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Tuesday, March 9, 2021

Walgreens Boots Alliance Site for Booking Covid-19 Vaccine Crashes

 Walgreens Boots Alliance Inc.'s online vaccine-booking system stopped working for several hours on Tuesday, preventing people from making appointments to get a Covid-19 vaccine.

Visitors to the Walgreens website were unable to log into a Walgreens.com account, a step required to book a vaccine appointment or conduct other business with the pharmacy, such as filling prescriptions. People took to social media to complain, saying they also were unable to get help through online chats or by calling.

The glitch happened as the drugstore chain announced it is expanding its partnership with the U.S. government to administer vaccines in 43 states and jurisdictions, up from 27.

Walgreens is a major provider of vaccines through the federal inoculation program, having administered about 8% of nearly 60 million shots given since vaccinations began in December.

Across the county, vaccine seekers have struggled with a patchwork of glitchy, hard-to-navigate and disjointed appointment-booking systems, further complicating a process already challenged by limited supply of vaccines.

A Walgreens spokeswoman said the site outage was unrelated to a new booking system the chain put in place on Friday. Under the new system, Walgreens now requires people to schedule an appointment for a second dose at the same time they book their first.

The site was down for about four hours on Tuesday, coming back online shortly after noon Eastern Time.

The two Covid-19 vaccines initially authorized in the U.S., from Moderna Inc. and from a partnership between Pfizer Inc. and Germany's BioNTech SE, entails a two-dose regimen. A third vaccine by Johnson & Johnson calls for only one dose.

Across the country people have reported long wait times and difficulty finding appointments to receive a second dose, similar to challenges in getting initial shots.

Walgreens's social-media team, responding on Twitter to complaints about the vaccine-scheduling site being inaccessible, addressed challenges with second doses.

"To ensure access to both doses, it is required to schedule them together," the company's "Social Care Team" said in a tweet. "Unfortunately the high demand for appointments, often combined with limited inventory is exceeding the appointment availability."

The Walgreens spokeswoman said a number of people either get their second dose from another provider or have difficulty scheduling an appointment with the chain.

https://www.marketscreener.com/quote/stock/WALGREENS-BOOTS-ALLIANCE-19356230/news/Walgreens-Boots-Alliance-nbsp-Site-for-Booking-Covid-19-Vaccine-Crashes-32644659/

Mexico leans on China after Biden rules out vaccines sharing in short term

 Mexico is turning to China to fill a vaccine shortfall with an order for 22 million doses, Foreign Minister Marcelo Ebrard said on Tuesday, a week after U.S. President Joe Biden ruled out sharing vaccines with Mexico in the short term.

President Andres Manuel Lopez Obrador spearheaded efforts to attain more help from China, Ebrard said.

“As a result of a process personally led by the president of the republic, we have received the confirmation that we will have an expansion of up to 22 million doses,” Ebrard said during Lopez Obrador’s regular news conference.

Mexico’s vaccine roll out has been criticized as overly slow, though officials say they’ve been hampered by delays in receiving vaccines amid global shortages.

The Biden administration appeared to have turned down Lopez Obrador’s request, at least in the short term, for the United States to share its vaccines by saying the immediate priority is to inoculate American citizens.

Mexico is now pinning its hopes on receiving some vaccines from the United States once Biden meets his goal of inoculating 100 million Americans in 100 days, a deadline due in late April.

Ebrard said Mexico has placed an order for an additional 10 million doses of China’s Sinovac COVID-19 vaccine to be delivered between May and July, on top of the 10 million already ordered, which are due to arrive between March and May.

Mexico will also order 12 million vaccine doses made by the state-backed China National Pharmaceutical Group (Sinopharm) once it has been approved by its health regulator, Ebrard added.

https://www.reuters.com/article/us-health-coronavirus-mexico-vaccines/mexico-leans-on-china-after-biden-rules-out-vaccines-sharing-in-short-term-idUSKBN2B11OY

Titan Medical Issues Corporate Update

 Large market opportunity, strong corporate foundation, innovative robotic-assisted technology

Clinical studies expected to commence in 2022

Titan Medical Inc. ("Titan" or the "Company") (TSX: TMD) (Nasdaq: TMDI), a medical device company focused on the design and development of surgical technologies for robotic single access surgery, today announced a corporate update in conjunction with its presentation at the H.C. Wainwright Global Life Sciences Conference. David McNally, President, CEO and Chairman of Titan Medical, will provide an overview of the Company and its Enos™ robotic single access surgical system at the conference, which is available for on-demand access on Titan Medical’s website under the "Investors" section.

