Axonics Gets FDA Approval for Third-Generation Implantable Neurostimulator

 Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has received PMA supplement approval from the U.S. Food & Drug Administration (FDA) for its third-generation implantable neurostimulator (INS).

This marks the sixth FDA approval Axonics has received for a significant product innovation since the company’s U.S. commercial launch in November 2019. The FDA previously approved Axonics' second-generation rechargeable INS in April 2020, which extended the recharge interval to one hour each month.

The third-generation INS upgrades the embedded software in the INS and the functionality of the patient remote control. These modifications give patients the ability to make broader stimulation parameter adjustments at home, including selecting a second therapy program that was set post-operatively based on interoperative findings. These enhancements provide an appropriate level of flexibility to maximize symptom relief as patients settle into their everyday lives. This is accomplished while patients continue to benefit from an intuitive, easy to use therapy experience.

Axonics expects to begin shipping the third-generation INS and patient remote control on March 1, 2021.

https://www.biospace.com/article/releases/axonics-receives-fda-approval-for-third-generation-implantable-neurostimulator/

CVS Health Tops Q4 Earnings Forecast, Posts Solid 2021 Outlook

 CVS Health Corp.  (CVS) posted stronger-than-expected fourth quarter earnings Tuesday thanks in part to solid pharmacy sales, sending shares higher in pre-market trading. 

CVS said adjusted earnings for the three months ending in December were pegged at $1.30 per share, down 25% from the same period last year but 6 cents ahead of the Street consensus forecast. Group revenues, the company said, rose 4% from last year to $69.55 billion, again topping analysts' estimates of a $68.75 billion tally.

Looking into the 2021 financial year, CVS said it sees adjusted earnings in the region of $7.39 to $7.55 per share, compared to a Refinitv estimate of $7.54 per share.

"The COVID-19 pandemic presented unique challenges to our business and to the entire health care industry. We utilized the full depth and breadth of our capabilities and our presence in local communities across the country, to play a leadership role in COVID-19 testing and vaccine administration," said new CEO Karen Lynch. "Our ability to deliver 2020 full-year results above expectations is a testament to the strength of our strategy and the flexibility of our diversified health services model."

"Our goal is to make health care more accessible, more affordable and simpler. In order to do this, we will accelerate the pace of our progress through targeted investments in key areas that will drive our consumer-focused strategy," she added. "We believe that solving consumer health needs will deliver better health outcomes and lower costs while creating future economic benefit for CVS Health and its shareholders. " 

CVS shares rose 0.13% in pre-market trading immediately following the earnings release to indicate an opening bell price of $74.31 each.

Pharmacy Services revenues slipped 1.9% to $33.355 billion, CVS said, as "primarily driven by continued price compression and changes in net new business mix, partially offset by growth in specialty pharmacy and brand inflation."

Retail sales rose 6.6% to $24.062 billion, as same-store sales accelerated 5.7%. The group's healthcare benefits division saw sales rise 11.4% to $19.1 billion as it added Aetna's operations to its legacy business.

https://www.thestreet.com/investing/cvs-health-tops-q4-profit-forecast-posts-solid-2021-outlook

Cortexyme: Partial Hold on Development Program for Atuzaginstat in Alzheimer’s

 Cortexyme, Inc. (NASDAQ: CRTX), a clinical-stage biopharmaceutical company focused on Alzheimer’s and other degenerative diseases, received a letter from the U.S. Food and Drug Administration (FDA) stating that a partial clinical hold has been placed on atuzaginstat (COR388) impacting the open-label extension (OLE) phase of the company’s ongoing Phase 2/3 study, the GAIN Trial. Under the hold, no new participants will be enrolled in the OLE and currently enrolled OLE participants will be discontinued. Participants in the fully enrolled (N=643) double-blind, placebo-controlled randomized phase of the GAIN Trial will continue to receive study drug at their assigned dose, with top-line results from the double-blind GAIN Trial in Q4 2021.

The partial clinical hold was initiated following the review of hepatic adverse events in the atuzaginstat trial by the FDA. These events have been reversible and without any known long-term adverse effects for the participants. Cortexyme will continue to collaborate with the FDA on the overall development program for atuzaginstat.

https://www.streetinsider.com/Corporate+News/Cortexyme+%28CRTX%29+Reports+Partial+Clinical+Hold+on+Development+Program+for+Atuzaginstat+in+Alzheimer%E2%80%99s/17972450.html

Kroger Health Partners with Gauss on Smartphone COVID Rapid Antigen Home Tests

 Kroger Health, the health care division of The Kroger Co. (NYSE: KR), today announced plans to offer the first smartphone-enabled, at-home Gauss COVID-19 Rapid Antigen Test Kit to patients nationwide, expanding the company's existing portfolio of in-clinic and employer-focused COVID-19 testing solutions.

