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Drug Farm candidate gains rare paediatric disease status

Drug Farm has been granted a rare paediatric disease (RPD) designation from the US Food and Drug Administration (FDA) for DF-003 to treat retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache (ROSAH) syndrome. DF-003 is an alpha-kinase 1 (ALPK1) indicated for the treatment of the rare autosomal dominant disorder ROSAH syndrome. The condition is caused by mutations in the ALPK1 gene, characterised by the symptoms listed in its name. ROSAH syndrome currently has no approved treatments. Drug Farm received FDA clearance of its investigational new drug (IND) application to initiate Phase I studies for the candidate in June 2023, after pre-clinical studies in ROSAH syndrome transgenic mouse models showed significant activity and favourable drug-like properties. If a new drug application for DF-003 is approved by the FDA, the company may be eligible to receive a priority review voucher (PRV) that can be redeemed to receive for any later marketing ...
- Source: drugdu
- 157
- January 17, 2024
CanSinoBio voluntarily disclosed the announcement on the recombinant polio vaccine initiating Phase I clinical trial in Australia and completing the enrollment of the first subject.

(“CanSinoBio” or the “Company”) has recently initiated a Phase I clinical trial of its recombinant polio vaccine in Australia and has completed the enrollment of the first subject. The Company has completed the clinical trial filing with the Therapeutic Goods Administration (TGA) under the Department of Health of Australia, and the vaccine has received ethical approval for the clinical trial from the Australian Human Research Ethics Committee prior to the filing of the clinical trial protocol. The Company’s virus-like particle (VLP)-based recombinant polio vaccine, which is based on the Company’s protein structure design and VLP assembly technology, is expected to contribute to the global control and eradication of polio. The recombinant polio vaccine is a non-infectious polio vaccine that does not rely on live viruses in the production process and is expected to have good safety and immunogenicity. Unlike the marketed attenuated and inactivated polio vaccines, the non-infectious VLP polio ...
- Source: drugdu
- 119
- January 17, 2024
Announcement of Zhejiang Hai Zheng Pharmaceutical Co., Ltd. on the Passing of Consistency Evaluation of Generic Drugs for Cycloserine Capsules of the Company

Zhejiang Hai Zheng Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company” or “Haizheng Pharmaceuticals”) has received a Notice of Approval of Supplementary Application for Cycloserine Capsule from the State Drug Administration (hereinafter referred to as the “State Drug Administration”), and the Company’s drug Cycloserine Capsule has passed the generic drug consistency evaluation. (hereinafter referred to as “the State Drug Administration”) issued the “Drug Supplement Application Approval Notice” for Cycloserine Capsule, and the Company’s drug Cycloserine Capsule has passed the consistency evaluation of the quality and efficacy of generic drugs. Cycloserine Capsule is suitable for the treatment of active pulmonary tuberculosis and extrapulmonary tuberculosis (including renal tuberculosis) caused by tuberculosis bacteria that are sensitive to the drug and have been poorly treated with first-line anti-tuberculosis drugs (e.g., streptomycin, isoniazid, rifampicin and ethanol). Cycloserine capsules were developed by Eli Lilly and Company in the United States, and were launched in the ...
- Source: drugdu
- 93
- January 17, 2024
Improve education, health equity to boost cervical cancer screening

Education needs to improve for cervical cancer screening to help drive down cases of a tumor type that kills more than 340,000 people a year. That is a takeaway from a Harris Poll survey of women in the U.S., U.K. and Sweden that identified confusion about screening as a barrier to effective preventative care. BD, which sells a test for the cancer-causing human papillomavirus (HPV), publicized the results of the survey. The poll found most women see cervical cancer screening a key part of their health management, with the percentage ranging from 76% in the U.S. to 86% in Sweden, but their grasp of the specifics can be shaky. Between 55% and 59% of women find the screening guidance confusing. In Sweden, 28% of women say they are knowledgeable about cervical cancer screening options. The figures are higher in the U.S. and U.K., 59% and 62%, respectively, but other responses ...
- Source: drugdu
- 117
- January 17, 2024
CAR-T hype faces infrastructure reality check

Since the FDA approved the first CAR-T therapy back in August 2017, high prices, small patients pools and limited manufacturing capacity have at times hindered these cell-based treatments. As biopharma companies clear those hurdles, a larger, more systemic problem now threatens the drug class. Six CAR-T therapies targeting either CD19 or BCMA have reached the U.S. market to treat various blood cancers. Impressive efficacy data, wide reimbursement acceptance, earlier-line approvals and steady production expansions have fueled blockbuster revenue predictions. But drug developers and Wall Street may have underestimated the bottlenecks from the healthcare infrastructure needed to deliver a cell therapy, Leerink Partners analyst Daina Graybosch, Ph.D., warns. CAR-T therapies are indeed on a fast trajectory of growth. By 2027, when the drug class celebrates its first decennial anniversary, Johnson & Johnson expects its Legend Biotech-partnered Carvykti—the last of the six existing CAR-T products to hit the market—will have reached about ...
- Source: drugdu
- 314
- January 17, 2024
Pfizer’s eye for China ADC deals; Astellas’ gastric cancer rejection

