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Versapor® RC Membranes: The next generation of venting materials

As the world leader in the design and production of membranes, filtration devices, and separation systems, Pall Corporation supplies products to nearly every industry in the world. Founded in 1946, Pall Corporation has set the standard for filtration solutions for 75 years and counting. Our customers have relied on us for their most sophisticated applications in diagnostics, healthcare, biopharmaceuticals, municipal water, aerospace, hydraulics, industrial fluid processing, and more. Our extensive portfolio of membrane materials offers you flexibility and peace of mind knowing that you will find the right solution for your application needs.

Pall Corporation has developed the highest quality of microporous membranes and materials for filtration, separation, and purification to help optimize product performance and minimize development costs. Whether you are choosing from our standard product portfolio, requesting a modification on an existing product, or explo…

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Avantor launches line of robotic tips for applications spanning cell biology and proteomics

The chemicals and materials specialist Avantor (NYSE:AVTR) has debuted J.T.Baker robotic tips for robotic liquid handling and research workstations.

The company says the new tips offer high precision and reliability.

Avantor will employ an independent test lab to verify the robotic tips are free of DNase, RNase, ATP and pyrogens.

The company will offer the robotic tips in two formats.

The first includes conductive tips that support the sampling of small liquid volumes with high precision without contamination. Included in this format are Hamilton- and Tecan-type compatible with a variety of robotic workstations.

J.T.Baker robotic tips

The second format spans clear robotic tips that optimize the performance for sample preparation and drug discovery applications. In addition, the transparency supports the visual recognition of foam to optimize sampling.

Avantor recently acqui…

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NIBRT chooses SP fill-finish system to train biopharmaceutical production workers

The National Institute for Bioprocessing Research and Training (NIBRT) center of excellence in Dublin, Ireland, has tapped SP Scientific Products (SP) to install a modular multi-container filling line and isolation system.

The technology will complement the training of professionals working on pharmaceutical production fill-finish processes requiring high cleanliness levels to prevent contamination from human contact or airborne germs.

NIBRT will use a SP i-Dositecno robotic filling and stoppering system for pre-sterilized vials, syringes and cartridges in a nested format and a vial capper. NIBRT plans to install the technology in Spring 2022.

The NIBRT global center of excellence in Dublin, Ireland.

NIBRT offers hands-on training in an environment based on advanced industrial bioprocessing facilities.

“We are proud to be recognized and selected by such a respected institute to contribut…

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Rani Therapeutics prices $73M IPO for robotic drug-delivery pill tech

​​Rani Therapeutics Holdings ​​(NSDQ:RANI), developer of a robotic drug-delivery pill system, has priced an underwritten initial public offering (IPO) of Class A common stock worth $73.3 million.

The San Jose, Calif.–based company’s IPO of 6.7 million shares priced at $11 a share, generating gross proceeds of $73.3 million.

The company initially targeted an IPO worth approximately $100 million, with shares trading between $14 and $16.

The company has developed a proprietary platform designed to provide a pill-based alternative to intravenous or subcutaneous administration of biologics. The robotic pill deploys its payload of proteins, peptides or antibodies when it reaches the intestine.

Talat Imran

In a Phase 1 trial, the company demonstrated the absorption of a biologic on the order of 65%. “That’s in line with subcutaneous injections, which ranged between 40% and 80%,” said Talat Imra…

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Cyclo Therapeutics announces positive Niemann-Pick disease from small study

Cyclo Therapeutics (NSDQ:CYTH) has announced new safety and efficacy data from the its ongoing Phase 1 open-label extension study of Trappsol Cyclo to treat Niemann-Pick disease type C (NPC). NPC is a rare, progressive genetic disorder that involves abnormal cellular cholesterol accumulation.

Initial results from the study demonstrated disease stabilization with considerable clinical improvements in some patients. In addition, Trappsol Cyclo was well-tolerated, and no adverse events were linked to the treatment.

The study measured efficacy using the 17-domain NPC Severity Scale. Eight patients measured from the baseline Phase 1 study to the extension study demonstrated a trend of overall stability.

Patients in the trial had an average worsening of their NPC Severity Scale of 0.4 points per year. In general, NPC patients have an average worsening of 1.4 points.

