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Tuesday, November 24, 2020

Nursing homes will be first to get COVID-19 vaccine in Spain

 Elderly residents and staff in nursing homes will be the first to get vaccinated against the coronavirus in Spain, Health Minister Salvador Illa said on Tuesday, unveiling a national vaccination plan due to begin in January.

Other healthcare workers will be next to be vaccinated, Illa said, with a total of 18 groups of citizens being, one after the other, allowed to get the vaccine in one of Spain’s 13,000 local public health centers.

Spain expects to cover a substantial part of the population within the first six months of 2021. Vaccination will not be compulsory and will be free of charge, Illa said.

The objective is “to be ready as a country to vaccinate from the moment we start receiving doses”, he told a news conference.

The government hopes to get the first doses in January, he said, but availability will be limited for the first few months.

Via the deals struck by the European Commission with the main providers of the potential COVID-19 vaccines, Spain hopes to get a total of 140 million vaccination doses, enough to vaccinate 80 million people in a country of 47 million, Illa said. Some would be shared with poorer countries, he added.

A dedicated registry will record who has been vaccinated.

The government’s aim is for 2.5 million priority people - nursing home staff, the elderly and other vulnerable people - to be vaccinated in a first phase. Illa said the government would spell out later who the other priority groups would be.

He did not go into details about how the vaccine or vaccines, some of which need to be stored at very low temperatures, would be transported, but said it would not be a problem.

“Our national system is prepared for the COVID-19 vaccination but we are also working on the logistics,” he said.

Government sources have said Spain will try to take advantage of all storage options available, without having to invest in new equipment if possible. That could include using trucks designed to transport animal drugs at very low temperatures, the sources said.

Spain will take part with seven other European countries in a joint study to follow how the vaccine is working, Illa said.

“We’re starting to see the light at the end of the tunnel,” government spokeswoman Maria Jesus Montero said.

https://www.reuters.com/article/health-coronavirus-spain-vaccine/nursing-homes-will-be-first-to-get-covid-19-vaccine-in-spain-idUSKBN2842FD

New product launches drive recovery in Medtronic fiscal Q2 sales, margins

 

  • Medtronic (NYSE:MDT) FQ2 results:
  • Revenues: $7,647M (-0.8%).
  • Cardiac & Vascular Group revenues of $2.73B (-4.6%), compared to estimate $2.63B.
  • Minimally Invasive Therapies Group revenues are $2.29B (+6.7%), vs. consensus of $2.01B.
  • Restorative Therapies Group: $2.06B (-2.3%) compared to expectations of $1.87B; Diabetes Group: $574M (-3.7%) vs. forecast of $568.9M.
  • Adjusted gross margin of 65.2% vs. estimate of 64.1%; Adjusted operating margin 22.3%, consensus 19.2%.
  • Organic growth +1.5% vs. -8.4% consensus.
  • Net Income: $489M (-64.1%); EPS: $0.36 (-64.4%); non-GAAP Net Income: $1,380M (-22.3%); non-GAAP EPS: $1.02 (-22.1%).
  • CF Ops: $2,139M (-36.7%).
  • "We're seeing a faster-than-expected recovery and approaching year-over-year growth. Our revenue growth is improving, our pipeline is advancing, and we're gaining share in an increasing number of businesses," said Geoff Martha, CEO.
  • Given COVID-19 uncertainty, the company is not providing formal annual or quarterly financial guidance at this time.
  • https://seekingalpha.com/news/3638988-new-product-launches-drive-recovery-in-medtronic-fiscal-q2-sales-and-margins

Bausch Health launches second late-stage study for NOV03 for dry eye

 

  • Bausch Health Companies (NYSE:BHC) and its global eye health business, Bausch + Lomb has initiated the second of two Phase 3 studies evaluating the investigational treatment NOV03 (perfluorohexyloctane) to treat the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian gland dysfunction (MGD).
  • Enrollment of the first Phase 3 study is currently underway and has reached 85% of its enrollment goal.
  • NOV03 is an investigational, water-free and preservative-free solution, based on patented EyeSol technology from Novaliq GmbH.
  • https://seekingalpha.com/news/3639003-bausch-health-launches-second-late-stage-study-for-nov03-for-dry-eye-disease

Oramed Pharma screens first patients under its Phase 3 oral insulin trial

 

