Search Results for “FDA” – Page 159 – media

Direct Acting Antiviral Drugs For The Treatment Of Hepatitis C

This is fourth installment in my series on progress toward the elimination of Hepatitis C infection and disease. Read more about Hepatitis C in part one, part two and part three. Figure 1. The direct-acting antiviral targets in the hepatitis C virus replication cycle. NS3/4A … [+] In the previous articles of this series, I’ve outlined the seriousness and uncontrolled nature of hepatitis C. In the absence of a vaccine, the control and treatment of hepatitis C, much like that of HIV/AIDS, depends on the use of antiviral medications. Recent progress in the development of several highly active, anti-hepatitis C drugs has been a triumph of modern medicine. These drugs usher in an era of effective treatment and even elimination of hepatitis C both nationally and globally. Later in this series I will describe how these drugs have been used to eliminate hepatitis C from some countries and discuss how that success may be ...
- Source: drugdu
- 264
- April 4, 2023
In $2.6B cell and gene therapy expansion, Sartorius buys viral vector specialist Polyplus

[Before the Sartorius buyout, Polyplus had itself been expanding through multiple acquisitions. (Sartorius)] As the biopharma industry struggles with a dire shortage of viral vectors to make cell and gene therapies, contract manufacturers are busy beefing up their capabilities. In the latest example of biopharma’s ongoing investment in cell and gene therapy production, Sartorius has agreed to acquire French company Polyplus for 2.4 billion euros ($2.6 billion), the German CDMO said Friday. The deal gives Sartorius additional know-how in nucleic acid delivery, including transfection reagents and plasmid DNA design, all of which are key elements in the production of viral vectors for building cell and gene therapies. Formed in 2001, Polyplus employs about 270 people in several locations in France, Belgium, the U.S. and China. Before the Sartorius buyout, Polyplus had itself been expanding through M&A deals. In 2021, Polyplus bought Asia-Pacific-focused reagent supplier Biowire. ...
- Source: drugdu
- 273
- April 4, 2023
Frozen Strawberries Recalled As Hepatitis A Outbreak Has Left 2 Hospitalized

This news isn’t “berry” good if you like strawberries. A hepatitis A outbreak has resulted in at least five people infected and two people hospitalized, according to the Centers for Disease Control and Prevention (CDC). This, in turn, has left those selling certain brands of frozen organic strawberries in a bit of a jam. The U.S. Food and Drug Administration (FDA) has indicated that the likely culprits behind this outbreak are soft, juicy, and red. We’re talking about strawberries—not all strawberries, but those specifically imported in 2022 by a supplier from particular farms located in Baja California, Mexico. That’s led to two companies that used these strawberries in their frozen products and one retailer to issue voluntary recalls. One of these companies is California Splendor, Inc., based in San Diego, California. They’ve recalled certain lots of their Kirkland Signature 4-lb. bag Frozen Organic Whole Strawberries that have been sold in Costco stores in Los Angeles ...
- Source: drugdu
- 131
- April 3, 2023
2 Manufacturers Recall Eyedrops Over Safety Concerns

Two manufacturers of eyedrops have recalled products over fears about contamination and sterility. The FDA issued recall notices last week for eyedrops made by Pharmedica and Apotex after the companies said they were voluntarily recalling the products. “Use of contaminated eye drops can result in the risk of eye infections that could result in blindness,” Pharmedica said about some of its Purely Soothing 15% MSM Drops. The company urged consumers to stop using the drops and return them to the point of purchase. They are sold over the counter to treat eye irritation. The recall affects about 3,000 bottles of product made in Arizona. The FDA said there have been no reports of injury. Apotex is recalling some of its glaucoma drops distributed as Brimonidine Tartrate Ophthalmic Solution, 0.15% and sold from last April through February. The company said it found cracks in a few ...
- Source: drugdu
- 150
- March 23, 2023
Frozen Strawberries Recalled Due to Hepatitis A Outbreak

A nationwide recall of organic frozen strawberry products is underway. The FDA is advising people who ate the products to get vaccinated against hepatitis A to prevent liver infection and symptoms like nausea and jaundice. The recalled products were sold at major retailers including Trader Joe’s, Costco, and ALDI, plus other regional retailers and suppliers. Five cases of hepatitis A in Washington state are linked to eating frozen strawberries, the FDA has warned. Two of the people were hospitalized. The illnesses started between Nov. 24, 2022, and Dec. 27, 2022, according to the CDC. The five people who were sickened all reported eating frozen strawberries and ranged in age from 38 to 61 years old. “Traceback and epidemiological investigations show that people with outbreak-associated cases in Washington purchased the same retail brand of frozen organic strawberries prior to becoming ill,” the CDC investigation report stated. The ...
- Source: drugdu
- 105
- March 23, 2023
Roche teams up with Lilly to validate Alzheimer’s blood test

