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☆ CNN Exclusive: Adderall prescriptions have been filled less often amid ongoing shortage in the US
▼ + stars: | 2024-04-02 | by ( Deidre Mcphillips | ) edition.cnn.com time to read: +10 min

CNN —About 1 in every 10 people in the US who uses Adderall or similar combination drugs to treat attention-deficit/hyperactivity disorder (ADHD) has been affected by an ongoing shortage, a new analysis suggests. The US Food and Drug Administration announced that Adderall was in shortage in mid-October 2022, and the share of people with ADHD who filled their prescriptions for Adderall and related medications plunged in the following months. Patients were considered eligible for a monthly prescription fill if they had filled one within the previous two years. Prescriptions for medications used to treat ADHD surged during the Covid-19 pandemic, especially among young adults and women, one study found. But it’s been about a year and a half since she’s been able to fill her Adderall prescription in a “totally uneventful” way, she said.

Persons: Adderall, Robert Califf, Anne Milgram, David Goodman, ”, Mary Beth King, it’s, she’s, ” King, King, ” Goodman, John Mitchell, ” Mitchell, they’re, ’ ”, –, “, Dr, Sanjay Gupta, hasn’t Organizations: CNN, US Food and Drug Administration, Drug, of Psychiatry, Behavioral Sciences, Johns Hopkins School of Medicine, American Professional Society, New, Psychiatric Institute, Columbia University Irving Medical Center, Duke University School of Medicine, Get CNN, CNN Health Locations: Sweden

☆ Healthcare startups are rushing to sell AI to hospital systems. But a new survey suggests many simply aren't ready for it.
▼ + stars: | 2024-02-20 | by ( Rebecca Torrence | ) www.businessinsider.com time to read: +4 min

As healthcare startups dive headfirst into building artificial intelligence products to sell to hospitals, a new report suggests many health systems don't yet have policies to support the tech. In a survey of 34 US health systems leaders, only 16% reported having systemwide policies for AI usage and data access. Some health system leaders said they haven't developed policies because the industry is in the early stages of AI adoption. Many health system leaders surveyed by KLAS expressed excitement about AI software for clinical documentation. Seventy percent of health system leaders surveyed by KLAS said their organizations planned to adopt AI software integrated with their EHRs.

Persons: —, hasn't, Robert Califf, KLAS, we'll, Bryan Roberts Organizations: Business, Center, Medicine, UPMC, KLAS Research, Healthcare, Food and Drug Administration, FDA, Venture, University of Pittsburgh Medical Center, University of Kansas Health, Microsoft, Industry

Read previewThe Food and Drug Administration on Friday cleared the way for Florida's first-in-the-nation plan to import lower-priced prescription drugs from Canada, a long-sought approach to accessing cheaper medications that follows decades of frustration with U.S. drug prices. Ron DeSantis signed the plan into law in 2019, but it required federal review and approval by the FDA, which controls prescription drug imports. "These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs," FDA Commissioner Dr. Robert Califf said in a statement. Health officials there previously have suggested their country's prescription drug market is too small to have any real impact on U.S. prices. The U.S. has long had the highest prescription drug prices in the world, with essentially no government limits on what companies can charge.

Persons: —, Florida's, Ron DeSantis, Joe Biden, Donald Trump —, Robert Califf, DeSantis Organizations: Service, Drug Administration, Business, Republican Gov, FDA, Democratic, U.S, Trump, Health Locations: Canada, Mexico, U.S

☆ Why this landmark cardiac study means a bigger market for Lilly's blockbuster weight loss drug
▼ + stars: | 2023-08-09 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +7 min

A landmark study of the cardiovascular benefits of weight loss drug Wegovy is being seen as a pivotal step toward broadening access to these drugs. The drug, also known as tirzepatide, is expected to be approved for weight loss by the Food and Drug Administration by year-end. Notably, Medicare does reimburse obese patients for weight loss surgery, but Mounjaro has been able to help patients realize an average weight loss that approaches the typical success of bariatric procedures. If CMS is able to reimburse patients for weight loss treatment that would significantly increase access, boosting sales. "This is the first time a weight [loss] medicinal intervention has shown to have cardiovascular risk reduction.

Persons: enrollees, Eli Lilly, Lilly, Akash Tewari, NVO, Tewari, Wells, Mounjaro, Mohit Bansal, Robert Califf, Goldman Sachs, Chris Shibutani, Shibutani, Goldman, Refinitiv, Morgan Stanley, comorbidities, Bansal Organizations: Nordisk's Ozempic, Centers for Disease Control, Food and Drug Administration, Jefferies, Medicare, Services, GLP, STAT, Goldman, Lilly, Novo Nordisk, BMI, Novo Locations: U.S, GLP, Tuesday's

☆ Pfizer says no major tornado damage to drug manufacturing areas of North Carolina facility
▼ + stars: | 2023-07-21 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

In this aerial image, damage is seen to a Pfizer pharmaceutical factory after a tornado hit the facility two days earlier, on July 21, 2023 in Rocky Mount, North Carolina. Pfize r on Friday said there does not appear to be major damage to the drug manufacturing areas of its plant in Rocky Mount, North Carolina, after a tornado hit the facility two days earlier. The North Carolina plant is closed while Pfizer and both local and federal authorities further evaluate the damage. It's one of 10 Pfizer manufacturing sites in the country. Pfizer also noted that it is working closely with Food and Drug Administration Commissioner Robert Califf, North Carolina Gov.

