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Kymera Therapeutics shares positive KT-474 data for atopic dermatitis

Kymera Therapeutics (NSDQ:KYMR), as a growing number of biotech companies, is intending to expand the druggable universe.

To that end, the company announced positive data related to targeted protein degradation (TPD). This modality enables oral small-molecule drugs to coax the body into clearing disease-causing proteins.

Kymera’s lead drug candidate, KT-474, targets a key protein known as IRAK4 involved in IL-1R/toll-like receptor–driven diseases such as hidradenitis suppurativa, atopic dermatitis and rheumatoid arthritis.

Recent Phase 1 trial data in healthy volunteers found that the drug promoted levels of IRAK4 protein degradation averaging at least 95%. Furthermore, a single dose led to degradation over six days.

The company also concluded that the drug impacted key biological pathways previously considered undruggable.

Kymera concluded that the drug appears to have the potential for a broad anti-inflammatory effect based on its reducti…

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BICO’s Scienion and Cellenion launch SpheroOne large-particle sorter and dispenser

The SpheroOne large-particle sorter and dispenser (Photo courtesy of BICO Group]

BICO Group subsidiaries Scienion and Cellenion today announced the launch of their SpheroOne single large-particle sorter and dispenser for drug testing using complex in-vitro 3D models.

The SpheroOne platform can dispense individual spheroids, organoids and tumoroids, handling cellular aggregates ranging from 80 µm to 600 µm and complementing Cellenion’s CellenOne platform for sorting and dispensing single cells (ranging from 0.5 µm to 80 µm), the companies said in a news release.

“Current offerings suffer from low throughput, inconsistent sorting and intensive manual dispensing,” Cellenion founder and Managing Director Guilhem Tourniaire said in the news release. “SpheroOne is going to play a significant role toward replacing animal models in pre-clinical research as it allows automated sorting, enables development of h…

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Edwards Lifesciences stock slides on Q3 financial results

Edwards Lifesciences (NYSE: EW) reported third-quarter financial results today that exceeded Wall Street’s expectations on profits but narrowly missed on sales.

The Irvine, California–based cardio device company reported earnings of $340.1 million (or 54¢ per share) off sales of $1.31 billion. That’s a 4.6% increase from Q3 2020’s earnings of $325.2 million (52¢ per share) off sales of $1.14 billion.

Edwards reported TAVR sales of $858 million, which were up 15% from the same three months a year ago. Edwards said transcatheter aortic valve replacement (TAVR) sales would have been higher if not for continued pressure on hospitals from COVID-19. The company said TAVR sales outside of the U.S. grew approximately 20% on a year-over-year basis.

Get the full story at our sister site, MassDevice.

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Edwards Lifesciences stock slides on Q3 financial results

Edwards Lifesciences (NYSE: EW) reported third-quarter financial results today that exceeded Wall Street’s expectations on profits but narrowly missed on sales.

The Irvine, California–based cardio device company reported earnings of $340.1 million (or 54¢ per share) off sales of $1.31 billion. That’s a 4.6% increase from Q3 2020’s earnings of $325.2 million (52¢ per share) off sales of $1.14 billion.

Edwards reported TAVR sales of $858 million, which were up 15 percent from the same three months a year ago. Edwards said transcatheter aortic valve replacement (TAVR) sales would have been higher if not for continued pressure on hospitals from COVID-19. The company said TAVR sales outside of the U.S. grew approximately 20 percent on a year-over-year basis.

“Although we experienced the encouraging signs of patient confidence and continued willingness to seek medical care in July, the Delta variant had a significant impact on hospital resources during the las…

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Avatour sees traction for 360° remote site meetings in pharma and beyond

Avatour technology in use at a Seqens facility

While COVID-19 has led to an uptick in remote inspections and virtual training, the startup Avatour (San Francisco) was working on its remote presence platform before the pandemic.

Devon Copley, CEO of the company, was the head of product, VR platform for Nokia from 2015 to 2017, where he was involved in creating a novel Nokia OZO 360° camera. “That was a $60,000 device made out of a single block of CNC-machined aluminum,” Copley recalled. “It was a beautiful piece of engineering, but a little ahead of its time, as it turned out.”

After Nokia decided to cancel the project, Copley reached out to Prasad Balasubramanian, who was in charge of the engineering team for the OZO advanced camera.

