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【EXPERT Q&A】What are the steps in the FDA’s drug approval process?

Drugdu.com expert’s response: The drug approval process by the FDA is quite standardized and rigorous. Here’s a detailed breakdown of the entire process: Preclinical Studies: This is the first step in the drug approval process, involving pharmacological and toxicological studies to assess the drug’s safety and efficacy. These studies are usually conducted in laboratories or animal models. Submission of an Investigational New Drug Application (IND): Once preclinical studies indicate that the drug might be safe, pharmaceutical companies submit an Investigational New Drug application (IND). The IND includes preclinical study data, manufacturing information, and clinical trial protocols. Clinical Trials: This is the core part of the drug approval process and mainly consists of three phases. Phase I primarily tests the drug’s safety and dosage in humans; Phase II focuses on the drug’s efficacy and side effects; Phase III further confirms efficacy, monitors side effects, and compares the drug with existing treatments. ...
- Source: drugdu
- 151
- February 8, 2024
AnaMar secures double orphan drug designation for systemic sclerosis drug

AnaMar has received orphan drug designations for its systemic sclerosis candidate AM1476 from the FDA and the EMA. The Swedish biotech is now eligible for several incentives in the two regions, according to the designations. Both agencies will provide regular feedback during the application process and waive certain fees. The FDA also offers seven years of market exclusivity while the EMA promises ten years of protection from competition. AnaMar’s AM1476 is an oral antagonist of the 5-hydroxytryptamine receptor (5-HT2B) receptor, which is also known as a serotonin receptor. The company says its candidate halts key signalling pathways associated with fibrosis in a 5 February press release. Systemic sclerosis, also known as scleroderma, is a progressive autoimmune disease characterised by inflammation and fibrosis. Not only is skin hardened in this condition, but internal organs can be affected too. Interstitial lung disease (ILD) is one of the most common disease consequences, occurring ...
- Source: drugdu
- 102
- February 8, 2024
BMS reports 2% revenue loss in 2023 after Revlimid generics hurt sales

BMS has reported its results for the 2023 financial year (FY), revealing a 2% decrease in revenues of $45bn from $46.2bn reported in 2022. The company saw a decrease in sales of Revlimid (lenalidomide) following the entry of generic versions after its patent loss in 2022. Revlimid generated $6bn in 2023, compared to $12.9bn in 2021 before the loss. BMS’ blockbuster cancer drug Opdivo generated $9bn in 2023, a 9% increase from 2022. The human IgG4 anti-PD-1 monoclonal antibody saw a label expansion, as well as increased demand from patients with gastric, bladder, non-small cell lung cancer (NSCLC) and melanoma. BMS’ top-seller is anti-stroke drug Eliquis (apixaban), generating $12.2bn in 2023, however, Eliquis loses its patent in 2026, with GlobalData predicting that sales will drop to $3bn by 2029.In a strategic move to counteract anticipated revenue declines from upcoming patent expirations on certain BMS drugs in the next few years, ...
- Source: drugdu
- 93
- February 8, 2024
Automated Mass Spectrometry-Based Clinical Analyzer Could Transform Lab Testing

Mass spectrometry, known for its higher sensitivity and specificity compared to immunoassays, is particularly effective for testing molecules like Vitamin D and certain hormones where antibody-based tests struggle to differentiate between similar forms. This method allows for more precise testing. Researchers and clinicians have been investigating the use of mass spectrometry for such assays for several years. However, due to its complexity compared to standard immunoassays, mass spectrometry has largely been limited to large clinical reference laboratories and specialized testing companies that have the necessary resources and expertise to develop and conduct these tests. Now, a fully automated clinical mass spectrometry system being developed for routine lab testing could change that. Roche Diagnostics (Basel, Switzerland) is currently developing a fully automated, standardized liquid chromatography-mass spectrometry (LC-MS) solution that will seamlessly integrate into existing clinical chemistry and immunochemistry testing as part of its cobas Pro integrated solutions, as well as laboratory ...
- Source: drugdu
- 116
- February 7, 2024
Cell Sorter Chip Technology to Pave Way for Immune Profiling at POC

Monitoring the response of the immune system of cancer patients during disease and treatment is important for achieving favorable outcomes. To do this, labs utilize flow cytometry to perform immune profiling, which involves identifying and quantifying a patient’s immune cells at a specific time. This information is vital for determining the most effective treatment for a cancer patient. Continuing this profiling during treatment helps clinicians understand how well the treatment is working. Despite the promise of immune profiling in guiding therapy being a burgeoning area in cancer research and treatment, it hasn’t been widely adopted in clinical practice due to the high cost, large size, and complexity of flow cytometry equipment. These machines are confined to specialized labs, and transporting blood samples to these facilities is time-consuming and requires special conditions to keep the cells viable, making routine monitoring of cancer patients challenging. Now, a novel cell sorter chip technology ...
- Source: drugdu
- 91
- February 7, 2024
Valneva sells Ixchiq priority voucher for $103m to fuel R&D

