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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
Seniors With Few Years Left Often Advised to Get Colonoscopy

Most of the time, when a polyp is found during an older adult’s colonoscopy, it is unlikely that a concerning polyp or colon cancer will be found during a future surveillance scan. Yet most patients are advised to repeat the colonoscopy even if they aren’t expected to live very long, a new study has found. “Given the lack of clear guidance about when to stop colonoscopy in older patients, I am not surprised that physicians recommend surveillance even in patients with low life expectancy,” said Ziad Gellad, MD, MPH, with Duke University Medical Center in Durham, NC, who was not involved in the research. “These are nuanced decisions that require shared decision making. It’s not easy to tell patients that they are too old to get preventive care, especially patients in whom your only interaction is the procedure itself,” Gellad said. Current guidelines recommend doctors and patients ...
- Source: drugdu
- 143
- March 23, 2023
US. Faces Severe Shortage of Some Drugs, Senate Report Says

The United States faces a rising medication shortage that’s so severe it’s causing a national security risk, according to a Senate report released Wednesday. Drugs in short supply recently include children’s medication, antibiotics and ADHD treatments, says the report by the U.S. Senate Committee on Homeland Security and Governmental Affairs. It says new drug shortages rose by almost 30% from 2021 to 2022. “Shortages continue to have devastating consequences for patients and health care providers, including medication errors and treatment delays, and in some cases, have led to doctors having to ration lifesaving treatments,” the report said. Committee Chairman Gary Peters, D-Mich., said Wednesday the shortages peaked at 295 drugs at the end of last year and “have left health care professionals grappling with limited resources to treat patients in need,” NBC News reported. The Hill noted, “The report also said the average drug shortage ...
- Source: drugdu
- 131
- March 23, 2023
US government announces plan to overhaul organ transplant system

The US government announced a plan Wednesday to overhaul the country’s organ transplant system. The US Department of Health and Human Services’ Health Resources and Services Administration said it will focus on accountability and transparency by seeking more contracts to operate the Organ Procurement and Transplantation Network and sharing data more transparently. The system has only ever been managed by the nonprofit United Network for Organ Sharing, which has been recently criticized for its handling of organs, long waitlists for transplants and the number of deaths among people waiting: about 6,000 per year. There are currently more than 100,000 people in the United States waiting for an organ transplant. In a statement, HRSA Administrator Carole Johnson said that oversight of organ transplants is a “top priority.” “That is why we are taking action to both bring greater transparency to the system and to reform and modernize ...
- Source: drugdu
- 139
- March 23, 2023
MHRA to introduce new UK clinical trials framework

The changes will aim to make it easier to gain approval and to run clinical trials in the UK The Medicines and Healthcare products Regulatory Agency (MHRA) has said it will be introducing a series of measures aimed at streamlining clinical trials approvals in the UK. The changes, which represent the biggest overhaul in UK clinical trials regulation in over 20 years, include a legislative requirement to publicly register clinical trials and share summary results with research participants, as well as guidance to help researchers recruit a diverse cohort of participants. A timeline for completion of an application review within a maximum of 30 days will also be implemented by the MHRA, with a maximum of ten days for a decision to be granted once the regulator has received any final information. Marc Bailey, MHRA chief science and innovation officer, said: “Our world-first COVID-19 approvals showed how ...
- Source: drugdu
- 129
- March 23, 2023
FDA Grants Breakthrough Therapy Designation to Pfizer’s Investigational Alzheimer’s Disease Treatment

Pfizer, a global pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational treatment for Alzheimer’s disease, called PF-05217917. This designation is intended to accelerate the development and review of promising drugs that have the potential to address serious or life-threatening conditions. Alzheimer’s disease is a progressive brain disorder that affects millions of people worldwide, causing memory loss and other cognitive impairments. There are currently no approved treatments that can slow or stop the progression of the disease. Pfizer’s PF-05217917 is an antibody that targets the tau protein, which is believed to play a key role in the development and progression of Alzheimer’s disease. The FDA’s decision to grant Breakthrough Therapy designation to PF-05217917 was based on the results of a Phase 2 clinical trial that involved patients with mild to moderate Alzheimer’s disease. The trial showed that ...
- Source: drugdu
- 252
- March 22, 2023
FDA Approves New Drug to Treat Migraine

The U.S. Food and Drug Administration (FDA) has approved a new drug, called Rizaport, for the treatment of acute migraine in adults. Rizaport is a fast-dissolving oral tablet that contains the active ingredient rizatriptan, which belongs to a class of drugs called triptans. Migraine is a neurological condition that affects approximately 39 million people in the United States. It is characterized by recurrent episodes of moderate to severe headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. Triptans are a commonly used class of drugs for the treatment of acute migraine, but they are not effective for all patients and may cause side effects such as dizziness and fatigue. Rizaport, developed by Intec Pharma, offers a new option for the treatment of acute migraine. It is designed to dissolve rapidly on the tongue, allowing for faster onset of action compared to traditional tablet formulations. In ...
- Source: drugdu
- 130
- March 22, 2023
Novartis Receives FDA Approval for New Heart Failure Drug

Novartis, a global pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for its new heart failure drug, called Entresto XR. This approval expands the use of the company’s existing heart failure drug, Entresto, by making it available in an extended-release form. Heart failure is a chronic condition in which the heart is unable to pump enough blood to meet the body’s needs. It affects millions of people worldwide and is a leading cause of hospitalization and death. Entresto XR is a once-daily tablet that combines two medications, sacubitril and valsartan, to reduce the strain on the heart and improve its ability to pump blood. The FDA’s approval of Entresto XR was based on the results of a clinical trial that involved over 5,000 patients with heart failure. The trial showed that Entresto XR was superior to the standard of care, enalapril, in ...
- Source: drugdu
- 252
- March 22, 2023
FDA Approves New Treatment for Rare Genetic Disorder

The U.S. Food and Drug Administration (FDA) has recently approved a new treatment for a rare genetic disorder called hereditary angioedema (HAE). The treatment, called Berinert, is manufactured by CSL Behring and is the first and only therapy approved for the treatment of acute attacks of HAE in pediatric patients. HAE is a rare genetic disorder that affects about 1 in 10,000 to 1 in 50,000 people worldwide. It is characterized by recurrent episodes of swelling, or edema, in various parts of the body including the hands, feet, face, and airways. These attacks can be severe and potentially life-threatening, especially when the swelling occurs in the airways, which can lead to difficulty breathing and asphyxiation. Berinert is a human plasma-derived C1 esterase inhibitor (C1-INH) that works by replacing the deficient or malfunctioning C1-INH protein in patients with HAE. The treatment is administered through intravenous infusion and can ...
- Source: drugdu
- 123
- March 22, 2023

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