SFDA

China Oncology Drugs Market Research Report 2024-2028 Featuring Major Players - Bristol Myers Squibb, Merck, Eli Lilly, Sino BioPharma, F Hoffmann-La Roche, Johnson & Johnson, AbbVie, AstraZeneca - ResearchAndMarkets.com

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星期二, 二月 20, 2024

High treatment expenses, inadequate insurance, and lack of know-how may also prevent sufferers' capacity to get hold of better oncology treatments in China.

Key Points: 
  • High treatment expenses, inadequate insurance, and lack of know-how may also prevent sufferers' capacity to get hold of better oncology treatments in China.
  • 2.3 Million Oncology deaths are pronounced in China, making Oncology liable for approximately 1 of 5th of all-purpose deaths within the China.
  • NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) and other rising remedies are poised to dominate ChinaOncology drugs market, securing the highest market proportion.
  • This shift signifies a dynamic panorama in China Oncology drugs market, reflecting a growing attention on revolutionary procedures and a broader commitment to preventing oncology comprehensively.

Co-Diagnostics, Inc. Shares List of Upcoming Industry Conferences and Events for February 2024

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星期四, 二月 1, 2024

The presentation will take place on Friday, February 2, 2024.

Key Points: 
  • The presentation will take place on Friday, February 2, 2024.
  • Co-Dx and CoSara representatives will be in attendance at Booth Z3.B39 in the Dubai World Trade Centre.
  • The annual Life Sciences Day on the Hill is hosted by BioUtah in conjunction with the Governor's Office of Economic Opportunity.
  • The PCR Pro and Co-Dx COVID-19 Test are currently under review by the FDA.

Vertex Announces Approval of First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™, for the Treatment of Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT) in Kingdom of Saudi Arabia

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星期二, 一月 9, 2024

CASGEVY is approved for the treatment of people 12 years of age and older with SCD or TDT.

Key Points: 
  • CASGEVY is approved for the treatment of people 12 years of age and older with SCD or TDT.
  • The Kingdom of Saudi Arabia has among the highest prevalence rates of SCD and TDT in the world, with thousands of patients living with these genetic blood disorders.
  • Vertex is working to qualify additional hospitals as ATCs to bring CASGEVY to patients, including the King Faisal Specialist Hospital (KFSH).
  • In order to enable rapid access to CASGEVY, Vertex is working to secure listing on hospital formularies to support reimbursement as soon as possible.

King Faisal Specialist Hospital and Research Centre Seeks to Achieve Self-Sufficiency in Radiopharmaceuticals in the Kingdom

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星期一, 十月 30, 2023

Since its establishment, the department has produced over 25 types of radiopharmaceuticals with a production capacity exceeding 600,000 radiopharmaceutical preparations.

Key Points: 
  • Since its establishment, the department has produced over 25 types of radiopharmaceuticals with a production capacity exceeding 600,000 radiopharmaceutical preparations.
  • The department continues to provide its products to over 50 specialized Saudi medical centers, aiming to achieve self-sufficiency in the field of radiopharmaceuticals in the Kingdom of Saudi Arabia.
  • The Cyclotron and Radiopharmaceuticals Department aspires to become a diagnostic and molecular imaging center and the first facility for Technetium-99m (Tc-99m) generators in the Kingdom.
  • It conducts research to develop high-quality radiopharmaceuticals for KFSH&RC and other hospitals throughout the Kingdom to meet all healthcare needs of patients.

Celularity Announces Commercial Biomaterial Products Receive Saudi Food and Drug Authority (SFDA) Product Classification

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星期三, 十月 18, 2023

FLORHAM PARK, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies and advanced biomaterial products, today announced that its Halal Certified biomaterial products have been classified by the Saudi Food and Drug Authority (SFDA) as “Minimally Manipulated Biological Products” for importation license purposes in the Kingdom of Saudi Arabia. The SFDA independently reviewed and issued classifications for each of the following Celularity Halal Certified biomaterial products:

Key Points: 
  • FLORHAM PARK, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies and advanced biomaterial products, today announced that its Halal Certified biomaterial products have been classified by the Saudi Food and Drug Authority (SFDA) as “Minimally Manipulated Biological Products” for importation license purposes in the Kingdom of Saudi Arabia.
  • The SFDA independently reviewed and issued classifications for each of the following Celularity Halal Certified biomaterial products:
    Biovance®, a decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy.
  • Biovance® is an intact, extracellular matrix structure that provides a natural scaffold to support the body’s wound-healing process.
  • “The SFDA’s Minimally Manipulated Biological Product classification establishes a clear regulatory pathway for the importation of our Halal Certified biomaterial products into Saudi Arabia,” said Robert J. Hariri, M.D., Ph.D., Chairman, CEO, and Founder of Celularity.

