PharmaFocus Today – Page 122 – media

FDA approves new administration routes for Xcopri

South Korea-based SK Life Sciences has received US Food and Drug Administration (FDA) approval for two new forms of administration of its epilepsy drug Xcopri (cenobamate), as an oral suspension mixed with water for mouth administration or via a nasogastric tube. Discovered and developed by SK Biopharmaceuticals, Xcopri is an anti-epileptic drug indicated for partial-onset seizures in adults. The therapy reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents, leading to a decreased occurrence of seizures. The oral form of the treatment is taken once daily. The FDA-approved label revision is based on findings from an open-label study comparing the bioequivalence of three ways of administering the medication: swallowing a whole tablet, taking a crushed tablet in water by mouth, and using a nasogastric tube to administer a crushed tablet in water. The approval addresses the needs of patients living with epilepsy, who are unable to swallow Xcopri tablets whole, ...
- Source: drugdu
- 104
- April 16, 2024
Candel wins FDA orphan drug designation for pancreatic cancer drug

The US Food and Drug Administration (FDA) has granted Candel Therapeutics’ immunotherapy candidate CAN-2409 (aglatimagene besadenovec) orphan drug designation for the treatment of pancreatic cancer. Orphan drug designations are granted to medicines intended to treat rare conditions and come with benefits such as tax credits for US-based clinical trials and potentially seven years of market exclusivity in the designated indication upon agency approval. Pancreatic cancer is one of the most lethal forms of cancer, with a survival rate beyond ten years of around 5%. CAN-2409 was also granted fast track designation in pancreatic cancer by the FDA in December 2023, meaning the candidate is in line for expedited development and review times. CAN-2409 is an off-the-shelf immunotherapy that is a combination of a genetically modified adenovirus and the herpes simplex virus thymidine kinase (HSV-tk) gene. The drug works by inducing T cell response at both the targeted tumour and at ...
- Source: drugdu
- 74
- April 16, 2024
YuanSong Bio-technology Receives Another Clinical Trial Approval, Its Innovative Lysoma Virus Product Receives Implied Clinical Trial Approval from China CDE

On April 12, 2024, Shanghai Yuansong Biotechnology Co., Ltd (“Yuansong Biotechnology”) announced that its self-developed lysosomal virus Class I new drug “Recombinant L-IFN Adenovirus Injection (YSCH-01)” has received implied clinical trial approval from the Center for Drug Evaluation of the State Drug Administration (CDE) and has been approved to conduct Class I clinical trials in China. The Center for Drug Evaluation (CDE) of the State Drug Administration has granted implied consent for clinical trials and approved to conduct Phase I clinical trials in China for the indication of advanced solid tumors. The approval of this IND filing by the CDE in China is another important progress made by YuanSong Biotech in exploring the clinical study of YSCH-01, in addition to the clinical approval by the US FDA in December 2023 for two original IIT programs under development, including capsular delivery for recurrent gliomas and lysosomal viral nebulized delivery for the ...
- Source: drugdu
- 146
- April 16, 2024
Enrollment of Subjects in Phase III Clinical Trial for Inhaled Aerosol Drug in Children by Kexing Biopharm

SHENZHEN, China, April 10, 2024 /PRNewswire/ — Recently, Kexing Biopharm (688136.SH) announced that the Phase III clinical trial of Human Interferon α1b Inhalation Solution developed by its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., had completed the enrollment of first patient and dosing. This drug is indicated for respiratory syncytial virus-associated lower respiratory infections (pneumonia, bronchiolitis) in children. It is designed specifically for children by using a nebulizer, which can directly deliver the active ingredients to the lesion site, resulting in a rapid onset of therapeutic effect, improved pediatric patient compliance and safety. As mentioned by relevant R&D directors of Kexing Biopharm, the Phase I clinical dose-escalation and bronchoalveolar lavage studies of Kexing Biopharm’s Human Interferon α1b Inhalation Solution were completed in October 2023. In these studies, the drug safety, tolerability and concentration in the lungs were systematically and comprehensively validated. The results showed high local drug concentration in the ...
- Source: drugdu
- 102
- April 15, 2024
Sinovac Biotech Ltd.’s 5-dose Sabin Strain Inactivated Polio Vaccine Approved for Global Polio Eradication Efforts

On April 9, 2024, Beijing Sinovac Biotech Ltd., a subsidiary of Sinovac Holdings Biotechnology Ltd. (Sinovac Biotech), obtained the approval for registration of the 5-dose Sabin Strain Inactivated Polio Vaccine (Vero Cells) (hereinafter referred to as the 5-dose sIPV) developed by Sinovac Biotech Ltd. from the National Drug Administration (NDA) for the prevention of polio caused by the poliovirus types I, II and III. (hereinafter referred to as “sIPV”) received the approval of drug registration from the State Drug Administration (NMPA) for the prevention of poliomyelitis caused by poliovirus types I, II and III (commonly known as “polio”), and is suitable for the immunization of children aged 2 months and above. Compared with the single-dose sIPV vaccine, the 5-dose sIPV vaccine can significantly reduce the global immunization cost, and has been listed as an urgently needed variety in the WHO Polio Eradication Action Plan, and the launch of Sinovac Biotech ...
- Source: drugdu
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- April 15, 2024
GlobalData

