Reuters Health News Summary
The companies are seeking the Food and Drug Administration's (FDA) approval of a weekly dose of Leqembi to be given as an under-the-skin injection. WHO clears Takeda's dengue vaccine The World Health Organization (WHO) said on Wednesday that it had cleared Takeda Pharmaceuticals' dengue vaccine, giving international procurement agencies another option against the disease that affects millions of people each year.
![Reuters Health News Summary](https://devdiscourse.blob.core.windows.net/imagegallery/27_06_2019_18_22_44_8556925.png)
Following is a summary of current health news briefs.
No shortage of Wegovy weight-loss drug in Denmark, Novo Nordisk says
Novo Nordisk does not expect a shortage of its Wegovy weight-loss drug in Denmark despite an earlier warning by the Danish Medicines Agency of strained supply of two separate doses in the coming weeks, the company said. The Danish regulator on Monday issued two statements saying the country faced a shortage of the Wegovy Flextouch 1 mg injection pen from late May to mid-June and the 0.5 mg Wegovy Flextouch injection pen between mid-June and mid-July.
Exclusive-Musk's Neuralink has faced issues with its tiny wires for years, sources say
Neuralink's disclosure last week that tiny wires inside the brain of its first patient had pulled out of position is an issue the Elon Musk company has known about for years, according to five people familiar with the matter. The company knew from animal testing it had conducted ahead of its U.S. approval last year that the wires might retract, removing with them the sensitive electrodes that decode brain signals, three of the sources said. Neuralink deemed the risk low enough for a redesign not to be merited, the sources added.
US relaxes regulations for labs handling bird flu samples to ease virus response
U.S. government officials have temporarily relaxed strict guidelines on how public health laboratories and healthcare facilities handle, store and transport H5N1 bird flu samples, which are considered high-risk pathogens, in response to the recent spread of the virus to dairy cattle. The revised guidance, which has not been previously reported, came at the request of the Association of Public Health Laboratories (APHL), which represents state and local labs that monitor and detect public health threats, according to interviews and correspondence seen by Reuters.
Novo Nordisk owner buys majority stake in Austrian life science tools company
Novo Holdings, the controlling shareholder of Danish obesity drugmaker Novo Nordisk, said on Wednesday it would buy a controlling stake of about 60% in Single Use Support, an Austria-based life science tools company. It declined to give a precise value for the deal but a spokesperson said it would be a "high triple-digit million euros" amount.
Merck KGaA's Q1 adjusted profit declines less than feared
Merck KGaA on Wednesday reported better-than-expected adjusted earnings, helped by strong demand for its pharmaceuticals and amid currency-adjusted sales growth in semiconductor materials. The German diversified group reported 8.4% lower first-quarter earnings before interest, taxes, depreciation and amortisation (EBITDA), adjusted for one-offs, at 1.45 billion euros ($1.57 billion).
Getinge limits sale of heart devices in the US after FDA warning
Sweden's Getinge will limit sales of some of its heart products in the U.S., the medical equipment maker said late on Tuesday, after recent advice from the U.S. Food and Drug Administration (FDA) to move away from its devices. "We have decided to immediately pause promotional activities of the Cardiohelp System and Cardiosave Intra-Aortic Balloon Pump in the U.S. until outstanding actions related to quality improvements have been addressed and approved," said CEO Mattias Perjos in a statement.
Eisai starts rolling submission for injectable version of Alzheimer's drug with US FDA
Eisai and partner Biogen said on Tuesday that the Japanese drugmaker has begun submitting data on a rolling basis to the US health regulator for a marketing application of a subcutaneous form of their Alzheimer's disease drug Leqembi. The companies are seeking the Food and Drug Administration's (FDA) approval of a weekly dose of Leqembi to be given as an under-the-skin injection.
WHO clears Takeda's dengue vaccine
The World Health Organization (WHO) said on Wednesday that it had cleared Takeda Pharmaceuticals' dengue vaccine, giving international procurement agencies another option against the disease that affects millions of people each year. The approval, called a prequalification, comes amidst a surge in mosquito-borne viral infections across Asia, Africa, and the Americas, including new spread into previously unaffected areas.
CDC makes public influenza A wastewater data to assist bird flu probe
The U.S. Centers for Disease Control and Prevention (CDC) on Tuesday released data on influenza A found in wastewater in a public dashboard that could assist in tracking the outbreak of H5N1 bird flu that has infected cattle herds. Last week, an agency official told Reuters about U.S plans to make public data collected by its surveillance system.
Roche says FDA approves HPV self-test in US
Swiss drugmaker Roche on Wednesday said the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV) self-testing kit. Screening for HPV can help identify women who are at risk of developing cervical cancer at an earlier stage.
(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)
- READ MORE ON:
- Exclusive-Musk's Neuralink
- Denmark
- Austrian
- Americas
- Sweden
- H5N1
- US FDA
- Swiss
- Leqembi
- Biogen
- the Association of Public Health Laboratories
- U.S.
- Single Use Support
- the U.S. Food and Drug Administration
- Wegovy Flextouch
- Mattias Perjos
- Getinge
- Eisai
- Novo Holdings
- The U.S. Centers for Disease Control and Prevention
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