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Category Archives: Global News Feed

Apexigen and Brookline Capital Acquisition Corp. Announce Effectiveness of Registration Statement and Annual Stockholder Meeting to Approve the…

Posted: July 19, 2022 at 2:14 am

SAN CARLOS, Calif. and NEW YORK, July 18, 2022 (GLOBE NEWSWIRE) -- On March 18, 2022 Brookline Capital Acquisition Corp. (“BCAC”), a life-science focused Special Purpose Acquisition Company (“SPAC”) affiliated with Brookline Capital Markets, a division of Arcadia Securities, LLC (“Brookline”), announced a proposed business combination with Apexigen, Inc. (“Apexigen”), a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology.

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AnPac Bio Approved Written Resolutions of a Majority of the Members Addressing the Removal of Directors and Officers, Re-designation of Officers, and…

Posted: July 19, 2022 at 2:14 am

PHILADELPHIA, July 18, 2022 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a biotechnology company with operations in the United States and China focused on early cancer screening and detection, announced that the Company’s Members approved Written Resolutions of a Majority of the Members (the “Resolutions”) on July 14, 2022 addressing the removal of directors and officers, re-designation of officers, and change of members of the committees. The Resolutions were approved by 69.29% of the total voting power of the Company entitled to vote at a general meeting in accordance with British Virgin Islands law, which allows Member’s resolutions to be approved by written resolutions signed by a majority of the votes of all Members entitled to vote on the resolution at a general meeting.

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Roche’s Elecsys Amyloid Plasma Panel granted FDA Breakthrough Device Designation to enable a timely diagnosis of Alzheimer’s disease

Posted: July 19, 2022 at 2:14 am

Basel, 19 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Elecsys® Amyloid Plasma Panel, an innovative new solution to enable Alzheimer’s disease to be detected earlier. The Elecsys Amyloid Plasma Panel test detects and measures Alzheimer’s disease biomarkers in blood plasma to indicate the need for further confirmatory testing for Alzheimer’s disease. Roche is the first in-vitro diagnostics manufacturer to receive this designation for a blood-based biomarker test for Alzheimer’s.Alzheimer's disease is the most common form of dementia. Dementia affects more than 55 million people worldwide with more than 10 million new cases each year.1 Barriers to early and accurate diagnosis of Alzheimer’s disease exist across the globe – up to 3 out of 4 people living with symptoms of Alzheimer’s disease have not been diagnosed2, and those who have received a diagnosis, on average waited 2.8 years."The key to transforming the life of people with Alzheimer’s disease is to diagnose as early as possible and intervene with the right care plans,” said Thomas Schinecker, CEO of Roche Diagnostics. "Our new diagnostics test has the potential to streamline a patient's journey, improving speed and access toward a confirmatory diagnosis, giving people with Alzheimer’s disease and their caregivers more time to plan and prepare for the future.”Currently, the diagnosis of Alzheimer’s disease is largely based on clinical symptoms, including cognitive assessment, with a significant number of patients diagnosed when their disease has already advanced. The Elecsys Amyloid Plasma Panel will be the first qualitative test that combines the result of the phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human plasma. Elevations in pTau occur in early stages of Alzheimer’s, while the presence of APOE E4 constitutes the most common genetic risk factor for Alzheimer’s disease. Patients testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline.The Elecsys Amyloid Plasma Panel has thus the potential to ensure better identification of patients that require further confirmatory testing. This could be done via PET scan or cerebrospinal fluid (CSF) testing, supporting a more timely and accessible diagnosis. In conjunction with other diagnostic tools and the work Roche is doing in developing potential new treatments, this could be an important building-block toward improved care and outcomes for people with Alzheimer’s disease.Roche has also received a Breakthrough Device Designation for the Elecsys® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF in vitro diagnostic immunoassays measuring ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of dementia. About the Elecsys® Amyloid Plasma PanelThe Elecsys Amyloid Plasma Panel measures phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma. Elevations in pTau occur in early stages of Alzheimer’s, while the presence of APOE E4 constitutes the most common genetic risk factor for Alzheimer’s disease. The result is intended for consideration in conjunction with other clinical information to advise for further confirmatory testing with amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. Patients testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline.About Alzheimer's diseaseAlzheimer’s is a progressive, fatal disease of the brain that gradually destroys memory, thinking skills and problem solving and impairs daily functioning such as the ability to manage one's own activities. Biological changes are believed to start decades before clinical symptoms of Alzheimer’s become evident. Early signs and symptoms include memory loss, changes in mood or personality, decreased judgement, confusion, and challenges with problem-solving, finding the right word or familiar tasks.Alzheimer's disease is the most common form of dementia. Dementia affects more than 55 million people worldwide with more than 10 million new cases each year. Up to 3 in 4 people with dementia worldwide have not been diagnosed.Roche has an extensive Alzheimer’s portfolio, including technology designed to more effectively detect and diagnose Alzheimer’s disease and monitor disease progression and multiple treatment approaches and molecules that may address key pathways of Alzheimer’s disease. Data from two Phase III studies with Roche’s investigational treatment, gantenerumab, in early Alzheimer’s disease are anticipated in November 2022. About the Breakthrough Device DesignationThe Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.All trademarks used or mentioned in this release are protected by law.References[1] “Dementia.” World Health Organization, World Health Organization, 2 Sept. 2021, https://www.who.int/news-room/fact-sheets/detail/dementia#:~:text=Rates%20of%20dementia,and%20139%20million%20in%202050. [2] Alzheimer's Disease International. “Adi - over 41 Million Cases of Dementia Go Undiagnosed across the Globe – World Alzheimer Report Reveals.” Alzheimer's Disease International (ADI), 21 Sept. 2021, https://www.alzint.org/news-events/news/over-41-million-cases-of-dementia-go-undiagnosed-across-the-globe-world-alzheimer-report-reveals/. Roche Group Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com