The Trappsol Cyclo is a proprietary formulation of hydroxypropyl beta-cyclodextrin, a hy…

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Salt baths increase stability in the medical device tempering process

Calibration baths, like salt baths, were originally for calibrating temperature assets. But there’s another use for them: manufacturing Nitinol medical devices.

Travis Porter, Fluke Calibration

The Fluke Calibration 6050H Extremely High Temperature Calibration Salt Bath (left) can handle high temperatures (550 °C) with stability (±0.002 °C) and uniformity (±0.005 °C). The Fluke Calibration 6331 Deep-Well Compact Bath (right) can handle both high (300 °C) and low (-80°C) temperature with excellent stability (±0.005 °C) and uniformity (±0.007 °C). [Images courtesy of Fluke Calibration]

Nitinol is a nickel-titanium alloy that exhibits both thermal shape memory behavior and super-elasticity. It’s a great metal to use in medical devices because it’s possible to set the wire or mesh design into a form using the tempering process. Then, fold it up into a fraction of end size to use in minimal…
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Hillrom beats The Street in Q3, raises guidance

Hillrom (NYSE: HRC) shares slightly dipped today on third-quarter results that beat the consensus forecast.

The Chicago-based company posted profits of $49.2 million, or 74¢ per share, on sales of $717.7 million for the three months ended June 30, 2021, for a -47.6% bottom-line slide on a sales decline of -6.5%.

Adjusted to exclude one-time items, earnings per share were $1.38, 4¢ ahead of Wall Street, where analysts were looking for sales of $708.3 million.

Hillrom noted that profit and revenue dips were particularly spurred by the company’s third-quarter performance in 2020, which benefited from a surge in one-time COVID-19-related revenue of approximately $130 million and adjusted EPS of $0.60.

“Our dedicated, global team continues to support customers’ evolving needs and we remain encouraged by the building momentum and recovery in our underlying business. This resulted in third-quarter financial performance that exceeded exp…

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FDA clears TransMedics OCS Lung System

TransMedics (NSDQ:TMDX) has won FDA clearance of its OCS Lung System to provide hypothermic flushing, storage and transportation of donor lungs for transplantation.

“This FDA clearance marks another achievement for TransMedics as we assemble the most comprehensive, market-leading portfolio of organ preservation products to meet the clinical needs of the organ transplant market,” TransMedics CEO Dr. Waleed Hassanein said in a news release.

“With this new clinical indication, we are demonstrating our commitment to establishing TransMedics as the trusted partner to supply world-class organ preservation products to meet customer needs across all transplant indications as we execute on our mission to transform organ transplant therapy for the future,” Hassanein said.

The company’s OCS Heart System and OCS Liver System are presently under FDA after receiving positive FDA advisory panel votes in April and July respectively.

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Smith+Nephew revenue up 48% in Q2

Smith+Nephew (LON: SN; NYSE: SNN) saw its sales jump 48% in Q2, with the company reiterating its projection of 10–13% underlying revenue growth in 2021.

British medtech giant yesterday reported $1.335 billion in revenue for the quarter ended July 3, 2021. For the first half of 2021, the company saw a trading profit of $459 million and an operating profit of $239 million off of $2.599 billion in revenue — versus a trading profit of $172 million and an operating loss of –$5 million off of $2.035 billion in revenue a year before.

“Our performance in the first half of 2021 demonstrates the value of our continued investment in our portfolio, our pipeline and our people. This has put us in a strong position as COVID restrictions eased and levels of elective surgery began to return to normal, with new products and recently acquired assets performing well across the portfolio,” CEO Roland Diggelmann said in a news release.

“Looking ahead, we believe we are…

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AbbVie dips despite Street-beating Q2, raised guidance

AbbVie (NYSE:ABBV) shares took a hit today despite second-quarter results that topped the consensus forecast.

The North Chicago-based company posted profits of $769 million, or 42¢ per share, on sales of $14 billion for the three months ended June 30, 2021, marking a massive bottom-line gain from losses of -$739 million last year on sales growth of 33.9%.

Adjusted to exclude one-time items, earnings per share were $3.11, 2¢ ahead of Wall Street, where analysts were looking for sales of $13.6 billion.

