ATA Freight expands in India to serve growing pharma industry

The international logistics company ATA Freight is opening a new facility in Hyderabad due to growing demand from India’s quickly-growing pharmaceutical industry.

The Hyderabad facility will primarily cater to the pharmaceutical industry.

“ATA Freight already has a strong footprint in India’s pharmaceutical industry, serving many of the area’s leading pharma manufacturers,” said ATA freight chief operating officer Matt Goker. “We are also responding to the growing need from pharma companies in the Telangana region [in south-central India].”

The Telangana region is home to a high concentration of pharma companies.

India is also home to Serum Institute of India, which is the world’s largest manufacturer of vaccines.

India ranks third in the world in terms of pharmaceutical product volume.

ATA Freight has more than 30 facilities in total. Outside of India, it has sites in the U.S., Russia, Turkey, China and Mexico.

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Paratek reveals Nuzyra data on pneumonia and skin infections

Antibiotic specialist Paratek Pharmaceuticals (NSDQ:PRTK) recently shared new data related to its tetracycline-class antibacterial Nuzyra (omadacycline).

Specifically, the company provided real-world data related to pneumonia, skin infections and nontuberculous mycobacterial infections in presentations at IDWeek 2021, a virtual conference organized by several infectious disease associations. The company also has collected data on in vitro activity related to B. anthracis, the bacterium that causes anthrax.

“With these presentations, Paratek continues to deepen the understanding of the utility of Nuzyra for serious community-acquired infections and nontuberculous mycobacterial infections, a rare disease for which there are no approved therapies,” said Randy Brenner, chief development & regulatory officer of Paratek, in a statement. “Notably, we will share the results of two studies examining the potential of Nuzyra in treating anthrax infections,…

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Lonza bolsters drug manufacturing services in Switzerland

Contract development and manufacturing organization Lonza has announced a series of expansion projects during the pandemic. Most recently, the Basel-based company revealed plans to expand its drug product manufacturing services on its home turf in Switzerland.

Included in the expansion will be an installation of a new aseptic fill and finish line in the city of Stein in northern Switzerland. The filling line will enable the company to process various drug types such as monoclonal antibodies, bioconjugates and viral vectors. The company aims to finish the expansion by 2023.

The company is also beefing up its drug product services in nearby Basel. Specifically, its investments in Stücki Technologiepark in Basel will increase its offerings for early and late clinical stages. The expansion will also add to its capabilities related to integrated drug substances and drug products. Lonza aims to finish this expansion in 2024.

In late August, the company unveile…

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Moderna CEO predicts the pandemic will be over in a year

In an interview with the German-language Neue Zürcher Zeitung, Moderna leader Stéphane Bancel shared his predictions about the course of the pandemic.

When asked when the pandemic phase would end, Bancel replied: “As of today, I assume in one year.”

Seniors will need yearly COVID-19 boosters, Bancel said, while the rest of the public will benefit from boosters once every three years.

The durability of COVID-19 vaccines depends on age. Bancel pointed to the coronavirus OC43 as a case in point. The virus, which causes mild-to-moderate respiratory infections, tends to infect older people annually, while younger people about once every three years. “That shows us approximately the path we will tread with COVID-19,” Bancel told the newspaper.

The company is developing a flu vaccine that will cover OC43. In addition, the company is also developing a combination flu–COVID-19 vaccine.

Bancel is confident in the need for boosters, arguing that the e…

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Fujifilm picks up 10-year contract from U.S. Navy for digital radiography systems

Fujifilm Medical Systems has been awarded a long-term sole-source contract from the U.S. government for its digital radiography (DR) systems.

Lexington, Massachusetts-based Fujifilm confirmed last month that the U.S. Navy and Defense Logistics Agency (DLA) awarded it the 10-year contract to outfit Naval Fleet vessels with its DR x-ray room systems.

Fujifilm’s DR x-ray room systems include next-generation detector technology and a high-quality, compact, floor-mounted room with all of the latest features. The company anticipates the initial DR system delivery and installation will occur for a new U.S. navy ship later this year.

The Navy selected Fujifilm’s DR system on the back of a two-year evaluation and comparison with competitive technologies. The company was selected as the singular vendor that best met or exceeded the Navy’s standards and criteria, it said.

“Fujifilm is honored to be awarded this significant contract from the…

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The MedTech Conference by AdvaMed to be a mixture of in-person and virtual

To hold an event or not to hold a live event. Medtech trade association AdvaMed chose both for The Medtech Conference, which takes place next week.

The September 27–30 conference includes a mixture of virtual presentations and in-person events in Washington, D.C., and Minneapolis. AdvaMed CEO Scott Whitaker mentioned several conference agenda highlights during a news conference today:

Former U.S. Secretary of Defense Chuck Hagel will deliver an afternoon keynote on Monday, September 27, in Washington, D.C. CMS’s chief medical officer Dr. Lee Fleisher will discuss his work during a late morning talk on September 27. FDA’s Virtual CDRH Town Hall — a perennial favorite at the conference — will take place virtually on the evening of September 27. The in-person Minneapolis events September 29–30 include a who’s who of medtech CEOs, including Abiomed’s Michael R. Minogue (also the present AdvaMed board chair), Edwards Lifesciences’ Michael…
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The MedTech Conference by AdvaMed to be a mixture of in-person and virtual

To hold an event or not to hold a live event. Medtech trade association AdvaMed chose both for The Medtech Conference, which takes place next week.