Nemaura Medical Provides Update on Nasdaq Compliance Status and Process

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星期四, 九月 14, 2023

LOUGHBOROUGH, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Nemaura Medical, Inc .

Key Points: 
  • LOUGHBOROUGH, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Nemaura Medical, Inc .
  • (Nasdaq: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing and commercialising non-invasive wearable diagnostic devices and supporting personalized lifestyle coaching programs, today provided an update regarding the status of its compliance with Nasdaq continued listed standards and anticipated next steps to maintain its listing on The Nasdaq Capital Market.
  • The Company plans to timely request such hearing and is considering all options available to it to regain compliance and maintain its listing on The Nasdaq Capital Market.
  • Dr Faz Chowdhury, the Company’s Chief Executive Officer, commented, “We are hopeful that there will be a positive outcome from a hearing before the Panel.

Nemaura Medical Completes 100 Patient Study for sugarBEAT® 24-hour Wear and Reports Interim Results

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星期一, 九月 11, 2023

The Company has previously received CE approval in Europe, and SFDA (Saudi Food and Drug Authority) approval for its sugarBEAT® glucose sensor for a wear period of 14 hours.

Key Points: 
  • The Company has previously received CE approval in Europe, and SFDA (Saudi Food and Drug Authority) approval for its sugarBEAT® glucose sensor for a wear period of 14 hours.
  • This study was designed to evaluate several factors, including the possibility of increasing the wear period to up to 24 hours, evaluating the possibility of auto-calibration, and different methods of application of the device to the skin.
  • The Company reports interim data from a first cohort comprising 25 patients, on a single day sensor wear.
  • The results indicate that a 24-hour sensor wear period using a single sensor is possible, which is expected to allow users to monitor their glucose fluctuations overnight.

Nemaura Medical Announces SFDA Approval of sugarBEAT®

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星期四, 八月 17, 2023

Loughborough, England, Aug. 17, 2023 (GLOBE NEWSWIRE) -- Nemaura Medical, Inc. (Nasdaq: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing and commercializing a daily disposable, wearable glucose sensor and supporting personalized lifestyle coaching programs, today announced SFDA (Saudi Food and Drug Authority) approval of sugarBEAT®, its non-invasive wearable glucose sensor.

Key Points: 
  • Loughborough, England, Aug. 17, 2023 (GLOBE NEWSWIRE) -- Nemaura Medical, Inc. (Nasdaq: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing and commercializing a daily disposable, wearable glucose sensor and supporting personalized lifestyle coaching programs, today announced SFDA (Saudi Food and Drug Authority) approval of sugarBEAT®, its non-invasive wearable glucose sensor.
  • The report states that nearly 4.5 million people, or 18.3% of the adult population in Saudi Arabia, have diabetes, compared to a global average of 9.3%.
  • Nemaura Medical is in advanced discussions to play a pivotal role in the region with its superior sensor technology, and diabetes and metabolic health management programs.
  • The Company believes that SFDA approval places Nemaura Medical in an unparalleled position to gain approval across the Gulf and other regions, and to commercialise its digital programs.

Saudi Arabia FMCG (Fast-Moving Consumer Goods) Full Market Entry Report 2023: Building Success and Winning Strategies for Entering the Booming Market - ResearchAndMarkets.com

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星期一, 八月 7, 2023

Entering the FMCG (Fast-Moving Consumer Goods) industry in Saudi Arabia (KSA) presents both opportunities and challenges.

Key Points: 
  • Entering the FMCG (Fast-Moving Consumer Goods) industry in Saudi Arabia (KSA) presents both opportunities and challenges.
  • However, it is essential to understand the market dynamics and navigate the regulatory landscape to successfully enter the KSA FMCG industry.
  • One of the critical aspects of entering the KSA FMCG industry is understanding the local market and consumer preferences.
  • Understanding the consumer market, building strategic partnerships, complying with local regulations, and implementing effective marketing strategies are key to successfully establishing a presence in the competitive KSA FMCG industry.

Saudi Arabia FMCG (Fast-Moving Consumer Goods) Activations & Market Entry Rates Guide 2023 - ResearchAndMarkets.com

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星期三, 六月 21, 2023

When entering the FMCG (Fast-Moving Consumer Goods) industry in Saudi Arabia (KSA), understanding FMCG activations and market entry rates is essential for a successful market entry strategy.

Key Points: 
  • When entering the FMCG (Fast-Moving Consumer Goods) industry in Saudi Arabia (KSA), understanding FMCG activations and market entry rates is essential for a successful market entry strategy.
  • Here is a guide to FMCG activations and market entry rates in KSA.
  • In conclusion, FMCG activations and market entry rates are critical considerations when entering the KSA market.
  • By implementing effective activations and considering market entry rates, FMCG companies can position themselves for success in KSA.