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US judge denies initial attempt by Novartis to block generic Entresto launch

Novartis’s bid to block the launch of a biosimilar for its best-selling drug Entresto (sacubitril/valsartan) got off to a faltering start, as the drugmaker failed to convince a US court that MSN Pharmaceuticals’ (MSNPI) copycat infringed on a patent. Richard Andrews, district judge for the District of Delaware, ruled the likelihood that Novartis would win the lawsuit was not high enough, meaning a preliminary injunction was not granted. While Andrews stated that stopping MSNPI’s generic launch was not justified, he did order a temporary 72-hour halt while Novartis goes to the US Court of Appeal to seek an injunction, as per a 12 August court document first released by Reuters. The hearing is part of a lawsuit initiated by Novartis to fend off MSNPI’s generic – which received US Food and Drug Administration (FDA) approval last month – to protect sales for its heart failure blockbuster. Novartis’s reference drug was ...
- Source: drugdu
- 64
- August 15, 2024
Hengrui’s Dexmedetomidine Hydrochloride Injection Passed GMP Certification Inspection in Japan

Recently, Hengrui Pharmaceuticals has received the GMP certificate issued by Japan Pharmaceuticals and Medical Devices Agency (PMDA) for its preparation production site located at No. 38, Huanghe Road, Lianyungang, and the company’s Dexmedetomidine Hydrochloride Injection has successfully passed the GMP compliance inspection by PMDA. This is the company’s quality management system again recognized by international authoritative institutions after the API dexmedetomidine hydrochloride PMDA site inspection was passed, which is conducive to the company to further strengthen the internationalization strategy and enhance the competitiveness in the global market. Japanese GMP certification is one of the authoritative certifications in the field of international drug production, and the inspection is characterized by rigor, meticulousness and attention to details.2023 In September, two qualification inspectors of Japan PMDA conducted a GMP on-site inspection for several days on Hengrui Pharmaceuticals’ Dexmedetomidine Hydrochloride Injection production line at the preparation production site located at No. 38 Huanghe Road, ...
- Source: drugdu
- 67
- August 15, 2024
VIETNAM MEDIPHARM EXPO

Organiser：VIETFAIR, Vietnam Time：May 8th – 11th, 2025 address：91 Tran Hung Dao St., Hoàn Kiếm, Hanoi, Vietnam Exhibition hall：Cultural Friendship Palace Product range: Medical Products: Medical equipment and instruments, medical consumables, medical dressings, surgical equipment, rescue equipment, diagnostic medical equipment and supplies, ENT equipment, dental products, equipment, and supplies, medical health products and equipment, medical institution and laboratory technology equipment, medical information and technology exchange, beauty instruments, etc. Pharmaceutical Equipment: Pharmaceutical production equipment and technology, pharmaceutical packaging equipment, pharmaceutical packaging materials, pharmaceutical production, cleaning, disinfection, and allocation systems, etc. Laboratory Equipment: Optical instruments and equipment, microscopes, optical image processing, electronic measuring instruments, multimeters, electronic probes, electronic simulation systems, microcontroller development systems, image analysis and processing systems, etc. Analytical Instruments: Optical analytical instruments, mass spectrometers, spectrographs, chromatographs, wave meters, spectrum analyzers, various portable instruments, surface analysis instruments, nuclear analysis instruments, elemental analysis instruments, process analysis instruments, compositional analysis instruments, injection analysis ...
- Source: drugdu
- 224
- August 14, 2024
Study suggests COVID-19 vaccination lowers incidence of arterial thromboses

Researchers from the Universities of Cambridge, Bristol and Edinburgh have suggested that COVID-19 vaccinations could lower the incidence of arterial thromboses. The study, published in Nature Communications, was supported by the British Heart Foundation (BHF) Data Science Centre at Health Data Research UK. Researchers analysed the de-identified health records of 46 million adults from GP practices, hospital admissions and death records in England between December 2020 and January 2022, provided by NHS England. The team compared the incidence of cardiovascular diseases (CVDs) following COVID-19 vaccination with the incidence before or without vaccination during the first two years of the vaccination programme. CVD affects around seven million people in the UK and is a significant cause of disability and death. Overall, the study revealed that the incidence of arterial thromboses, such as heart attacks and strokes, which affect 200,000 people in the UK every year combined, was up to 10% lower ...
- Source: drugdu
- 60
- August 14, 2024
UCL study reveals routine blood tests could improve early cancer diagnosis