  • Oramed Pharmaceuticals (NASDAQ:ORMP) starts Phase 3 trial of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes.
  • The first patients were screened at U.S. sites in Oramed's ORA-D-013-1 trial, one of two Phase 3 trials. The trials will recruit a total of 1,125 patients who have inadequate glycemic control over a period of 6 to 12 months and the  efficacy data will become available after all patients have completed the first 6-month treatment period.
  • "ORMD-0801 is the first oral insulin capsule to achieve the requisite efficacy and safety data enabling us to run the world's first FDA Phase 3 oral insulin trial. Oramed is proud to lead the field in reaching this very significant diabetes treatment milestone," says CEO Nadav Kidron.
  • https://seekingalpha.com/news/3639073-oramed-pharma-screens-first-patients-under-phase-3-oral-insulin-trial-sharesplus-8

Relief/NeuroRx's RLF-100 results in 72% survival in COVID-19 under EAP

 

  • Relief Therapeutics (OTCQB:RLFTF) and NeuroRx announce that more than 175 patients with Critical COVID-19 and Respiratory Failure have now been entered into an Expanded Access Protocol (EAP) with RLF-100 in the U.S.
  • All patients had severe comorbidities (such as organ transplant, recent heart attack, and cancer) that rendered them ineligible for the ongoing Phase 2b/3 trial for COVID-19.
  • Of the 90 patients who have so far reached 28 days of follow-up, 72% survived to day 28.
  • As previously reported, 21 RLF-100 treated patients when compared to 24 control patients, only 17% of the control group survived to day 28.
  • The survival rate with RLF-100 reported today is comparable to that of the open-label patients treated with RLF-100 by Youssef et al.
  • No drug-related serious adverse events have been reported in either EAP or Phase 2b/3 U.S. trial currently underway.
  • Currently, 25 U.S. hospitals have enrolled patients in the EAP, suggesting that RLF-100 can demonstrate effectiveness.
  • Physicians enrolling patients in the EAP have reported that initial patients at their sites have frequently been in ICU for several weeks without recovery prior to treatment with RLF-100.
  • https://seekingalpha.com/news/3638922-relief-neurorxs-rlfminus-100-results-in-72-survival-of-covidminus-19-patients-under-eap

Nearly a Quarter of New Yorkers Say They Won't Take Covid-19 Vaccine

 Nearly a quarter of New Yorkers say they are unlikely to take a vaccine against the coronavirus when it becomes available, according to a poll released Tuesday.

Twenty-four percent of the 803 New York state voters surveyed by the Siena College Research Institute last week said they would either probably not or definitely not take a coronavirus vaccine if approved by the Food and Drug Administration.

The survey showed 35% said they definitely would take the vaccine, and 34% said they would probably take it. Three drugmakers have said in recent weeks that vaccines under their development were shown to be broadly effective in late-stage trials. On Friday Pfizer Inc. and partner BioNTech SE asked U.S. health regulators to permit emergency use of their two-shot vaccine.

Siena spokesman Steven Greenberg said the survey found support for the vaccine was "regardless of party, region, race, age, religion, gender, or even who they supported in the presidential election."

Even after approval, mass distribution will take months. New York Gov. Andrew Cuomo said in October that he expected people might be skeptical that FDA approvals could be influenced by President Trump, who has cheered the rapid deployment of a vaccine. The Democratic governor formed a panel of state experts to review any FDA determination, and he has criticized the Trump administration's vaccine-distribution plans.

The poll also found an increase in support for legalizing recreational marijuana for adults as well as letting New Yorkers bet on sports matches from their mobile devices. Both issues are on the table in Albany, as the state looks for ways to raise revenue to fill a projected $8.7 billion deficit in its coming fiscal year.

Sixty percent of voters surveyed support legalizing marijuana, and 32% oppose doing so -- up from a split of 55-40 in a February survey by Siena. Support for sports betting increased to 50% in the latest poll from 44% in February 2019.

This month's Siena survey has a margin of error of plus or minus 4.1 percentage points.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Pfizer-Nearly-a-Quarter-of-New-Yorkers-Say-They-Won-t-Take-Covid-19-Vaccine-31854995/

Novartis to Repurchase Up to $2.5 Billion in Shares

 Novartis AG said Tuesday it is initiating a share-buyback program of up to $2.5 billion that will start immediately and last into the first half of 2021.

The Swiss pharmaceutical major also said it will deliver $2 billion in cost savings by the end of the year through its Novartis Technical Operations and Novartis Business Services units.

Novartis's Technical Operations unit has productivity programs in place that are set to generate a further $2 billion in mid-term cost reductions, the company said.

The company said that it expects its pipeline to fuel growth in the mid- to long term, and that it expects key milestones from mid- to late-stage assets from its pharmaceutical business to come through in 2021 and 2022.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-to-Repurchase-Up-to-2-5-Billion-in-Shares-31853417/