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Home » Topics » Medical devices and technologies » Combination drug-device

Combination drug-device
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Vaxxas HD-MAP

SK Bioscience, Vaxxas partner to develop needle-free typhoid vaccine

Aug. 29, 2023
By Tamra Sami
SK Bioscience Co. Ltd.  and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid.
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Vaxxas HD-MAP

SK Bioscience, Vaxxas partner to develop needle-free typhoid vaccine

Aug. 25, 2023
By Tamra Sami
SK Bioscience Co. Ltd.  and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid.
Read More
Liver illustration

Delcath gets FDA win for Hepzato Kit for metastatic uveal melanoma

Aug. 16, 2023
By Meg Bryant
Delcath Systems Inc. reported that the FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma (mUM). The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March.
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Liver illustration

Delcath gets FDA win for Hepzato Kit for metastatic uveal melanoma

Aug. 15, 2023
By Meg Bryant
Delcath Systems Inc. reported that the FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma (mUM). The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March.
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Laptop displaying FDA logo

Stakeholders prod FDA to include drugs in scope of device software functions guidance

Feb. 10, 2022
By Mark McCarty
The FDA’s November 2021 draft guidance for contents of premarket submission for device software functions may have been a desperately needed update for a legacy 2005 guidance, but stakeholders see one glaring omission from the draft. Both the Advanced Medical Technology Association and Pharmaceutical Research and Manufacturers of America pointed to the absence of sign-off by the FDA’s Center for Drug Evaluation and Research (CDER) for the draft, a conspicuous omission because a combination product with software may include a drug regulated by CDER.
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FDA website and logo

FDA combo products guidance offers more flexibility for cross-labeling

Jan. 31, 2022
By Mark McCarty
U.S. FDA regulation of combination products has always been complicated, and a new final guidance takes up the long-standing controversy over FDA review of these applications. The final guidance makes explicit the possibility that the individual components of a cross-labeled combination product will be reviewed separately, a concession that industry saw as critical to ensure that these applications can make it through the FDA gauntlet without undue delay.
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Cansino partners with Aerogen for inhalable COVID vaccine

Dec. 14, 2021
By Gina Lee
Cansino Biologics Inc. has entered a development and commercial supply partnership with Aerogen Ltd. for an inhalable version of its COVID-19 vaccine, Convidecia, also known as Ad5-nCoV. Cansino will combine Convidecia with Aerogen’s vibrating mesh aerosol drug delivery technology to produce a consistent droplet size for optimal lung deposition.
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Cansino partners with Aerogen for inhalable COVID vaccine

Dec. 9, 2021
By Gina Lee
Cansino Biologics Inc. has entered a development and commercial supply partnership with Aerogen Ltd. for an inhalable version of its COVID-19 vaccine, Convidecia, also known as Ad5-nCoV. Cansino will combine Convidecia with Aerogen’s vibrating mesh aerosol drug delivery technology to produce a consistent droplet size for optimal lung deposition. The technology delivers up to six times more medication to the lungs compared to jet nebulizers. It also enables consistency and drug denaturing to improve efficacy. Cansino and Aerogen did not disclose the deal’s commercial terms.
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Doctor holding an e-cigarette in one hand, tobacco cigarette in the other

MHRA invites e-cigarette makers to submit their products for approval as medical devices

Nov. 2, 2021
By Nuala Moran
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) is inviting manufacturers to submit electronic cigarettes for approval as medical devices, after drawing up new guidance on the standards that will be required for approval. The move means the U.K. could become the first country in the world where e-cigarettes are available on prescription as smoking cessation aids.
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Medici drug delivery system

No happy ending for once-charmed biotech unicorn

Sep. 29, 2021
By Mari Serebrov
Once upon a time, Intarcia Therapeutics Inc. was a biotech unicorn valued at $3.5 billion. Its allure was its implantable Medici drug delivery system that consisted of a mini pump about the size of a matchstick. But a unicorn’s life is never completely charmed. Intarcia faced obstacles along the way – two complete response letters from the U.S. FDA and the denials of three formal dispute resolution requests. Now it looks like this story won’t have a happy ending.
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