PharmaFocus Today – Page 220 – media

FDA Authorizes Florida’s Drug Importation Program

Today, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada. Through this pathway, the FDA may authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety. President Biden’s Executive Order on Promoting Competition in the American Economy directed the FDA to work with states and Indian tribes on these plans to reduce costs to American consumers while supporting public health and safety. Florida’s SIP is authorized for two years from the date the FDA is notified of the first shipment of drugs ...
- Source: drugdu
- 93
- January 9, 2024
UK online pharmacies selling prescription drugs without proper checks

Some UK online pharmacies are selling high-risk prescription drugs based on online questionnaires, a BBC investigation has found. The news organisation was able to buy over 1,600 pills from 20 pharmacies without challenge, raising concerns over the level of regulation these companies face. The BBC found that unnamed prescription-only drugs including painkillers anti-anxiety medication and benzodiazepines (a depressant drug group including Valium) were available by providing false information and without the need for a video consultation or medical records. Online pharmacies in the UK are regulated by the General Pharmaceutical Council (GPhC) and are unable to prescribe drugs without approval from a qualified pharmacist. This should in theory make these sites safe, but it also allows them to operate without heavy oversight. The GPhC gives guidance, and is able to take regulatory action should breaches be deemed dangerous enough, but pharmacist and former chair of the Royal Pharmaceutical Society Thorrun ...
- Source: drugdu
- 93
- January 9, 2024
China Biological Wuhan Institute of Biological Products Receives Another International Registration Certificate for Influenza Vaccine

On January 3, 2024, the quadrivalent influenza virus lysate vaccine independently developed by Wuhan Institute of Biological Products of China Biologicals (WIBP) was granted a certificate of drug registration by the Ministry of Health and Prevention (MOHAP) of the United Arab Emirates (UAE). This is another international registration certificate obtained after the Kenyan registration certificate in 2023, marking the steady progress of the internationalization strategy of Wuhan Bioproducts Research Institute and the gradual opening of a new channel for exporting vaccine products to the Middle East. Influenza is an acute respiratory infectious disease caused by influenza virus. According to WHO’s estimation, about 600 million people are infected with influenza virus globally every year, and as many as 250,000 to 500,000 cases of death. Influenza vaccination is the most cost-effective preventive measure. Influenza vaccine of Wuhan Institute of Biological Products is prepared by a patented process without antibiotics and preservatives. It ...
- Source: drugdu
- 108
- January 9, 2024
China’s first self-developed! Hengrui Pharmaceuticals’ New Sugar-Lowering Compound Drug Henggrexin Metformin Extended-Release Tablets (I)(II) Approved for Marketing

Recently, Hengrui Pharmaceuticals’ subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the Certificate of Drug Registration approved for issuance by the State Drug Administration, approving the company’s self-developed Hengrui Pharmaceuticals Metformin Extended-Release Tablets (I) (II) (Ruicinda®) for marketing, which, together with dietary control and exercise, is applicable to adult patients with type 2 diabetes mellitus (T2DM) who are suitable for receiving treatment with Hengrui Pharmaceuticals and Metformin, in order to improve the glycemic control of such patients. This marks the successful launch of China’s first self-developed sodium-glucose cotransporter protein 2 inhibitor (SGLT2i) combined with metformin in a fixed-complex, extended-release formulation, which will bring more convenience to T2DM patients in China. Diabetes mellitus has become the third chronic disease that seriously endangers human health after tumor and cardiovascular disease. At present, China has become the first country with diabetes, in which patients with type 2 diabetes mellitus (T2DM) have a progressive decline ...
- Source: drugdu
- 95
- January 9, 2024
BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod

By PharmaCompass BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod This week’s Phispers is a double bill with news from last week and the first days of the New Year. Bristol Myers Squibb (BMS) and AstraZeneca have been on year-end shopping sprees with the former picking up Karuna Therapeutics for a whopping US$ 14 billion and the latter expanding its already dominant presence in China through an acquisition and a deal. Novo Nordisk is investing over US$ 2 billion, this time in Ireland, to meet the skyrocketing demand for its blockbuster diabetes and weight-loss drugs, Ozempic and Wegovy. In drug approvals, AstraZeneca and Ionis Pharmaceuticals’ drug Wainua became the first self-administered treatment in the United States for a rare nerve damage disease. In trial news, a potential first-in-class small molecule that was on course to becoming the first new drug approved in 20 years ...
- Source: drugdu
- 139
- January 8, 2024
Cryoablation induces systemic metabolic changes in patients with paroxysmal atrial fibrillation