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Roche's Elecsys Amyloid Plasma Panel granted FDA Breakthrough Device Designation to enable a timely diagnosis of Alzheimer’s disease

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Novartis delivers continued strong momentum of key growth brands, progress on strategic initiatives and confirms FY’22 Group guidance

Posted: July 19, 2022 at 2:14 am

Ad hoc announcement pursuant to Art. 53 LR

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Novartis delivers continued strong momentum of key growth brands, progress on strategic initiatives and confirms FY’22 Group guidance

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eureKARE launches synthetic biology studio network with inaugural biomedical studio in Belgium

Posted: July 19, 2022 at 2:14 am

eureKARE launches synthetic biology studio network with inaugural biomedical studio in Belgium

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eureKARE launches synthetic biology studio network with inaugural biomedical studio in Belgium

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Kymera Therapeutics Strengthens Board of Directors with Appointment of People and Business Leader Leigh Morgan

Posted: July 11, 2022 at 2:10 am

WATERTOWN, Mass., July 08, 2022 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today announced the appointment of Leigh Morgan to its Board of Directors. Ms. Morgan joins Kymera’s Board as a senior executive accomplished in scaling global, profitable, high-performing organizations.

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Kymera Therapeutics Strengthens Board of Directors with Appointment of People and Business Leader Leigh Morgan

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ProMIS Neurosciences to Commence Trading on Nasdaq Under the Symbol “PMN”

Posted: July 11, 2022 at 2:10 am

TORONTO, Ontario and CAMBRIDGE, Massachusetts, July 08, 2022 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN) (TSX: PMN) (“ProMIS” or the “Company”), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers, implicated in the development of neurodegenerative diseases, today announced that it has received final approval from The Nasdaq Capital Market LLC (“Nasdaq”) to list its common shares (the “Common Shares”) on Nasdaq. The Company’s Common Shares will begin trading on Friday, July 8th, 2022, under the symbol “PMN”.

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ProMIS Neurosciences to Commence Trading on Nasdaq Under the Symbol “PMN”

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OpGen Announces Preliminary Unaudited Revenue and Cash Position for Second Quarter 2022 and Provides Business Update

Posted: July 11, 2022 at 2:10 am

ROCKVILLE, Md., July 08, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that total preliminary unaudited revenue for the second quarter of 2022 was approximately $1.0 million, up from $0.8 million in the second quarter of 2021. Cash as of June 30, 2022 was approximately $16.6 million.

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OpGen Announces Preliminary Unaudited Revenue and Cash Position for Second Quarter 2022 and Provides Business Update

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SIGA Technologies Receives Approval from UK for Tecovirimat

Posted: July 11, 2022 at 2:10 am

Treatment Approved for Smallpox, Monkeypox, Cowpox, and Vaccinia Complications Treatment Approved for Smallpox, Monkeypox, Cowpox, and Vaccinia Complications

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SIGA Technologies Receives Approval from UK for Tecovirimat

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MediWound Announces Presentation on EscharEx at the Advanced Wound Care Summit in Boston on July 13

Posted: July 11, 2022 at 2:10 am

YAVNE, Israel, July 08, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced an oral presentation at the Advanced Wound Care Summit taking place on July 13-14, 2022 in Boston, MA.

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MediWound Announces Presentation on EscharEx at the Advanced Wound Care Summit in Boston on July 13

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