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Monday, September 27, 2021

Novo Nordisk smartens disposable insulin pens with digital diabetes devicemaker Biocorp

 To make it easier for people with diabetes to track their insulin doses, Novo Nordisk has inked a deal with devicemaker Biocorp to smarten up its line of mass-produced, disposable insulin pens.

Biocorp’s Mallya digital device clips directly onto prefilled insulin injectors and logs delivery amounts and times by linking to a smartphone via Bluetooth. The French company has already been tapped by Roche to connect pens to its diabetes care platform to help share patients' treatment information with their healthcare providers.

The new deal with Novo Nordisk provides for the reusable Mallya’s eventual distribution after a new version has been proven to work with the company’s FlexTouch insulin pen.

FlexTouch—which carries most of Novo Nordisk’s insulins and will serve as a platform for all new insulins going forward—features a unique, push-button dosing mechanism that required a redesign of the current Mallya device, which previously received a CE mark for use in Europe.

In a statement, Biocorp CEO Éric Dessertenne described the project as a huge recognition of Mallya’s potential, with Novo Nordisk providing almost half of the insulin used worldwide while distributing more than 500 million insulin pens to 30 million users in 2020 alone.

Biocorp is set to receive an upfront payment as well as milestone funding tied to the new device’s development. The exact amounts were not disclosed, but the companies expect to be able to ramp up production starting in 2022.

Earlier this month, Biocorp announced a deal to expand Mallya’s scope, working with Germany’s Merck KGaA to develop a specific version to help monitor injections of human growth hormone among children and teenagers with certain hormone deficiencies.

Over the first half of this year, Biocorp posted an operating loss of about 1.3 million euros, or about $1.5 million U.S., with revenues of 3.8 million euros being outpaced by 5.2 million euros in operating expenses. 

Dessertenne said, “the prolonged COVID-19 crisis and Big Pharma's priority choices have clearly slowed patients’ adoption of Mallya,” and added that its commercial alliances with Roche—as well as a digital insulin pen partnership with Sanofi, launched in late 2019—have had only marginal impacts so far, with their full effects expected to come next year.

https://www.fiercebiotech.com/medtech/novo-nordisk-to-smarten-up-its-disposable-insulin-pens-digital-diabetes-devicemaker-biocorp

Amgen Repatha gains on rival Praluent with FDA OK for kids with rare cholesterol condition

 Though it has struggled to live up to early commercial expectations, Amgen’s cholesterol treatment Repatha has largely had the best of its rival in the market, Sanofi and Regeneron’s Praluent.

On Friday, Repatha gained another edge with an FDA approval for pediatric patients 10 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce bad cholesterol. The nod is for Repatha to be used as an add-on treatment to diet modification and statins.

HeFH is an inherited, genetic condition that affects 1 in 250 people worldwide. The disease is characterized by high levels of LDL-C (bad cholesterol) that start at birth and accelerate the development of cardiovascular disease. Children with the condition can be of normal weight and have good diet and exercise regimens. 

People with HeFH have cholesterol levels generally two to three times higher than normal. Of the approximately 1 million Americans with the disorder, only 10% are diagnosed, says the CDC. Those with HeFH have a 50% chance of passing it on to their children.

“As pediatric FH is an under-recognized condition that can lead to premature coronary artery disease, it’s critically important to have additional treatments that can significantly lower cholesterol,” Katherine Wilemon, the CEO of the FH Foundation said in a statement. 

Repatha, which is self-injected every two weeks or monthly, was already approved for another less-common FH condition—homozygous familial hypercholesterolemia (HoFH)—for those 13 and older. This FDA action expands its usage to those 10 and older with HoFH.

The FDA based its green light on a study of Repatha’s safety and efficacy in pediatric patients ages 10 to 17 with HeFH. Treatment reduced bad cholesterol by a mean of 38% over 24 weeks compared to placebo, with no new safety risks identified.  

Repatha and Praluent were approved a month apart in 2015. Both target the PCSK9 protein. Repatha generated sales of $887 million last year, a 34% increase from 2019, compared to $359 million for Praluent.

In April, Praluent gained FDA approval to treat those with HoFH. It has yet to be endorsed for those with HeFH.

Upon their approval, both drugs were expected to be blockbusters. But with each priced at more than $14,000 for a yearly course of treatment, uptake suffered from payer restrictions. The companies have since reduced their prices.

Looking forward, a new threat to the meds is likely to emerge with the expected approval of Novartis’ inclisiran, which also targets PCSK9 but operates differently. In studies, the drug has shown better efficacy with few safety issues. It also has the advantage of being administered twice a year. 

https://www.fiercepharma.com/pharma/fda-approval-for-pediatric-patients-hehf-cholesterol-condition-amgen-s-repatha-solidifies

Small study shows antibody growth from AstraZeneca, Sputnik Light COVID vaccine mix

 A small-scale clinical study of the combined use of the AstraZeneca and Sputnik Light vaccines against COVID-19 has shown strong antibody growth in a majority of the study's participants, the Russian Direct Investment Fund said on Monday.

