Search Results for “FDA” – Page 155 – media

To protect kids from tobacco, pediatricians say, focus should be on quitting – or never starting

Although smoking rates for adults in the US are at their lowest recorded levels, more must be done to stop children from using tobacco, according to a new set of policy statements from the American Academy of Pediatrics. The statements, published Monday, are the association’s first tobacco policy update since 2015. They’re based on newer science and better reflect how many children now use e-cigarettes as more kid-friendly products have flooded the market. AAP policy statements are created by expert pediatricians to help leaders craft more effective public health policy and to guide physicians on how to keep kids safe – in this case, from tobacco. High rates of tobacco use Researchers have been telling Americans for generations that tobacco products are bad for them, yet nearly 200 US children take up smoking every day, according to the US Centers for Disease Control and Prevention. Tobacco ...
- Source: drugdu
- 120
- April 17, 2023
Spherix

U.S. neurologists are “cautiously optimistic” about using Eisai’s Leqembi in Alzheimer’s disease as concerns about safety and the need for the FDA’s full green light for the drug remain high barriers to uptake. That’s according to a new survey and report out by drug launch analyst Spherix Global Insights, which in March asked 73 neurologists working in the U.S. about their use and receptivity of Leqembi, which was partially approved by the FDA at the start of the year. Now launched, the drug finds itself at a strange junction. It still does not have a full FDA approval; that isn’t set to come until early July. While there is another new drug on the market for Alzheimer’s—namely Aduhelm, which Eisai helped create with Biogen—that drug is commercially dead in the water. The Centers for Medicare & Medicaid Services (CMS) refused to cover payments of Aduhelm, which was ...
- Source: drugdu
- 128
- April 14, 2023
Appeals court rules abortion drug can stay on market — but limits access

A three-judge panel decided mifepristone’s FDA approval shouldn’t be revoked, but its decision could still make the drug much harder to obtain. An appellate court has blocked a ruling that would have suspended the approval of a decades-old abortion pill, but decided the medicine should only stay on the market with strict limitations. The 2-1 decision from the U.S. Court of Appeals for the 5th Circuit upholds the Food and Drug Administration’s 2000 approval of mifepristone, a medicine used in more than half of all U.S. abortions and to treat miscarriages. But the panel also unwound long-running efforts by the regulator to expand access to mifepristone in recent years. Since 2016, the FDA has enabled the drug to be used through ten weeks of gestation, instead of seven. The agency has also allowed the medication to be delivered by mail and prescribed through a teleheath visit, rather than ...
- Source: drugdu
- 189
- April 14, 2023
A Future Without Screening Colonoscopies?

Kerry Dooley Young April 05, 2023 US regulators may soon clear blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening. Most recently, Guardant Health, Inc, announced the completion of its US premarket approval application for its Shield blood test to screen for CRC. Approval by the US Food and Drug Administration (FDA) would position Guardant to later secure Medicare coverage for its test. Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC. If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years. “They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, ...
- Source: drugdu
- 114
- April 12, 2023
US health officials aim to ‘transform’ Alzheimer’s disease research with $300 million data platform

The US National Institute on Aging is moving forward with efforts to build a real-world Alzheimer’s disease database as part of its aim to improve, support and conduct more dementia research. Last month, the agency, part of the National Institutes of Health, posted a notice of the grant for the six-year database project, setting its earliest start date as April 2024. The NIH confirmed Tuesday that plans are underway to fund the Alzheimer’s disease and Alzheimer’s disease-related dementias’ real-world data platform. The National Institute on Aging intends to commit $50 million per year, starting in fiscal year 2024, to fund one award. The nonprofit Alzheimer’s Association is among those planning to apply for the grant. “The newly-announced NIA funding for a large-scale Alzheimer’s disease research database is truly exciting and a very important step forward for our field, and the Alzheimer’s Association will apply for ...
- Source: drugdu
- 141
- April 12, 2023
GSK will have to pay additional royalties to AstraZeneca on cancer drug Zejula

[GSK already has concerns with cancer drug Zejula, which is under scrutiny as a member of the PARP inhibitor class. Not the company has taken a loss in court as it will have to surrender added royalties to AstraZeneca for the drug which rolled up sales of 463 pound sterling ($571 million) last year. (GSK)] When Emma Walmsley took over as CEO at GSK in 2017, one of her first moves was to beef up the company’s oncology portfolio with a $5.1 billion acquisition of cancer specialist Tesaro and its newly approved drug Zejula. The ovarian cancer treatment generated 463 pound sterling ($571 million) in 2022, representing a 17% increase from the previous year. So far, so good, right? Well, not exactly. After losing a patent case in court on Wednesday, GSK will have to surrender a portion of its sales of Zejula to Tesaro’s partner on ...
- Source: drugdu
- 151
- April 6, 2023
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
- 258
- 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
- 267
- 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
- 127
- 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
- 143
- March 23, 2023

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