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【EXPERT Q&A】How to apply for Biologics License Application (BLA)?

Drugdu.com expert’s response: The Biologics License Application (BLA) is a licensing application for biologic products, typically managed and approved by the United States Food and Drug Administration (FDA). BLA submission is required to obtain approval for the sale of biologic products in the U.S. market. The following are the key aspects to consider and the required documents for BLA submission: 1.Clinical Trial Data: Detailed clinical trial data must be provided in the BLA submission, including study design, trial results, safety, and efficacy data. These data should adhere to FDA’s requirements for clinical trial design and reporting. 2.Product Quality Control: Information on product quality control, including manufacturing processes, quality control methods, stability data, etc., needs to be provided. These data ensure that the manufacturing process and quality of the product comply with FDA requirements. 3.Nonclinical Data: Relevant nonclinical data, such as animal model studies, toxicology data, etc., should be provided to assess ...
- Source: drugdu
- 192
- February 29, 2024
World’s First Low-Cost, High-Throughput, Near-Patient Molecular Diagnostic Test System Dramatically Reduces Wait Times

It is important for doctors to rapidly and accurately identify prevalent respiratory pathogens like COVID-19, influenza A and B, RSV-A, and RSV-B for administering prompt, tailored treatment to infected individuals. In a significant advancement, a near-patient test system using automation technology detects pathogens with unrivaled speed and cuts the typical waiting time of 24 to 48 hours to just one to two hours without the need for expensive biosafe laboratories. Fast MDx Limited (Middlesex, UK) and Festo (London, UK) have jointly designed and developed the world’s first, low-cost, high-throughput, near-patient molecular diagnostic test system that will provide clinicians with earlier, more informed results, allowing each patient to receive a faster, personalized clinical pathway. The Fast MDx system comprises everything necessary for testing, including sample tubes, swabs, and even electronic result transmission to the originating hospital, clinic, or doctor’s office. The system incorporates Fast MDx’s latest, ultra-fast, NGx2 4-Channel qPCR thermal ...
- Source: drugdu
- 125
- February 29, 2024
Simple Measurement Predicts Risk of Rapid Progression of Chronic Kidney Disease

Chronic kidney disease (CKD) is increasingly becoming a major health issue worldwide. For those diagnosed with CKD, the rate of disease progression can vary, with some individuals experiencing a rapid deterioration in kidney function. Healthcare providers need to spot patients who are newly diagnosed with CKD and are at a heightened risk of rapid disease progression. Early identification can allow for timely interventions that could slow down, or in some cases, prevent the progression of the disease. Now, researchers have made a breakthrough by discovering a simple method to identify individuals at high risk for rapid CKD progression, an advancement that could greatly enhance prevention and treatment strategies. In a comprehensive study, a team of researchers from Aarhus University (Aarhus, Denmark) examined the precise risk of rapid CKD progression utilizing data from Danish health registers. This study provides valuable insights for medical professionals on identifying patients who are more likely ...
- Source: drugdu
- 114
- February 29, 2024
FDA Approves Imbruvica Label Expansion to Include Oral Suspension Formulation

Don Tracy, Associate Editor New label marks the first Bruton’s tyrosine kinase inhibitor to be approved with an oral suspension formulation. The FDA has approved an addendum to the Imbruvica (ibrutinib) label to include an oral suspension formulation across the drug’s indications. Johnson & Johnson (J&J), in partnership with Pharmacyclics LLC, an AbbVie Company, announced that the new formulation is approved to treat patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) following the failure of one or more lines of systemic therapy. This option is designed for patients who have difficulty swallowing pills, part of J&J’s ongoing efforts to provide multiple patient-friendly treatment options, the company stated in a press release.1 “As the most comprehensively studied therapy in its class, Imbruvica has helped change the standard of care for adults living with certain blood cancers and cGVHD. Nearly 300,000 ...
- Source: drugdu
- 143
- February 29, 2024
Allecra Therapeutics’ Exblifep Approved by FDA for Complicated Urinary Tract Infections

Davy James The FDA granted Allecra with a five-year marketing exclusivity extension for Exblifep (cefepime/enmetazobactam) through the Generating Antibiotic Incentives Now Act. The FDA has approved Allecra Therapeutics’ Exblifep (cefepime/enmetazobactam) for the treatment of complicated urinary tract infections (cUTIs), including the kidney infection pyelonephritis, in patients aged 18 years and older.1 The FDA also granted Allecra with a five-year marketing exclusivity extension for the β-lactam/β-lactamase inhibitor combination through the Generating Antibiotic Incentives Now Act (GAIN Act), which is legislation that incentivizes the development of new anti-infective treatments. “Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals. I extend my sincere congratulations to my colleagues Omar Lahlou and Patrick Velicitat for their leadership and oversight throughout this whole process,” Iain Buchanan, supervisory board member of Allecra Therapeutics, said in a press release. “As ...
- Source: drugdu
- 137
- February 29, 2024
China’s marketed drug patent information registration platform has a new “legal document submission module”