The data was collected from 20 people who took part in a 100-person study in Azerbaijan that began in February. They first received the AstraZeneca shot followed by the one-dose Russian-made Sputnik Light shot 29 days later, RDIF said.

"According to the results of the interim analysis, a fourfold or higher increase in neutralising antibodies to the spike protein (S-protein) of the SARS-CoV-2 was found in 85% of the volunteers on the 57th day of the study," RDIF said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Small-study-shows-antibody-growth-from-AstraZeneca-Sputnik-Light-COVID-19-vaccine-mix-36523297/

EU reviewing data on Moderna's COVID-19 booster shot

 The European Union's (EU) drug regulator said on Monday it was evaluating whether a booster dose of Moderna's COVID-19 vaccine could be given at least six months after the second shot of the two-dose course in people over 12 years of age.

The review by the European Medicines Agency (EMA) comes after its statement last week that it aims to decide in early October whether to endorse a booster for Pfizer-BioNTech vaccine, nearly a month after it started the evaluation process.

While European authorities have yet to approve any booster shots for coronavirus vaccines unlike their U.S. counterpart, surging cases and breakthrough infections may prompt them to take additional precautionary measures.

"Although EMA and ECDC (European Centre for Disease Prevention and Control) do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, EMA is evaluating the present application to ensure evidence is available to support further doses as necessary," the EU regulator said.

The application for the Moderna vaccine, called Spikevax, has been submitted by the U.S.-based company and includes results from an ongoing trial.

Many EU countries have decided to administer a booster dose despite facing higher legal risks as there is no formal approval from the EMA, a decision the regulator thinks has merits.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-EU-reviewing-data-on-Moderna-s-COVID-19-booster-shot-36527884/

'Time to rapid home-test every American every day'

 Victory over COVID-19 doesn’t mean eliminating it. That’s impossible given its global spread and mutation. Victory means suppressing it in the same way we have suppressed measles.

Measles is eight times more contagious than COVID. But in the 2019 global outbreak, only 1,282 out of 330 million Americans became infected. The reason is vaccine-induced herd immunity. With over 90 percent of Americans vaccinated, the measles virus almost always jumps from a host to its death — to someone with vaccine-induced immune defenses that will instantly kill it.

This, of course, is the goal of COVID vaccination. But so far only 54 percent of Americans have chosen to become fully vaccinated. Another 13 percent have become infected. This means 67 percent of the population has antibodies against the disease. For the nation as a whole, that’s not very far from the 80 percent minimum needed for herd immunity estimated back in May.

But the 80 percent estimate presumed vaccines could fully prevent infection and transmission, as well as illness. Unfortunately, as we’ve recently discovered, the vaccinated can still get infected, they can still spread the disease and they can still get sick and die.

Yes, the chances of each of these outcomes is significantly reduced by vaccination. Still, the fact that vaccination isn’t a panacea and that its efficacy wanes with time raises the herd immunity threshold, placing everyone – but particularly the unvaccinated, including most of our children – at great risk. 

Moreover, the percentage vaccinated ranges from close to 70 percent in Vermont to only 41 percent in Idaho. And where vaccination rates are lower, infection rates are generally higher. Were one part of the country with 80 percent of the population fully vaccinated, with no chance of getting or spreading COVID, and another part with 20 percent of the country entirely unvaccinated, the virus would, absent other measures, potentially infect one-fifth of the population. In short, we need a national, not a local, fix.

When COVID broke out, we locked down, then we opened up and masked, then we tested and masked, and then we vaccinated, unmasked and stopped testing. None of the preventive actions was applied uniformly due to politicians who too often placed their political health above the public’s health.

We can only learn from the past. As for the present, we are, once again, in COVID hell with hospital ERs in Florida and other states full to the brim with COVID patients and COVID daily deaths exceeding 2,000, nationwide. Plus, public schools across the country have fully opened, giving the disease access to tens of millions of unvaccinated children, not to mention their tens of millions of potentially unvaccinated parents and grandparents.

It’s time to once again rethink and reset our COVID-fighting strategy based on the latest knowledge and available weapons. Let’s start with the obvious. Everyone needs to get vaccinated immediately. This includes young children. Pfizer has just reported vaccine efficacy in 5-to-12-year-olds. The Food and Drug Administration (FDA) should issue emergency use authorization for this population and, indeed, for younger children — in days, not weeks.

Second, we need to return to fulltime masking, including of all children in every school in the country.

