DarioHealth Partners with MediOrbis on Virtual Care Offering for Diabetes

 DarioHealth will Provide Remote Patient Monitoring Services to MediOrbis for New Offering to Medicare Patients with Diabetes

Approximately 20% of Medicare's 60M+ Members have Diabetes

NEW YORK, April 20, 2021 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO), a pioneer in the global digital therapeutics market, announced today the launch of a new virtual care initiative with MediOrbis, a telehealth provider specializing in chronic conditions. Eligible Medicare members who have diabetes can receive convenient virtual care for their diabetes, including telehealth delivered by MediOrbis and remote patient monitoring through DarioHealth's AI-powered digital chronic care platform under their existing Medicare benefit.

As part of the launch the new virtual care program will be made available to Dario's approximately 75,000 members with diabetes, of which 30% are over 65. This will enable current Dario members to access high quality, convenient care at a potentially lower out-of-pocket cost. In addition, the virtual care program will be marketed to qualified Medicare members who aren't currently using Dario's offering. This represents a significant expansion opportunity for Dario's remote patient monitoring business, as CMS has estimated that 1 in 5 of its 62 million Medicare beneficiaries has diabetes. The commercial terms of the MediOrbis agreement are consistent with the terms of Dario's other RPM contracts.

"We are excited to partner with MediOrbis to launch this virtual care service for qualified Medicare beneficiaries. Offering our existing users this program, provides users with enhanced services and support at a lower cost. Increasing our offerings to existing customers across all of our market segments is part of our strategy to improve value to our users while increasing revenue per member and lowering our average member acquisition cost." stated Rick Anderson, President and General Manager North America. "We are excited to partner with MediOrbis and support the expansion beyond Dario's existing user base to the broader Medicare population, which we believe has the potential to be a multi-million dollar remote patient monitoring opportunity for Dario."

https://finance.yahoo.com/news/dariohealth-partners-mediorbis-virtual-care-131500820.html

Cyclo Therapeutics to Proceed with IND Filing for Phase 2 Alzheimer's Trial

 FDA feedback supports Company’s Phase 2 development strategy for Alzheimer’s disease asset; IND filing on track for H2 2021

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) ("Cyclo Therapeutics" or the "Company"), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from diseases, today announced that it has received feedback from the U.S. Food and Drug Administration ("FDA") supporting the Company’s development strategy to submit an initial new drug application ("IND") application for a Phase 2 study of Trappsol® Cyclo™ in the treatment of early Alzheimer’s disease, following a positive Type B interaction.

https://finance.yahoo.com/news/cyclo-therapeutics-proceed-ind-filing-132500068.html

Pfiz­er, Mod­er­na eye $38B prize as safe­ty frets side­line glob­al vac­cine play­ers

 While the wrangling over the relative safety of new, virally vectored Covid vaccines from J&J and AstraZeneca appears to be unending, analysts aren’t waiting around to see how the market will play out for the leaders.

As far as Bernstein’s Ronny Gal is concerned, the fight for market share in the developed world is over, and Pfizer/BioNTech and Moderna are the big winners, divvying up $38 billion in mega-blockbuster money.

Given the manufacturing clout that Pfizer has, Gal is assigning the lion’s share of that windfall to Pfizer, which he expects to record $24 billion in 2021 sales. Moderna will earn a mighty — though second place — $14 billion, Gal expects.

J&J, which today reported a modest $100 million in revenue from their vaccine — sidelined by safety concerns — is going to get iced out of the main market in the US/EU/Japan. AstraZeneca is also getting pushed aside by Pfizer and Moderna, Gal expects, as mRNA vaccines dominate the field.

We revise our model to assume no JNJ or AZN doses will be delivered in the US beyond the 100M pre-purchased JNJ doses. Incremental doses (and booster doses in the fall and winter) will come from the mRNA manufacturers (with possibly some from NVAXl). It seems EU will follow a similar pattern as many countries discontinued use of AZN vaccines and now purchased ~600M combined PFE and MRNA doses, and few AdVec doses will be ‘needed’ to vaccinate the population by YE21.

Let’s keep in mind here that J&J was forced to take a knee after a handful of cases of blood clotting, a tiny risk in the world of therapeutics when compared to the potential benefit it offers in terms of ending the pandemic. But with governments raising red flags in front of billions of people, while the mRNA vaccines continue to lengthen their lead, the risk/benefit algorithm that has long decided the winners and losers in this game has been thrown out the window. And even if NIAID director Anthony Fauci is right and J&J gets a green light to jump back in at the end of the week, no one is likely to forget those red flags.

One big question I have is how the major players will yet decide to line up for future pandemics. Will GSK, Merck and Sanofi do something definitive to gain a place in the mRNA field, or risk handing over the entire market to the mRNA leaders as they continue to ramp up manufacturing? Right now they seem virtually dormant in this setting.

Still vying to get into the game are new vaccines from Novavax and CureVac. And with more traditional jabs under a cloud, they may yet have a chance to make their mark as the rest of the world seeks a way out of the pandemic.

Just not in the biggest drug market of them all.

https://endpts.com/a-top-analyst-sees-pfizer-and-moderna-seizing-a-38b-prize-as-safety-frets-sideline-global-vaccine-players/

EU regulator finds possible blood clot link with J&J vax, but says benefits beat risks

 The European Medicines Agency said Tuesday the Johnson & Johnson Covid-19 vaccine has possible links to rare blood clot incidents, but reiterated that its benefits still outweighed the risks.

