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【EXPERT Q&A】What are the regulations and requirements for exporting medical devices to the European Union?

Drugdu.com expert’s response: Entering the European Union market requires medical device products to adhere to a series of stringent regulations and quality standards. Firstly, products must obtain CE certification, a mark that signifies compliance with EU requirements for safety, health, and environmental protection. Before submitting an application, make sure that all relevant application forms are completed in detail, including key data such as product specifications and manufacturer information. Upon passing preliminary review, the product will be sent to an EU-designated third-party certification body for comprehensive and accurate testing and evaluation. This body will assess the product’s compliance with the EU Medical Device Directive (MDD) or Medical Device Regulation (MDR), depending on the case. After successfully completing the certification process, you will receive EU export product certification, an indispensable credential proving that your product can be legally sold in the EU market. It should be noted that due to the wide variety ...
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- September 5, 2023
European Union medical device regulations
Hamilton Medical’s urgent ventilator notice deemed Class I recall by FDA

Dive Brief Hamilton Medical’s recall of ventilators for a software problem was designated Class I by the U.S. Food and Drug Administration, the agency wrote in a Monday notice. Hamilton contacted customers in June after learning that its C1, C2, C3 and T1 ventilators switch to “ambient state” if used in neonates for more than 91 days without a restart. In ambient state, the device sounds an alarm and no active ventilation is provided to patients. In light of the fault, which has caused 80 complaints but no injuries or deaths, Hamilton is asking users of its ventilators to regularly restart their devices. Dive Insight Hamilton sells mechanical ventilators for use in adults, children and infants. The problem that caused the Class I recall happens when the devices “are used for long-term ventilation in neonatal group.” If the ventilation time exceeds 91 days, the devices enter ambient state, causing them ...
- Source: drugdu
- 289
- September 4, 2023
Low-dose aspirin linked to 15% lower risk of type 2 diabetes in older adults

New research to be presented at this year’s Annual Meeting of the European Association for the Study of Diabetes (EASD) in Hamburg, Germany (2-6 October) shows that use of low dose (100mg daily) aspirin among older adults aged 65 years and older is associated with a 15% lower risk of developing type 2 diabetes. The authors, led by Professor Sophia Zoungas, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia, say the results show that anti-inflammatory agents such as aspirin warrant further study in the prevention of diabetes. The effect of aspirin on incident type 2 diabetes among older adults remains uncertain. This study investigated the randomised treatment effect of low dose aspirin on incident diabetes and fasting plasma glucose (FPG) levels among older adults. The authors did a follow-up study of the ASPREE trial – a double-blind, placebo-controlled trial of aspirin, the principal results of which were ...
- Source: drugdu
- 300
- September 4, 2023
Counterfeit pills involved in growing share of overdose deaths in the US, CDC study finds

By Deidre McPhillips, CNN Overdose deaths with evidence of counterfeit pill use became more than twice as common between the second half of 2019 and the end of 2021, according to a new CDC report. Tomas Nevesely/iStockphoto/Getty Images CNN — Overdose deaths reached record levels in the United States in recent years, and a new report shows that counterfeit pills are involved in a growing share of those deaths. The US Drug Enforcement Administration issued a public safety alert about a sharp increase of fake prescription pills laced with fentanyl and methamphetamine about two years ago. According to the agency, more than 9.5 million counterfeit pills were seized in 2021, more than the prior two years combined. A new report from the US Centers for Disease Control and Prevention captures the deadly consequences, tracking detailed accounts of deaths that were submitted to the CDC’s State Unintentional Drug Overdose Reporting System ...
- Source: drugdu
- 329
- September 4, 2023
Over-the-counter opioid overdose antidote Narcan to hit shelves next week, drugmaker says

By Meg Tirrell and Nadia Kounang, CNN Doctor explains new over-the-counter medicine that’s a ‘complete antidote to opioids’ CNN — The first over-the-counter naloxone, a drug used to reverse opioid overdose, will be available in retail stores and online as soon as next week, its manufacturer said Wednesday. The medicine, with the brand name Narcan, will have a suggested retail price of $44.99 per carton of two doses, maker Emergent BioSolutions said in a news release. It will be available initially in stores and online from retailers including Walgreens, Rite Aid, Walmart and CVS. The US Food and Drug Administration approved Narcan as an over-the-counter drug in March against a backdrop of record high deaths from opioid overdose, driven by powerful synthetic drugs like fentanyl. Narcan is a nasal spray version of naloxone, which can revive a person from an overdose within minutes. Nearly every state in the US has ...
- Source: drugdu
- 446
- September 4, 2023
Johnson & Johnson slashes price of tuberculosis drug Sirturo after relinquishing patent protections

Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson has slashed its own drug’s price in those markets. Under the new pricing structure, J&J’s drug will cost $130 for a six-month course in LMICs, a 55% discount from its prior price. Lupin also has reduced the cost of its generic version of bedaquiline by 33% to $194. The United Nations-backed Stop TB Partnership revealed the new prices on Wednesday. Last month, J&J said it would not enforce secondary patents on Sirturo in LMICs, paving the way for generic competition in many countries around the globe. The primary patent for Sirturo—which in 2012 became the first new TB drug approved in more than four decades—expired last month. But J&J had also patented improvements to its formulation, extending its protection for Sirturo into 2027. The reduced ...
- Source: drugdu
- 292
- September 4, 2023
Zerva acquires Acer Therapeutics to bolster rare disease portfolio

Zerva Therapeutics, formerly KemPharm, has announced a strategic acquisition of Acer Therapeutics to expand its rare therapies portfolio. The biggest Acer assets include the marketed rare therapy Olpruva (sodium phenylbutyrate formulation), and late-stage drug celiprolol. The acquisition is expected to be worth up to $91m in stock and cash payments, of which $76m is contingent upon milestone-based payments for Olpruva and celiprolol. Additionally, Zerva purchased Acer’s secured debt of more than $17m at a discounted value of $16.5m from its creditor, Nantahala Capital. The news caused Acer’s stock to skyrocket by 140% when the markets opened on 31 August. Zerva has a market cap of $165.25m, with a reported Q1 2023 revenue of $2.9m, as per the company’s financial report. Whilst Acer reported a loss of $8.1m in Q2 2023, as per the company’s Q2 financials. Olpruva is an oral suspension approved for the treatment of urea cycle disorders by ...
- Source: drugdu
- 282
- September 4, 2023
HHS calls for easing restrictions on marijuana, sending cannabis stocks higher

The U.S. Department of Health and Human Services has recommended reclassifying marijuana as a lower-risk drug, which would in turn ease restrictions on the budding business, a spokesperson for the Drug Enforcement Administration told CNBC on Wednesday. Marijuana is currently a Schedule I drug under the Controlled Substances Act, meaning it’s deemed to have no currently accepted medical use and a high potential for abuse. Despite being legalized for recreational use in nearly half of states, marijuana’s federal classification alongside drugs such as heroin and LSD has hindered the industry’s growth. After enjoying a sales surge during the Covid-19 pandemic, the industry is in free fall as investors turn away and capital dries up. The industry has also been barred from accessing most banking services, or from being traded across state lines, resulting in a glut of cannabis in many states and a drop in prices. A federal reclassification could ...
- Source: drugdu
- 229
- September 4, 2023
International survey reveals varying effects of oral medicines for Parkinson’s

An international survey conducted by Parkinson’s Europe, developed in partnership with STADA, has revealed that people taking oral medications for Parkinson’s disease experience varying effects. The survey, financially supported by STADA’s affiliate Brittania Pharmaceuticals, involved 992 participants with advanced Parkinson’s across 53 countries. It revealed that more than 96% of respondents said that they took medication for their condition, two-thirds of which were receiving oral levodopa or another single oral therapy. Parkinson’s disease is a neurodegenerative disease that progressively damages parts of the brain. Symptoms of advanced Parkinson’s are more complex and have a stronger effect on day-to-day life. The study revealed that 65% of respondents reported varying effects; 42% reported a partial response without the usual resolution of motor symptoms; 40% reported a delayed onset of effect; and 60% reported that they ‘regularly’ or ‘often’ experienced the effect of a medication wearing off before the next dose. It also ...
- Source: drugdu
- 223
- September 4, 2023
Trade groups urge CMS to expand, quickly finalize breakthrough device pathway

Dive Brief Medtech trade groups have voiced support for the Centers for Medicare and Medicaid Services’ plan to accelerate reimbursement of certain breakthrough devices. In letters sent on the same day, AdvaMed and the Medical Device Manufacturers Association (MDMA) urged CMS to quickly finalize the program, while also naming changes they want the centers to make. The trade groups recommended changes including the expansion of the CMS program to cover breakthrough diagnostics, products authorized in the previous three years and medical devices that are nearing approval. Dive Insight In June, CMS released a draft version of the Transitional Coverage for Emerging Technologies (TCET) pathway for consultation. The path could fill a gap created by the repeal of the contentious Medicare Coverage for Innovative Medical Technologies plan and address industry calls to cut the gap between device approval and reimbursement. AdvaMed and MDMA submitted feedback on the new proposal to CMS ...
- Source: drugdu
- 394
- September 1, 2023

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