"We are pleased to further detail our corporate strategy and the market opportunity for our Enos surgical system. The achievements to date position Titan for success in attaining our vision for robotic-assisted surgery that may allow patients less trauma, shorter hospitalization time, less scarring, faster recovery times and reduced post-operative pain," said David McNally. "With a strong cash position and expert in-house technical talent, the advanced development of the Enos surgical system is at full intensity. We plan to continue executing on our corporate milestones with the objectives of completing product development in 2021 and human clinical studies in 2022."

Corporate highlights, including those found in the presentation are included below.

Market Opportunity:

  • Based on independent research, the total addressable US surgical robotics market could reach $18 billion1 with up to six million addressable procedures annually, and gynecologic surgery representing about $1 billion in market potential, in the US alone.Titan intends to initially pursue gynecologic surgical indications with the Enos system.

  • The current robotic surgery market appears to be underpenetrated due in part to costs associated with existing robotic surgical systems. The Enos surgical system is being developed to allow hospitals to benefit from increased procedure throughput and reduced post-operative hospitalization of patients.

  • Surgical procedures have evolved from open surgery with the growth of minimally invasive surgery, and further with the evolution in robotic assisted surgery. Current robotic assisted surgical systems are primarily comprised of multi-port systems, typically involving three instruments and a camera, and each requiring a separate incision. With single port, or single access, robotic surgery, the number and size of incisions, or access points, is further reduced. The Enos surgical system is a robotic surgical system designed for single access surgery.

  • Reducing the number of incisions to a single access point may potentially reduce the trauma, complications, scarring, healing time, and use of post-operative pain medications associated with surgery. This may especially be relevant in the context of a post-COVID-19 environment.

Titan Medical’s Enos Surgical System:

  • Through an aperture of approximately 25-millimeter diameter, the Enos robotic single access surgical system is designed to provide:

    • Two multi-articulating instruments with fluid "snake-like" movement engineered to generate the forces necessary for performing complex surgical tasks, including suturing, and built with an open architecture to accommodate a variety of end-effectors and to adapt to future surgical tools and technologies.

    • A dual-view 3D and 2D endoscopic high-definition vision system, each supporting independent integrated illumination.

  • An easy to maneuver ergonomic surgeon workstation has been designed with embedded software for simulation training and surgeon overlays for providing interoperative feedback.

  • A compact single-arm patient cart provides for fast set-up and unencumbered assistance by operating room staff.

  • The complete surgical system of a surgeon workstation, patient cart, instrument and accessories is designed to deliver operating room efficiency and positive hospital economics.

  • While the initial indication for use is expected to be benign gynecologic surgery, preclinical evidence suggests that the system may ultimately have application in other subspecialties, including urologic, colorectal and general surgery.4

  • An expanding intellectual property portfolio presently comprises over 150 U.S. and international patents issued or pending. Titan’s intellectual property stems from several years of innovation in robotic assisted surgery covering technologies from hand controllers, to multi-articulating instruments, to unique software functionality including interoperative feedback. A select portion of the intellectual property portfolio and associated technologies have been licensed to global medical device leader Medtronic plc in exchange for license fees, with the Company retaining world-wide rights to commercialize the technologies for use with the Enos surgical system. The Company continues to build on and seek additional avenues for leveraging and/or expanding its intellectual property portfolio.

Corporate Resources:

  • As of January 31, 2021, the Company had pro forma cash and cash equivalents of approximately $65.5 million when including proceeds of over $30 million in equity financings and $10 million in warrant exercises in January and February 2021.

  • In 2020, the Company generated $20 million in license revenue from its development and license agreements with Medtronic.

Future Company Milestones:

  • Under an ongoing development and license agreement with Medtronic and with the satisfaction of certain milestones thereunder, the Company expects to generate $21 million in additional license revenue in 2021.

  • With its Enos surgical system, over the next two years the Company plans to complete product development and tooling for initial manufacturing, apply for an Investigational Device Exemption from the U.S. FDA, and once approved, conduct human clinical studies compiling data to prepare for FDA marketing authorization application.

