U.S. vaccines for children plan fully operational next week: White House

  The United States is rolling out Pfizer/BioNTech COVID-19 vaccines for children aged 5 to 11 this week, but most of the 15 million shots being shipped initially are unlikely to be available before next week, the White House said on Monday.

Millions of doses specifically formulated for children of that age group will start arriving at distribution centers over the next few days, White House coronavirus response coordinator Jeff Zients said, and the federal government has purchased enough supply for all eligible 28 million children.

"The bottom line is there's plenty of supply of the Pfizer vaccine and we look forward to parents having the opportunity to vaccinate their kids," Zients told reporters at a briefing.

The U.S. Food and Drug Administration on Friday authorized the Pfizer Inc and BioNTech SE coronavirus vaccine for children aged 5 to 11 years, making it the first COVID-19 shot for young children in the United States.

The U.S. Centers for Disease Control and Prevention still needs to advise on how the shot should be administered, which will be decided after a group of outside advisers discuss the plan on Tuesday.

Following the CDC's decision, parents will be able to visit vaccines.gov and filter locations offering the vaccine for the children, Zients said.

"The whole plan is based on Pfizer vaccines," he said.

Moderna Inc said on Sunday it would delay filing its request for an emergency use authorization for a half-strength 50-microgram dose of the vaccine for children ages 6 to 11.

At the end of last week, the seven-day average number of coronavirus cases dropped 3% to around 69,000 daily cases and the daily deaths average fell 10% to around 1,100, though the average hospitalization rate climbed 10% to around 5,100 cases, CDC Director Dr. Rochelle Walensky said at the same briefing.

U.S. Chief Medical Advisor Dr. Anthony Fauci said it was "very likely" everyone would be able to get a vaccine booster shot "within a reasonable amount of time."

Currently the CDC recommendations for boosters cover specific categories of people. 

https://finance.yahoo.com/news/1-u-vaccines-children-plan-165921512.html

BioSig Increases Case Volume Estimates

 The Company reports increased adoption and commercial activity of its signal processing technology for arrhythmia care

BioSig Technologies, Inc. (Nasdaq: BSGM) ("BioSig" or the "Company"), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it exceeded its procedural target of 1500 patient cases in 2021.

As of October 21, 2021, the PURE EP(tm) System had been used in over 1560 patient cases by 71 physicians, up from 1000 cases in June 2021, when the procedural guidance was raised amid increased technology usage in elective procedures. As the adoption of the technology increases and the COVID-19 hospitalization rates continue to decline, the Company intends to complete between 1700-1800 procedures by the end of 2021.

“We are seeing increased utilization of PURE EP(tm) in the 13 hospitals we are currently working in. Physicians recognize value both clinically and economically or they would not be increasing their usage. Hospitals are rapidly scaling their elective procedures and thus we are now seeing increased case volumes and commercial activity,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

Clinical data acquired by the PURE EP(tm) System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP(tm) signals over conventional sources.

https://finance.yahoo.com/news/biosig-increases-case-volume-estimates-163000960.html

Weeks into CEO shakeup, Mirati bids adieu to 2 C-suiters with KRAS drug filing around corner

 Mirati is on the cusp of emerging as the sole challenger against Amgen in the suddenly hot KRAS inhibitor market and thinks it has the man to take it across the finish line. But new leadership often means shakeups, and now two Mirati execs are being shown the door.

Mirati CMO Joseph Leveque and Daniel Faga, the biotech’s chief operating officer and principal financial officer, have both departed the company as it enters the homestretch for filing its KRAS drug adagrasib with the FDA, Mirati revealed in an SEC filing Monday.

Details on the departures are slim, with Mirati noting the decisions on both positions were made Oct. 28. In Faga’s place, Mirati accounting lead Vickie Reed will step into the principal financial officer role without an increase in pay, the biotech said.

The shakeup comes a little over a month after Mirati appointed David Meek, a former CEO at FerGene and Ipsen, to the head role, replacing founding CEO Charles Baum.

