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A newly approved drug intended to slow the progression of Alzheimer’s disease offers patients hope, but it will come with a steep price tag: $26,500 a year. That drug initially cost $56,000 per year before Biogen slashed the price in half, to $28,000 annually. Dr. David Rind, the institute's chief medical officer, said an appropriate cost for the drug is $8,500 to $20,600 a year. John Domeck, 60, of Aurora, Ohio is currently enrolled in a phase 3 clinical trial testing Leqembi. But right now, the clinical trial for Leqembi shows that the drug provides "modest efficacy at a big, big price," Caplan said.

The Food and Drug Administration on Friday approved an Alzheimer’s drug shown in clinical trials to slow cognitive decline in patients in the early stages of the illness. The FDA approved Leqembi for use in people with mild cognitive impairment or early Alzheimer’s disease. Most drugs approved by the FDA for Alzheimer’s are aimed at helping symptoms, not actually slowing the progression of the disease. Friday's announcement comes on the heels of a scathing congressional report released last week detailing the approval of a different Alzheimer’s drug, called Aduhelm. The Alzheimer's Association has said that based on the Eisai and Biogen phase 3 clinical trial results, the FDA should approve Leqembi for early-stage Alzheimer’s.

More young children are getting sick from inadvertently eating marijuana edibles, according to a study published Tuesday in the journal Pediatrics. Eating too much can lead to serious health problems in young children, including confusion, hallucinations, fast heart rate and vomiting, experts said. Nearly a quarter of the children were admitted to the hospital, 8.1% of whom who needed intensive care, the study found. Wang called for regulation of how marijuana manufacturers can advertise their products, including regulations that ensure the advertising doesn't appeal to children. Osterhoudt went a step further: "The safest thing for a parent of young children to do would be not to bring edible THC products into their homes."

Covid hospitalizations are rising in the United States, even as hospitalizations for respiratory syncytial virus and the flu continue to fall. For the week ending Dec. 24, around 18,800 people were hospitalized with flu, down from around 20,700 hospitalizations the week prior. RSV hospitalization rates have fallen significantly since their peak in mid-November of 5.1 hospitalizations per 100,000 people. The seven-day average of daily Covid hospitalizations reached 42,140 on Friday, an increase of 4.2% from two weeks ago, according to an NBC News tally. The CDC recommends up-to-date Covid vaccines for everyone ages 6 months and older, as well as annual flu shots.

How much does insulin cost? People with Type 1 diabetes need, on average, one to three vials of insulin per month, according to the American Diabetes Association. Patients with Type 2 diabetes don't always need to take insulin, but those who do can sometimes require more than people with Type 1 diabetes. Even people with what's considered good health insurance coverage can face steep costs in certain situations. In addition to insulin and insurance premiums, Gibson also must spend $550 every three months for glucose monitors and $1,100 for insulin pumps.

More adults in the U.S. expect to be more stressed in 2023 than at this time last year, but they also say they're more willing to take steps to tackle that stress, a survey released Wednesday finds. And about 37% of adults (nearly 2 out of 5) rated their mental health as “fair or poor” this month, up from 31% a year ago. Young adults, low-income adults and parents were most likely to rank their mental health as fair or poor. At the same time, more adults say they plan to take steps to improve their mental health next year, such as journaling or going to therapy, the survey found. McKernan said other ways people can take care of their mental health include paying attention to signs of stress.

The Mark Cuban Cost Plus Drug Company negotiates directly with drugmakers. So far, that's been the strategy for the Mark Cuban Cost Plus Drug Company. In October, Cost Plus Drug Company announced a partnership with Capital Blue Cross. Cuban said he wanted Cost Plus Drug Company to be as transparent as possible on pricing. Cost Plus Drug Company is considering a test program for insulin that would offer a 90-day supply of insulin, or a total of 12 vials, for $170.

☆ POTS, a debilitating heart condition, is linked to Covid and, to a lesser degree, vaccines
▼ + stars: | 2022-12-12 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +4 min

Research published Monday has confirmed a link between a Covid infection and a debilitating heart condition called POTS, or postural orthostatic tachycardia syndrome, that has been diagnosed in some patients with long Covid. POTS was also linked, to a lesser degree, to Covid vaccination with an mRNA vaccine, according to the new study. He also said that the link between POTS and Covid vaccination needs to be confirmed with further studies. Other vaccines have also been linked to POTS in early accounts, but further research did not establish a causal link. The link between an infection — including Covid — and POTS, however, is more well-established.

☆ Myocarditis after Covid vaccine low among teens and young adults, large study finds
▼ + stars: | 2022-12-05 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +4 min

The incidence of myocarditis and pericarditis after Covid vaccination is low and most patients make a full recovery, a large international study from Nationwide Children’s Hospital found. The findings confirm earlier studies that found myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the outer lining of the heart, following Covid vaccination are rare. The review included more than 800 teens and young adults who developed myocarditis and pericarditis following Covid vaccination. The heart-related conditions usually occurred within four days after the second dose of a Covid vaccine, the study found. Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins University, said he would still like to see estimates of myocarditis risk by age, gender, vaccine type and spacing between doses.

