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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
- 137
- 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
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- 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
- 142
- 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
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- 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
Study provides valuable insights into the DCB-only strategy for left main coronary artery disease

Sanna Uskela et al., at North Karelia Central Hospital-Heart Center, Finland, conducted a retrospective single-center registry study that focused on the use of drug-coated balloon (DCB)-only strategy for treating de novo left main coronary artery disease. This study is significant as it addresses a treatment approach that has not been extensively studied before, particularly in the context of high bleeding risk (HBR) patients. The study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using the DCB-only strategy between August 2011 and December 2018. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups based on whether the lesion preparation was done according to the international consensus group guidelines. Key findings from the study include: (1) The study included 66 patients with a ...
- Source: drugdu
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- April 15, 2024
UK’s NICE recommends AbbVie’s Aquipta to treat migraines

The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered ...
- Source: drugdu
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- April 13, 2024
Rallybio and J&J collaborate to tackle maternal-foetal blood disorder

Following Johnson & Johnson’s (J&J) recent US Food and Drug Administration (FDA) fast track designation of nipocalimab for the reduction of foetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in pregnant adults, Rallybio has announced a collaboration with the pharma giant to advance complementary therapeutic solutions for the rare disorder. The collaboration will see the development of therapeutic approaches that comprehensively address FNAIT, as J&J aims to treat patients who have already alloimmunised while Rallybio focuses on preventing alloimmunisation altogether, Dr. Steve Uden, Rallybio’s CEO, told Pharmaceutical Technology in an exclusive interview. “They are very much complementary and not competitive approaches; and both are needed,” said Uden. As per the 10 April press release, the clinical-stage biotech received an equity investment of $6.6m from J&J, with eligibility for future milestone payments. The funds will be deployed to support a FNAIT natural history study that will be conducted across North America and ...
- Source: drugdu
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- April 13, 2024
Researchers call to reduce repeat antibiotic prescriptions for respiratory tract infections

RTIs account for around 60% of global antibiotic prescribing and are a key driver of AMR Researchers from the Universities of Bristol, Bath, King’s College London and the University Medical Center Utrecht have called for a reduction in the use of repeat antibiotic prescriptions in primary care for the same respiratory tract infection (RTI) episode, based on findings from a study. Published in the Journal of Infection, the study found high rates of repeat within-episode prescriptions for RTI in primary care in England, despite evidence of little benefit. Accounting for around 60% of antibiotic prescribing in primary care globally, RTIs are caused by viruses and are one of the key drivers of antimicrobial resistance. The study analysed over 900,000 RTI episodes from clinical records across 530 English general practices. Researchers found that nearly 30% of adults and 10% of children had received a second course of antibiotics within the same ...
- Source: drugdu
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- April 13, 2024

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