 14, the day Philip…

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