People who got the updated booster shots after two or more shots of the original vaccine were compared to another group of people who received only two or more doses of the original vaccine. The updated booster shots performed better in preventing infections in all adult age groups, with higher vaccine efficacy seen in people who waited longer before getting the updated booster, the CDC found. He noted that studies have shown longer intervals between Covid vaccine doses can lead to higher antibody levels. Previous Covid infections may be underreported, the agency said, and low uptake of the updated boosters could have affected the results. New subvariants BQ.1.1 and BQ.1 are on the rise in the U.S., she said, and it’s unclear how the updated boosters will perform against those strains.

The Food and Drug Administration on Thursday approved the first drug to delay the onset of Type 1 diabetes. It’s been approved for people ages 8 and older who have early signs of Type 1 diabetes. Nearly 2 million people in the United States have Type 1 diabetes, according to the American Diabetes Association. People with Type 1 diabetes usually need multiple injections of insulin every day for the rest of their lives, often a great financial burden. The most common side effects of the medication include decreased levels of certain white blood cells, rash and headache, according to the FDA.

The Food and Drug Administration is pushing for drugmakers to apply for over-the-counter approval for naloxone, the opioid overdose antidote. Naloxone is only offered as a prescription, though many states have found work-arounds to make the drug easier to get. By making the medication available over the counter, it removes stigma, said Dr. Scott Hadland, an addiction specialist at Mass General for Children in Boston. Nearly 20,000 deaths from overdose, between 1999 and 2020, have been prevented by the self-administering of naloxone, according to the FDA. The FDA noted that over-the-counter naloxone will not divert supplies away from community-based naloxone distribution programs and hospitals.

Poison control centers in the U.S. have seen an increase in reports of children ingesting a type of prescription cough medicine, a study published Tuesday by the Food and Drug Administration found. From 2010 through 2018, reports of pediatric poisonings involving the drug, benzonatate, increased each year, the study found. The reports included children who were unintentionally exposed to the drug, as well as children who abused or misused it intentionally. As non-narcotic drugs become more common in homes, "the likelihood of errors is going to increase," Creech said. Still, the study reminds doctors to provide good counsel about when and how to use the medication, Creech said.

Moderna’s updated Covid booster appears to increase the immune response to omicron subvariants BA.4 and BA.5, as well as another subvariant, called BQ.1.1, that's gaining ground in the United States, the company said in a release Monday. The results are based on blood samples taken from 511 adults who got the updated booster, which targets BA.4 and BA.5, along with the original coronavirus strain, in a single shot. In people who got the updated booster, neutralizing antibodies against BA.4 and BA.5 were about fivefold higher in those with a previous Covid infection and sixfold higher in those without a documented infection, the company said. Moderna also said an additional analysis of 40 people found the updated booster demonstrated “robust neutralizing activity” against the subvariant BQ.1.1, though the response wasn’t as strong as what was seen against BA.4 and BA.5. Earlier this month, Pfizer and BioNTech said their updated booster shot generated a stronger immune response against BA.4 and BA.5 compared with their original Covid vaccine.

In October 2021, Da’Vion Miller was found unconscious in the bathroom of his home in Detroit a week after receiving his first dose of Pfizer's Covid vaccine. Courtesy Da’Vion MillerMiller is one of a very small group of people in the United States who have experienced myocarditis following vaccination with the Pfizer-BioNTech or the Moderna Covid vaccines based on mRNA technology. Video: CDC says waiting longer between Covid vaccine doses could reduce myocarditis risk. Cooper joined an expert advisory panel formed by Moderna to monitor its Covid vaccine safety. The Pfizer study will include people who were previously hospitalized with vaccine-associated myocarditis, and it will also follow those who were more recently diagnosed.

☆ California expected to partner with nonprofit Civica Rx to produce its own low-cost insulin, sources say
▼ + stars: | 2022-11-11 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +3 min

California plans to partner with Civica Rx, a nonprofit generic drug company, in the state's effort to produce its own low-cost insulin, according to two people familiar with the matter. Gavin Newsom announced in July that he had approved a budget that would allocate $100 million to allow the state to begin making its own insulin. It'll be the first state to produce insulin for its residents, which experts see as a road map for other states to make the lifesaving medication more affordable. California expects to announce the partnership in mid-December, although it hasn't been finalized and the state could select a different company, the sources said. A Civica Rx spokesperson didn't confirm the plan but said the company welcomes "the opportunity to partner with California."

Pfizer-BioNTech's updated booster shot generates a stronger immune response against the omicron subvariants BA.4 and BA.5 compared with the original Covid vaccine, the companies said in a release Friday. Pfizer's original vaccine formula, which was first administered to older adults in December 2020, was designed to target the original coronavirus strain. The updated booster shot is designed to target the original virus strain, as well as BA.4 and BA.5, in a single shot. Two independent studies posted online late last month suggested that the updated shots do not offer better protection against the new omicron subvariants than the original vaccines do. The new findings may hint that the updated booster is better than the original vaccine, but not by much, said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College.