The new at-home testing solution, which is currently awaiting Food and Drug Administration (FDA) Emergency Use Authorization (EUA), will offer affordable access to cutting-edge testing technology developed by Gauss, a leader in computer vision-aided healthcare diagnostics. Once authorized, it will be the first rapid COVID-19 test that can be fully performed using only a smartphone and a lateral flow assay (similar to an at-home pregnancy test), without involving a laboratory, a telemedicine visit or any specialized electronics. Last month, Gauss produced its first 1.5 million tests, which will be available for immediate distribution when the test receives EUA from the FDA, and the company has the capability to produce up to 30 million tests per month.

Kroger Health expects the at-home rapid antigen test will be available to purchase on Kroger.com and over the counter at its 2,200 pharmacies nationwide.

https://www.streetinsider.com/Corporate+News/Kroger+%28KR%29+Health+Partners+with+Gauss+to+Provide+Smartphone-Enabled+COVID-19+Rapid+Antigen+Home+Tests/17972143.html

Seagen (SGEN) PT Lowered at RBC Capital

 To $169

https://www.streetinsider.com/Analyst+PT+Change/Seagen+%28SGEN%29+PT+Lowered+to+%24169+at+RBC+Capital/17972110.html

UK to consider making excess vaccines available to other nations after its adults inoculated

The UK will look at making excess doses of coronavirus vaccinations available to other nations after it has vaccinated its adult population, vaccine deployment minister Nadhim Zahawi said on Monday.

“My priority is to make sure I vaccinate the UK adult population as quickly as we can and then if there are any excess doses, we will look at how we make those excess doses available to other countries,” Zahawi told LBC radio.

https://www.reuters.com/article/us-health-coronavirus-britain-vaccines-c/uk-to-consider-making-excess-vaccines-available-to-other-nations-after-its-adults-inoculated-official-says-idUSKBN2AF1VO 

North Korean hackers tried to steal Pfizer vaccine know-how: lawmaker

 South Korea’s intelligence agency has said North Korea attempted to steal information on coronavirus vaccines and treatments by hacking Pfizer Inc, a lawmaker briefed by the agency said on Tuesday.

Digital espionage targeting health bodies, vaccine scientists and drugmakers has surged during the COVID-19 pandemic as state-backed hacking groups scramble to secure the latest research and information about the outbreak.

Ha Tae-keung, an opposition member of the parliamentary intelligence panel, said the pharmaceutical giant was among those hacked in the bid to steal information on vaccines and treatments.

“There were attempts to steal COVID vaccine and treatment technology during cyber attacks and Pfizer was hacked,” he said.

Speaking to reporters after a briefing by the agency, Ha did not elaborate on the timing or success of the attempt, a transcript of his remarks reviewed by Reuters showed.

Ha’s office confirmed his comments but gave no details.

Pfizer’s offices in Asia and South Korea did not have an immediate comment.

Tuesday’s news comes after attempts last year by suspected North Korean hackers to break into the systems of at least nine healthcare firms, such as Johnson & Johnson, Novavax Inc, and AstraZeneca.

South Korea’s National Intelligence Service (NIS) has said it had foiled attempts by its neighbour to hack into South Korean firms developing coronavirus vaccines.

North Korea is often accused of turning to an army of hackers to fill its cash-strapped coffers amid international sanctions that ban most international trade with it.

Health experts have said the North’s hackers may be more interested in selling the stolen data than using it to develop a homegrown vaccine.

North Korea is expected to receive nearly 2 million doses of the AstraZeneca-Oxford COVID-19 vaccine by the first half of this year through the COVAX vaccine-sharing programme.

It has not confirmed any infections, but the NIS had said an outbreak could not be ruled out as the North had trade and people-to-people exchanges with China before closing the border in early 2020.

Leader Kim Jong Un’s wife, Ri Sol Ju, not seen in public for more than a year, is keeping a low profile to avoid infection risks, Ha said, citing the South’s intelligence.

https://www.reuters.com/article/us-northkorea-cybercrime-pfizer/north-korean-hackers-tried-to-steal-pfizer-vaccine-know-how-lawmaker-says-idUSKBN2AG0NI