Over beers, the two concluded that the concept of enabling individuals to remotely visit a location and talk to individuals there in real-t…

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Avail Medsystems hires Varian veteran as president

[Image courtesy of Avail Medsystems]Telemedicine technology developer Avail Medsystems announced today that it appointed Ryan Magnes as its president.

Santa Clara, California-based Avail develops an audio and video telepresence platform designed to offer real-time collaboration through interactive broadcasts of live procedures from the operating room.

The company said in a news release that Magnes will report to Founder & CEO Daniel Hawkins while leading all commercial and customer-facing activities for the company.

Among Magnes’ focuses will be to work with the sales, marketing and field service leadership and teams to continue the expansion of Avail’s platform within a broad base of care settings.

“We started Avail to address a range of structural challenges that have emerged alongside the enormous changes in the healthcare and medical device industries over the last decade.  These challenges directly impact access to clinic…

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Advanced Energy debuts new mobile app version for streaming critical temperature data

Advanced Energy (NSDQ:AEIS) has introduced the TEGAMLink T2.0 mobile app, which works with the company’s TEGAM 930 Series Bluetooth thermometers for pharmaceutical and food safety applications.

The app supports the streaming and recording of temperature data from production-floor equipment to programs and quality management systems. A Touch Entry keyboard extension supports automation capability for companies with smart manufacturing implementations. The keyboard extension permits pharmaceutical companies to enter temperature data into form fields, documents, spreadsheets and quality management systems without modifying hardware or software.

Advanced Energy notes that the app eliminates the need for manual temperature data collection and measurement.

The app (shown below with the 932B datalogging thermometer), which is completely redesigned for its second version,  is available for both Android and iOS devices.

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Monteris Medical scores reimbursement win with Cigna

Monteris Medical announced today that Cigna released a national coverage policy supporting the use of its laser ablation therapy.

The medical coverage policy considers Minnetonka, Minnesota-based Monteris’ robot-assisted, MR-guided laser interstitial thermal therapy (LITT or laser ablation) medically necessary in the treatment of drug-resistant epilepsy and symptomatic brain tumors and radiation necrosis when medical necessity is met and the patient is not suitable for open brain surgery, according to a news release.

Cigna, one of the biggest payors in the U.S., awarded the coverage policy following recently issued position statements on the use of LITT for epilepsy and brian tumors, respectively, by the major neurological societies, according to Monteris. Additionally, LITT was included in guidelines issued by the National Comprehensive Cancer Network and Category Level 1 CPT codes approved by the American Medical Association with an effective date of Ja…

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What makes something ‘undruggable’?

Raymond Deshaies image courtesy of Amgen

A growing number of researchers believe the pharma industry has entered a new wave of innovation involving multispecific medicines. Among them is Ray Deshaies, a biochemist and cell biologist, who is now an SVP of global research at Amgen. 

In 2020, Deshaies wrote an article for Nature explaining why multispecific drugs may grant access to portions of the proteome currently off-limits for drug targeting. In other words, multispecifics could take aim at previously undruggable disease targets. 

Deshaies hosts the new ‘Undruggable’ podcast from Amgen’s R&D team that provides a historical context of drug innovation and insights into multispecific drug discovery and development.  

The podcast considers the conclusion that approximately 85% of the human proteome remains “undruggable,” meaning that small molecule drugs are unable to target given proteins to…

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BICO’s Scienion and Cellenion Launch SpheroOne large-particle sorter and dispenser

The SpheroOne large-particle sorter and dispenser (Photo courtesy of BICO Group]

BICO Group subsidiaries Scienion and Cellenion today announced the launch of their SpheroOne single large-particle sorter and dispenser for drug testing using complex in-vitro 3D models.

The SpheroOne platform can dispense individual spheroids, organoids and tumoroids, handling cellular aggregates ranging from 80 µm to 600 µm and complementing Cellenion’s CellenOne platform for sorting and dispensing single cells (ranging from 0.5 µm to 80 µm), the companies said in a news release.