For full financial information, including a detailed milestone table, please see the Company’s consolidated financial statements and annual management’s discussion and analysis for the year ended December 31, 2020 and December 31, 2019, which may be viewed at www.sedar.com and at www.sec.gov.

https://finance.yahoo.com/news/titan-medical-issues-corporate-114500221.html

NexImmune started at Overweight by Barclays, Cantor

 Both targets $35

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

ANI to Acquire Novitium Pharma, Strengthening R&D, Generics, CDMO

 

  • Creates Sustainable Generics Growth Engine with Approximately 25+ Launches Expected in 2021 and 2022
  • Expands Brand Portfolio with Addition of 505(b)(2) Pipeline and Enhances Scale of CDMO Business
  • Purchase Price of $163.5 Million, including $89.5 Million in Cash and $74 Million in Equity, plus Two Potential Future Earnouts of Up to $46.5 Million
  • Expected to be Accretive to Adjusted non-GAAP Earnings per Share within First 12 Months
  • Strengthens Capital Structure with New Senior Credit Facilities of $340 Million (Replacing the Company’s Existing Term Loan A) Committed by Truist Securities and $25 Million PIPE by Ampersand Capital Partners

2 big telehealth groups team up to expand virtual care training

 The American Telemedicine Association and the American Board of Telehealth announced Tuesday that they were partnering to expand access to training and education for virtual care.  

The partnership comes on the heels of the ABT's recently launched CORE Concepts in Telehealth Certificate, which consists of seven telemedicine-focused training models.

"We share a common goal with ATA. That is to weave telehealth into the everyday fabric of healthcare. By improving access to quality education, we can help ensure effective care for all patients, particularly those in rural and underserved communities," said Deanna Larson, chief executive officer of Avera eCARE and a founding board member of the American Board of Telehealth, in a statement.  

WHY IT MATTERS  

As part of the collaboration, members of the ATA will receive discounted access to the ABT's certificate programs.

The CORE Concepts in Telehealth Certificate consists of:   

  • Introduction to telehealth.
  • Telepresence skills.
  • Technology.
  • Legal, regulatory and quality.
  • Licensing, credentialing and privileging. 
  • Reimbursement. 
  • Ethical considerations.

According to the statement, ABT will also offer a behavioral telehealth certificate and a primary telehealth certificate in the coming weeks. The courses may be used for Continuing Medical Education or Continuing Nursing Education credits.  

"We are thrilled to provide ATA’s fast-growing membership with the educational tools they need to ensure a successful future for telehealth," said Larson.  

THE LARGER TREND

Although the future of telehealth remains uncertain from a federal policy perspective, patients have largely expressed satisfaction with the modality – which suggests that providers may benefit from offering it as a service in the long term.  

One open question, of course, is reimbursement: If providing telehealth isn't financially feasible, patient demand may not be enough to compel mass adoption.

Still, some states are taking steps to guarantee parity in this regard, at least for certain specialties. A recently signed Massachusetts law would implement permanent rate parity for virtual behavioral health services, among its other provisions.   

ON THE RECORD  

"We are pleased to partner with the American Board of Telehealth to offer high-quality, evidence-based telehealth education to our diverse membership," said ATA Chief Executive Officer Ann Mond Johnson in a statement.  

"ABT’s Certificate Program is the gold standard for telehealth education, preparing healthcare providers to use telehealth and virtual care in the delivery of safe, effective, quality care to their patients, wherever and whenever they need it," Johnson said.

https://www.healthcareitnews.com/news/two-major-telehealth-orgs-team-expand-virtual-care-training

Gilead Investigational Lenacapavir for HIV Shows Sustained Efficacy Through Week 26


 Lenacapavir Maintained High Rates of Virologic Suppression Among Heavily Treatment-Experienced People with Multi-Drug Resistant HIV 

 Late-Breaking Preclinical Data Support Further Study of Lenacapavir as a Long-Acting Agent for HIV Prevention 

Gilead Sciences, Inc. (Nasdaq: GILD) today presented additional results from the Phase 2/3 CAPELLA trial evaluating the company’s investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The data build on the positive primary endpoint results announced previously. The new interim efficacy results demonstrate that lenacapavir administered subcutaneously every six months maintained high rates of virologic suppression through 26 weeks in a difficult-to-treat patient population with limited therapy options and high unmet medical need. In this analysis of the ongoing maintenance period of CAPELLA, which evaluated lenacapavir in combination with an optimized background regimen, 73% (n=19/26) of participants who reached Week 26 since the first dose of subcutaneous lenacapavir achieved undetectable viral load (<50 copies/mL). The data were presented at the 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021).

https://finance.yahoo.com/news/gilead-investigational-lenacapavir-demonstrates-sustained-182200406.html