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The United States prohibits the flow of data to China and other countries, and clinical trials in the United States are challenged again?

Recently, U.S. President Joe Biden officially signed the “Executive Order on Preventing Countries of Concern from Obtaining Extensive Sensitive Personal Data of U.S. Citizens and U.S. Government-Related Data,” calling for measures to be taken to prevent “bad actors” and “countries of concern” from abusing data related to the United States. Various types of data about citizens, including genomic data, biometric data, personal health data, geolocation data, financial data and other types of personally identifiable information. The executive order may pose new challenges to Chinese life sciences companies operating in the United States. The order requires the Departments of Justice, Homeland Security, Health and Human Services, Veterans Affairs and other agencies to take a variety of actions over the next 12 months, including: Ministry of Justice: Regulations will be enacted to govern cross-border transfers of large-scale data related to genomics, biometrics, personal health data, geolocation and the above areas, including a ...
- Source: drugdu
- 118
- March 8, 2024
Drugmakers submit counteroffers to US Medicare pricing negotiations

The US Department of Health and Human Services (HHS), as part of the Centers for Medicare and Medicaid Services (CMS), has announced that all ten pharmaceutical manufacturers taking part in the Medicare drug price negotiations have submitted counteroffers. The announcement comes after the HHS sent initial offers on 1 February in an ongoing effort to lower drug prices in the US as part of the Inflation Reduction Act (IRA) and negotiations will continue over the next several months. First selected last August, the ten medicines subject to the first round of Medicare pricing negotiations included therapies for diabetes, heart failure, immunological disorders and cancer, as well as anticoagulants. The medicines selected included Bristol Myers Squibb/Pfizer’s Eliquis (apixaban), Novartis’ Entresto (valsartan/sacubitril), AstraZeneca’s Farxiga (dapagliflozin), AbbVie/Johnson & Johnson’s Imbruvica (ibrutinib), Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin), and Johnson & Johnson’s Stelara (ustekinumab) and Xarelto (rivaroxaban). According to the HHS, collectively, the drugs were ...
- Source: drugdu
- 88
- March 8, 2024
Noninvasive, Low-Cost Test Accurately Diagnoses Oral Cancer in 30 Minutes

Oral cancer comprises about 90% of head and neck cancer (HNC), which ranks as the seventh most common type of malignancy globally. HNC constitutes roughly 5% of all cancer cases worldwide, with approximately 640,000 new cases annually, leading to around 350,000 deaths. Its incidence is particularly increasing in developing countries. These cancers predominantly affect socioeconomically disadvantaged populations and underserved communities. Diagnosing oral cancers and precancerous mouth lesions early and accurately presents significant challenges. Traditional biopsy methods are not only expensive and invasive, causing stress and potential complications for patients, but also unfeasible for repeated screenings of the same lesion. Now, researchers have developed a noninvasive, affordable test for detecting oral cancer, monitoring precancerous lesions, and determining the need for a biopsy. The findings of the study by a team of researchers, led by Case Western Reserve University (Cleveland, OH, USA), are based on a novel scoring system that assesses the ...
- Source: drugdu
- 94
- March 7, 2024
Simple Blood Test Measures Repetitive DNA for Early Cancer Detection

Cancer patients can have varying levels of a specific kind of repetitive DNA known as Alu elements in comparison to those without cancer. Despite constituting about 11% of the DNA in humans and other primates, Alu elements have traditionally been considered too complex to be effectively utilized as biomarkers due to their small, repetitive nature. Now, advancements in machine learning can allow for the measurement of these elements through a simple blood draw. Researchers at Johns Hopkins Medicine (Baltimore, MD, USA) leveraged this insight to improve a test designed for early cancer detection. They began their study with a sample size that was ten times larger than what is usually seen in such research. Alu elements are relatively small, each being about 300 base pairs in length within the vast 2 billion-step DNA ladder. Yet, changes in the proportion of Alu elements in blood plasma are consistent, irrespective of the ...
- Source: drugdu
- 179
- March 7, 2024
FDA Approves AbbVie’s Juvederm Voluma XC for the Treatment of Moderate to Severe Temple Hollowing

