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November 24, 2020

Tuesday
  • Baxter International Inc receives approval from the FDA for Homechoice Claria
  • Merck enters into agreement to acquire all outstanding shares of OncoImmune
  • Roche receives FDA approval for Xofluza as a treatment to prevent influenza
  • Beckman Coulter launches Access SARS-CoV-2 lgG II Assay
  • Tuesday
    Baxter International Inc receives approval from the FDA for Homechoice Claria
     Baxter International Inc (Deerfield, IL) announced that it received approval from the FDA for its Homechoice Claria automated peritoneal dialysis (APD) system with Sharesource connectivity platform. Cleared for both adult and pediatric patients, Homechoice Claria combines a simple user interface with the benefits of Sharesource, the only two-way remote patient management platform for patients on peritoneal dialysis in the U.S.

    Sharesource offers patients and clinicians the ability to stay closely connected in order to proactively address key aspects of peritoneal dialysis (PD) therapy. Using this technology, clinicians can manage patients remotely and make timely therapy decisions while keeping patients safely at home. Clinicians using Homechoice Claria with Sharesource also have greater visibility to patient adherence patterns, allowing for early intervention and an increased focus on proactive care.

    For patients, Homechoice Claria offers intuitive control buttons, an easy-to-read screen with straightforward instructions available in 38 languages, and a web-based app with additional features. For clinicians, a web-based app called MySharesource features step-by-step guidance and quick demo videos on how to use the Sharesource platform.

    Homechoice Claria is part of Baxter Internationals APD cycler portfolio.

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    Merck enters into agreement to acquire all outstanding shares of OncoImmune
     Merck (Kenilworth, NJ) entered into a definitive agreement to acquire all outstanding shares of OncoImmune (Rockville, MD), a privately-held, clinical-stage biopharmaceutical company, for an upfront payment of $425 million in cash. In addition, OncoImmune shareholders will be eligible to receive sales-based payments and payments contingent on the successful achievement of certain regulatory milestones.

    Recently, Oncolmmune announced positive top-line findings from an interim efficacy analysis of a Phase 3 study evaluating its lead therapeutic candidate CD24Fc for the treatment of patients with severe and critical COVID-19. According to Dr. Roger M. Perlmutter, President of Merck Research Laboratories, “Recent clinical investigations support the view that CD24Fc may provide benefit beyond standard of care therapy for COVID-19 patients requiring oxygen support, and hence will represent an important addition to the Merck pipeline of investigational medicines and vaccines designed to address the COVID-19 pandemic.

    ”Prior to the completion of the acquisition, OncoImmune will spin-out certain rights and assets unrelated to the CD24Fc program to a new entity to be owned by the existing shareholders of OncoImmune. In connection with the closing of the acquisition, Merck will invest $50 million, and become a minority shareholder, in the new entity. The acquisition is expected to close before the end of 2020.

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    Roche receives FDA approval for Xofluza as a treatment to prevent influenza
     Roche (Basel, Switzerland) received FDA approval for a supplemental New Drug Application (sNDA) for Xofluza® as a treatment to prevent influenza in people aged 12+ following contact with someone with influenza. Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis. Roche is hopeful that reducing the burden of influenza may help to mitigate the strain on the healthcare system amid the COVID-19 pandemic.

    Xofluza is already FDA-approved to treat acute uncomplicated influenza in people 12+ who have had flu symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing flu-related complications. It is available in the U.S. and in several other countries for the treatment of influenza types A and B.

    Roche also is determining a path forward with the FDA for a potential indication for Xofluza as a treatment for acute uncomplicated influenza in otherwise healthy children (one to 12 years of age) and for the prevention of flu in the same age group who have been exposed to influenza. Xofluza is currently not approved for use in this population.

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    Beckman Coulter launches Access SARS-CoV-2 lgG II Assay
     Beckman Coulter (Brea, CA) launched its Access SARS-CoV-2 IgG II assay, which measures a patients relative level of antibodies in response to a previous SARS-CoV-2 infection. These new capabilities enable clinicians to establish a baseline to evaluate an individuals immune response to the virus based on a numerical value and assess relative changes of an individuals immune response to the virus over time. The assay may also help researchers understand the levels of IgG antibodies needed to be considered protective.

    Beckman Coulter will file for Emergency Use Authorization of the assay with the FDA and will immediately begin shipping assays to its customer base throughout the U.S. under Policy D. The company also plans to make the assay available to markets accepting the CE Mark before the end of the year.

    Access SARS-CoV-2 IgG II semi-quantitative assay provides a numerical result in Arbitrary Units (AU) from 2.00- 450 AU/mL1 as well as a qualitative result and offers the same high level of quality as Beckman Coulters Access SARS-CoV-2 IgG and IgM serology tests already on the market. The assays use the receptor-binding domain (RBD) of the spike protein, which is critical for viral entry into human cells and has been shown to be the target for neutralizing antibodies in a surrogate model.

    The Access SARS-CoV-2 IgG II semi-quantitative assay is the latest addition to Beckman Coulters full suite of testing solutions to help with the fight against COVID-19.

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