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Want to reopen your pharma lab amid COVID-19? Consider these strategies first

Here are a few real estate and facility management strategies to help you get your pharma R&D lab up and running amid the COVID-19 pandemic, courtesy of commercial real estate outfit JLL.

Roger Humphrey, JLL

[Photo by Fusion Medical Animation on Unsplash]

COVID-19 has unleashed a logistical conundrum for pharmaceutical leaders: How do you keep momentum in therapeutics development, when, like all workplaces, most labs have had to either restrict use or close altogether? The answer lies, at least in part, in what companies do now to prepare for a safe, effective reopening.

It won’t be easy, given the pandemic’s colossal impact. Every company will have its own best path to reopening, based on variances in local regulations and capital flow. But there are four key real estate and facility management strategies that can support leaders through this crisis:

1. Harness the power of data to supp…
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BD launches COVID-19 antigen test that can produce results in 15 minutes

Becton Dickinson (NYSE:BDX) announced today that it’s received an FDA emergency use authorization for its COVID-19 antigen test, which the company will start shipping this week.

BD plans to ramp-up manufacturing capacity to 2 million tests per week by the end of September, with 10 million tests produced by the end of September. The tests run on BD’s highly portable Veritor instruments; the company already has about 25,000 Veritor instruments installed at healthcare providers and pharmacies across the U.S.

The assay can produce results in 15 minutes, with 84% sensitivity (ability to exclude false positives) and 100% specificity (ability to exclude false negatives).

“This will be a game-changer for frontline health care workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real-time at convenient locations like retail pharmacies, urgent care centers and doctors’ offices,” sai…

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Novartis, Alexion charged with FPCA violations

 

Novartis (NYSE:NVS) and Alexion Pharmaceuticals (NSDQ:ALXN) were charged with violations of the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA).

The Securities & Exchange Commission (SEC) announced that the pharmaceutical companies both committed violations and both agreed to pay millions of dollars to settle the charges. Novartis settled to pay over $112 million and Alexion agreed to pay more than $21 million.

Basel, Switzerland-based Novartis, with its local subsidiaries or affiliates, or former subsidiary Alcon, was found to have engaged in schemes to make improper payments or to provide benefits to public and private healthcare providers in South Korea, Vietnam and Greece in exchange for prescribing or using Novartis or Alcon products.

The SEC says the schemes took place between 2012 and 2016 and were known among certain managers of the subsidiaries or affiliates. According t…

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RTI Surgical posts losses ahead of potential OEM business sale

RTI Surgical (NSDQ:RTIX) shares dipped today on first-quarter results that fell short of the consensus forecast.

The Deerfield, Ill.-based company posted losses of -$17.9 million, or -24¢ per share, on sales of $73.7 million for the three months ended March 31, 2020, for a 91% bottom-line slide on sales growth of 5.3%.

Adjusted to exclude one-time items, losses per share were also -24¢, 23¢ behind Wall Street, where analysts were looking for sales of $75.3 million.

“I am very proud of the actions taken by our entire organization over the last several months as we have navigated the COVID-19 pandemic while at the same time managing through the pending sale of the OEM business and a number of other headwinds,” RTI Surgical president & CEO Camille Farhat said in a news release. “The integrity, dedication, and talent of our people have enabled us to come out on the other side of this unique period in time ready to take advantage of the opportunities that…

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Forest Devices partners with Alberta Health Services

Forest Devices announced that it entered into a partnership with Alberta Health Services (AHS) to improve healthcare delivery for stroke patients.

Pittsburgh-based Forest Devices and Calgary, Alberta-based AHS aim to evaluate, implement and scale technologies that can improve patient outcomes and health system economics in Alberta throughout the five-year collaboration, according to a news release.

Forest Devices develops the AlphaStroke stroke diagnostic platform to support prehospital health care providers in identifying strokes in the field so they can make the best triage decisions for patients. The company won the 2019 MedTech Innovator global competition in September and was included in Medical Design & Outsourcing’s list of 20 medtech startups you need to know.