The September 27–30 conference includes a mixture of virtual presentations and in-person events in Washington, D.C., and Minneapolis. AdvaMed CEO Scott Whitaker mentioned several conference agenda highlights during a news conference today:

Former U.S. Secretary of Defense Chuck Hagel will deliver an afternoon keynote on Monday, September 27, in Washington, D.C. CMS’s chief medical officer Dr. Lee Fleisher will discuss his work during a late morning talk on September 27. FDA’s Virtual CDRH Town Hall — a perennial favorite at the conference — will take place virtually on the evening of September 27. The in-person Minneapolis events September 29–30 include a who’s who of medtech CEOs, including Abiomed’s Michael R. Minogue (also the present AdvaMed board chair), Edwards Lifesciences’ Michael…
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TFF Pharmaceuticals sees promise in Phase 1 trial of inhaled tacrolimus powder for lung transplant

The biopharma TFF Pharmaceuticals (NSDQ:TFFP) has announced that its inhalation powder of the immunosuppressive drug tacrolimus was well tolerated in a Phase 1 trial in lung transplant patients.

Tacrolimus is a traditional option for preventing rejection of a transplanted organ, albeit in tablet or capsule form.

It is common for lung transplant recipients to have high tacrolimus blood concentrations. Such concentrations are linked to an elevated risk of acute kidney injury and, potentially, chronic kidney disease. To minimize the risk of injury, physicians rely on therapeutic drug monitoring to maintain consistent drug levels in a narrow window.

TFF Pharmaceuticals believes that inhalable tacrolimus can potentially address the problem by maintaining high levels of the drug at the graft site rather than systemically.

TFF plans to conduct a Phase 2 study of the powdered tacrolimus in lung transplant recipients.

“The data from this Phase 1 stu…

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Pavmed subsidiary Lucid Diagnostics files registration statement for IPO

Pavmed (NSDQ:PAVM) subsidiary Lucid Diagnostics announced that Lucid publicly filed a registration statement related to a proposed initial public offering (IPO).

The number of shares of common stock and the price range for the offering have not yet been determined, according to a news release. Lucid Diagnostics intends to list its common stock on the Nasdaq market under the “LUCD” ticker.

Cantor Fitzgerald & Co. and Canaccord Genuity LLC will act as joint book-running managers for the proposed offering. BTIG, LLC and Needham & Co., LLC will act as co-lead managers for the proposed offering.

In February of this year, PavMed announced that Lucid would spin off into a separate public company “if favorable market conditions continue to hold, whether it be through an initial public offering (IPO) or a business combination with a healthcare special purpose acquisition corporation.”

At the time of announcing the planned sp…

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FDA authorizes Pfizer boosters with caveats

The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow a third dose in individuals who face a high risk of infection or developing severe COVID-19. Those groups include people at least 65 and those aged 18 to 64 with a high risk of developing severe COVID-19.

The EUA also covers individuals aged 18 to 64 “whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”

According to Acting Commissioner Dr. Janet Woodcock, the EUA will apply to “health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others.”

The latter recommendation deviates somewhat from those presented at the most recent Vaccines and Related Biological Products Advisory Committee (VRBAC) meeting, which recommended boosters to those with high occupational risk to the virus, including medical …

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Varta launches online battery monitoring feature

Varta’s Cloud Monitoring Dashboard [Image courtesy of Varta]

Battery maker Varta has launched a cloud computing feature to let customers remotely monitor battery charging, health and the temperature of the battery management system.

While Varta makes microbatteries for medical devices such as hearing aids, the new online monitoring dashboard is meant for its “Easy Block” and “Easy Blade” modular smart batteries. The smart batteries go into forklifts, driverless transport systems and other small or medium vehicles at manufacturers and distributors. Users of Varta’s customer-specific batteries will also have access to the remote monitoring feature, and Varta said it plans to expand its cloud services in the future.

The rechargeable “Easy Block” and “Easy Blade” lithium batteries are modular and expandable. They’re adaptable for applications …

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GE Healthcare to acquire BK Medical and its ultrasound portfolio for $1.45B

GE Healthcare (NYSE:GE) announced today that it entered into an agreement to acquire BK Medical for $1.45 billion.

BK Medical develops intraoperative imaging and surgical navigation technology for guiding clinicians during minimally invasive and robotic surgeries, for visualizing deep tissue during procedures in neuro and abdominal surgery and in ultrasound urology, according to a news release.

The company has headquarters in Boston and Copenhagen with more than 650 employees. GE Healthcare said it acquired BK Medical from Altaris Capital Partners and that the company is delivering double-digit revenue growth. The companies expect the transaction to close in 2022.

By acquiring BK Medical, GE Healthcare expects to create value by strengthening the company through what it calls significant synergies with the benefit of GE’s technology and commercial scale.

“Ultrasound today forms an integral part of many care pathways, and BK Medical is a stra…

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