Don Tracy, Associate Editor This marks the first time that a hyaluronic acid dermal filler has received FDA approval for temple hollowing. Allergan Aesthetics, an AbbVie company, announced that the FDA has approved Juvéderm Voluma XC to treat moderate to severe temple hollowing in adults over 21 years of age. According to the company, the medication has the ability to yield results that last up to 13 months with peak treatment, with approximately 80% of test subjects reporting satisfaction with the outcomes. With this regulatory action, Juvéderm Voluma becomes the first hyaluronic acid (HA) dermal filler indicated for moderate to severe temple hollowing to be approved by the FDA.1 “The approval of Juvéderm Voluma XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs,” said Carrie Strom, president, Allergan Aesthetics, SVP, AbbVie, in a press release. “This is the first US FDA approval of ...
- Source: drugdu
- 128
- March 7, 2024
FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs

Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies. By FRANK VINLUAN A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products. The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication will be marketed under the name Jubbonti. For cancer, the Sandoz product will be called Wyost. The Amgen and Sandoz drugs work by binding to a ...
- Source: drugdu
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- March 7, 2024
Lundbeck Pharmaceuticals’ “Anti-Parkinson’s Category 1 Chemical Drug” Submits Clinical Application in China

March 4), according to the CDE official website, Lundbeck’s clinical trial application for Class 1 chemical drug Lu AF28996 capsules has been accepted. Currently, the drug is undergoing Phase I clinical trials overseas. Parkinson’s disease is a neurological dysfunction disease with complex symptoms and difficult early diagnosis. It is common in middle-aged and elderly people. At present, the main treatment for Parkinson’s disease is drug therapy, with the purpose of reducing symptoms, delaying the progression, and improving the patient’s quality of life. Lu AF28996 is a dopamine D1/D2 receptor agonist developed by Lundbeck Pharmaceuticals. It is a relatively new anti-Parkinson therapy and is currently undergoing Phase I clinical trials overseas. Among them, a study to evaluate the safety, tolerability, etc. of Lu AF28996 in Parkinson’s patients is expected to be completed in 2025. This time, the approval of Lu AF28996’s clinical trial application in China is expected to bring a ...
- Source: drugdu
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- March 7, 2024
FDA Clears First Over-the-Counter Continuous Glucose Monitor

Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. “CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Giving more individuals valuable ...
- Source: drugdu
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- March 7, 2024
Sinopharm and the University of Macau Signed Strategic Cooperation Framework Agreement

On February 26, Liu Jingzhen, Secretary of the Party Committee and Chairman of Sinopharm, and his delegation visited the University of Macau, where the two sides signed a strategic cooperation framework agreement and held talks on further deepening cooperation. President of the University of Macau Mr. Song Yonghua, Vice President Mr. Xu Jian, Vice President of Sinopharm Mr. Hu Jianwei, Vice President of Sinopharm Mr. Dong Zenghe, Vice President of Sinopharm and Vice President of Sinopharm Mr. Jin Bin attended the event. Before the meeting, the two sides held a signing ceremony for the strategic cooperation framework agreement, in which Sinopharm’s Vice General Manager Dong Zenghe and University of Macau’s Vice President Xu Jian signed the agreement on behalf of the two sides. Mr. Liu Jingzhen, Chairman of the Board of Directors of Sinopharm, introduced Sinopharm’s innovative development strategy and the key work it has done to help the development ...
- Source: drugdu
- 122
- March 7, 2024
Shuangcheng Pharmaceuticals Octreotide Acetate Injection Obtained Certificate of Drug Registration

Hainan Shuangcheng Pharmaceuticals was approved by the State Drug Administration to issue Drug Registration Certificate to Octreotide Acetate Injection. Basic drug information 1, drug name: octreotide acetate injection 2、Dosage form: Injection 3、Specifications: 1ml:0.1mg (C₄₉H₆₆₁₀O₁₀S₂) 4、Registration Classification: Class 4 chemical drugs 5、Drug Approval Number: State Drug License H20243223 6、Prescription drug/over-the-counter drug: prescription drug 7、Listed Licensee: Hainan Shuangcheng Pharmaceutical Co. 8、Manufacturer: Hainan Shuangcheng Pharmaceutical Co. 9, Production Address: Haikou City, Xiuying District, No. 16 Xingguo Road Approved indications Octreotide acetate injection is indicated for the control of symptoms and reduction of plasma levels of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) in patients with acromegaly who are unable or unwilling to undergo surgery or radiation therapy. Treatment of patients with acromegaly who are unable or unwilling to undergo surgery, or treatment of patients with intermittent acromegaly for whom radiation therapy has not yet taken effect; alleviation of symptoms ...
- Source: drugdu
- 128
- March 7, 2024

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