Meek, who was mostly recently ousted from FerGene after the biotech imploded in spectacular fashion earlier this year, came on board right as Mirati races to an expected filing for adagrasib this quarter, looking to keep the heat on Amgen and its own KRAS inhibitor Lumakras. The company rolled out Phase II data for adagrasib in non-small cell lung cancer in September it says will serve as the basis for that filing, as well as winning mid-stage colon cancer data at ESMO21.

Leveque had served as CMO at Mirati since May 2020, jumping over from Synthorx, where he served as CMO for a little under two years. Prior to that, Leveque jumped around between a spate of biotechs and Big Pharmas, including EMD Serono, Bristol Myers Squibb, Onyx and Amgen.

Faga had been with Mirati since January 2020, previously holding the chief business officer role at Spark Therapeutics for more than three years. He was previously a managing director at Centerview Partners and an associate at Merrill Lynch.

https://endpts.com/weeks-into-ceo-shakeup-mirati-bids-adieu-to-a-pair-of-c-suiters-with-kras-drug-filing-around-the-corner/

Evelo upped to Buy from Neutral by Chardan

 Target $12

https://finviz.com/quote.ashx?t=EVLO&ty=c&ta=1&p=d

4 sell siders start Theseus Pharma at Buy

                                                                                                                                                Target 

Nov-01-21 Initiated Wedbush Outperform $24

Nov-01-21 Initiated SVB Leerink Outperform $28

Nov-01-21 Initiated Jefferies Buy $23

Nov-01-21 Initiated Cantor Fitzgerald Overweight $25

https://finviz.com/quote.ashx?t=THRX

Galmed Announces Positive Results from First 16 Patients in Liver Study

 -- Treatment with Aramchol 300mg BID reduced fibrosis progression measured by histology in 15 out of the 16 patients completed as of data cutoff --

-- 50% of the 16 patients showed fibrosis improvement by ≥1 stage, seen as early as 24 weeks --

--Data demonstrates that treatment with Aramchol 300mg BID resulted in clinically significant greater histological improvement than observed previously with Aramchol 600mg QD --

-- Data add to body of evidence from prior studies demonstrating the benefit of Aramchol for patients with histologically confirmed NASH and fibrosis and provides clinical support for the hypothesis that a higher daily dose will result in improved clinical benefit --

-- Data will be presented at a late-breaking poster presentation at The Liver Meeting Digital Experience 2021, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will be held from November 12-15, 2021 --

Galmed's management team will host a conference call and webcast to provide an update on current developments with respect to its clinical programs for Aramchol including NASH Expert Insights on the ongoing Open-Label Part of the ARMOR study, and to discuss financial results for the quarter ended September 30, 2021 on November 8th @ 8.30am Eastern Time

Conference Call & Webcast:

Monday November 8, 2021, 8:30 AM ET

Toll Free: 1-877-425-9470
Toll/International: 1-201-389-0878
Israel Toll Free: 1 809 406 247
Conference ID: 13724243
Webcast: https://78449.themediaframe.com/dataconf/productusers/vvdb/mediaframe/47052/indexl.html

Replay Dial-In Numbers

Toll Free: 1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number: 13724243
Replay Start: Monday November 8, 2021, 11:30 AM ET
Replay Expiry: Monday November 22, 2021, 11:59 PM ET

https://finance.yahoo.com/news/galmed-announces-positive-results-first-141000189.html

Outset Medical’s Tablo® Hemodialysis System Receives Landmark TPNIES Approval From CMS

 TPNIES approval to provide additional reimbursement for Tablo home dialysis treatments

Outset Medical, Inc. (Nasdaq: OM) ("Outset") today announced that its Tablo® Hemodialysis System has received the first-ever approval from the Centers for Medicare & Medicaid Services (CMS) for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES). This pioneering decision will help encourage healthcare providers to embrace new technology enabling more patients to dialyze at home and reclaim their independence.

https://finance.yahoo.com/news/outset-medical-tablo-hemodialysis-system-120300770.html