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Shanghai Serum Bio-technology Co., Ltd. voluntarily discloses the announcement of obtaining the ethical review approval for Phase II clinical trial of Anti-Viper Venom Serum

Shanghai Serum Bio-technology Co., Ltd. (hereinafter referred to as the “Company”) has passed the approval of the Medical Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University, the lead organization of the Phase II Clinical Study of Anti-Viper Venom Serum Injection, and obtained the ethical review approval document. The relevant information is announced as follows: The results of the completed Phase I clinical trial study of Anti-Viper Venom Serum Injection (Registration No. CRT20202621) showed that good safety and tolerability were observed in healthy subjects given different dose groups of Anti-Viper Venom Serum. The results of drug dose, drug concentration, and correlation analysis with effect indicated that the efficacy of the anti-viper venom serum (ability to neutralize viper venom in vitro) was well correlated and dependent on the dose of the test drug administered, and the concentration of the drug in the blood. Based on the positive safety results ...
- Source: drugdu
- 137
- January 18, 2024
Announcement of Changchun Hi-Tech Industrial (Group) Co., Ltd. on the Acquisition of FDA Implied License for Clinical Trials of Drugs by its Controlling Subsidiary

According to the relevant rules of the U.S. Food and Drug Administration (hereinafter referred to as “FDA”), Changchun Hi-Tech Industrial (Group) Co. (hereinafter referred to as “GenSci”) will carry out Phase I clinical trials in the United States for GenSci125 for injection (IND No. 168162), and the relevant information is hereby announced as follows: The Company had issued the ”Announcement on the Approval of the Application for Clinical Trial of GenSci125 for Injection by the Controlling Subsidiary” (Announcement No. 2023-096) on December 15, 2023, obtaining the ”Notification of Approval for Clinical Trial of Drugs” by the State Drug Administration of the PRC in respect of the project of GenSci125 for injection and agreeing to carry out the clinical trial. On December 15, 2023, GenSci obtained the IND confirmation letter from FDA. According to the requirements of the letter, there is an implied license period of 30 days after the receipt ...
- Source: drugdu
- 185
- January 18, 2024
Takeda picks up 2nd FDA-approved indication for immune globulin treatment HyQvia

It was a decade and four companies ago that HyQvia was first approved by the FDA for primary immunodeficiency (PI). Ten years later, Takeda’s subcutaneous immune globulin treatment has scored its second indication, as the FDA has approved it as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). A progressive neurological disorder, CIDP causes weakness and reduced feeling in the arms and legs. In 2014, when it was owned by Baxter, HyQvia was endorsed to treat adults with PI, an umbrella term referring to 400-plus rare diseases that can affect the immune system. Then in April of last year, Takeda won a label expansion to treat children ages 2 to 16. The approval for CIDP was based on a phase 3 trial that enrolled 122 adults. The study showed that 14% of those on HyQvia relapsed, compared with 32% of those on placebo. Another phase 3 trial assessed the ...
- Source: drugdu
- 154
- January 18, 2024
Gilead calls off Oceanside manufacturing expansion, uproots biologics development team

Gilead Sciences is halting the expansion of its biologics site in Oceanside, California, and is moving the existing team’s responsibilities to its Foster City campus in the same state, a spokesperson confirmed. The move is based on Gilead’s desire to bring members of the biologics development and manufacturing team closer to the company’s R&D unit, which is based in the Bay Area in Foster City, the spokesperson said. “Over the next few years, the majority of our Gilead Biologics teams in our Pharmaceutical Development & Manufacturing organization, most of whom are currently in Oceanside, CA, will transition to Foster City,” the spokesperson said. The move will begin this year and conclude by 2027 “at the latest,” according to Gilead, with business operations continuing “as usual” for the time being. Oceanside and Foster City are about an 8-hour drive apart. The company did not specify how many employees, if any, would ...
- Source: drugdu
- 192
- January 18, 2024
Vertex, CRISPR’s gene-editing therapy Casgevy wins early FDA nod to treat beta thalassemia

Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FDA approval for their gene-editing therapy Casgevy (exa-cel) to treat transfusion-dependent beta thalassemia (TDT). The approval comes less than six weeks after the U.S. regulator signed off on Casgevy to treat patients with sickle cell disease (SCD). With the TDT nod, Casgevy becomes the first treatment for the rare blood disorder using CRISPR gene-editing technology. Bluebird Bio also gained approval in 2022 for its gene therapy, Zynteglo, to treat TDT. The endorsement arrived more than two months early as an FDA decision was due on March 30. “On the heels of the historic FDA approval of Casgevy for sickle cell disease, it is exciting to now secure approval for TDT well ahead of the PDUFA date,” Reshma Kewalramani, M.D., Vertex’s CEO said in a release. The companies have opened nine authorized treatment centers (ATCs) to administer Casgevy to patients, Vertex said. Each ...
- Source: drugdu
- 102
- January 18, 2024
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
- 172
- 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
- 243
- 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
- 149
- 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
- 140
- 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

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