Search Results for “EC” – Page 280 – media

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
- 161
- 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
- 161
- 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
- 93
- 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
- 135
- 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
- 106
- 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
- 127
- March 13, 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
- 148
- March 12, 2024
FDA Grants Accelerated Approval to Brukinsa Plus Gazyva for Relapsed or Refractory Follicular Lymphoma

Davy James BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies. The FDA has granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) in combination with Roche’s Gazyva (obinutuzumab) for patients with relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy.1 Brukinsa is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies, such as chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma; Waldenström’s macroglobulinemia; patients with mantle cell lymphoma (MCL) previously treated with at least one prior therapy; and patients with relapsed or refractory marginal zone lymphoma previously treated with at least one anti-CD20-based regimen.1 Gazyva is a CD20-directed cytolytic antibody indicated in combination with chlorambucil for the treatment of patients with previously untreated CLL; in combination with chemotherapy ...
- Source: drugdu
- 128
- March 12, 2024
How Marketing Fueled the Opioid Overdose Crisis and What We Can Learn From It

Given the link established across studies between marketing practices and the opioid overdose crisis, a few strategic steps can form a path forward for clinicians and policymakers. By SUZETTE GLASNER-EDWARDSThe recent series of settlements linked with claims against advertising and pharmaceutical manufacturing companies involved in the sales and marketing of opioid drugs are encouraging, demanding accountability for promoting highly addictive drugs such as OxyContin as non-addictive. These settlements, ranging from $350 to $465 million, provide a source of optimism for those living with opioid use disorders, especially given the inclusion of funding to support the treatment of such individuals. Yet questions about the potential future impact of these criminal and civil suit settlements on the opioid overdose epidemic remain. Coupled with the observation that opioid marketing practices have not shifted in the face of lawsuits in the past, under-recognition of addiction and overprescribing of medications with high addiction potential for ...
- Source: drugdu
- 119
- March 12, 2024
MIT study reveals non-invasive treatment holds promise for treating ‘chemo brain’

The gamma treatment also shows potential for treating patients living with neurological diseases Researchers from the Massachusetts Institute of Technology (MIT) have shown that a non-invasive treatment called gamma treatment could protect cancer patients from “chemo brain,” memory impairment and other cognitive effects of chemotherapy. Chemo brain is a term used to describe thinking and memory problems that a patient may experience before, during or after cancer treatment. Originally developed to treat Alzheimer’s disease (AD), the treatment works to stimulate gamma-frequency brain waves, involving exposure to light and sound with a frequency of 40 hertz. In the new study, MIT researchers used mouse models, which evaluated a chemotherapy drug known as cisplatin, often used to treat testicular and ovarian cancers, for five days and then took it off for five days and repeated it. One group received chemotherapy only, while another group was also given 40-hertz light and sound therapy ...
- Source: drugdu
- 130
- March 12, 2024

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