Through the Prehospital Stroke Diagnostics Project, created by AHS in 2019, a team assessed 14 technologies and ultimately determined that AlphaStroke was the most viable solution…

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AdaptHealth prices $124m upsized offering

AdaptHealth (NSDQ:AHCO) announced today that it upsized and priced an underwritten offering of common stock at approximately $124 million.

Plymouth Meeting, Pa.-based AdaptHealth is offering 8 million shares of its Class A common stock at $15.50 per share. The maker of home medical equipment, supplies and related services had previously set the offering at 6.5 million shares of common stock.

Before deducting underwriting discounts and commissions and estimated offering expenses, AdaptHealth expects to pull in approximately $124 million. Additionally, it granted underwriters a 30-day option to purchase up to 1.2 million additional shares of Class A common stock.

AdaptHealth expects the offering to close on July 6, subject to customary closing conditions. It intends to use the net proceeds for general corporate purposes, including acquisitions and other business opportunities, along with capital expenditures and working capital.

Jefferies, Deutsche …

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Switchback Medical adds ‘sandbox approach’ to device testing

Contract manufacturer Switchback Medical (Maple Grove, Minn.) today announced that it has added a new division.

Switchback BioSim Innovations offers functional dynamic biosimulator model development, cell culture services and physician training, according to the company. Biosimulator models use animal and human tissue to create functional models, such as a pumping heart with working valves to assess a valve repair device, perfused tissues to evaluate neurovascular catheter usability, or a neuron cell culture built on a biodegradable scaffolding.

The new service allows Switchback to develop preclinical models for device testing and training that currently do not exist, improve the safety and efficacy of the devices and significantly speed the development cycle, according to the company.

“We are extremely excited about this new venture,” Switchback Medical principal said Brady Hatcher in a news release. “It allows our customer’s product develop…

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TransEnterix prices $13m offering

TransEnterix (NYSE:TRXC) announced today that it priced its previously announced common stock offering at approximately $13 million.

Research Triangle Park, N.C.-based TransEnterix is offering nearly 37.3 million shares of common stock at a public offering price of 35¢ per share to total the $13 million in proceeds, before deducting underwriter discounts and commissions and expenses payable by the company, according to a news release.

TransEnterix expects the offering to close on or about July 6, subject to customary closing conditions. The surgical robotics company also granted the underwriter a 45-day option to purchase up to nearly 5.6 million additional common stock shares at the public offering price.

All the shares in the offering are being sold by TransEnterix, which currently intends to use the net proceeds for general corporate purposes, including working capital. Ladenburg Thalmann & Co. is acting as sole book-running manager in connection …

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Abiomed touts results of U.S. study of its latest Impella heart pump

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]

Abiomed (NSDQ:ABMD) says a study of U.S. patients receiving the new Impella 5.5 with SmartAssist found that 84% survived to explant and 76% experienced native heart recovery.

The study — published in the July edition of the American Society for Artificial Internal Organs (ASAIO) Journal — examined the outcomes of the first 55 patients treated with Impella 5.5 with SmartAssist at Cleveland Clinic, Hackensack University Medical Center/Hackensack Meridian Health and Cedars-Sinai Medical Center.

Study authors and cardiac surgeons Drs. Ed Soltesz, Mark Andersonv and Danny Ramzy cautioned that the study represented an early experience in a heterogeneous patient population, but they still found the results encouraging. They deemed the Impella 5.5 with SmartAssist to be safe and effective for a number of chal…

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Smith College team wins ventilator design challenge

(Image courtesy of CoVent-19 Challenge)

A team of Smith College engineering alumnae, staff and faculty has won the CoVent-19 Challenge to design a rapidly deployable ventilator to address shortages caused by the COVID-19 pandemic, particularly in developing countries.

A dozen anesthesiology resident physicians from Massachusetts General Hospital kicked off the public challenge April 1, attracting 200 entries. The 30-person team from the Northampton, Mass., college took a winning design from concept through working prototype. The next step could be a final product for regulatory approval in Nigeria, one of the countries that have been talking with the CoVent-19 Challenge organizers.