“Current offerings suffer from low throughput, inconsistent sorting and intensive manual dispensing,” Cellenion founder and Managing Director Guilhem Tourniaire said in the news release. “SpheroOne is going to play a significant role toward replacing animal models in pre-clinical research as it allows automated sorting, enables development of …

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Takeda plans to acquire GammaDelta for its solid tumor drug pipeline

Takeda Pharmaceutical Company Ltd. (TSE:4502/NYSE:TAK) is moving forward with its plan to acquire its collaborator GammaDelta Therapeutics Ltd. (London).

The acquisition is subject to customary closing conditions. Takeda projects that the deal will close in the first quarter of its fiscal year, which will end on June 30, 2022.

The acquisition would bolster Takeda’s immuno-oncology and immunotherapy portfolio, given GammaDelta’s experience working with gamma delta (γδ) T cells as potential therapies for solid tumors hematological malignancies.

GammaDelta had developed allogeneic variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy platforms. Those platforms encompass blood-derived and tissue-derived cells.

“We’re committed to developing cell therapies that will have an impact on large segments of patients by focusing on off-the-shelf, allogeneic cell therapies that are highly accessible and have the potential to address solid tumors,” Christopher…

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CDC authorizes fourth COVID-19 vaccine dose for some immunocompromised patients

As a growing number of Americans become eligible for a third dose of COVID-19 vaccines, CDC continues to expand its booster guidelines.

The agency has amended its criteria for moderately to severely immunocompromised people to allow a fourth dose of COVID-19 vaccine six months after receiving the third dose.

The criteria pertain to immunocompromised individuals who are 18 years of age or older who have received three doses of an mRNA vaccine.

CDC will allow COVID-19 vaccines from Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX), Moderna (NSDQ:MRNA) or Janssen (NYSE:JNJ) for the fourth dose. For Moderna recipients, the guidance recommends a 100-µg dose of mRNA for the third dose and a 50-µg dose for the fourth.

The guidelines, however, are more overt in their recommendations for moderately or severely immunocompromised individuals who have only received two doses of an mRNA vaccine. Assuming at least 28 days have elapsed since the second dose, CDC recommends t…

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Thermo Fisher Scientific ticks up on Street-beating Q3 results

Thermo Fisher Scientific (NYSE:TMO) today posted third-quarter results that beat the overall consensus on Wall Street.

The Waltham, Massachusetts–based laboratory supply company reported profits of $1.9 billion, or $4.79 per share, on sales of $9.3 billion for the three months ended October 2, for a bottom-line loss of -1.6% on sales growth of 9.49% compared with Q3 2020.

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

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Teva announces two offerings worth $7.5 billion, dips on missed Q3 projections

Teva Pharmaceuticals (NYSE:TEVA) shares took a hit today on third-quarter results that fell short of the consensus forecast.

TEVA shares were down -4.7% at $8.95 per share in mid-morning trading. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down -0.8%.

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

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Bioventus cleared to acquire Misonix

Bioventus (NSDQ:BVS) this week announced that its stockholders approved the merger and acquisition of Misonix for an undisclosed amount.

The Durham, N.C.-based company’s stockholders approved the issuance of shares of Bioventus class A common stock to the stockholders of Misonix for the previously announced merger of the two companies. Through the deal, Misonix will become a wholly-owned subsidiary of Bioventus.

“We are pleased by the outcome of today’s vote and thank our stockholders for supporting the acquisition,” Bioventus CEO Ken Reali said in a news release. “The combination with Misonix creates significant value and provides a deeper global portfolio of pain treatments, restorative therapies and surgical solutions for patients. We are excited to welcome the Misonix team to Bioventus.”

“We are excited about our progress in completing the transaction that will drive long-term value for Misonix shareholders and look forward to closing,” Misonix…

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Thermo Fisher Scientific ticks up on Street-beating Q3 results

Thermo Fisher Scientific (NYSE:TMO) today posted third-quarter results that beat the overall consensus on Wall Street.

The Waltham, Massachusetts-based laboratory supply company reported profits of $1.9 billion, or $4.79 per share, on sales of $9.3 billion for the three months ended October 2, for a bottom-line loss of -1.6% on sales growth of 9.49% compared with Q3 2020.

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

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Thermo Fisher Scientific ticks up on Street-beating Q3 results

Thermo Fisher Scientific (NYSE:TMO) today posted third-quarter results that beat the overall consensus on Wall Street.

The Waltham, Massachusetts-based laboratory supply company reported profits of $1.9 billion, or $4.79 per share, on sales of $9.3 billion for the three months ended October 2, for a bottom-line loss of -1.6% on sales growth of 9.49% compared with Q3 2020.