March 22 (Reuters) – Roche (ROG.S) and Eli Lilly and Co (LLY.N) are joining forces to develop a blood test for Alzheimer’s disease, and plan to kick off a two-year clinical trial involving hundreds of volunteers with the aim of winning U.S. regulatory approval. The effort, unveiled in a statement on Wednesday, comes as Lilly as well as Eisai (4523.T) and Biogen (BIIB.O) are gearing up to sell drugs aimed at slowing the advance of the mind-robbing illness, but their use will require a diagnosis at earlier disease stages than is the norm today. Roche Holding AG would recruit several hundred volunteers with early signs of dementia over the next 18 to 24 months with trial data potentially ready for a U.S. regulatory filing in 2025, Bruce Jordan, leader of Personalized Healthcare Solutions at Roche Diagnostics, told Reuters. The U.S. Food and Drug Administration has asked Roche to recruit a significant number of patients at primary care facilities ...
- Source: drugdu
- 144
- March 22, 2023
Fate of 1,000 trafficked lab monkeys at center of US investigation in limbo

‘Long-tailed macaques at risk of being killed, or laundered or re-trafficked if returned to Cambodia, animal welfare groups say’ More than a thousand Cambodian monkeys at the center of a US government investigation into wildlife trafficking are at risk of being killed or returned to their country of origin, laundered and re-trafficked, animal welfare groups say. The monkeys’ plight first came to light last year when the US Fish and Wildlife Service (FWS) asked the animal rights organization Peta about finding a sanctuary for 360 monkeys. Born Free USA, and the US Department of Justice (DoJ) later joined the discussions and the number of monkeys increased to over 1,000 as talks progressed. Last week, however, discussions stalled when Peta learned on 13 March that the monkeys would instead be flown out of the US. Under US law the monkeys can only return to their country of origin, Cambodia, said Dr Lisa Jones-Engel of Peta, ...
- Source: drugdu
- 177
- March 21, 2023
The high price of Ozempic is pushing many to unregulated, copycat drugs for weight loss

Some compounding pharmacies are offering what they say are generic versions of the drugs, which have soared in popularity for weight loss. When Robin Langois, 58, was prescribed the weight-loss drug Wegovy last year, she couldn’t afford the high price tag after her insurance wouldn’t cover it. But she later discovered on TikTok that people could get their hands on what appeared to be the drug’s active ingredient, semaglutide, from compounding pharmacies for a fraction of the price. Langois, of Tucson, Arizona, said she was initially hesitant, because of safety concerns, but she eventually found a telehealth provider to write her a prescription. “I’m not 100% sure it’s what I’m getting,” Langois said. She noted, however, that she’s experienced feelings of fullness and weight loss, as well as nausea, a common side effect of the drug. “It’s working like it should,” she said. Either due to cost or ongoing shortages, ...
- Source: drugdu
- 168
- March 20, 2023
NICE questions value and efficacy of five Covid-19 drugs with rejection

This week, NICE rejected five major Covid-19 therapies due to high costs and uncertainties in clinical evidence. The UK’s National Institute for Health and Care Excellence (NICE) has published a draft guidance that does not recommend the use of five major Covid-19 therapies. This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK. The therapies with a negative appraisal included three anti-Covid-19 antibodies; Regeneron Pharmaceuticals’ Ronapreve (casirivimab +imdevimab), GSK’s Xevudy (sotrovimab) and, AstraZeneca’s Evusheld (tixagevimab + cilgavimab). Between November 5 and November 12, a total of 20,588 people have reported testing positive for Covid-19 in England, according to government data. This number is likely an underestimation given the lack of testing amongst the population. Furthermore, in that same period, 3,407 patients were admitted to a hospital in the country for severe cases of Covid-19. ...
- Source: drugdu
- 152
- March 17, 2023
Websites and Tools You Need to Know!

The pharmaceutical foreign trade industry is fiercely competitive, demanding a constant grasp of the latest market information and tech tools to successfully expand business. Today, we're showcasing must-have websites and practical tools for pharmaceutical foreign trade professionals, empowering you to operate more efficiently.
- Source: drugdu
- 237
- March 3, 2023
pharmaceutical foreign trade practical tools

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