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

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Smith College team wins ventilator design challenge

(Image courtesy of the CoVent-19 Challenge)

A team of Smith College engineering alumnae, staff and faculty has won the CoVent-19 Challenge to design a rapidly deployable ventilator to address shortages caused by the COVID-19 pandemic, particularly in developing countries.

A dozen anesthesiology resident physicians from Massachusetts General Hospital kicked off the public challenge April 1, attracting 200 entries. The 30-person team from the Northampton, Mass., college took a winning design from concept through working prototype. The next step could be a final product for regulatory approval in Nigeria, one of the countries that have been talking with the CoVent-19 Challenge organizers.

The SmithVent design, which is one-tenth the cost of traditional ventilators, combines economical proportional solenoid valve technology with an air-oxygen mixing chamber to meet the full set of requirements for COVID-…

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VyCor Medical, NovaVision sign licensing agreement

Vycor Medical (OTC:VYCO) announced that its wholly-0wned subsidiary NovaVision entered into a licensing agreement with HelferApp GmbH.

The exclusive licensing agreement gives HelferApp the exclusive rights for NovaVision’s diagnostic products and therapies provided directly to patients and medical professionals in Germany, Austria and Switzerland, according to a news release.

Vycor previously said in May that it planned to close NovaVision’s German office and evaluate a transition to a license model for the subsidiary in Europe. NovaVision will look to partner with regional companies to leverage its clinically supported vision therapies, as well.

HelferApp plans to drive the adoption of NovaVision’s NeuroEyeCoach saccadic training program, which recently demonstrated effectiveness in assisting patients who have a visual field deficit with their visual search tasks, according to the release.

Existing NovaVision pat…

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Aerus healthcare-specific air purifier cleared by FDA

(Image courtesy of Aerus)

Aerus announced today that it received Class II medical device clearance from the FDA for the Aerus Medical Guardian with ActivePure technology, which the company calls the first active air purifier for healthcare.

ActivePure was designed to operate continuously in occupied spaces and prevent recontamination in real time. The free-standing, portable unit uses NASA-inspired technology to purify the air continuously and actively without the use of ozone, according to the Dallas, Texas-based company formerly known as Electrolux.

The device is intended to reduce staphylococcus epidermidis and erwinia herbicola bacteria; MS2 and Phi-X174 viruses; aspergillus niger fungal spores; and bacillus globigii bacterial spores from the air in a temperature-controlled professional health care-environment of 70 to 71 degrees Fahrenheit, 40%-45% RH.

“We believe our breakthrough technolo…

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Xeris Pharmaceuticals launches autoinjector for severe hypoglycemia

Xeris Pharmaceuticals today said it has launched its Gvoke HypoPen glucagon injection to treat severe hypoglycemia.

The autoinjector is designed to treat severe hypoglycemia in adults and children with diabetes that are ages two years and older. The premixed autoinjector has no visible needle and has a reliable delivery method. According to the company, 99% of people were able to use the device correctly and 99% of adults and 100% of kids had their blood sugars raised to safe levels.

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

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Xeris Pharmaceuticals launches autoinjector for severe hypoglycemia

Xeris Pharmaceuticals today said it has launched its Gvoke HypoPen glucagon injection to treat severe hypoglycemia.

The autoinjector is designed to treat severe hypoglycemia in adults and children with diabetes that are ages two years and older. The premixed autoinjector has no visible needle and has a reliable delivery method. According to the company, 99% of people were able to use the device correctly and 99% of adults and 100% of kids had their blood sugars raised to safe levels.

It is available in 0.5mg/0.1mL doses for children who weigh less than 100 pounds and 1mg/0.2mL for adolescents and adults who weigh more than 100 pounds.

“We are excited to announce that Gvoke HypoPen is now available. The simplicity and reliability of Gvoke HypoPen has the potential to change people’s ability to confidently respond to a severe hypoglycemic event in a timely manner,” CEO Paul Edick said in a news release. “In addition, as we prepared for launch, we had…

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FDA gives certain device makers more time to add UDIs

The FDA said today that it will grant manufacturers of Class 1 and unclassified medical devices and certain others more time to add unique device identifiers (UDIs) to their products.

