‘Freeze-Lock’ cryo label supports the needs of frozen medications

The Freeze-Lock cryo label from Schreiner MediPharm (Oberschleissheim, Germany) is suited for mRNA-based vaccines. The labels also support many cell and gene therapy medications and clinical trials, given their ability to withstand subzero storage and transport temperatures required by pharmaceutical and biopharmaceutical manufacturers and clinical researchers.

Schreiner MediPharm notes that conventional labels fail to offer consistent adhesion. The company’s Freeze-Lock cryo label comprises two interlocking label layers to optimize for adhesive strength and product information readability.

The label includes two components: a bottom and a top label.

The bottom label layer has a microfine surface texture that bonds to a container at room temperature. After being filled with the active ingredient, the label is ready to be stored at subzero temperatures requiring dry ice (–78 °C/–108.4 °F) or liquid nitrogen (–196 °C/–320.8 °F).

The top label layer …

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Moderna commences Phase 2 study of omicron-specific booster

Mere days after rivals Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced the launch of a study testing an omicron-based booster vaccine candidate, Moderna (NSDQ:MRNA) has announced its own trial of an omicron-specific vaccine.

The vaccine booster candidate, mRNA-1273.529, will be the subject of a Phase 2 study involving approximately 600 participants divided into two cohorts.

The first cohort in the trial will receive a dose of the mRNA-1273.529 after receiving a primary series of the COVID-19 vaccine mRNA-1273. The second cohort will receive a dose of mRNA-1273.52 after receiving a two-dose primary series and a 50-µg booster dose of the same vaccine.

The company is also considering including the omicron-specific vaccine candidate in its multivalent booster program.

The company had previously announced that a third dose of the mRNA-1273 appeared to result in a considerable increase in protection against the omicron variant. A 50-µg booster of t…

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How Phillips-Medisize helped Sotech Health develop a breath analyzer for COVID-19

Sotech Health and Phillips-Medisize claim the breath analyzer can detect traces of the virus that causes COVID-19 within 30 seconds. [Image courtesy of Phillips-Medisize and Sotech Health]Medtech contract manufacturing giant Phillips-Medisize used its human-factors product design expertise to help startup Sotech Health create what the companies claim is a breath sensor system that can detect COVID-19 in less than 30 seconds.

Dallas-based Sotech Health has submitted the device to the FDA for an emergency use authorization. It’s also seeking regulatory nods in Canada, the United Kingdom and the European Union.

Phillips-Medisize (Hudson, Wisconsin) is readying its global production facilities to keep pace with the anticipated demand for the Sotech Health breath analyzer. A Molex company, Phillips-Medisize has 36 facilities worldwide.

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

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How Phillips-Medisize helped Sotech Health develop a breath analyzer for COVID-19

Sotech Health and Phillips-Medisize claim the breath analyzer can detect traces of the virus that causes COVID-19 within 30 seconds. [Image courtesy of Phillips-Medisize and Sotech Health]

Medtech contract manufacturing giant Phillips-Medisize used its human-factors product design expertise to help startup Sotech Health create what the companies claim is a breath sensor system that can detect COVID-19 in less than 30 seconds.

Dallas-based Sotech Health has submitted the device to the FDA for an emergency use authorization. It’s also seeking regulatory nods in Canada, the United Kingdom and the European Union.

Phillips-Medisize (Hudson, Wisconsin) is readying its global production facilities to keep pace with the anticipated demand for the Sotech Health breath analyzer. A Molex company, Phillips-Medisize has 36 facilities worldwide.

The contract manufacturer boasts that its electronics, produ…

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How Bigfoot Biomedical plans to take diabetes management forward

Bigfoot Biomedical’s smart insulin pen cap [Image from Bigfoot Biomedical]

For close to 20 years, Jeffrey Brewer has focused on finding ways to support insulin delivery and manage diabetes.

Mazlish was the first person in the world to hack into an insulin pump and continuous glucose monitor (CGM) and enable a do-it-yourself closed-loop insulin dosing system, Brewer told Drug Delivery Business News.

“It turned my attention to the opportunities as an entrepreneur that I might be able to pursue, and then doing so with him, to see what we could add to the equation in terms of industry and how you can take technologies and make them usable and easy and ultimately make life more convenient, easy and safe for people with insulin-requiring diabetes,” said Brewer, who is CEO of Bigfoot. “We’ve been on this journey for about seven years now.”

Initially an entrepreneur, Brewer got involved with the Juvenile …

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How Bigfoot Biomedical plans to take diabetes management forward

Bigfoot Biomedical’s smart insulin pen cap [Image from Bigfoot Biomedical]For close to 20 years, Jeffrey Brewer has focused on finding ways to support insulin delivery and manage diabetes.

Mazlish was the first person in the world to hack into an insulin pump and continuous glucose monitor (CGM) and enable a do-it-yourself closed-loop insulin dosing system, Brewer told Drug Delivery Business News.

“It turned my attention to the opportunities as an entrepreneur that I might be able to pursue, and then doing so with him, to see what we could add to the equation in terms of industry and how you can take technologies and make them usable and easy and ultimately make life more convenient, easy and safe for people with insulin-requiring diabetes,” said Brewer, who is CEO of Bigfoot. “We’ve been on this journey for about seven years now.”