On February 26, the Center of Drug Evaluation of the NMPA issued the “Notice on Setting up a Legal Document Submission Module on the Patent Information Registration Platform for Marketed Drugs in China” (hereinafter referred to as the “Notice”). The following is the original content of the Notice: Since the implementation of the “Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)”, patent disputes have been resolved simultaneously during the review of generic drug marketing applications. In order to further improve work efficiency and facilitate patent holders, interested parties and generic drug applicants to submit relevant legal documents, a legal document submission module has been set up on the Chinese marketed drug patent information registration platform. From the date of issuance of this notice, patentees, interested parties or generic drug applicants can directly submit an “application for setting a waiting period”, acceptance notice, judgment, decision or settlement ...
- Source: drugdu
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- February 29, 2024
Inclusion of noncommunicable disease care in response to humanitarian emergencies will help save more lives

Noncommunicable diseases (NCDs), such as cardiovascular disease, cancer, chronic respiratory disease and diabetes, are responsible for 75% of deaths worldwide. People affected by humanitarian emergencies are at increased risk of NCDs. It is estimated that strokes and heart attacks are up to 3 times more likely following a disaster. However, care and treatment for NCDs are often not included as a standard part of humanitarian emergency preparedness and response, which focus on the most immediate needs. To support integration of essential services for NCDs into emergency preparedness and humanitarian response, the World Health Organization (WHO), the Kingdom of Denmark, the Hashemite Kingdom of Jordan, the Republic of Kenya, and UNHCR, the UN Refugee Agency, are jointly convening a global high-level technical meeting on NCDs in humanitarian settings on 27-29 February in Copenhagen, Denmark. Humanitarian emergencies in recent years are becoming more complex and interconnected. Hunger and shortages of essential goods ...
- Source: drugdu
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- February 29, 2024
China Pharma Holdings Inc. Announces 1-for-5 Reverse Stock Split

HAIKOU, China, Feb. 24, 2024 /PRNewswire/ — China Pharma Holdings Inc. (“China Pharma” or the “Company”) (NYSE American: CPHI) reported that it expects to implement a 1-for-5 reverse stock split on its common stock effective Wednesday, March 6, 2024, with trading to begin on a split-adjusted basis at the market open on that day. Trading in the common stock will continue on the NYSE American under the symbol “CPHI”. The new CUSIP number for the common stock following the reverse stock split is 16941T-302. The reverse stock split at a ratio of 1-for-5 shares was approved by the Company’s Board of Directors through unanimous written consent on October 16, 2023 and adopted by the Company’s stockholders through Annual Meeting for the fiscal year ended on December 31, 2022, which was held on December 17, 2023. Upon the effectiveness of the reverse stock split, every 5 shares of the Company’s issued ...
- Source: drugdu
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- February 29, 2024
Hengrui Pharmaceuticals’ PD-L1 Inhibitor Adebelizumab Combined with HER2 ADC SHR-A1811 Approved for Breast Cancer Clinical Treatment

Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved by the State Drug Administration, which authorizes the company to carry out the clinical trial of adelberizumab in combination with SHR-A1811 for the treatment of breast cancer. According to the data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, breast cancer has become the world’s number one malignant tumor and is the most common malignant tumor in women. Statistics show that in 2020, there were about 2.26 million newly diagnosed cases of female breast cancer and 685,000 deaths worldwide, ranking first in female malignant tumor morbidity and mortality. The incidence and mortality rates of breast cancer worldwide vary according to regional distribution. In China, the 2020 China Cancer data show that the incidence rate of breast ...
- Source: drugdu
- 161
- February 29, 2024
Sponge-on-a-string test to benefit NHS patients with oesophageal cancer

Eight out of ten patients who took the test were discharged without needing further testing The NHS has announced that a simple sponge-on-a-string test developed by researchers from the early cancer institute at the University of Cambridge will replace the need for endoscopy to prevent oesophageal cancer. The NHS trialled the test to help diagnose Barrett’s oesophagus, a condition that affects the food pipe and can lead to oesophageal cancer. Responsible for around 9,200 new cases every year in the UK, oesophageal cancer occurs in the long, hollow tube that runs from the throat to the stomach, known as the oesophagus. During the pandemic, the NHS began piloting the test at 30 hospitals across 17 areas in England, including Manchester, Plymouth, London, Kent and Cumbria. The test requires the patient to swallow a small capsule-shaped device containing a small sponge that collects cell samples for analysis before being extracted via ...
- Source: drugdu
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- February 29, 2024

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