How big medtech fared during a year of COVID-19

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Despite numerous challenges, the medtech industry showed itself to be fairly recession-proof in 2020, according to a Medical Design & Outsourcing analysis of financials.

Annual reports recently released by 20 of the world’s largest medical device companies showed only a slight dip in revenue during 2020 — a year in which medtech held the front lines against the COVID-19 pandemic. Employment was also up slightly amongst the top earners, while R&D spending held its own.

The 20 companies included in the MDO analysis include 3M Healthcare, Abbott (medical device segment), Alcon, Align Technology, Baxter, Boston Scientific, Danaher (life sciences and diagnostics segment), Dentsply Sirona, Edwards Lifesciences, GE Healthcare, Henry Schein, Intuitive Surgical, Johnson & Johnson (medical device segment), Medline Industries, Owens & Minor, Royal Philips, Smith+Nephew, …

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J&J Vision wins Japanese approval for first drug-releasing contact lens

Johnson & Johnson Vision announced that it received approval in Japan for its Acuvue Theravision lens with Ketotifen.

The company touts the lens as the first and only vision-correcting contact lens that relieves allergic eye itch through drug delivery, according to a news release.

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

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Catalent to produce J&J’s COVID-19 vaccine in Indiana

Catalent will produce millions of extra doses of Johnson & Johnson’s COVID-19 vaccine at its recently expanded Bloomington, Ind. facility, according to a statement posted on LinkedIn.

Bloomberg broke the news yesterday, reporting that FDA has authorized the use of the facility to make the J&J vaccine.

Catalent announced late last year that it would spend $50 million to install an additional high-speed vial filling line in Bloomington. The company last year also agreed to make Moderna’s COVID-19 vaccine.

The COVID-19 vaccine manufacturing partnership between Catalent and J&J is but the latest in a string of partnerships meant to boost vaccine development and enable the U.S. to reach President Joe Biden’s goal of some post-pandemic normalcy by July Fourth. Other recent announcements include:

Baxter’s plans to make 60–90 million doses of the Moderna vaccine in 2021, also in Bloomington; Merck providing two U.S. facil…
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FDA approves oral multiple sclerosis treatment from J&J’s Janssen unit

Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical announced today that it received FDA approval for its Ponvory treatment.

Ponvory (ponesimod) is a once-daily, oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator for treating adults with relapsing forms of multiple sclerosis (MS). It’s areas of treatment include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, according to a news release.

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

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Johnson & Johnson introduces new Acuvue Oasys multifocal lens

Johnson & Johnson Vision (NYSE:JNJ) announced that it launched the Acuvue Oasys multifocal contact lenses with a pupil-optimized design.

The new lens, available in the U.S. and in Canada, expands on the Acuvue Oasys portfolio to offer a new eye care option for patients with presbyopia, according to a news release.

Acuvue Oasys multifocal lenses offer pupil-optimized technology, used in the 1-day Acuvue moist multifocal and designed for crisp, clear, reliable vision at all distances to enable those with presbyopia to see distant, intermediate and near objects.

The technology also includes what J&J touts as “hybrid back curve” technology, along with a proprietary embedded wetting agent, which altogether is aimed at creating a lens designed for both performance and comfort.

“This Acuvue Oasys multifocal contact lens brings a long-awaited solution to patients with presbyopia who have been looking for continuous, clear and comfortab…

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MedTech 100 roundup: Industry rebounds from massive dip

The medtech industry saw its largest fall in several months last week, but it has rebounded slightly after a couple of bad weeks.

A strong start to 2021 hit a skid at the end of February and carried over into March, with MassDevice‘s MedTech 100 index hitting its lowest point on March 8 (102.16). It had only notched an all-time best of 110.96 on Feb. 15, leading to a precipitous fall not seen since October.

While the heights of last month have not yet been returned to, the industry has shown signs of bouncing back. The index ended the week (March 12) at 104.62, marking a 1.3% rise from the 103.3-point mark set one week before (March 5).

The industry remains in a strong position and one that is particularly stronger than it was at this time a year ago, as the index is now 13.3% up on the pre-COVID-19 pandemic high of 92.32 set on Feb. 19, 2020.

