Search Results for “FDA” – Page 24 – media

FDA Fast Tracks Nurix Therapeutics, Inc’s Novel BTK Inhibitor for CLL, SLL

Pharmaceutical Executive Editorial Staff NX-5948 is under evaluation for for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor. The FDA has granted Fast Track Designation to Nurix Therapeutics, Inc’s investigational Bruton’s tyrosine kinase (BTK) inhibitor NX-5948 for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor.1 NX-5948 has previously demonstrated that it is highly potent across a range of tumor cell lines with BTK inhibitor–resistance, which is an important treatment consideration for heavily pretreated patients with CLL and SLL, according to Nurix. “Fast Track designation for NX-5948 is an important recognition of the unmet patient need in CLL, particularly in the growing number of patients whose cancer has progressed ...
- Source: drugdu
- 120
- January 22, 2024
With manufacturing-related rejection, FDA turns its nose up at Satsuma’s migraine nasal spray

Considering trial setbacks and cash concerns, Satsuma Pharmaceuticals faced an uphill climb to even file for approval of its migraine spray treatment at the FDA. Now, the agency has thrown another wrench in the company’s commercial hopes by issuing a manufacturing-related complete response letter. In rejecting the application, the agency cited chemistry, manufacturing and controls concerns, Satsuma’s parent company, Shin Nippon Biomedical Laboratories, said in a press release. The agency did not flag issues with the clinical data package or request new trials. “We remain committed to working expeditiously with the FDA to complete the review for STS101 as soon as possible,” Satsuma’s CEO Ryoichi Nagata, M.D., Ph.D., said in the release. The company will detail potential timing for a resubmission after consulting with the FDA. The update is just the latest in a series of setbacks for Satsuma and its migraine asset, dubbed STS101. After coming up short two ...
- Source: drugdu
- 105
- January 20, 2024
Gene-Edited Cell Therapy Casgevy Gains FDA Approval for Transfusion-Dependent Beta Thalassemia

Pharmaceutical Executive Editorial Staff Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Cas9 therapy Casgevy approved as a one-time treatment for transfusion-dependent beta thalassemia on the heels of its approval last month for sickle cell disease. The FDA has granted another approval to Vertex Pharmaceuticals’ and CRISPR Therapeutics’ gene-editing therapy Casgevy (exagamglogene autotemcel [exa-cel]) as a one-time treatment for transfusion-dependent beta thalassemia (TDT) in patients 12 years of age and older.1 Last month, Casgevy became the first FDA-approved novel genome editing technology for sickle cell disease (SCD), which was a significant advancement in gene therapy. The latest approval was months ahead of the FDA’s assigned Prescription Drug User Fee Act (PDUFA) date. “We are pleased with the approval of Casgevy in TDT well ahead of the PDUFA date,” said Samarth Kulkarni, PhD, chairman and chief executive officer of CRISPR Therapeutics.2 “The approval is a reflection of the power and versatility of the CRISPR ...
- Source: drugdu
- 115
- January 19, 2024
Vertex’s CRISPR Gene Therapy Lands Another FDA Nod in a Rare Blood Disease

The FDA approved Vertex Pharmaceuticals’ gene therapy Casgevy for treating beta thalassemia, an inherited blood disease that leads to low levels of functioning hemoglobin. Last month, the one-time treatment won its first FDA nod for treating sickle cell disease. By FRANK VINLUAN A one-time CRISPR-based gene therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics now has an additional FDA approval as a treatment for the rare blood disease beta thalassemia. The affirmative decision announced Tuesday for the therapy, Casgevy, was widely expected following its December approval in sickle cell disease, but it comes more than two months early. The target date for an FDA decision in the beta thalassemia indication was March 30. Casgevy won its first ever regulatory approval in the United Kingdom, a November decision that covered both sickle cell disease and beta thalassemia. Beta thalassemia is an inherited disease in which genetic mutations lead to low levels ...
- Source: drugdu
- 213
- 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
- 184
- 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
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
- 101
- January 18, 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
FDA yet to find link between suicidal risk and GLP-1RA use

The US Food and Drug Administration (FDA) released an update on its evaluation of suicidal risk related to glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The agency did not find a clear link to suicidal risk through a review of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System agency (FAERS) and a meta-analysis of GLP-1 RA clinical trials. Looking at FAERS data, regulators found that reported incidents were often limited in the information provided and did not offer enough evidence to determine a clear relationship with GLP-1 RA use. Furthermore, the large outcome studies and observational studies showed no association between suicidal thoughts or actions and the use of the drug class. Despite this, the agency said that due to the small number of suicidal ideation cases, it would not yet definitively rule out a potential link with GLP-1RA use. The FDA will share its ...
- Source: drugdu
- 159
- January 16, 2024
FDA’s early review finds no evidence linking Novo, Lilly weight-loss drugs to suicidal thoughts

A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. regulator said. Over the last several months, the agency has been looking into reports of suicidal thoughts or actions from users of the GLP-1 treatments gathered through its FDA Adverse Event Reporting System (FAERS), it said. “Because the information provided was often limited and because these events can be influenced by other potential factors, we determined that the information in these reports did not demonstrate a clear relationship with the use of (GLP-1s),” the FDA wrote. The agency said its reviews of clinical trials and observational studies found no association between the treatments and suicidal thoughts. Ten days ago, the FDA drew attention when it included the trendy therapies on a list of medicines it said it was monitoring for side ...
- Source: drugdu
- 89
- January 16, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.