MedTech 100 roundup: Industry shatters all-time best with remarkable rise

The medtech industry’s steady growth provided optimism in recent weeks, but an unforeseen leap sees it hitting new heights now.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 16) at 145.88 points, a remarkable 27.1% rise week-over-week, registering by far the greatest increase the index has seen since its inception.

Remarkably, the industry’s July 9 tally of 114.79 points a week prior had, at that point, been known to be the index’s all-time best to date. The new high set on Friday of last week totals an increase of 31.09 points.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too, especially after this latest unpredictable rise. The industry has registered a 58% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus it has fully eclipsed 100% growth from the mid-pand…

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Eli Lilly acquires glucose-sensing insulin developer Protomer Technologies

Eli Lilly (NYSE:LLY) announced today that it acquired peptide- and protein-engineering platform developer Protomer Technologies.

The potential value of the transaction is over $1 billion, depending on the achievement of future development and commercial milestones.

Pasadena, Calif.–based Protomer Technologies develops next-generation protein therapeutics designed to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity.

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

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Eli Lilly acquires glucose-sensing insulin developer Protomer Technologies

Eli Lilly (NYSE:LLY) announced today that it acquired peptide- and protein-engineering platform developer Protomer Technologies.

Pasadena, Calif.-based Protomer Technologies develops next-generation protein therapeutics designed to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity.

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

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Lilly’s tirzepatide bests semaglutide in type 2 diabetes trial 

Eli Lilly (NYSE:LLY) has announced that its investigational drug tirzepatide led to more substantial blood glucose and body weight improvements in a Phase 3 trial than semaglutide, a diabetes drug from Novo Nordisk (NYSE:NVO) that recently scored FDA approval for weight loss in early June.

Lilly’s SURPASS-2 results published in The New England Journal of Medicine show tirzepatide achieved superior A1C and body weight reductions compared to injectable semaglutide in adults with type 2 diabetes.

A JAMA opinion article recently posited that semaglutide could lead to a ‘new dawn’ for obesity treatment.

The Lilly trial randomly assigned patients to receive tirzepatide at doses of 5 mg, 10 mg, or 15 mg or a 1-mg dose of semaglutide.

Semaglutide is a glucagon-like peptide 1 receptor agonist. Conversely, tirzepatide is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist.

In the 40-week SURPASS-2 trial, i…

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HHS halts distribution of Lilly’s bamlanivimab/etesevimab antibody cocktail

U.S. government authorities have decided to immediately pause the distribution of Eli Lilly’s bamlanivimab and etesevimab over concerns that the monoclonal antibody cocktail is ineffective against some SARS-CoV-2 variants.

CDC recently concluded that the Gamma variant (P.1) and the Beta variant (B.1.351) make up 11% of COVID-19 infections. They are also continuing to become more dominant, as is the Delta variant (B.1.617.2). CDC has determined that the Delta variant is possibly less responsive to some monoclonal antibody treatments.

The Beta and Gamma variants are significantly less responsive to bamlanivimab and etesevimab than other viral lineages.

Bamlanivimab and etesevimab image courtesy of Lilly.

FDA is recommending Regeneron’s REGEN-COV and GSK’s sotrovimab as more robust antibody therapies.

In related news, FDA recently granted emergency use authorization to tocilizumab, a monoc…

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FDA authorizes lower dose of REGEN-COV COVID-19 antibody cocktail

Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200 mg of Imdevimab.

The initial EUA for REGEN-COV did not include the option for a subcutaneous dose of the antibody cocktail. The option to make the product available via injection makes it easier for doctors or nurses to administer. The use of SARS-CoV-2 monoclonal antibodies has lagged behind vaccines, with only a fraction of eligible patients receiving such antibodies in the past year.

FDA came to its decision after reviewing data from a pivotal Phase 3 study that showed that the drug reduced the risk of hospitalization or death by 70%. The efficacy of the reduced dose is similar to the 2,400 mg dose.

REGEN-COV appears to be …

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Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system

[Image from Bigfoot Biomedical]Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes management system.

Milpitas, Calif.-based Bigfoot’s first-of-its-kind Bigfoot Unity system features connected smart pen caps designed to recommend insulin doses for diabetes patients using multiple daily injection (MDI) therapy, according to a news release.

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

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MedTech 100 roundup: Largest slide for industry in 2021

The medtech industry’s 2021 performance has been all over the place and the past weekend highlighted its topsy-turvy nature.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been on the rise since the beginning of April, with its mark of 112.25 on April 16 representing an all-time best, topping the previous high of 110.96 set on Feb. 15.

Just one week later, the index topped itself again, reaching 114.58 to end the week on April 23, marking an increase of 2.1% from the previous week.

After a -1.6% decrease over the week ending on April 30, there was little indication of in which direction the index would head next. The industry’s response to the slight dip was an even sharper downturn with a 4.49-point loss.

On May 6, the index finished the day at 108.21, representing a -4% slide from the previous week’s mark and a -5.6% fall from the high-point set the previous week. Th…

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Lilly partners with four companies on insulin pen tech

Eli Lilly (NYSE:LLY) today announced deals with four companies whose diabetes management tech will work with on Lilly’s latest insulin pen.

The Tempo Pen is a modified version of Lilly’s existing prefilled, disposable insulin pen to which the Tempo Smart Button — in late-stage development – attaches. Through these new agreements, the Tempo Smart Button will pair with software and/or medical devices offered by Dexcom (NSDQ:DXCM), Glooko, myDiabby Healthcare (Bordeaux, France) and Roche, with its mySugr app, to facilitate the integration of personalized data and actionable insights.

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

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FDA nixes EUA for Lilly’s bamlanivimab

On April 16, Lilly announced that it was requesting FDA to revoke the emergency use authorization (EUA) for the monoclonal antibody bamlanivimab (LY-CoV555) when used alone.

Hours after, the agency agreed to rescind the EUA on the grounds that bamlanivimab is potentially ineffective against some SARS-CoV-2 variants.

Bamlanivimab, however, won’t be disappearing as a COVID-19 treatment but will be paired with another monoclonal antibody known as etesevimab.

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

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The top 5 pharma firms by reputation

Photo by Anton on Unsplash

Recent research from reputation data specialist RepTrak (Boston) indicates that the pharma industry had the largest year-over-year reputational improvement of any sector, according to its roundup of top 100 corporations. The sector saw significant gains in consumers’ perception of its citizenship and governance. 

Now ranked eighth overall, the pharma industry came in just ahead of the consumer services industry and just behind the automobiles and components sector. 

Get the full story from our sister site, Pharmaceutical Processing World. 

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Lilly’s bamlanivimab and etesevimab cut COVID-19 hospitalization and deaths in study

A recent Phase 3 trial found that bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) administered jointly led to an 87% reduction in hospitalization and deaths in high-risk patients recently diagnosed with COVID-19.

The randomized, double-blind, placebo-controlled trial administered 700 mg of bamlanivimab (LY-CoV555) and 1400 mg of etesevimab (LY-CoV016) to 511 patients in the treatment arm. FDA granted emergency use authorization to the dosing regimen, which is also supported by the European Medicines Agency’s Committee for Medicinal Products for Human Use. A total of 258 patients in the cohort of the BLAZE-1 study received a placebo.

There were no deaths in the treatment arm but four deaths in the placebo arm. All of the deaths were considered related to COVID-19.

The BLAZE-1 trial has been ongoing for several months, giving Lilly the ability some indication that its monoclonal antibodies are effective against a range of SARS-CoV-2 varia…

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