Initially an entrepreneur, Brewer got involved with the Juvenile Diabetes Research Foundation (JDRF) and the Artificial Pancrea…

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Smart bone growth company Intelligent Implants announces CEO

Intelligent Implants’ new CEO Benjamin Hertzog

Digital medicine and orthopedics startup Intelligent Implants announced that it has brought on Benjamin A. Hertzog as its CEO

Hertzog was most recently Entrepreneur in Residence with Johnson and Johnson’s Center for Device Innovation at the Texas Medical Center. He previously was founding CEO of catheter-deployed heart pump developer Procyrion, which he led through a Series C financing.

“Ben joined Intelligent Implants as Executive Chairman of the Board in 2020, and his broad experience in complex Class-III medical devices, leadership, and exceptional track record made it an obvious choice to have Ben join us at the helm of the company,” said John Zellmer, Intelligent Implants’ co-founder and founding CEO.

“Ben has the skills and credibility to guide Intelligent Implants as we navigate through the next stage of clinical and commercial activities, Zellmer added in a news release that posted yester…

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BioVentrix expands heart failure treatment portfolio with MateraCor acquisition

BioVentrix announced today that it has acquired MateraCor, a company developing injectable alginate-based hydrogel to treat heart failure.

San Ramon, Calif.–based BioVentrix is a privately held medical device company focused on less invasive therapies to treat the left ventricle.

The financial terms of the deal were not disclosed.

“This is an exciting time for BioVentrix as we build a platform of synergistic therapies to treat a dilated left ventricle, the root cause of ischemic and idiopathic heart failure,” BioVentrix CEO Jim Dillon said in a news release.

Dillon added that buying MateraCor and its lead Trans-Catheter Myocardial Restoration (TCMR) product reinforces BioVentrix’s position to treat left ventricular heart failure with a variety of products and services.

Also today, BioVentrix announced the appointment of Steve Chartier, former VP of global clinical affairs at liver cancer therapies company Sirtex Medical, as the compan…

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Data breaches targeting pharma companies are ‘rampant,’ report says

Photo by Edward Jenner from Pexels

For pharmaceutical companies, cyberattacks can get expensive quickly. 

In 2021, the average cost of a data breach was $5 million, which is the third-highest of any industry, according to the IBM Cost of a Data Breach report. 

Cyberattacks can also cause operational disruptions. For example, in 2017, Merck & Co. (NYSE: MRK) struggled to keep up with demand for hepatitis B vaccine because it was a victim of Notpetya ransomware. Merck estimated the damages from that attack to be roughly $1.4 billion. 

Breaches in the pharma industry are rampant, concludes a recently published report from the cybersecurity firm Constella (Los Altos, California), which analyzes data exposures, breaches and leakages within the industry from January 2018 to September 2021. In that time frame, the company identified 9,030 breaches or leakages and more than 4,500,000 exposed record…

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Accuray dips despite Q2 revenue beat, raised guidance

Accuray (NSDQ:ARAY) shares dipped this morning despite second-quarter results that beat the consensus sales forecast.

The Sunnyvale, California-based radiation oncology company posted profits of $179,000, breaking even at $0.00 on earnings per share, on sales of $116.3 million for the three months ended Dec. 31, 2021, for a major bottom-line slide from profits of $4.8 million this time last year despite sales growth of 19.3%.

Accuray’s earnings per share of $0.00 equaled expectations on Wall Street, where analysts were looking for sales of $103.3 million.

“Accuray’s fiscal 2022 second-quarter performance continues to reflect the strong customer demand and revenue momentum our business is generating, but also highlighted global supply chain challenges and operational headwinds created by the Covid environment,” Accuray CEO Joshua Levine said in a news release. “Driving our accelerated revenue growth is the continued adoption …

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Fujifilm to aquire Atara’s T-cell manufacturing facility in California for $100M

Atara Biotherapeutics announced yesterday that Fujifilm will acquire its T-cell operations and manufacturing (ATOM) facility for $100 million.

South San Francisco-based Atara entered into a long-term strategic agreement with Fujifilm’s Diosynth Biotechnologies (FDB) subsidiary under which Fujifilm will acquire the ATOM facility in Thousand Oaks, Calif., and retain current manufacturing and quality staff at the site.

The deal also includes a long-term supply agreement that could extend to 10 years. After the transaction completes — which is expected to happen in April 2022 — FDB will provide Atara with access to the capacity and capability needed to manufacture clinical and commercial-stage allogeneic cell therapies for its pipeline. FDB will also expand the use of the manufacturing site and use its staff to manufacture a broader portfolio of cell therapies, according to a news release.

Atara’s pipeline includes tabelecleucel (tab-cel),which i…

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FDA considers another Philips ventilator recall serious

[Image from Philips/FDA]The FDA has identified another recall for Royal Philips‘ (NYSE:PHG) Respironics business, confirming it as Class I, the most serious kind.

Philips said last summer that it is no longer taking orders of sleep therapy systems as it handles an earlier recall, which may knock it out of the sleep therapy market for a year. last year’s urgent medical device recall for Philips’ DreamStation continuous positive airway pressure (CPAP) devices.

The FDA classified the company’s recall of the DreamStation continuous positive airway pressure (CPAP) devices as Class I, the most serious kind, in July 2021 as a result of polyester-based polyurethane (PE-PUR) sound abatement foam breaking down, allowing for the potential for the foam to enter a device’s air pathway, causing a host of health problems and toxic carcinogenic effects for the user.

Along with supply chain issues, the Respironics recall adversely affected Philips’ fourth-…

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