Third, President Biden should invoke the Defense Procurement Act to mass produce rapid home tests, giving all Americans a year's supply for free. If the cost per test can be lowered to $1 per day, which it surely can, that's $365 per person, per year. That's a highly affordable $117 billion annual cost. Were most or all of us to test every day, COVID would be halted in perhaps two or three weeks.

Rapid tests are highly accurate when they need to be — that is, when people are contagious and have a high viral load. Their cumulative false negative rate is extremely low if the testing is repeated daily, which we’re proposing. Positive test results, whether false or true, would be followed up with confirming PCR tests.

Rapid home tests are painless and take only a few minutes to administer. They would also be voluntary, thus depoliticizing COVID. Vaccine resisters will have a way to protect themselves and others and have the time to rethink their reluctance to vaccinate.

Rapid home tests are being sent for free to Swiss households and are being used daily to test children attending German schools. They are being used to test outbreak neighborhoods in the UK. The rapid tests can be manufactured to identify the date used. Consequently, they can serve as daily COVID passports for attending school, entering restaurants, going to work, going to movie theaters and more.

The U.S. has been deadly slow to adopt rapid testing. The Trump administration bought 150 million tests and distributed them to institutions, including nursing homes and universities. But it’s not clear what happened to many of them.

The Biden administration only recently acted — committing $2 billion to purchase rapid tests and distribute them for free to certain entities. The FDA has approved rapid tests from six companies. The European Union has approved 30 tests and the World Health Organization has approved three.

Writing in the Wall Street Journal last fall, one of us (Kotlikoff) along with Harvard epidemiologist Michael Mina wrote that, “Frequent at-home rapid testing could help keep outbreaks at bay and restore the economy.” Let’s not let hundreds of thousands more Americans die or become permanently impaired because of government ineptitude or indifference. It’s time to test everyone every day.

John Goodman is president of the Goodman Institute. He is the author of "New Way to Care: Social Protections That Put Families First." Laurence Kotlikoff is a professor of economics at Boston University.

https://thehill.com/opinion/healthcare/573144-its-time-to-rapid-home-test-every-american-every-day

Cortexyme to Present Results from Phase 2/3 Alzheimer’s Study at CTAD 2021

 Cortexyme, Inc. (Nasdaq: CRTX), a company advancing a pivotal Phase 2/3 trial in Alzheimer’s disease and a growing pipeline of therapeutics for degenerative diseases, today announced that it will participate at the upcoming 14th Clinical Trials on Alzheimer's Disease (CTAD 2021) conference scheduled for November 9-12, 2021, in Boston, Massachusetts, as well as virtually. Cortexyme will present results from its Phase 2/3 GAIN Trial evaluating the efficacy of its lead small molecule atuzaginstat in 643 mild to moderate Alzheimer’s patients. Cortexyme expects to announce top-line results in advance of its scientific presentation at CTAD 2021. Results of the GAIN Trial’s Phase 2 periodontal disease REPAIR sub-study also are expected to be announced by mid-November.

https://finance.yahoo.com/news/cortexyme-present-results-gain-trial-120000778.html

Cellect Biotech Holders OK Merger with Quoin Pharma

 Cellect Biotechnology Ltd. (NASDAQ: "APOP"), announced shareholders voted to approve the previously announced strategic merger agreement with privately-held Quoin Pharmaceuticals, a specialty pharmaceutical company focused on rare and orphan diseases, and all other proposals presented at the Special General Meeting of shareholders held on September 26, 2021, including the sale of the Company’s subsidiary, Cellect Biotherapeutics Ltd, to EnCellX Inc. , a privately held company based in San Diego, CA.

Approximately 99% of the votes cast on the strategic merger agreement at the Special General Meeting voted in favor of approving the proposal. The Company has filed the results of the Special General Meeting, as tabulated by an independent inspector of election, in a Current Report on Form 6-K with the U.S. Securities and Exchange Commission (the “SEC”).

Subject to the satisfaction or waiver of all other closing conditions, the strategic merger is expected to close in October, 2021. The Agreement and Plan of Merger and Reorganization has been amended by the parties therein to extend the Outside Date thereunder from September 30, 2021 to November 1, 2021. The Amended and Restated Share Transfer Agreement has also been amended to extend the outside closing date of the share transfer to November 1, 2021. Following the completion of the strategic merger, Cellect will be renamed Quoin Pharmaceuticals, Ltd., and will trade on the Nasdaq Capital Market under the symbol “QNRX”.

The sale of the intellectual property (IP) to EnCellX will be concurrent with the closing of the strategic merger with Quoin Pharmaceuticals, allowing for the seamless development of ApoGraft and continuation of the Phase 1/2 clinical trial being performed at Washington University for patients with hematological malignancies who are undergoing a haploidentical Bone Marrow Transplantation (BMT).

https://finance.yahoo.com/news/cellect-biotechnology-announces-shareholder-approval-131000126.html