The pharma industry has experienced a notable uptick in licensing agreements for innovator drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology over the past five years. These agreements, primarily concentrated in oncology, immunology, and central nervous system therapeutics, have collectively accumulated an impressive $21 billion in deal value. Furthermore, the period from 2020 to 2022 witnessed a remarkable surge in deal worth, particularly in the domain of hematological disorders, reaching a substantial total deal value of $1.8 billion, reveals GlobalData. Ophelia Chan, Business Fundamentals Analyst at GlobalData, comments: “This underscores the increasing significance of CRISPR advancements in the development of therapies for hematological disorders.” The FDA’s approval of Casgevy in December 2023 marked a significant breakthrough in gene therapy. Developed jointly by Vertex Pharmaceuticals and CRISPR Therapeutics, Casgevy is the first CRISPR and CRISPR-associated protein 9 (Cas9) genome editing therapy for sickle cell disease and beta thalassemia. This ...
- Source: drugdu
- 135
- April 15, 2024
Dr Reddy’s launches drug-free migraine management device Nerivio in Europe

Dr Reddy’s Laboratories announced the launch of the drug-free non-invasive migraine management wearable device Nerivio in Germany through its step-down subsidiary betapharm. The launch marks the company’s entry into digital therapeutics in Europe. Nerivio is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe. Nerivio was presented in 2023 by Dr Reddy’s at the DGN Kongress organised by the German Association of Neurology in Berlin, and the 17th European Headache Congress held in Barcelona, Spain. Dr Reddy’s will present and launch Nerivio during the Neurological Association of South Africa annual congress on April 17, 2024, in the presence of Dr Stewart Tepper, Professor of Neurology at the Geisel School of Medicine – Dartmouth, and Vice President, New England Institute for Neurology and Headache. In May 2024, Nerivio will also be presented at International Headache Society 2024 iHEAD meeting in Berlin, Germany. In subsequent ...
- Source: drugdu
- 119
- April 15, 2024
Invenra, Astellas Launch Partnership Focused on Discovering Therapeutic Bispecific Antibodies

Don Tracy, Associate Editor Joint venture aims to implement Invenra’s B-Body bispecific antibody platform to enhance Astellas’ research and development efforts. Invenra Inc. and Astellas Pharma announced that they have agreed to terms on a collaboration that seeks to utilize Invenra’s B-Body bispecific antibody platform to bolster Astellas’ research and development efforts in bispecific therapeutic research. Per the agreement, Astellas will acquire full access to the B-Body platform, with the opportunity for further license negations upon the completion of this initiative. Both teams stated that they remain dedicated to pushing the boundaries of healthcare through innovative research, with the ultimate goal of providing new, effective treatments to patients worldwide.1 “We are honored to partner with the Astellas team, one of the world’s foremost developers of therapeutics,” said Roland Green, PhD, CEO, Invenra, in a press release. “We are excited by the potential of this partnership to yield profound benefits to ...
- Source: drugdu
- 140
- April 15, 2024
Pfizer Asks FDA to Approve RSV Vaccine for Adults as Young as 18 Years Old

Mike HollanIt could be time for many Americans to add another vaccine to their list. Pfizer recently announced the results of a study for its RSV vaccine. While the vaccine is already approved for older Americans, the results of the study reportedly show that it is also effective for adults as young as 18. As such, Pfizer is asking FDA to approve the vaccine for adults aged 18 to 59. In a press release, Pfizer stated that Abrysvo met all of its primary endpoints for adults in specified age range who had an increased risk of RSV.1 The study was named MONeT, which is short for RSV Immunization Study in Adults at Higher Risk of Severe Illness. It was conducted to see the efficacy of the vaccine in adults who suffer from certain conditions, such as asthma, diabetes, and chronic obstructive pulmonary disease. These conditions put the patients at a ...
- Source: drugdu
- 141
- April 15, 2024
MMI receives de novo nod for microsurgery robot

Dive Brief Medical Microinstruments (MMI) has received de novo authorization for a robotic system that enables surgeons to reconnect tiny blood vessels, the company said Monday. The Food and Drug Administration authorized the device, called the Symani Surgical System, for soft tissue manipulation to perform microsurgery, a way to restore blood flow and redirect fluid during reconstruction or repair. CEO Mark Toland said the commercial availability of Symani could increase the number of physicians who can perform complicated microsurgical procedures. MMI plans to immediately launch the system in the U.S. Dive Insight Microsurgery and supermicrosurgery, a technique for 0.3mm to 0.8mm vessels, are microscope-assisted operations that enable physicians to take a piece of tissue from one part of the body and use it to reconstruct another area. By reconnecting blood vessels, surgeons can restore form and function to parts of the body damaged by trauma or disease. The potential for ...
- Source: drugdu
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- April 15, 2024

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