“AbbVie delivered another strong quarter and our business continues to perform extremely well across the portfolio, with AbbVie’s new immunology assets contributing more than $1 billion of combined sales in the quarter,” AbbVie chairman & CEO Richard A. Gonzalez said in a news release. “The Allergan integration also continues to track exceptionally well, with both the neuroscience and aesthetics portfolios delivering double-digit …

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Kaiser files lawsuit against Merck over cholesterol drugs

The managed care consortium Kaiser Permanente is suing Merck (NYSE: MRK) over alleged pay-to-delay agreements to withhold the production of generic drugs for Zetia and Vytorin.

Zetia (ezetimibe) is a cholesterol absorption inhibitor while Vytorin combines ezetimibe with simvastatin, an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase. FDA drugs treat high cholesterol levels.

The lawsuit also names Glenmark, a manufacturer of generics of Zetia and Vytorin. It alleges that Merck’s plan to delay the introduction of generics for those drugs had cost Kaiser hundreds of millions of dollars, according to a report from the San Francisco Business Times.

The Oakland, Calif.–headquartered Kaiser Foundation Health Plan first filed the suit in San Francisco Superior Court. That court, however, transferred the case to the U.S. District Court in San Francisco.

FDA first approved Zetia in October 2002.

FDA approved Vytorin in July 20…

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Tenaya Therapeutics prices $180M IPO for targeted therapies

Tenaya Therapeutics announced that it priced an underwritten, upsized initial public offering of common stock worth $180 million.

South San Francisco-based Tenaya develops therapies for rare generic disorders and more prevalent heart conditions through gene therapy, cellular regeneration and precision medicine. The company is actively exploring different routs of administration and different infusion- and injection-based methods for delivering its therapies.

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

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Abbott launches latest insertable cardiac monitor

[Image from Abbott]Abbott (NYSE:ABT) announced that it launched the Jot Dx — its latest insertable cardiac monitor (ICM) — in the U.S.

Jot Dx offers clinicians and hospitals control of the management of the flow of information through a feature that allows the viewing of abnormal heart rhythm data and offers the opportunity to simplify which irregular heart rhythms are recorded with a “key episodes” feature, according to a news release.

Abbott Park, Ill.-based Abbott said the technology allows for remote detection and improved diagnosis accuracy for cardiac arrhythmia in patients. The platform is supported by SyncUP, a personalized service that provides one-on-one training and education to help patients connect to their ICM.

The Jot Dx platform monitors patient cardiac rhythms 24 hours a day, seven days a week and connects to myMerlin, a mobile app designed to transmit data in real-time to clinicians and patients. Abbott said all wireless commun…

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Biden offers $100 incentives to spur COVID-19 vaccination

Image courtesy of Pexels

With COVID-19 transmission continuing to accelerate, President Biden called for state and local governments to offer financial incentives for vaccination.

Speaking at a White House briefing dedicated to the novel coronavirus, Biden offered to draw such funding from the $1.9 trillion American Rescue Plan.

“People are dying and will die who don’t have to die,” he said in the announcement. “If you’re out there unvaccinated, you don’t have to die.”

Biden also said the government would reimburse small- and medium-size businesses that support vaccinating their employees.

He has also called for federal employees to be fully vaccinated or face regular testing and masking restrictions indoors.

Biden acknowledged that the plan might seem unfair for people who are already fully vaccinated but said the initiative could help beat back the spread of the virus.

Ju…

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Dexcom rises on Street-beating Q2, raised guidance

Dexcom (NSDQ:DXCM) shares ticked up after hours on second-quarter results that topped the consensus forecast.

The San Diego-based continuous glucose monitor developer posted profits of $62.9 million, or 63¢ per share, on sales of $595.1 million for the three months ended June 30, 2021, for a 35.9% bottom-line gain on sales growth of 31.7%.

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

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Edwards Lifesciences beats The Street in Q2, boosts guidance

Edwards Lifesciences (NYSE: EW) reported second-quarter results this evening that beat the consensus forecast on Wall Street — and raised its 2021 guidance in the process.

