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【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 ...
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- 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 ...
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- 144
- 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 ...
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- 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 ...
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- 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 ...
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- 118
- December 4, 2023
FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

The US Food and Drug Administration (FDA) has announced its intention to investigate the safety of CAR-T therapies following reports that they could be linked to the development of T-cell cancers. Following reports from clinical trials and post-marketing adverse event data sources, the wide probe is directed at patients who received treatment with all currently approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies. CAR-T-cell therapy is a type of immunotherapy that involves collecting and using patients’ own immune cells to treat conditions including lymphoma, leukaemia and multiple myeloma. T-cell malignancies have been seen in patients treated with several approved products in the class, including Bristol Myers Squibb’s (BMS) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Johnson & Johnson and Legend Biotech’s Carvykti (ciltacabtagene autoleucel), Novartis’s Kymriah (tisagenlecleucel), and Gilead and Kite’s Yescarta’s Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel). Currently, the potential risk of developing secondary malignancies is labelled as ...
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- 133
- December 4, 2023
Boehringer Ingelheim and IBM announce AI antibody drug discovery partnership

Boehringer Ingelheim and IBM have announced a partnership aimed at advancing generative artificial intelligence (AI) and foundation models for therapeutic antibody development. The collaboration agreement will see Boehringer use an IBM-developed, pre-trained AI model that will be “further fine-tuned” on the German drugmaker’s specific proprietary data to help accelerate the pace at which it can create new antibody therapeutics. The companies noted that, despite “major” technological advances, the discovery and development of therapeutic antibodies against diverse targets remains a “highly complex and time-consuming process”. IBM’s foundation model technologies, which have already shown success in generating biologics and small molecules with relevant target affinities, are used to design antibody candidates for specific disease targets. These are then screened with AI-enhanced simulation to select and refine the best binders for the target. Boehringer Ingelheim outlined that it will produce small quantities of the candidates that can be tested experimentally. Andrew Nixon, global ...
- Source: drugdu
- 126
- December 4, 2023
Generation bio cuts 40% of staff in blow for non-viral gene therapy sector

US-based Generation Bio is cutting its workforce by 40%, becoming the latest company to announce lay-offs to save money this year. The restructuring includes the departure of key personnel, with medical chief Douglass Kerr and development leader Tracy Zimmerman among those leaving. The 29 November announcement adds to a series of setbacks in the field, with the cell therapy startup NexImmune reducing its workforce by over half this year, halting the development of its three adoptive T cell therapies. Generation anticipates that the downsizing and streamlining of its research and development focus will result in a cost-saving of $120m over the next three years, as outlined in a 27 November SEC filing. In April, Takeda announced that it was moving away from the adeno-associated virus (AAV) gene therapies sector amidst difficulties associated with gene therapy research development at the preclinical stage, highlighting that it is unlikely that many current AAV ...
- Source: drugdu
- 107
- December 4, 2023
EU’s IVD guidelines continue affecting early clinical work

The implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR) by the European Union (EU) continues to be a disadvantage for companies looking to start their clinical trials in the EU, said Malte Oppermann, senior director of clinical operations at Medigene. Oppermann spoke at a session of the Clinical Trials in Oncology (CTO) Europe 2023 conference in Munich, Germany, which took place 28 – 29 November. The session focused on the impact of IVD regulation changes on early-stage clinical trials and the challenges that come with clinical trials that incorporate IVDs. In a nutshell, IVDs are tests carried out on patient samples that can be used to prevent and treat diseases. In oncology, IVDs are used to detect biomarkers, which have become increasingly important in precision medicine. Examples of established biomarkers with approved therapies include the prognostic biomarkers HER2 and BRCA1. The IVDR came into effect on 26 May ...
- Source: drugdu
- 107
- December 4, 2023
Intas Pharmaceuticals Hit with Another FDA Warning Letter, Put on Import Alert

By Tristan Manalac Pictured: Sign outside the FDA’s office in Maryland The FDA has slapped Intas Pharmaceuticals with another warning letter over manufacturing violations, quality control lapses and compromised data integrity, this time at its plant in Gujarat, India. The regulator has also put the Indian facility on its import alert list, which allows the FDA’s field operatives to detain products from Intas without physical examination. In its Nov. 21 warning letter, the FDA pointed to four main issues found at the Gujarat plant over a 12-day site inspection in May 2023. According to the regulator, Intas failed to ensure that the drug products that it manufactures comply with ...
- Source: drugdu
- 133
- December 2, 2023

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