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Injectable anti-HIV therapies could see strong growth

Photo by Miguel Á. Padriñán from Pexels

The market for injectable anti-HIV therapeutics will be worth $28 billion by 2029, according to projections from the analyst and consulting firm GlobalData.

GlobalData valued the broader HIV therapeutics market at $22.9 billion in 2019 across the U.S., France, Germany, Italy, Spain, U.K. and Japan.

While the overall market is growing at a low single-digit rate, injectable therapies will likely see more brisk growth, GlobalData projects.

To date, the majority of HIV therapies are orally-delivered antiretroviral drugs although a handful of injectable drugs have hit been introduced over the years.

Future injectable anti-HIV therapies could be administered less frequently than oral drugs.

One early injectable anti-HIV therapy, Fuzeon (enfuvirtide) from Roche (OTCMKTS:RHHBY), is administered multiple times per day, posing a challenge for adh…

Boston Scientific has another serious recall on the same heart device

The FDA has declared a second Class I recall within a month on a Boston Scientific implantable cardioverter defibrillator (ICD).

This recall, which the company initiated with a trio of warnings in December, notified physicians that 3,350 Emblem S-ICD model A209 and A219 devices may exhibit electrical overstress while delivering high-voltage therapy. Variations in header assembly may allow a “very small pathway” to develop, allowing moisture to penetrate the device and cause it to short out during high-voltage therapy, the warning said.

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MedTech 100 roundup: Slight dip after all-time best for industry

The medtech industry’s stocks rose higher than they ever had to begin last week before eventually dropping to a slightly more normal level.

MassDevice‘s MedTech 100 index ended the week (Feb. 19) at 108.72 points, marking a -1.7% dip from the 110.63-point mark set at the end of the previous week (Feb. 12). On Monday (Feb. 15) the index hit its highest mark ever, though, rising to 110.96 points.

That mark sets an all-time best for the index, which has been on the rise for practically all of 2021 so far. It previously reached 106.81 points on Jan. 8, then 107.4 points on Jan. 20 before besting itself again with last week’s finish. The improvement has been considerably impressive given that the index had never reached even the 100-point mark before November 2020.

Medtech’s latest tally means the index has risen 17.8% from the pre-COVID-19 pandemic high of 92.32, set on Feb. 19, 2020. Additionally, the industry has very much rebounded from its lowest p…

Fifth round of medtech user fee talks set to begin soon

Every five years, the FDA, the medtech industry and the public sit down and hammer out how the agency should spend the money it collects in fees from medical device developers seeking approvals and clearances.

The agency also uses the Medical Device User Fee Amendment (MDUFA) to set fees for biologics license applications, 513(g) requests for information and de novo requests.

Negotiations on MDUFA V were scheduled for April 2020 but were waylayed by the pandemic. Following an initial stakeholder meeting in October, the FDA now says the virtual monthly meetings may begin in March. Congress must pass by MDUFA V by September 2022, when the current user fee law expires.

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Pfizer-BioNTech COVID-19 vaccine stable at standard freezer temps

Pfizer-BioNTech vaccine image courtesy of Wikipedia

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80⁰ C and –60⁰ C, according to current CDC guidelines.

Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would enable vaccine vials to be stored in the warmer temperature range for up to two weeks, reducing the need for ultracold freezers, which are in short supply.

“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” said BioNTech CEO Ugur Sahin in a statement. “We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”

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New FDA medtech cybersecurity chief: Guidance to debut in 2021

The FDA’s first medical device cybersecurity chief says he will work across private and public lines to lower the threat of cyberattacks against medical devices and the healthcare systems and patients who use them.

Kevin Fu, acting director of medtech cybersecurity at the FDA (Image courtesy of the University of Michigan)

Medical device manufacturers can expect a new FDA cybersecurity draft guidance for new medical devices sometime this year, according to the agency’s first acting director of medical device cybersecurity.

University of Michigan computer science researcher Kevin Fu has a big assignment to tackle during his one-year tenure — to bridge the gap between medicine and computer science and help manufacturers protect medical devices from digital security threats.

An associate professor of electrical engineering and computer science, Fu is the founder of the Archimedes Center for Medical Device Security at the university and considers updating leg…

FDA approves expanded labeling for Medtronic InterStim SureScan MRI leads

Medtronic (NYSE:MDT) announced today that it received FDA approval for expanded MRI labeling of its InterStim SNM systems.