Pfizer is still hungry for ADC opportunities, including in the Far East. Astellas’ impressive phase 3 data for its gastric cancer candidate couldn’t garner an approval because of manufacturing issues. Takeda’s 2022 TYK2 buy from Nimbus was highly competitive, an exec said. And more. 1. JPM24: Even after Seagen buyout, Pfizer oncology chief still eyes ADC deals As Pfizer continues its prowl for antibody-drug conjugate (ADCs) deals, the company is keeping an eye on opportunities around the globe. In an interview, Pfizer’s new oncology chief Chris Boshoff, Ph.D., said the company is looking for opportunities in China, which he said “is important in this whole area, especially ADC development.” The company is “not currently looking for big acquisitions,” Boshoff added. 2. Astellas’ gastric cancer candidate rejected by FDA because of manufacturing issues After running two phase 3 trials, Astellas’ near-term approval ambitions for its zolbetuximab have been dashed because of ...
- Source: drugdu
- 150
- January 17, 2024
【EXPERT Q&A】How to Start a Medical Device Trading Company?

Drugdu.com expert’s response: Medical trade, encompassing international exchanges of goods and services in the healthcare sector, is a distinct kind of commerce. Like other commodities, the trade of medical services includes both imports and exports. The essence of medical service trade lies in the local export of goods and services, characterized by its comprehensive and integrative nature. a. Local Export of Goods In countries or regions providing medical facilities, expenses incurred by international patients and their families for medical care, food, accommodation, transportation, tourism, shopping, and entertainment are paid in foreign currency. This method of generating foreign exchange revenue essentially represents a form of local export trade, realized through the provision of medical services on-site. b. Local Export of Services Apart from purchasing and consuming medical material products, patients and their families also utilize various service-related activities, as medical products inherently involve a significant proportion of service labor. For example, the ...
- Source: drugdu
- 241
- January 16, 2024
Benchtop Analyzer Promises 1-Hour UTI Detection and Antibiotic Sensitivity Indication

More than 400 million cases of urinary tract infections (UTIs) are reported every year across the world. The gold standard for diagnosing UTIs and planning a treatment course depends on rapid dipstick tests and clinical diagnostic analysis. However, dipsticks have low specificity and can yield false positives, resulting in the overuse of antibiotics. Additionally, clinical tests have a lengthy turnaround time and offer 80% accuracy, resulting in physicians opting for the wrong course of treatment. Now, a benchtop analyzer with the ability to accurately identify the causative bug and the right antibiotic in under an hour could be a game changer for UTI diagnosis. Astek Diagnostics (Baltimore, MD, USA) is developing the JIDDU benchtop analyzer to improve UTI diagnosis through rapid, one-hour turnaround times and an unprecedented 96% accuracy. Leveraging a novel method for antibiotic susceptibility testing (AST), JIDDU rapidly detects bacterial infections in urine samples, assesses infection severity, and ...
- Source: drugdu
- 164
- January 16, 2024
Hundreds of chemicals linked to breast cancer risk identified in new study

In a recent study published in the journal Environmental Health Perspectives, researchers examined published studies investigating the genotoxicity of potentially carcinogenic chemicals and their roles in inducing mammary tumors and activating progesterone or estradiol signaling. The researchers aimed to identify chemicals that could present breast cancer risk to humans. Background Recent statistics indicate that breast cancer is the most prevalent form of cancer and the major cause of cancer-related mortality among women across the world. In the United States (U.S.), the lifetime risk of women developing breast cancer is double that of the risk of developing lung cancer. Furthermore, the incidence of breast cancer among younger women is increasing, with mortality rates due to breast cancer among women between the ages of 20 and 49 years being double that of other forms of cancers affecting individuals of both sexes. A nine-year assessment since 2010 also indicates that the diagnostic rate ...
- Source: drugdu
- 231
- January 16, 2024
Dexcom Announces Preliminary and Unaudited Revenue For Fourth Quarter and Fiscal Year 2023

Mike Hollan The company also announced that it has submitted its new glucose monitoring system to the FDA for approval. Dexcom announced that the company’s revenue for the fourth quarter of 2023 is expected to be at least $1.03 billion in a presentation at the JP Morgan Healthcare Conference. These numbers are preliminary and unaudited. This revenue would be a 26% over the earnings of the same quarter in the previous year. Similarly, the preliminary and unaudited revenue for the fiscal year 2023 is expected to $3.62 billion. Dexcom is a San Diego-based company that develops, manufactures, and sells continuous glucose monitoring systems for diabetes. In a press release, Dexcom’s chairman, president, and CEO Kevin Sayer said, “Dexcom had an incredible year in 2023 with the largest expansion of coverage in our company’s history, a successful rollout of Dexcom G7 in the U.S. and expansion of G7 to more than ...
- Source: drugdu
- 158
- January 16, 2024

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