Clarus Equips Top Pharmaceutical Company, AstraZeneca, With Innovative TherMobile Boards in the Fight Against COVID-19

Clarus | April 22, 2020

Clarus, the industry leader in glassboard innovation and creator of the new TherMobile, a non-porous mobile board that serves as a protective shield during the health screening process, is successfully supporting AstraZeneca's efforts in keeping their essential employees safe while continuing to work during the COVID-19 crisis. "We initially developed TherMobile as a way to keep our own employees safe while implementing employee temperature screening at our facility," said Marc Mansell, CEO of Clarus. "We quickly realized that many other companies were facing the same challenge, and we knew that we had to find a way to bring this innovative product to market quickly." TherMobile's small cut-out window allows companies to safely take the temperature of incoming employees or handoff necessary documents, all through a non-porous, easily cleanable safety shield. Thanks to the natural properties of glass, it can be sanitized easily, protecting all parties during health screenings. Ultimately, TherMobile serves as an ideal first line of defense against COVID-19.

Spotlight

Innovative pharmaceutical companies engage in sophisticated strategies to moderate the loss of revenue they will face when generic competitors enter the market. Known in the industry as product lifecycle management, these strategies often rely on the development and launch of pharmaceutical line extensions. Line extensions are incremental innovations on the product facing generic competition, and usually enter the market with exclusivity periods that outlast those of the original product.

Spotlight

Innovative pharmaceutical companies engage in sophisticated strategies to moderate the loss of revenue they will face when generic competitors enter the market. Known in the industry as product lifecycle management, these strategies often rely on the development and launch of pharmaceutical line extensions. Line extensions are incremental innovations on the product facing generic competition, and usually enter the market with exclusivity periods that outlast those of the original product.

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BUSINESS INSIGHTS

Louis Drapeau Has Resigned from the Board of Directors of Avita Medical, Inc

AVITA Medical | April 22, 2022

Louis Drapeau has resigned from the Board of Directors of AVITA Medical, Inc. a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, effective April 29, 2022. Mr. Drapeau's resignation is not the result of a disagreement with the Company over any of its operations, policies, or procedures. Rather, he is stepping down for personal reasons. Since January 2016, Mr. Drapeau has served as Chair of the Audit Committee and as a non-executive Director of AVITA Medical. Louis Drapeau had already stepped down as Chair of the Audit Committee as of February 23, 2022, as disclosed in the Company Form 10-KT dated March 1, 2022. James Corbett was appointed Chair of the Audit Committee in his place as of February 23, 2022, as disclosed in the Company Form 10-KT dated March 1, 2022. “We want to thank Louis for his time, dedication and contributions to AVITA Medical over the past six years. We appreciate his insights and dedication to the Company and wish him the best.” Lou Panaccio, Chairman of the Board

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PHARMACY MARKET

Kairos Pharma Received FDA Approval of the IND Application for an Investigational New Drug

Kairos Pharma, Ltd. | March 15, 2022

Kairos Pharma, Ltd. a privately-held clinical-stage biotechnology company focused on cancer drug resistance and immunotherapy, announced today that its activated T cell therapy, KROS 201, has received FDA approval to move forward with a Phase 1 clinical trial in patients with recurrent glioblastoma. Kairos Pharma is funding the phase I trial, which will occur at Cedars Sinai Medical Center in Los Angeles. John Yu, M.D., Kairos CEO, commented, "This IND acceptance is the second substantial clinical milestone within the past month as Kairos accelerates toward its clinical goals for 2022. This first-in-man Phase 1 clinical trial will activate T cells against the cancer stem cells at the root of glioblastoma." "This achievement pushes the envelope of immune therapies designed to target T cells against devastating cancers." Neil Bhowmick, Ph.D., Kairos Chief Scientific Officer KROS 201 activated T cells (ATCs) are killer T cells created in cell culture by activating a patient's white blood cells with cytokines or T cell activating signals and priming dendritic cells with antigens specific to glioblastoma cancer stem cells. Patients with recurrent glioblastoma are given the strongly activated T cells intravenously. As a result, cancer stem cells, which are the source of cancer, are killed by these cells. In February, the FDA granted an IND for a Phase 2 trial of ENV105 with apalutamide, in addition to the planned Phase 1 trial of activated T cell treatment for KROS 201. In 2022, an ENV105 Phase 1 trial with Tagrisso (AstraZeneca) for lung cancer is expected. Kairos Pharma also published a notice of allowance of their patent Compositions and Methods for Treating Fibrosis by the United States Patent and Trademark Office, which coincides with the advancement of its clinical milestones. The method of treating fibrosis and certain types of cancer, the composition of matter, and the administration of therapy utilizing KROS-401, a cyclic peptide inhibitor of the IL-4 and IL-13 cytokine receptor complex, are all covered by this patent. This drug has been proven to treat fibrosis and cancer by reversing the M1 to M2 immunosuppressive macrophage shift in cancer and fibrosis. CEO of Kairos Pharma, Dr. John Yu, stated, "This milestone further supports the already substantial and diversified intellectual property portfolio of Kairos and enables the unfettered clinical development of this novel and transformative therapeutic." Dr. Ramachandran Murali, Kairos VP of Research and Development and inventor of the KROS 401 molecule, commented, "KROS-401, in addition to fibrosis and cancer, opens a new avenue in therapeutic development for neurological disorders such as Alzheimer's disease."

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PRACTICE MANAGEMENT

AstraZeneca's Farxiga scores a speedy FDA review in kidney disease—and gets another jump on rival Jardiance

Farxiga | January 07, 2021

Pushing for another endorsement for SGLT2 prescription Farxiga in persistent kidney illness (CKD), AstraZeneca a year ago posted amazing information in its critical preliminary. Presently, the FDA has acknowledged its CKD application and granted a need survey, setting up a choice for the subsequent quarter—and putting Farxiga significantly farther in front of its future adversaries. In that preliminary, named Dapa-CKD, AZ's Farxiga in addition to standard of care cut the joined danger of deteriorating kidney capacity or demise brought about via cardiovascular or kidney issues by 39% over fake treatment in certain CKD patients. Furthermore, the medication cut the danger of death from any reason by 31%. Initially endorsed to control glucose, Farxiga a year ago scored a class-first FDA gesture to lessen the danger of major cardiovascular occasions in patients with cardiovascular breakdown—regardless of whether they have diabetes. Presently, AstraZeneca is planning to change the therapy worldview in persistent kidney sickness. Johnson and Johnson's Invokana conveys a FDA endorsement in diabetic kidney infection, however Farxiga is gunning for a gesture in ongoing kidney sickness with or without type 2 diabetes. At the point when AZ introduced its definite stage 3 Dapa-CKD results back in August, an executive said the information "truly can possibly modify" clinical course readings. Before that, the organization halted its preliminary early last March after break information "demonstrated Farxiga's advantages sooner than initially envisioned." The FDA's Wednesday move "presents to us a bit nearer to conveying this new therapy choice for the large numbers of patients living with ongoing kidney illness in the U.S.," AZ's chief VP of biopharma R&D, Mene Pangalos, said in an assertion. "Farxiga can possibly be a really groundbreaking medication across an expansiveness of illnesses, including type 2 diabetes, cardiovascular breakdown with diminished discharge division and, whenever endorsed, constant kidney infection."

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