Nearly one year ago, on March 23, 2020, as the pandemic took hold, the industry sat at 62.13 points on th…

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Tinnitus reports grow amid COVID-19 vaccinations

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A handful of patients in Johnson & Johnson’s Phase 3 COVID-19 clinical trial complained of tinnitus, or ringing in the ears.

After reporting on the subject, we’ve received a steady stream of reports from Moderna and Pfizer-BioNTech vaccine recipients who experienced tinnitus.

The U.S. Vaccine Adverse Event Reporting System database cites 152 reports of tinnitus among 25,072 COVID-19 recipients of vaccines from Pfizer-BioNtech and Moderna. The database also has 11 reports of sudden hearing loss and 39 reports of hypoacusis (loss of hearing acuity).

A U.K. database cataloging adverse events related to AstraZeneca and Pfizer-BioNtech vaccines also lists a number of cases of tinnitus. In a summary of adverse reaction reports for the 54,180 recipients of the AstraZeneca vaccine from Jan. 1 to Feb. 28, there were 320 tinnitus reports. For the Pfizer-BioNTech vacc…

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Why emergency authorization of COVID-19 therapies could pose regulatory questions

Image by Arek Socha from Pixabay

Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications.

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard,” said Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland.

The FDA’s decision to grant emergency use authorization to investigational vaccines could lead to the development of a “marketplace” where vaccines are deemed “good enough to be authorized, but never approved,” Doshi opined in the public comment period of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Johnson & Johnson’s vaccine.

Get the full story from our sister site, Drug Discovery & Development.

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Report: Biden to buy 100M additional doses of J&J COVID-19 vaccine

President Joe Biden is reportedly set to announce plans to purchase an additional 100 million doses of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine.

An NBC News report said that Biden is set to announce the purchase of the single-dose vaccines on Wednesday, according to two officials from his administration.

Get the full story at our sister site, Drug Discovery & Development.

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Report: Biden to buy 100M additional doses of J&J COVID-19 vaccine

President Joe Biden is reportedly set to announce plans to purchase an additional 100 million doses of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine.

An NBC News report said that Biden is set to announce the purchase of the single-dose vaccines on Wednesday, according to two officials from his administration.

The purchase of doses from Johnson & Johnson, which became the third authorized COVID-19 vaccine in the U.S. last month (and the first single-dose vaccine), puts the U.S. in a position in which it has more than enough supply to vaccinate the entire population of the country. This comes after Biden recently pushed forward the timeline for having enough doses to vaccinate every American, moving it from the end of July to the end of May.

Biden is reportedly set to direct the U.S. Dept. of Health & Human Services to procure the doses during a meeting with executives from J&J and Merck, having announced earlier this month that the…

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Amid controversy, Biden cancels Emergent Biosolutions visit 

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The White House scrapped plans to hold a Wednesday meeting at a Baltimore-based vaccine plant from Emergent BioSolutions following an exposé from The New York Times.  

The Biden administration also announced plans to conduct an audit of the Strategic National Stockpile after the publication of the article, which described how the biopharmaceutical company lobbied the federal government to buy millions of anthrax vaccine doses. 

Over the past ten years, the U.S. government has devoted almost half of its stockpile budget to BioSolutions’ anthrax vaccine, leaving a dearth of funding for pandemic response. 

Biden relocated the meeting to the White House, where he will host executives from Merck and Johnson & Johnson, which are jointly manufacturing COVID-19 vaccine. 

“We just felt [the White House] was a more appropriate place to have the meeting,” Jen …

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Canada authorizes J&J’s COVID-19 vaccine

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Canada is hoping to accelerate its mass-vaccination program with the authorization of Johnson & Johnson’s COVID-19 vaccine, which the FDA also recently authorized.

Canada has now authorized four vaccines.

Pfizer has also agreed to ramp up deliveries to the country.

By the end of June, Canada could have 36.5 million vaccine doses. The country’s population is 37.9 million.

Ontario, the most densely populated province, also announced that it would allow the first and second doses of the Pfizer-BioNTech and Moderna vaccines to be administered with an up to four-month interval between doses.

The J&J vaccine currently requires only a single dose, although the company is testing a two-dose regimen.

Because the U.S. isn’t currently allowing domestically produced vaccines to be exported, Canada has relied on Europe and Asia to provide vacci…

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