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[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on phase II/III SKYSCRAPER-06 study in metastatic non-squamous non-small cell lung…

Basel, 04 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis with a hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival (OS) at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature. The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes the phase II and phase III cohorts. The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified. Based on these results, patients and investigators will be unblinded and we intend to halt the study. A communication will be sent to the investigators and results will be shared with health authorities and subsequently presented at an upcoming medical meeting.

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[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on phase II/III SKYSCRAPER-06 study in metastatic non-squamous non-small cell lung...

Psyence Biomedical Ltd. Receives Nasdaq Notification Regarding Minimum Bid Price Deficiency

NEW YORK, July 03, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (the “Company”) (Nasdaq: PBM) announced that it received a notification letter dated June 27, 2024, from the Listings Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the closing bid price per share of the Company’s common shares was below $1.00 for a period of 30 consecutive business days and that the Company did not meet the minimum bid price requirement set forth in Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Rule”).

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Psyence Biomedical Ltd. Receives Nasdaq Notification Regarding Minimum Bid Price Deficiency

HUTCHMED Announces NDA Acceptance in China for Tazemetostat for the Treatment of Relapsed or Refractory Follicular Lymphoma with Priority Review…

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 04, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:?HCM; HKEX:?13) today announces that the New Drug Application (“NDA”) for tazemetostat for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) has been accepted for review and granted Priority Review by the China National Medical Products Administration (“NMPA”).

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HUTCHMED Announces NDA Acceptance in China for Tazemetostat for the Treatment of Relapsed or Refractory Follicular Lymphoma with Priority Review...

NewAmsterdam Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NAARDEN, The Netherlands and MIAMI, July 03, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that the Compensation Committee of NewAmsterdam’s Board of Directors approved the grant of inducement share options covering an aggregate of 195,000 of NewAmsterdam’s ordinary shares to three non-executive new hires. The share options were granted as an inducement material to the employees’ acceptance of employment with NewAmsterdam pursuant to the NewAmsterdam Pharma Company N.V. 2024 Inducement Plan (the “2024 Inducement Plan”) and in accordance with Nasdaq Listing Rule 5635(c)(4).

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NewAmsterdam Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Rafarma pharmaceutical updates: registration of Rafarma microspheres in South Korea

Sheridan, Wyoming, USA, July 04, 2024 (GLOBE NEWSWIRE) -- Rafarma Pharmaceuticals (OTC: RAFA) - Rafarma Pharmaceuticals is pleased to announce its participation in the scientific conference on radioembolization using Yttrium 90 microspheres for the treatment of cancer at Severance Hospital in Seoul, South Korea. It is one of the largest university hospitals in South Korea and is of strategic importance to the country.

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Rafarma pharmaceutical updates: registration of Rafarma microspheres in South Korea

FDA approves Roche’s Vabysmo prefilled syringe (PFS) for three leading causes of vision loss

Basel, 05 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the United States Food and Drug Administration (US FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to 80 million people globally.1-4 The Vabysmo PFS will become available to United States (US) retina specialists and their patients in the coming months.

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FDA approves Roche’s Vabysmo prefilled syringe (PFS) for three leading causes of vision loss

Harnessing benefits of stem cells for heart regeneration | ASU News – ASU News Now

Mehdi Nikkhah, an associate professor of biomedical engineering in theIra A. Fulton Schools of Engineeringat Arizona State University, and his collaborators at Mayo Clinic in Arizona have been awarded a $2.7 million grant by the National Institutes of Health to research how stem cell engineering and tissue regeneration can aid in heart attack recovery.

The research will be conducted in collaboration withWuqiang Zhu, a cardiovascular researcher and professor of biomedical engineering atMayo Clinic.

Nikkhah and Zhu are exploring stem cell transplantation to repair and possibly regenerate damaged myocardium, or heart tissue. Their work is focused on the development of a new class of engineered heart tissues with the use of human-induced pluripotent stem cells, or hiPSCs, and has resulted in two published papers in ACS Biomaterials.

Aheart attack, medically termed as a myocardial infarction, occurs when a coronary artery that sends blood and oxygen to the heart becomes obstructed. This blockage is often the result of an accumulation of fatty cholesterol-containing deposits, known as plaques, within the hearts arteries.

When these plaques rupture, a cascade of events is initiated, leading to the formation of a blood clot. These blood clots can obstruct the artery, impeding blood flow to the heart muscle, thus triggering a heart attack.

When someone has a heart attack, a portion of muscle tissue on the left ventricle, which pumps the blood throughout the whole body, is damaged, Nikkhah says. Over time, the other parts of the heart have to take on more workload, consequently leading to catastrophic heart failure.

A team of biomedical engineers in theSchool of Biological and Health Systems Engineering, part of the Fulton Schools, and medical researchers at Mayo Clinic in Arizona are taking a novel step forward in using stem cell technology and regenerative medicine to aid in heart attack recovery.

Nikkhah is developing engineered heart tissues, or EHTs, with electrical properties to simulate the contraction function typically found within the native hearts tissue.

He is integrating the EHTs with gold nanorods to enhance electrical conductivity among stem cells. Gold is a suitable material because it is conductive and nontoxic to human cells, making the nanorods safe for medical research and translational studies.

In the lab, Nikkhahs team mixes the gold nanorods with a biocompatible hydrogel to form a tissue construct a patch of stem cells to rejuvenate damaged cardiac muscle tissue, offering a promising outcome for heart regeneration.

After we generate the patch, we get the engineered hiPSCs from Dr. Zhus lab at Mayo Clinic, Nikkhah says. They seed the cells on the patch and look at their biological characterization, including cell proliferation, cell viability and gene expression analysis, to see how the cells respond to the conductive hydrogel.

We have successfully used hiPSC-derived cardiomyocytes and cardiac fibroblasts to create beating heart tissues.

The successful integration and proliferation of these cells can lead to the formation of new, healthy heart tissue, potentially reversing the damage caused by the heart attack and enhancing the recovery process.

Reprogrammed human stem cells have nearly limitless potential because they can be differentiated into various cell types. That means hiPSCs can also be used to construct capillaries and blood vessels, which are essential for restoring adequate blood flow and oxygen supply to the damaged areas of the heart.

This process involves the differentiation of hiPSCs intoendothelial cells, which form the lining of blood vessels, thereby facilitating the reconstruction of the hearts vascular network.

Michelle Jang, a graduate student in Nikkhahs lab, is currently studying EHTs to improve cell maturation and observe its electrical properties.

My engagement in this project showed a deep interest in how biomedical engineering technology and biology intersect to create new therapeutic possibilities in the field of regenerative medicine, Jang says. Im excited to see how my current research will further evolve and potentially contribute valuable insights to biomedical research.

Using these techniques, Nikkhah and Zhu can observe the capacity of programmed cells to regenerate damaged heart tissue. With continued advancement in regenerative medicine, there is potential for significant positive impact on outcomes for patients suffering from heart attacks.

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Harnessing benefits of stem cells for heart regeneration | ASU News - ASU News Now