Search Results for “EC” – Page 328 – media

Bright Uro Snags $23M To Make Urology Diagnostics Easier for Providers & Patients

Bright Uro raised $23 million in Series A funds to help achieve FDA clearance for its urodynamics system and launch the product in the U.S. Should it be cleared, the system will become the first product on the market able perform urodynamic monitoring wirelessly and without a catheter, the company’s CEO said. By KATIE ADAMS Bright Uro, a Irvine, California-based startup founded in 2021, is on a mission to make urodynamic testing more accurate for clinicians, more comfortable for patients, and more efficient for clinics. On Thursday, the company announced it has raised $23 million to help it get closer to achieving those goals — the Series A funding round was led by Laborie Medical Technologies, a provider of urology diagnostic and therapeutic products. The round reflects the total amount of equity investment Bright Uro has raised since its founding, said CEO Derek Herrera. The startup also received a $2 ...
- Source: drugdu
- 147
- December 5, 2023
GlobalData

As gene therapies ramp up in spinal muscular atrophy and hemophilia, it may soon be the turn of Gaucher disease patients to realize the latent potential of this type of treatment. That’s according to analysts at GlobalData, which spoke to key opinion leaders (KOLs) during the recent International Gaucher Disease Awareness Month to gauge their thoughts of gene therapy in this space. GlobalData said in an accompanying report that these KOLs believe pipeline gene therapies “will significantly impact the Gaucher disease landscape,” given that it has the curative potential to provide patients with a healthy GBA1 copy, disrupting the Gaucher drug market. However, much “groundwork remains to be covered,” the analysts cautioned. Gaucher disease is a rare inherited metabolic disorder caused by defects in the GBA1 gene and comes with three distinct types of the disease with varying severity. The rare condition is typically characterized by the accumulation of fatty ...
- Source: drugdu
- 93
- December 5, 2023
Phenomic scores two deals in two days with Boehringer and Astellas

Canada-based Phenomic AI has landed two strategic collaborations this week with Boehringer Ingelheim and Astellas-owned cell therapy biotech Xyphos Biosciences to develop cancer therapies. Phenomic and Boehringer have teamed up on a target identification collaboration, announced on 29 November. Under the deal, Phenomic will receive an upfront payment of $9m and may be entitled to up to $500m in research funding and milestones. The Canadian company hasn’t disclosed the financial terms of the deal with Astellas, but the companies aim to develop cell therapies with an antibody directed at a novel target of the tumour stroma, utilising Phenomic’s scTx platform. The company singled out colorectal and pancreatic cancers as being stroma-rich, which would be amenable to being targeted by Phenomic’s platform. These developments mark the first deals announced by Phenomic in three years since the company launched in 2020 with $6m in seed funding. Phenomic’s scTx is a single-cell RNA ...
- Source: drugdu
- 120
- December 5, 2023
NHS to offer stem cell transplants to patients living with rare blood disorder

The NHS has announced that it will offer stem cell transplants that could cure patients living with thalassaemia, a severe and life-limiting inherited blood disorder. Funded for the first time by the NHS, curative stem cell transplants will be eligible for patients living with the condition following new guidance from NHS England’s Clinical Advisory Group. Thalassaemia is a rare disorder that affects the haemoglobin in the blood and requires patients to have blood transfusions every two to four weeks. Across the UK, more than 600 adults are estimated to be living with transfusion-dependant thalassaemia. The procedure, known as allogeneic haematopoietic stem cell transplant (Allo-HSCT), involves replacing the bone marrow stem cells of patients with ones from a matched sibling donor. The procedure was previously only used as a treatment for children due to the potential risk of complications among adults. However, thanks to new advances in transplant treatment, including better ...
- Source: drugdu
- 92
- December 5, 2023
Eli Lilly and PRISM BioLab enter drug discovery collaboration worth over $660m

Eli Lilly has entered into a licence and collaboration agreement with PRISM BioLab aimed at discovering oral inhibitors of a protein-protein interaction (PPI) target, with the deal worth over $660m. The partnership centres around PRISM’s proprietary PepMetics technology, which the Japanese biotech says has the potential to “expand the field of drug discovery by turning previously undruggable PPIs into targets readily druggable with small molecules and by generating oral small molecule alternatives for injectable biologics”. Despite PPI dysfunction being implicated in a broad range of diseases, including cancer, fibrosis and autoimmune disorders, only a small proportion of PPIs are targeted by approved drugs. Lilly, which will select the first PPI target, has the option to add another two to the collaboration and will be responsible for the clinical development and commercialisation of any resulting products. In exchange, PRISM will receive undisclosed upfront payments from Lilly and will be eligible to ...
- Source: drugdu
- 101
- December 5, 2023
【EXPERT Q&A】What are the differences between the MDR and IVDR regulations?