″(The) EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen,” the agency said in a press release.

“Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.”

The EMA researched all available evidence, it said, including eight reports from the U.S. of serious cases of unusual blood clots — one of which had a fatal outcome. Over 7 million people had received the vaccine in the United States as of April 7, it said.

The U.S. Food and Drug Administration decided earlier this month to suspend the use of J&J’s shot “out of an abundance of caution.” As a result, the pharmaceutical firm decided to delay the rollout of its vaccine in Europe while regulators assessed any risks.

The EMA already said last week that while reviewing the latest details, it was still of the view that the benefits of the vaccine outweighed the risks.

The J&J shot, which only requires one does, was initially greenlit in the European Union on March 11. It now remains to be seen how the different countries will interpret the latest guidance from the EMA. France has already indicated it will only use the vaccine on people aged above 55.

“COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects,” the EMA stated on Tuesday, using the name of J&J’s Belgian unit.

This is not the first issue with blood clots and a Covid-19 vaccine.

More than a dozen European countries suspended the use of the AstraZeneca shot in March after some people who received the shot reported unusual incidents with blood clots, 18 of which were fatal.

The EMA reviewed the cases and also said the vaccine was safe and should be used in the fight against coronavirus.

Nonetheless, a few days later, the EMA also said there was a “possible link to very rare cases of unusual blood clots with low blood platelets” and this should therefore be listed as “very rare side effects” for the AstraZeneca vaccine.

Some countries adjusted the rollout of this vaccine, deciding to administer it only to people above 60 years of age, and Denmark went further by completely stopping its use.

So far, there have been more than 103 million doses administered in the EU, according to data from the European Centre for Disease Prevention and Control.

https://www.cnbc.com/2021/04/20/covid-vaccine-ema-says-jj-shot-can-be-rolled-out-across-eu.html

China Likely to Approve BioNTech's COVID-19 Vaccine by July

 China is planning to authorize the COVID-19 vaccine developed by Germany's BioNTech SE by July, the Wall Street Journal reported on Friday, citing people familiar with the matter.

If approved, it would become the first foreign COVID-19 vaccine to be authorized in the country.

Chinese officials are reviewing clinical-trial data for the vaccine and are expected to authorize it for domestic use within the next 10 weeks, the report said.

BioNTech said in a statement that it does not speculate on timings of approvals.

The National Health Commission of China and Shanghai Fosun Pharmaceutical Group Co Ltd, which signed a potential supply deal with the German drugmaker in August for the vaccine, did not immediately respond to Reuters requests for comment. (https://reut.rs/2Q8psHJ)

The vaccine, developed in collaboration with Pfizer Inc, is already approved in several countries, including the United States, the United Kingdom and Israel.

https://www.usnews.com/news/world/articles/2021-04-16/china-likely-to-approve-biontechs-covid-19-vaccine-by-july-wsj

China US Embassy Accepting Non-Chinese Vaccine Records

 Beijing has started to accept vaccination records from people seeking to enter China who have been inoculated in the United States with COVID-19 shots made by U.S. drug makers.

Travellers who have had the Pfizer Inc-BioNTech shot or the Moderna Inc and Johnson & Johnson vaccines can submit proof as part of the documentation needed for entry into China, the Chinese embassy in Washington said in an April 16 statement.

The guidance suggests the beginnings of an easing in travel requirements.

The world's second-largest economy has yet to approve vaccines developed by non-Chinese drug makers for use domestically, although the Wall Street Journal reported on Friday that China was planning to authorise the BioNTech COVID-19 vaccine by July.

BioNTech's Chinese partner Fosun Pharma has sole marketing rights in Greater China and the German company partners with Pfizer in other parts of world.

Other Chinese embassies that accept non-Chinese vaccination records include the embassy in Iraq. It said in March it would accept any COVID-19 vaccine approved in Iraq, which has given the emergency-use nod to vaccines from China's Sinopharm and Britain's AstraZeneca.

China's Foreign Minister Wang Yi said last month China was willing to hold talks with other countries over mutual recognition of the Chinese QR health code, which would contain a digital certificate of COVID-19 vaccination.

https://www.usnews.com/news/world/articles/2021-04-20/chinas-us-embassy-has-begun-accepting-non-chinese-vaccine-records

Israel Logs Indian COVID-19 Variant, Sees Some Vaccine Efficacy

 Israel has registered eight cases of a coronavirus variant first identified in India and believes that the Pfizer/BioNTech vaccine is at least partially effective against it, an Israeli health official said on Tuesday.

An initial seven cases of the Indian variant were detected in Israel last week among people arriving from abroad and who have since undergone preliminary testing, the Health Ministry said.

"The impression is that the Pfizer vaccine has efficacy against it, albeit a reduced efficacy," the ministry's director-general, Hezi Levy, told Kan public radio, saying the number of cases of the variant in Israel now stood at eight.

The ministry did not immediately respond to a Reuters request for more details on the research into the Indian variant.

Britain and Ireland have also said they are investigating the variant after detecting it within their borders.

Israel, whose population is 9.3 million, has fully vaccinated around 81% of citizens or residents over the age of 16. COVID-19 infections and hospitalisations are down sharply.

https://www.usnews.com/news/world/articles/2021-04-20/israel-logs-indian-covid-19-variant-sees-some-vaccine-efficacy-against-it