These companies will now have until Sept. 24, 2022 to comply with the agency’s UDI rule, including standard date formatting, labeling and Global Unique Device Identification Database (GUDID) data submission requirements. The new guidance, published here, revises guidance issued in 2018. It also covers certain devices that require direct marking, but does not include implantable, life-sustaining, or life-supporting devices.

The FDA implemented a final rule in 2013 requiring UDIs on most medical devices, including updated labeling designs and requiring that certain information be submitted to GUDID. The national UDI system is intended to provide structure to improve best practices, including in care and delivery of medical devices and is especially important for high-risk impl…

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Eurofins launches 10-minute COVID-19 exposure testing device

Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19.

The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release.

Get the full story at our sister site, MassDevice.

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Eurofins launches 10-minute COVID-19 exposure testing device

Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19.

The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release.

Eurofins’ CE-Marked INgezim dual-recognition immunochromatographic assays determine the presence of total antibodies (IgG, IgA and IgM) specific to SARS-CoV-2 in a single blood, serum and plasma sample by using nucleoprotein as an antigen to detect the antibodies.

Kits for the assay include all materials needed to perform the finger-prick test, with analysis capable of being performed outside a laboratory, although the tests are intended for use by healthcare professionals and not for self-diagnosis.

According to the release, more than 400 sera samples were observed to validate the assays, as no cross-reactivity…

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How is RF technology shaping the future of medtech?

RF technology, including microwaves, isn’t just about wireless communications or military radar these days. Times Microwave Systems experts point out that it is increasingly important when it comes to medtech.

Many medical electronics systems such as magnetic resonance imaging (MRI) systems for cancer detection rely on RF/microwave technology. Times Microwave Systems (Wallingford, Conn.) is hosting two upcoming webinars  — July 9, at 9 a.m. Eastern time, and July 15, at 2:30 p.m. Eastern time — to explore current and future medical device applications of RF/microwave technology.

Click here to register for one of Times Microwave Systems’ webinars. 

Discover how high-performance RF/microwave components, including precision cable assemblies, contribute to a variety of custom medical applications. RF/microwave technology enables diagnostic imaging systems, electrosurgical devices, patient and equipment monitoring, and overall medical facility con…

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UK officials question market impact of Stryker-Wright Medical merger

The United Kingdom Competition & Markets Authority (CMA) issued a statement of concern over the impact of the purchase of Wright Medical (NSDQ:WMGI) by Stryker (NYSE:SYK).

CMA believes that, should the $4.7 billion acquisition go through, it would have a “negative impact on vulnerable patients in the U.K. who need ankle replacements,” according to a news release.

After a Phase 1 investigation, the CMA observed that the purchase would result in the merged entity obtaining a share of over 90% in the total ankle replacement prostheses market in the U.K., leading to concerns over a lack of competition from other suppliers and potentially higher prices or fewer choices for hospitals and their patients.

CMA launched a probe into the acquisition in May, saying it will decide by July 15, 2020,if it will launch the second phase of its investigation. It now says Stryker and Wright have until July 7 to address its concerns through the offer of under…

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Smith & Nephew expects 29% sales dip in Q2

Smith & Nephew (NYSE:SNN) said today it expects second-quarter revenues to dip by 29% due to the coronavirus pandemic, although results gradually improved as time went on.

Sales were hardest hit in the company’s orthopedic reconstruction, sports medicine and ENT businesses due to the pandemic-related lockdown and pause in elective surgeries. The company’s advanced wound management and trauma businesses fared better, executives said in a statement, but “significant uncertainty and geographical variation” persist, they added.

While the revenue drop is in line with SNN’s previously published outlook, sales gradually improved over the quarter, with revenue declines of -47% in April, -27% in May and -12% in June, they noted.

“As a result of the trading performance across the first and second quarters, we continue to expect that the first half trading margin will be substantially down on the prior year,” company of…

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