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FDA Approves Expanded Indication for Praluent to Lower LDL-C in Pediatric Patients with HeFH

Davy James Regeneron’s PCSK9 inhibitor approved to reduce low-density lipoprotein cholesterol in patients 8 years of age and older with heterozygous familial hypercholesterolemia. The FDA has approved an expanded indication for Regeneron’s PCSK9 inhibitor Praluent (alirocumab) to include patients 8 years of age and older for the reduction of low-density lipoprotein cholesterol (LDL-C) in those with heterozygous familial hypercholesterolemia (HeFH).1 In clinical trials, the fully human monoclonal antibody, which binds and inhibits to circulating PCSK9, has been found to lower LDL-C in patients with hyperlipidemia either as a monotherapy or combined with other lipid-lowering therapies (LLTs).2 “Many children with (HeFH) are able to substantially improve their LDL-C (bad cholesterol) with currently available therapies,” said Mary P. McGowan, MD, chief medical officer of the Family Heart Foundation, in a press release. “But for those children whose LDL-C remains dangerously high, this approval is an important milestone as it gives these children ...
- Source: drugdu
- 173
- March 13, 2024
Boehringer Ingelheim Places €25M Bet on Sosei’s Novel Approach to Schizophrenia

Sosei Heptares’ schizophrenia drug candidate addresses a novel, difficult-to-drug target for neurological disorders. Boehringer Ingelheim can exercise its option on the small molecule following a Phase 1 test expected to yield data in 2025. By FRANK VINLUANAntipsychotic medications used to treat schizophrenia don’t work for all patients, and even when they do, side effects lead many people to stop taking them. Sosei Heptares is developing a novel drug that could bring patients better efficacy along with fewer side effects, and that potential has caught the interest of Boehringer Ingelheim. The German pharmaceutical company has inked a deal for an exclusive option on Sosei Heptares’s schizophrenia drug candidate, which is in early clinical development. Under deal terms announced Monday, Boehringer is paying its new partner €25 million up front. Sosei Heptares’s schizophrenia research address a G protein-coupled receptor (GPCR) called GPR52. This particular receptor is highly expressed in the brain, making ...
- Source: drugdu
- 164
- March 13, 2024
Biokin Pharmaceutical has successfully completed the initial payment of USD 800 million under the development and commercialization license agreement with Bristol Myers Squibb for BL-B01D1

As of March 7, 2024, Biokin Pharmaceutical has received an initial payment of USD 800 million from Bristol Myers Squibb under the development and commercialization license agreement for BL-B01D1. Agreement Signing and EffectivenessOn December 11, 2023, SystImmune, Inc., a wholly-owned subsidiary of Biokin Pharmaceutical, entered into an exclusive licensing and collaboration agreement (hereinafter referred to as the “Collaboration Agreement”) with Bristol Myers Squibb (hereinafter referred to as “BMS”, NYSE ticker: BMY) pertaining to the BL-B01D1 (EGFR×HER3 bispecific ADC) project. Under the terms of the Agreement, the Parties will jointly pursue the development and commercialization of BL-B01D1 in the United States. SystImmune will exclusively be responsible for the development, commercialization, and production of BL-B01D1 within Chinese mainland through its affiliated entities, including manufacturing some drugs for supply to regions outside of Chinese mainland. Conversely, BMS will retain exclusive right to develop and commercialize BL-B01D1 in all other regions globally. The Collaboration ...
- Source: drugdu
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- March 13, 2024
New action to tackle ethnic and other biases in medical devices

The government has today announced action to tackle potential bias in the design and use of medical devices, as it accepts recommendations from a UK-first independent review. The Department of Health and Social Care commissioned senior health experts to identify potential biases in these devices and recommend how to tackle them. The government fully accepted the report’s conclusions and has made a series of commitments, including ensuring that pulse oximeter devices used in the NHS can be used safely across a range of skin tones, and removing racial bias from data sets used in clinical studies. Minister of State, Andrew Stephenson said: I am hugely grateful to Professor Dame Margaret Whitehead for carrying out this important review. Making sure the healthcare system works for everyone, regardless of ethnicity, is paramount to our values as a nation. It supports our wider work to create a fairer and simpler NHS. Ministers agree ...
- Source: drugdu
- 140
- March 13, 2024
Study reveals children with amblyopia are at higher risk of serious disease in adulthood

The neurodevelopmental condition affects up to four in 100 children A new study led by researchers at University College London (UCL) and other collaborators has revealed that adults who experienced amblyopia as children are more likely to experience serious diseases in adulthood. Published in eClinicalMedicine, the study was funded by the Medical Research Council, the National Institute of Health and Care Research (NIHR) and the Ulverscroft Foundation. Affecting up to four in 100 children, amblyopia, otherwise known as a ‘lazy eye,’ is a neurodevelopmental condition where the vision in one eye does not develop properly, caused by a breakdown in how the brain and eye work together. Carried out alongside seven other collaborators, including King’s College London, the NIHR Biomedical Research Centre and Great Ormond Street Hospital, researchers analysed more than 126,000 people aged 40 to 69 years from the UK Biobank cohort who had an ocular examination. Out of ...
- Source: drugdu
- 112
- March 13, 2024
KCL joins new project launched by European consortium to improve newborn health