The Irvine, Calif.–based cardio device company reported earnings of $489.5 million, or 78¢ per share, off sales of $1.376 billion – a turnaround from the loss of –$121.9 million, or –20¢ per share, off sales of $925 million that Edwards Lifesciences saw in Q2 2020.

Adjusted to exclude one-time items, earnings per share were 64¢, 9¢ ahead of The Street, where analysts were looking EPS of 55¢ on sales of $1.28 billion.

“We were encouraged by the clear signs of recovery during the second quarter,” Edwards Lifesciences CEO Michael A. Mussallem said in a news release.

“Vaccine adoption in key regions has contributed to an increased number of patients seeking and, most importantly, receiving treatment,” Mussallem said. “This quarter, we were pleased that …

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Traco Power announces new TMW 24 and TMW 36 series

Traco Power’s new TMW 24 and TWM 36 series of power supplies [Image courtesy of Traco Power]

Traco Power (San Jose, Calif.) recently announced the company’s new TMW series of 24- and 36-W power supplies.

The new power supplies are IP68 rated and fully encapsulated — with flexible options for PCB or chassis mounting for the medical and industrial markets.

The TMW Series were also designed for flush box-mounting to support IoT and home/building automation markets. All models are supported by a global safety approval package.

TMW 24 (24 W models) offer 5, 12 or 24 V single outputs, and TMW 36 (36 W models) offer 12 or 24 V single outputs. All models have a compact footprint of 2.1 x 2.1 in. They’re available with flying leads or PCB mount through-hole connections (Suffix P) that are fully encapsulated in a dust-resistant, waterproof IP68 housing.

These power supplies are safe…

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Align Technology skyrockets on Street-beating Q2

Align Technology (NSDQ:ALGN) shares shot up today on second-quarter results that came in ahead of the consensus forecast.

ALGN shares were up 9.4% at $680.27 per share in late-afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.9%.

The Tempe, Ariz.-based company posted profits of $199.7 million, or $2.51 per share, on sales of $1 billion for the three months ended June 30, 2021, for a bottom-line gain from losses of $40.6 million this time last year as it nearly tripled last year’s second-quarter sales.

Adjusted to exclude one-time items, earnings per share were $3.04, 49¢ ahead of Wall Street, where analysts were looking for sales of $937.9 million.

“I’m pleased to report our first $1 billion revenue quarter with record volumes reflecting continued momentum from both Clear Aligners and Systems and Services,” Align Technology president &a…

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Merck results miss in Q2

Merck (NYSE: MRK) posted second-quarter results today that missed the consensus forecast on Wall Street, though the company expects up to 14% sales growth this year.

The Kenilworth, N.J.–based pharmaceutical giant reported profits of $1.213 billion, or 48¢, off $11.402 billion in sales, nearly halving its bottom line while boosting sales 19% from Q2 2020. Merck adjusted earnings and revenue to take into account its June 2021 spinoff of Organon, which brought Merck a $9 billion windfall.

Adjusted to exclude one-time items, earnings per share were $1.31, 13¢ behind The Street, where analysts looked for EPS of $1.44 on sales of $11.54 billion.

Related: FDA approves Merck’s Keytruda to treat certain types of breast cancer

“We are encouraged by the strong momentum of our underlying business led by our key growth drivers as the impact of the pandemic on our performance lessens,” said Merck CEO Rob Davis said in a news release. “We are confident that we …

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Novocure plummets on missed Q2 projections

Novocure (NSDQ:NVCR) shares took a dive today on second-quarter results that came up short of the consensus forecast.

NVCR shares were down -11.7% at $160.67 in mid-afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.9% on the day.

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

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Protolabs reports mixed-bag results for Q2

Protolabs (NYSE: PRLB) posted second-quarter earnings today that missed the consensus forecast on Wall Street, though the company beat on revenue.

The Maple Plain, Minn–based digital manufacturing outsourcer — which serves medtech and a host of other industries — reported profits of $12.9 million, or 47¢ per share, on sales of $123.0 million for the three months ended June 30, 2021, for a bottom-line gain of 2.4% and sales growth of 15.4% compared with Q2 2020.

Adjusted to exclude one-time items, earnings per share were 39¢, a nickel behind The Street, where analysts were looking EPS of 44¢ on sales of $122.2 million.

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

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