Adjusted to exclude one-time items, earnings per share were $5.76, $1.09 ahead of The Street, where analysts were looking for sales of $8.4 billion.

“Our incredibly strong performance in the third quarter demonstrates our proven growth strategy powered by our PPI business system,” president and CEO Marc Casper said in a news release. “We continue to deliver exceptional performance in revenue, earnings and free cash flow. And we are launching innovative new products and expanding our capabilities and capacity to enhance our customer value proposition.”

R…

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Masimo beats the street in Q3 results

Masimo (NSDQ:MASI) this week posted third-quarter results that beat the overall consensus forecast on Wall Street.

The Irvine, California-based monitoring technology company reported profits of $57.8 million, or $1.00 per share, on sales of $307.4 million, for the three months ended October 2, for a bottom-line gain of 17% on sales growth of 10.5% compared with Q3 2020.

Adjusted to exclude one-time items, earnings per share were 94¢, 3¢ ahead of The Street, where analysts were looking for sales of $295.8 million.

“In the wake of the pandemic and its ongoing challenges, we have continued to demonstrate the commitment and responsiveness required to meet the needs of clinicians and patients around the world. We are happy to report double-digit revenue growth and EPS growth that exceeded expectations for the third quarter,” CEO Joe Kiani said.

Masimo adjusted its full-year revenue estimates from $1.216 billion to $1.230 billion.

Shares in…

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NuVasive to launch virtual reality training platform for spine surgery

NuVasive (NSDQ:NUVA) announced today that it will release a virtual reality (VR) training module for its NuVasive X360 system.

San Diego-based NuVasive said in a news release that the launch of the cutting-edge training module complements its market-leading clinical professional development (CPD) program.

The NuVasive X360 VR training module — developed in collaboration with PrecisionOS — integrates NuVasive’s comprehensive lateral approach to single-position spine surgery, which includes XLIF, XALIF and XFixation, into a virtual simulation of the procedural workflow in an effort to offer remote access to hands-on learning experiences with the company’s surgical techniques.

“Our collaboration with PrecisionOS reiterates our long-standing commitment to surgeon training and education to help further the adoption of less invasive surgical procedures like X360,” NuVasive CCO Massimo Calafiore said in the release. “The integratio…

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Boston Scientific tops earnings estimates in Q3

Boston Scientific (NYSE:BSX) shares were down before hours today on third-quarter results that were mixed compared to the consensus forecast.

The Marlborough, Massachusetts-based company posted profits of $419 million, or 28¢ per share, on sales of $2.9 billion for the three months ended Sept. 30, 2021, for a bottom-line gain from losses of $155 million this time last year on sales growth of 10.3%.

Adjusted to exclude one-time items, earnings per share were 41¢, 1¢ ahead of Wall Street, where analysts were looking for sales of $3 billion.

Each of Boston Scientific’s business segments experienced year-over-year revenue growth from 2020, with its cardiovascular business growing the most (19.4%). MedSurg increased by 11.2% and rhythm and neuro grew by 8.2%.

“We’ve seen this year that our strategy of category leadership, focus on high-growth markets and smart tuck-in M&A deals, combined with execution by our global team and an ex…

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Moderna doses first patient in Phase 3 trial mRNA cytomegalovirus vaccine

Stéphane Bancel, Moderna’s (NSDQ:MRNA) CEO, has stressed that the company is not just a COVID-19 vaccine maker.

Now, the Cambridge, Massachusetts–based company has announced that its mRNA-based cytomegalovirus (CMV) vaccine candidate is entering a Phase 3 pivotal registration study. Known as mRNA-1647, the investigational vaccine integrates six mRNAs in a single vaccine.

A total of five mRNAs encode the subunits that form the membrane-bound pentamer complex. Another mRNA encodes the full-length membrane-bound glycoprotein B (gB).

There are presently no CMV vaccines available in the U.S. market.

CDC notes that more than half of U.S. adults have been infected with CMV by the age of 40. Expectant mothers can pass the virus on to unborn children. One out of 200 newborns has the virus. Roughly one in five babies with the virus has health problems stemming from the infection, including jaundice, low birth weight, hearing loss, seizures and blindness. In…

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