The HYPIEND project consists of 14 partners from eight European countries King’s College London (KCL) has announced that it is one of 14 partners from eight European countries to join the HYPIEND project to improve newborn health. Co-ordinated by the Eurecat technology centre, the five-year study aims to reduce the impact of endocrine disruptors on pregnancy and pre-puberty. Endocrine-disrupting chemicals (EDCs) can be found in products including cosmetics, food, drink and cleaning products. Particularly during pregnancy, infancy and childhood, these products can affect the operation of the hormonal system. The HYPIEND project will analyse the impact on the hypothalamic-pituitaryaxis, the structure where the central nervous system and the endocrine systems connect and regulate hormones that operate body functions such as somatic growth, lactation and stress coping. The project will involve Dr Marika Charalambous, school academic lead, research and impact, at KCL, who will lead group studies of the metabolism and ...
- Source: drugdu
- 131
- March 13, 2024
2024 AAD ︱ Hengrui’s Self-exempt Class 1 Innovator Emacetinib Phase III Study for Moderate to Severe Atopic Dermatitis Debuts in Oral Presentation

The 82nd Annual Meeting of the American Academy of Dermatology (AAD) was held from March 8 to 12, 2024 in San Diego, USA. This is one of the largest and most influential international events in the field of dermatology in the world. on the afternoon of March 10, Professor Zhang Jianzhong, a well-known dermatologist and professor of Peking University People’s Hospital, delivered an oral report in the Late-Breaking Research session of the conference, introducing Hengrui Pharmaceuticals’ innovative drug, Emaxitinib ( SHR0302) in the treatment of moderate-to-severe atopic dermatitis (AD). “Emaxitinib is a highly selective JAK1 inhibitor originally developed in China, which is a major breakthrough for us in the field of innovative drug development.” Prof. Zhang Jianzhong explained that the Phase III clinical study showed that patients with moderate-to-severe AD treated with emaxitinib for 16 weeks showed significant improvement in skin lesions and itching symptoms, and the 52-week long-term follow-up ...
- Source: drugdu
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- March 13, 2024
【EXPERT Q&A】Is there a requirement for the registration address of the second type of medical device business filing?

Drugdu.com expert’s response: There are usually requirements for the registered address when applying for the record-filing of the distribution of Class II medical devices. The registered address is typically required to be a legally operated premises that complies with relevant regulations, ensuring that the storage, sales, and management of medical devices meet the standards. Specific requirements may include the area of the premises, environmental conditions, storage facilities, safety measures, etc.
- Source: drugdu
- 228
- March 12, 2024
Rapid AST Platform Provides Targeted Therapeutic Results Days Faster Than Current Standard of Care

Bacteria are outpacing scientific advancements, leading to a worrying increase in antibiotic resistance, a situation the World Health Organization has identified as an emerging global health crisis. The key to countering this trend lies in achieving quicker diagnostic results, comprehensive susceptibility testing across various sample types, and the ability to test against a broad range of commercially relevant antibiotics simultaneously. Now, a rapid antibiotic susceptibility testing (AST) system can provide targeted therapeutic results days faster than the current standard of care. Selux Diagnostics (Boston, MA, USA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary Positive Blood Culture (PBC) Separator. The addition of positive blood culture sample type expands the Selux Next Generation Phenotyping (NGP) System, making this the only FDA-cleared, single-platform technology to deliver rapid AST results for both positive blood culture and isolated colonies. The Selux PBC Separator streamlines the process for ...
- Source: drugdu
- 158
- March 12, 2024
First Ever Prototype Applies AI to Colorectal Diagnosis

The incidence and mortality rates of colorectal cancer (CRC) are on an alarming rise, with predictions showing a continuous increase until at least 2040. Currently, CRC ranks as the third most diagnosed (10.7% of all cancer cases) and the second deadliest cancer type. Despite the effectiveness of imaging and endoscopic techniques in CRC detection, the final cancer diagnosis always relies on a pathologist’s assessment of histological samples. Grading dysplasia is still routinely performed by pathologists worldwide when assessing colorectal tissue samples. Computer-aided diagnosis (CAD) systems for colorectal pathology face challenges due to the high data volume and the massive resolution of images, leading to a bottleneck in deep learning (DL) approaches that extract patches from the whole slides. Now, researchers at INESC TEC (Porto, Portugal) and IMP Diagnostics (Porto, Portugal) have created a pioneering prototype that employs artificial intelligence (AI) for colorectal diagnosis. This prototype is a result of a ...
- Source: drugdu
- 150
- March 12, 2024

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