PharmaFocus Today – Page 184 – media

Cerebrospinal Fluid Testing of Alzheimer’s Patients to Help Identify Disease Molecular Subtype

Scientists have made a significant discovery by identifying five distinct biological variants of Alzheimer’s disease, each potentially requiring unique therapeutic approaches. This finding suggests that drugs previously tested for Alzheimer’s might have been wrongly deemed ineffective or only slightly beneficial due to these variants being unaccounted for. At the core of Alzheimer’s disease is the accumulation of amyloid and tau proteins in the brain. However, this aggregation is just one aspect of the disease’s complexity. Researchers, including those from Amsterdam UMC (Amsterdam, Netherlands), have employed innovative methods to analyze additional biological processes involved in Alzheimer’s. These processes, which include inflammation and the growth of nerve cells, were studied through the measurement of various biomarkers in the cerebrospinal fluid of patients exhibiting amyloid and tau accumulations. In their analysis of the cerebrospinal fluid of 419 individuals diagnosed with Alzheimer’s, the researchers assessed 1,058 proteins and identified five distinct biological subtypes within ...
- Source: drugdu
- 167
- January 17, 2024
Simple DNA test Capable of Identifying 18 Early-Stage Cancers Could Be a Game Changer

Cancer, responsible for one-sixth of all global deaths, presents a formidable challenge, particularly because early detection is crucial for improving survival rates. However, current screening tests often fall short due to factors like invasiveness, cost, and limited accuracy in detecting early-stage diseases. In response to this challenge, researchers have now developed an innovative blood test that can identify 18 types of early-stage cancers across various major organs in the human body. This groundbreaking test from Novelna Inc. (Palo Alto, CA, USA) leverages a gender-specific panel of 10 proteins, providing a significant advancement in the ongoing battle against cancer. The foundation for the test was laid by pioneering research that underscores the potential for a new class of cancer screening tests, promising enhanced accuracy, reduced cost, and a move towards personalized healthcare. In their research, the Novelna team analyzed plasma samples from 440 individuals, encompassing both healthy subjects and those diagnosed ...
- Source: drugdu
- 239
- January 17, 2024
FDA Clears AnX Robotica’s NaviCam SB for Expanded Indications

Mike Hollan The device can produce AI-assisted readings. FDA announced that it has cleared the NaviCam Small Bowel Video Capsule Endoscopy for expanded indications. In a press release, the device’s producer AnX Robotica, revealed the agency’s decision. According to the company, the NaviCam SB is one of the most advanced pieces of technology available for small bowel video capsule endoscopy. The device uses AI to assist medical professionals as they perform tests. FDA also cleared the company’s NaviCam Tether to be used as an accessory with the NaviCam SB. These devices are designed to work together and can improve the visualization process of the esophagus. In a press release, AnX Robotica’s vice president of marketing and product management Stu Wildhorn said, “With FDA clearance, NaviCam Small Bowel Capsule Endoscopy represents a groundbreaking leap forward, now extending its revolutionary diagnostic capabilities to patients as young as 2 years old. Furthermore, clinicians ...
- Source: drugdu
- 147
- January 17, 2024
Genetic Medicines Biotech Dyne Pulls In $345M for Clinical Tests of Muscle Drugs

Dyne Therapeutics recently reported encouraging Phase 1/2 clinical data in myotonic dystrophy type 1 and Duchenne muscular dystrophy. At the J.P. Morgan Healthcare Conference, CEO Joshua Brumm said Dyne’s existing cash combined with the new capital is expected to last through 2025—well beyond the next key milestones for both therapeutic candidates. By FRANK VINLUAN Dyne Therapeutics started the new year with proof-of-concept clinical data for experimental genetic medicines addressing two rare muscle diseases—one of which has no FDA-approved treatments. Now the biotech has $345 million as it looks toward key tests for both therapies. Ahead of the Martin Luther King Jr. holiday weekend, Dyne closed a stock offering of 19.7 million shares priced at $17.50 each. In the prospectus, Dyne said the net proceeds of the stock offering will be combined with its existing capital to fund ongoing clinical development of the two clinical-stage programs, DYNE-101 and DYNE-251. Dyne CEO ...
- Source: drugdu
- 137
- January 17, 2024
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
- 148
- 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
- 107
- 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
- 84
- 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
- 106
- 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
- 301
- 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
- 139
- January 17, 2024

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