Researchers from University College London (UCL) have found that common routine blood tests could be used to speed up and improve early cancer diagnosis for patients in a new study published in PLOS Medicine. Researchers analysed data from more than 400,000 people aged 30 or older in the UK who had visited a GP due to stomach pain from the Clinical Practice Research Datalink, collected between 2007 and 2016, and from more than 50,000 who had visited their GP due to bloating – two-thirds of whom had blood tests following their appointment. The team found abnormal results in 19 commonly used blood tests were linked to a higher risk of being diagnosed with cancer within a year – one in 50 people who reported stomach pain, as well as bloating, to a GP were diagnosed with cancer within 12 months. If taken into account, researchers estimated that there would have ...
- Source: drugdu
- 68
- August 14, 2024
Pfizer touts positive topline data for RSV vaccine Abrysvo

Pfizer has announced positive topline results from a pivotal late-stage study of its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults who are immunocompromised and at risk of developing severe RSV-associated lower respiratory tract disease (LRTD). As per the 12 August press release, Abrysvo was found to be well tolerated in the substudy B portion of the pivotal Phase III MONeT study (NCT05842967). While substudy B evaluated two 120 µg dose doses of Abrysvo, Pfizer reported that a single 120 µg dose of the vaccine led to “strong neutralizing” responses against RSV-A and RSV-B. The safety profile of Abrysvo was consistent with that of previous studies. “Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” said senior vice president and CSO, Vaccine ...
- Source: drugdu
- 72
- August 14, 2024
FDA approves Sandoz’s Enzeevu as Eylea biosimilar saga continues

The US Food and Drug Administration (FDA) has approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD). Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease. Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products. The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release. Interchangeable biosimilars are eligible for a year of market exclusivity if they are the first biosimilar of a given product ...
- Source: drugdu
- 87
- August 14, 2024
【EXPERT Q&A】How to apply for the management record of Class II medical devices?

Drugdu.com expert’s response: The application process for the Class II medical device operation registration mainly involves the following steps: Ⅰ. Prepare Registration Materials 1.Enterprise Qualification Documents: Copy of the enterprise’s business license, certifying its legal business qualifications. 2.Organization code certificate (if applicable), verifying the enterprise’s organization code. 3.dentity cards, educational background, or professional title certificates of the enterprise’s legal representative or person in charge, and quality managers, to verify the identity and qualifications of relevant personnel. 4.Quality Management Personnel and Professional Technical Personnel Information: Work resumes of quality management personnel. 5.A list of professional technical personnel, along with their identity cards, educational certificates, and professional title certificates, to demonstrate the enterprise’s quality management capabilities and professional technical proficiency. 6.Business Premises and Warehouse Information: Geographical location maps and floor plans of the enterprise’s business premises and warehouse addresses, as well as commercial property ownership certificates, red lease contracts, or site usage certificates, to prove ...
- Source: drugdu
- 103
- August 14, 2024
Blood Test Predicts Chronic Lung Disease in Preterm Babies

Bronchopulmonary dysplasia (BPD) is a condition that impacts 65% of preterm infants, leading to chronic lung disease and neurodevelopmental impairments that persist throughout life. BPD typically arises when premature infants require respiratory support and prolonged oxygen therapy, which can damage their developing lungs. Currently, options for predicting, preventing, and treating BPD are inadequate. Diagnoses are often not confirmed until 36 weeks post-menstrual age, delaying interventions that could reduce lung damage and enhance respiratory health. Existing early prediction tools do not effectively address the underlying pathology of the disease. However, timely lung protective measures can modify BPD incidence. More precise care could be administered if the likelihood of lung damage and other complications in these infants were known sooner. Researchers have now developed a blood test that can predict which preterm infants will go on to develop chronic lung disease, facilitating earlier intervention and more focused treatment strategies. The research, led ...
- Source: drugdu
- 71
- August 13, 2024
Saliva Test More Accurately Indicates Severity of Recurrent Respiratory Infections in Children

Approximately 10-15% of children experience recurrent respiratory infections, prompting hospital visits where blood tests are commonly performed to check for antibody deficiencies. Yet, these tests often fail to provide helpful insights. There is a pressing need for alternative methods that better assess the severity of the condition, which would aid in determining when increased care or antibiotic treatment is necessary. Now, new research reveals that saliva testing might offer a more accurate reflection of the severity of recurrent respiratory infections in children compared to traditional blood tests. If saliva contains too few broadly protective antibodies, there is a higher likelihood of pneumonia episodes for the children. The collaborative study by researchers at Radboudumc Amalia Children’s Hospital (Nijmegen, Netherlands) and UMC Utrecht Wilhelmina Children’s Hospital (Utrecht, Netherlands) involving 100 children with recurrent respiratory infections found that saliva tests are better indicators of disease severity than blood tests. The study demonstrated no ...
- Source: drugdu
- 72
- August 13, 2024

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