Drugdu.com expert’s response: Although the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) share a common purpose, they apply to different categories of products, with specific differences in the following aspects: Scope of Application: MDR is a regulation for medical devices: It applies to all medical devices not used for in vitro diagnostics, including surgical tools, medical equipment, implants, etc. IVDR is a regulation for in vitro diagnostic medical devices: It specifically applies to in vitro diagnostic devices, such as reagent kits and equipment used for blood analysis. Classification System: MDR: Implements a new risk-based classification system, detailing medical devices into different levels more comprehensively. IVDR: Introduces a new risk classification rule, which is a significant change for the in vitro diagnostic device industry, especially increasing the scrutiny requirements for high-risk IVD products. Clinical Requirements: MDR: Strengthens the requirements for clinical evidence, demanding manufacturers to conduct clinical assessments and ...
- Source: drugdu
- 181
- December 4, 2023
Samsung Bioepis, J&J Ink Settlement and License Deal for Stelara Biosimilar

By Tyler Patchen Samsung Bioepis has inked a settlement and license agreement with Johnson & Johnson, which will settle all U.S. patent litigation and allow for the commercialization of a biosimilar for the arthritis drug Stelara, known as SB17. According to Thursday’s announcement, Samsung Bioepis’ license period for its Stelara biosimilar will kick in on February 22, 2025. However, all the other terms of the deal were labeled as confidential and no further details were revealed. The BLA for the SB17 drug is under review by the FDA. If the drug is approved, it will be commercialized by Sandoz.   The issues between J&J and Samsung Bioepis come from the South Korean biotech filing a petition for an Inter Partes Review of J&J’s Stelara, or ustekinumab patent. According to a legal intelligence website lexology, Samsung Bioepis stated that the claims of J&J’s patent were invalid.  Patent protections over the use of ...
- Source: drugdu
- 127
- December 4, 2023
AbbVie Buys ImmunoGen in $10B Deal, Gains Access to ADC for Ovarian Cancer

By Tyler Patchen AbbVie is the latest big pharma to target the hot antibody-drug conjugate market by acquiring ImmuoGen and its Elahere ADC for platinum-resistant ovarian cancer. The deal worth $10.1 billion was announced Thursday. Under the terms of the agreement, AbbVie will acquire all outstanding shares of ImmunoGen for $31.26 per share. The board of directors of AbbVie and Immunogen have approved the acquisition, which is expected to close sometime in the middle of 2024. The deal will give AbbVie access to Elahere (mirvetuximab soravtansine-gynx), which was granted FDA accelerated approval last year, and ImmunoGen’s follow-on pipeline of ADCs. ImmunoGen currently has several ADCs in development for treatments such as solid tumors, acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm, among other conditions. “The acquisition of ImmunoGen demonstrates our commitment to deliver on our long-term growth strategy and enables AbbVie to further diversify our oncology pipeline across solid ...
- Source: drugdu
- 117
- December 4, 2023
AbbVie to Acquire ImmunoGen With its Platinum-Resistant Ovarian Cancer Drug Elahere

Pharmaceutical Executive Editorial Staff AbbVie acquiring all outstanding shares of ImmunoGen, Inc. for $31.26 per share, valuing the company at a total equity value of approximately $10.1 billion. AbbVie Inc. has announced the acquisition of ImmunoGen, Inc. along with its first-in-class antibody-drug conjugate (ADC) mirvetuximab soravtansine-gynx (Elahere), which has been FDA-approved to treat platinum-resistant ovarian cancer.1 With the transaction, AbbVie acquires in cash all outstanding shares of ImmunoGen for $31.26 per share, valuing ImmunoGen at a total equity value of approximately $10.1 billion. Boards of directors for both AbbVie and ImmunoGen approved the transaction, which they anticipate closing in mid-2024, subject to approval by ImmunoGen shareholders and regulatory agencies, as well as other customary closing conditions. The pending transaction is anticipated to be accretive to diluted earnings per share starting in 2027. In a press release, AbbVie said the acquisition accelerates its commercial and clinical presence in the solid tumor ...
- Source: drugdu
- 124
- December 4, 2023
Research Explores Adverse Outcomes From Energy Drink Intake Before, During Pregnancy

Don Tracy, Associate Editor JAMA study investigates whether consuming energy drinks was associated with adverse pregnancy outcomes and whether caffeine consumption affects fetal-growth restriction. Image Credit: Adobe Stock Images/Viktor Energy drinks, popular for increasing awareness and energy, have seen a 240% increase in sales since 1987, reaching $9.7 billion in US sales in 2015. Marketing for these products typically targets young adults; however, there are also safety concerns with their consumption, with associations found between energy drinks and health issues, including mental health symptoms and organ damage. There have been very few studies that have explored the link between energy drink intake before and during ...
- Source: drugdu
- 102
- December 4, 2023

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