Announcing a new article publication for Cardiovascular Innovations and Applications journal. Cryoablation (CRYO) is a novel catheter ablation technique for atrial fibrillation (AF). However, uncertainty persists regarding the role of metabolic modifications associated with CRYO. This study was aimed at exploring whether CRYO influences the metabolic signature – a possibility not previously investigated. Paired serum samples from patients with AF (n = 10) were collected before and 24 h after CRYO. Untargeted metabolomic analysis was conducted with LC-MS. Univariate and multivariate analyses were applied to identify differential metabolites between samples. Pathway enrichment and Pearson correlation analyses were performed to reveal the perturbed metabolic pathways and potential interactions. Levels of 19 metabolites showed significant changes between baseline and 24 h after CRYO. Pathway analysis revealed that the perturbed metabolites were enriched in unsaturated fatty acid biosynthesis, retrograde endocannabinoid signaling, and neuroactive ligand-receptor interactions. Pearson correlation analysis indicated strong correlations among differential ...
- Source: drugdu
- 110
- January 8, 2024
Optimizing patient care with the best risk scores

Announcing a new article publication for Cardiovascular Innovations and Applications journal. Risk prediction models are an important part of assessing operative mortality and postoperative complication rates in current cardiac surgery practice. Furthermore, they guide clinical decision-making and perioperative patient management. In recent years, a variety of clinical prediction models have been developed in China and other countries to assess the risk of mortality and complications after cardiac surgery. Currently, the most widely used and mature models are the new version of the European Cardiac Surgery Evaluation System (EuroSCORE II), the American Society of Thoracic Surgeons Cardiac Surgery Risk Model (STS score), and the Chinese Coronary Artery Bypass Graft Surgery Risk Evaluation System (SinoSCORE). This article reviews the application of these three risk prediction models, to identify the optimal model for guiding clinical practice. Source: https://www.news-medical.net/news/20240105/Precision-surgery-powered-by-prediction-Optimizing-patient-care-with-the-best-risk-scores.aspx
- Source: drugdu
- 100
- January 8, 2024
Invivyd Seeks EUA for Monoclonal Antibody Designed to Prevent COVID-19 in Immunocompromised Individuals

Pharmaceutical Executive Editorial Staff VYD222 is a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents. Invivyd, Inc. has filed a request with the FDA for emergency use authorization (EUA) for VYD222, a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents. The EUA submission was based on positive initial findings from the pivotal Phase III CANOPY clinical trial for VYD222 and data for ongoing in vitro neutralization activity against relevant COVID-19 variants. VYD222 was found to demonstrate a potent response against multiple SARS-CoV-2 variants currently circulating, including the fastest growing variant in the United States, JN.1, as well as HV.1, BA.2.86, XBB.1.5.10/EG.5, and HK.3. “We are tremendously pleased by the fact that VYD222 continues to demonstrate in vitro neutralization activity against the latest dominant variant, JN1, as well as other prevalent SARS-CoV-2 strains,” said Dave ...
- Source: drugdu
- 127
- January 8, 2024
Lilly Pens Open Letter Raising Concerns Regarding Use of Mounjaro for Cosmetic Weight Loss

Don Tracy, Associate Editor Company cites potential safety risks for patients who ignore the intended indication of Mounjaro and Zepbound. In a letter to the public, Eli Lilly and Company warned against the use of its medicines for cosmetic weight loss. Citing the fact that neither Mounjaro or Zepbound are indicated for cosmetic purposes, the pharma company stressed that both are intended to treat serious diseases, with Mounjaro focusing on type 2 diabetes and Zepbound for obesity in specific BMI ranges of a BMI of 30 kg/m2 or greater or those who are overweight with a BMI ≥ 27 kg/m2 or greater. Additionally, caution is advised for patients with severe gastrointestinal conditions and the medications should only be prescribed by licensed healthcare professionals. “Patients should consult with their healthcare providers to determine whether Mounjaro or Zepbound is right for them,” the company stated in a press release. “Mounjaro and Zepbound ...
- Source: drugdu
- 199
- January 8, 2024
First in China! Hengrui Pharmaceuticals’ Abiraterone Acetate Nanocrystal Formulation Approved for Marketing, Bringing New Treatment Options for Prostate Cancer Patients

Recently, Hengrui Pharmaceuticals’ subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. has received the Certificate of Drug Registration approved by the State Drug Administration, which authorizes the company’s self-developed Abiraterone Acetate Tablets (II) (Trademark: Eragon®) to be listed on the market. This is the first Abiraterone Acetate nanocrystalline preparation approved for marketing in China, and also the second new chemical drug of Class 2 approved for marketing by Hengrui Pharmaceuticals. Abiraterone Acetate Tablets (II) innovatively introduces nanocrystal technology, which can significantly improve drug bioavailability and reduce the degree of food influence, thus improving patients’ drug adherence, and will bring new and better therapeutic choices for metastatic prostate cancer patients in China. Prostate cancer is the most common malignant tumor of the urinary male reproductive system. In China, the incidence rate and mortality rate of prostate cancer account for the sixth and tenth of male malignant tumors, respectively. The 5-year survival rate of ...
- Source: drugdu
- 185
- January 7, 2024

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