Fridley, Minn.-based Medtronic’s InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads were approved under updated MRI guidelines allowing for a wider range of MRI scan parameters and shorter wait times between scans, according to a news release.

Medtronic’s InterStim SNM systems use a small device to send electrical impulses to sacral nerves in the lower back in an effort to improve bladder and bowel control.

With application to existing and future implants of InterStim systems that use SureScan MRI leads, the expanded labeling is designed to improve patient access to MRI exams and add flexibility for MRI providers, Medtronic said.

The guideline updates are in addition to what is already provided by SureScan MRI technology. They provide new scanning parameters and decrea…

FDA lets Everlywell sell its COVID-19 home collection kit direct to consumers

Everlywell announced today that it received FDA emergency use authorization for its COVID-19 test home collection kit DTC.

Under EUA, the home collection kit made by Everlywell can now be used directly by individuals who are not experiencing symptoms and have no suspected exposure and who are without a doctor’s prescription, according to a news release.

Austin, Texas-based Everlywell received its first EUA for the home collection kit in May 2020 with an indication for use by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider. The collection kit would then be sent to specified laboratories for COVID-19 testing. It launched the kit the following month.

The mail-in home collection kit for COVID-19 testing is suitable for anyone 18 years old and up and is processed using rt-PCR technology to identify the presence of the virus in individuals who are symptomatic or asymptomatic.

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EUAs help push FDA to record novel-device nods in 2020

(Image courtesy of the FDA)

The FDA approved, cleared or authorized a record high of 132 novel medical devices in 2020, with pandemic-related emergency use authorizations (EUAs) adding significantly to the total.

That compares with 29 novel devices the agency authorized in 2010, according to a new article by officials from the agency’s Center for Devices and Radiological Health (CDRH).

Novel devices include those brought to market through the premarket approval (PMA), humanitarian device exemption (HDE) and de novo pathways, as well as a subset of those that gain 510(k) clearance or an EUA.

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4 things to keep in mind as COVID-19 vaccination efforts scale

In the early days of the pandemic, hopes were high that a vaccine could return society to normalcy. But now that FDA has authorized two vaccines, much of the general public is waiting for them to become broadly available.

Some 4.5% of the U.S. population has been fully vaccinated as of Feb. 17, according to the New York Times vaccination tracker. “If you’re looking over the past 12 months, it doesn’t look like we’ve gotten very far,” said Reed Stephens, a partner at the global law firm Winston & Strawn.

But the rate of vaccination is picking up. The U.S. vaccination rate is now hovering between 1.5 to 2 million doses per day. Production is ramping up, and FDA will likely authorize additional vaccines in the coming months. Stephens said the goal of getting a large percentage of U.S. adults vaccinated by the end of summer seems within reach.

To get the full story, check out our sister site Pharmaceutical Processing World.

4 things to keep in mind as COVID-19 vaccination efforts scale

[Photo by Fusion Medical Animation on Unsplash]

In the early days of the pandemic, hopes were high that a vaccine could return society to normalcy. But now that FDA has authorized two vaccines, much of the general public is waiting for them to become broadly available.

Some 4.5% of the U.S. population has been fully vaccinated as of Feb. 17, according to the New York Times vaccination tracker. “If you’re looking over the past 12 months, it doesn’t look like we’ve gotten very far,” said Reed Stephens, a partner at the global law firm Winston & Strawn.

But the rate of vaccination is picking up. The U.S. vaccination rate is now hovering between 1.5 to 2 million doses per day. Production is ramping up, and FDA will likely authorize additional vaccines in the coming months. Stephens said the goal of getting a large percentage of U.S. adults vaccinated by the end of summer seems within reach.

Sinc…

FDA issues mea culpa for early COVID-19 serology test nods

(Image by the National Cancer Institute on Unsplash)

Early in the pandemic, when the numbers of asymptomatic COVID-19 cases were mounting, officials at the FDA decided to authorize the use of serology tests that laboratories had validated but that the agency hadn’t actually reviewed.

Now two FDA officials are admitting that this was a mistake, but one the agency has learned from. In an article published in the New England Journal of Medicine, two top officials of the FDA’s Center for Devices and Radiological Health (CDRH) said that the agency was trying to slow the spread of SARS-CoV-2, the virus that causes COVID-19, by using the results of serology tests to screen for antibodies for the virus.

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