Valneva has sold its US Food and Drug Administration (FDA) priority review voucher for €95m ($103m) to an undisclosed party. The French company received the priority review voucher when its chikungunya vaccine, Ixchiq, got FDA approval in November 2023.Valneva plans to use the funds from the voucher sale to advance its research and development (R&D) efforts, as per a 5 February press release. The voucher sale price is in line with the company’s previous projections of gaining €90m-€110m with such a sale. One of the projects that the company plans to use its proceeds for is the Lyme disease vaccine, VLA15. Valneva is co-developing the vaccine in partnership with Pfizer. VLA15 is an experimental multivalent protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia. The vaccine is being evaluated in a placebo-controlled Phase III trial (NCT05477524). The trial suffered a delay when both companies paused patient ...
- Source: drugdu
- 92
- February 7, 2024
Contentious Medicare price negotiations underway as US drug prices rise

The US’ HHS has sent the first offers to participating drug companies eligible for negotiation under the Medicare price negotiation programme as required by the Inflation Reduction Act (IRA). The Centers for Medicare and Medicaid Services is managing these talks, with a 30-day window given to involved drug companies to indicate acceptance of the suggested prices or present an alternative offer. Once both Medicare and the drug company agree on a price, the revised prices will become effective within Medicare in 2026.The IRA allows Medicare to directly negotiate to reduce prescription prices for certain drugs and requires certain companies to pay rebates back to Medicare if the drug prices exceed the rate of inflation. The first ten drugs selected to be negotiated in the programme include those marketed by pharma giants AstraZeneca and Merck & Co’s anti-diabetic drugs, Farxiga (dapagliflozin), and Januvia (sitagliptin), respectively. In the announcement accompanying the offers, CMS administrator Chiquita ...
- Source: drugdu
- 91
- February 7, 2024
Moderate kimchi intake linked to lower obesity rates, study shows

In a recent study published in the journal BMJ Open, researchers explored the relationship between kimchi consumption and obesity in South Korea. Obesity is associated with nutritional, environmental, and lifestyle factors and is a significant risk factor for diabetes, chronic kidney disease, cardiovascular disease, and hyperlipidemia. Obesity prevalence in South Korea has increased steadily over the years. Meanwhile, the prevalence of abdominal obesity has also increased over time. Increased obesity prevalence is associated with higher medical expenditure; thus, obesity prevention remains a public health priority. In Korea, kimchi is a traditional side dish low in calories but rich in vitamins, dietary fiber, polyphenols, and lactic acid bacteria. There are concerns about kimchi as one of the major contributors to sodium intake. A 2019-20 survey revealed that daily sodium intake from kimchi was 500 mg (15% of total sodium intake). Studies have shown associations between increased sodium intake and a greater ...
- Source: drugdu
- 85
- February 6, 2024
COVID-19 recovery disparities uncovered among racial and ethnic groups

In a recent study published in Frontiers in Public Health, researchers from the United States of America (US) investigated the racial and ethnic variation in symptoms, activity level, health status, and missed work. They assessed this via follow-ups post-initial infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although the symptoms were equally prevalent among the groups, they found that three and six months post-infection, Hispanic participants reported poorer health and reduced activity compared to non-Hispanic participants. Further, racial minority participants reported more negative impacts on health status, activity, and absence from work as compared to the White population. Background The coronavirus disease 2019 (COVID-19) pandemic highlighted disparities, wherein ethnic and racial minoritized populations were observed to face greater infection risks due to the essential nature of their work, limited remote work options, and challenges in practicing social distancing. The infected individuals faced barriers to care, including underinsurance and lack ...
- Source: drugdu
- 164
- February 6, 2024
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace

Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy uses mPNS to deliver a quick, painless and non-invasive treatment in sessions lasting just 13.5 minutes, according to Neuralace. Each session utilizes magnetic pulses to provide relief for a potential improvement in pain management. Neuralace said a recent trial of 71 patients demonstrated efficiency, plus significant improvements in subject outcomes. The company believes its therapy represents a paradigm shift in PDN treatment. Axon Therapy offers a non-pharmacological and non-invasive option that could reduce dependence on medications and their associated side effects. The company says FDA clearance paves the way for broader access to innovative pain ...
- Source: drugdu
- 81
- February 6, 2024

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