☆ RSV vaccine for kids: Pfizer shot for pregnant women protects infants from severe illness
▼ + stars: | 2022-11-01 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +5 min

An experimental RSV vaccine for pregnant women from Pfizer is effective at protecting newborns against severe illness for at least six months, the company said in a press release Tuesday. The vaccine was also about 70% effective against severe infections through the first six months of life. Pfizer said in a statement that it is currently not conducting an RSV vaccine trial in infants. Pfizer's RSV vaccine could be "a major step forward so that we can attack this last really bad communicable disease of the neonatal period," Schaffner said. Aside from pregnant women, Pfizer is testing its vaccine in older adults, who are also at risk for severe RSV infections.

That there is no RSV vaccine for kids is not for lack of interest, experts say. But a trial gone wrong many years ago and a tricky target protein have made developing an RSV vaccine difficult. Researchers’ attempts to develop an RSV vaccine go back decades, according to Dr. Ofer Levy, the director of the Precision Vaccines Program at Boston Children's Hospital. In August, Pfizer announced that its experimental RSV vaccine was nearly 86% effective in preventing severe illness in adults ages 60 and older. GSK, however, said it abandoned its efforts last year to develop a pediatric RSV vaccine, because trials suggested it wasn't effective.

Pediatric cases of the flu and RSV, or respiratory syncytial virus, are on the rise. Here are the signs and symptoms to look out for if your child has a respiratory virus. Does my child have RSV, Covid or the flu? Early symptoms of Covid, RSV and the flu can look similar for many children, including:CongestionCoughRunny noseMuscle achesFeverHeadacheA sore throat, Moffitt said, could be a sign of Covid, as doctors have noticed that infections with omicron subvariants often begin with sore throats. Hotez also urged parents to get their children vaccinated against Covid and the flu.

Pfizer plans to sell the Covid vaccine it developed with BioNTech at $110 to $130 per dose for teens and adults once the U.S. government stops paying for them, the drugmaker said Friday. Since the start of the pandemic, the government has provided Americans with free Covid tests, vaccines and treatment, through a combination of funding from Congress and other government programs. The government has already stopped providing free Covid tests. A CDC advisory committee voted Wednesday to add Covid vaccines to the Vaccines for Children program, a federal plan that provides free vaccines to children eligible for or covered by Medicaid. Pfizer said it also plans to provide free vaccines to people without insurance through its patient assistance program.

☆ FDA panel recommends revoking the approval of controversial drug for preterm births
▼ + stars: | 2022-10-19 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +4 min

The panel voted on three questions: whether the drug is effective, whether trial data support its approval and whether it should remain on the market. The trial found that the drug failed to reduce the risk of preterm births or produce better health outcomes for newborns. When a 2019 trial showed that the drug produced no benefits, the same FDA advisory panel voted to revoke the drug's approval. What's more, "retaining Makena’s approval likely hinders study of more promising treatments for preterm birth," FDA scientists wrote. It also proposed a partial withdrawal of the drug, making the drug only available to women at the highest risk of preterm birth.

The cost of insulin remains a barrier for many Americans with diabetes who depend on the drug, research published Monday suggests. It was the first time that the CDC had included questions about insulin use, though concerns about sky-high insulin prices have been reported for years. Meanwhile, those with public health coverage, such as Medicaid and Medicare, had the lowest rates of rationing. According to the American Diabetes Association, people with type 1 diabetes need, on average, two to three vials per month. He said the "most ambitious" proposal he would like to see in the U.S. is universal health coverage with no copays for consumers.

☆ Pfizer-BioNTech releases first human results on updated booster, citing an increase in antibodies
▼ + stars: | 2022-10-13 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +3 min

The results are based on blood samples taken from adults one week after they received the updated booster. The FDA also authorized Moderna's updated booster based on similarly limited data. The FDA authorized the updated shots based on studies in mice — plus human trial results from a similar booster that targets the original omicron strain, called BA.1. At the time, Dr. Peter Marks, the FDA's top vaccine regulator, said the agency hoped the updated vaccines will provide stronger protection against symptomatic disease than the older vaccines. Moderna didn't immediately respond to a request for comment about when it will release new data on its updated booster.

The Food and Drug Administration on Wednesday authorized updated Covid booster shots that target the omicron variant of the virus for young children. The decision will now go to the Centers for Disease Control and Prevention, which could issue its final recommendation on the updated shots within hours. Only about 31% of children ages 5 to 11 have received two doses of any Covid vaccine, according to CDC data. Experts say it's important for people to receive the updated shots because the nation could face yet another potential wave of Covid infections this winter. The boosters are important because data has shown that any Covid vaccine greatly decreases the risk of severe outcomes from the virus, said O’Leary.

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