Persons: it's, Robert Califf, Roy Cooper, Califf Organizations: Pfizer, Food and Drug, North Carolina Gov, FDA Locations: Rocky Mount, North Carolina, U.S, North

☆ FDA approves Opill, the first over-the-counter birth control pill
▼ + stars: | 2023-07-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

HRA Pharma expects a final decision by the FDA this summer on its application for nonprescription sales of Opill, which is generically called norgestrel. The Food and Drug Administration on Thursday approved the first over-the-counter birth control pill, a landmark decision that will allow more women and girls in the U.S. to prevent unintended pregnancies without a prescription. The daily pill, called Opill, was first approved by the FDA as a prescription in 1973. Medical organizations like the American College of Obstetricians and Gynecologists and women's health advocates have pushed for wider access. More than 50 members of Congress in March 2022 also called on FDA Commissioner Dr. Robert Califf to ensure the agency reviewed applications for over-the-counter birth control pills without delay.

Persons: Biden, Wade, –, Welgryn, Robert Califf, Patrizia Cavazzoni, Opill Organizations: HRA Pharma, FDA, Drug Administration, American College of Obstetricians, FDA's Center, Drug, Research Locations: U.S, Paris, Dublin

☆ FDA to review Schumer's concerns about YouTube stars' Prime Energy drink
▼ + stars: | 2023-07-12 | by ( Chelsey Cox | ) www.cnbc.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, August 29, 2020. WASHINGTON — The Food and Drug Administration will address concerns raised by Senate Majority Leader Chuck Schumer about a caffeinated energy drink popular among teens. An agency spokesperson said it "is reviewing the concerns" outlined in Schumer's letter to FDA Commissioner Dr. Robert Califf about the dangers of Prime Energy, a beverage founded by YouTube stars Logan Paul and KSI. Prime Energy is not intended for anyone under the age of 18, according to a company representative. Prime Energy boasts 200 mg of caffeine.

Persons: Chuck Schumer, Robert Califf, Logan Paul, KSI, Schumer, Paul, Annika Kim Constantino Organizations: Food and Drug Administration, FDA, WASHINGTON, Drug Administration, Energy, YouTube, Prime Energy, American Academy of Child, Psychiatry Locations: White Oak , Maryland

☆ Schumer urges FDA to probe Prime energy drink backed by YouTube stars Logan Paul and KSI
▼ + stars: | 2023-07-10 | by ( Chelsey Cox | ) www.cnbc.com time to read: +3 min

Logan Paul and KSI pose with Prime hydration bottles prior to a regular season game between the Arizona Diamondbacks and Los Angeles Dodgers on March 31, 2023, at Dodger Stadium in Los Angeles, CA. The brand offers a bottled hydration drink and a canned energy beverage, which is said is not intended for children. Several countries, including Australia, South Africa, the United Kingdom, Canada and New Zealand have already banned Prime Energy drinks or its caffeine-free version, Prime Hydration, in some schools. The company's lack of sufficient warnings about its caffeine content also invites scrutiny, he wrote. "This content and the claims made should be investigated, along with the ingredients and the caffeine content in the Prime energy drink."

Persons: Logan Paul, Brandon Sloter, Chuck Schumer, KSI, Schumer, Robert Califf, Red Bull, Califf Organizations: Arizona Diamondbacks, Los Angeles Dodgers, Dodger, Getty Images, WASHINGTON, Food and Drug Administration, YouTube, Futbol Club Barcelona, Energy, CNBC, Prime Energy Locations: Los Angeles , CA, Washington, Australia, South Africa, United Kingdom, Canada, New Zealand

☆ FDA Commissioner Califf defends need for IRA Price negotiation
▼ + stars: | 2023-06-23 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailFDA Commissioner Califf defends need for IRA Price negotiationFDA Commissioner Robert Califf says his department is working with Medicare to help develop criteria for the first drugs to be subjected to price negotiations under the Inflation Reduction Action Act. Speaking with CNBC's Bertha Coombs at Aspen Ideas Health, Califf says the process may need adjustments but defended the need to try to bring down drug prices.

Persons: Califf, Robert Califf, CNBC's Bertha Coombs Organizations: Medicare, Aspen Ideas Health

☆ FDA advisors recommend sale of birth control pill without a prescription
▼ + stars: | 2023-05-10 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

A panel of experts who advise the Food and Drug Administration unanimously recommended Wednesday that the agency for the first time allow women to obtain a birth control pill without a prescription. The panel had been asked whether the benefits of selling HRA Pharma's birth control pill Opill outweighed the risks of consumers improperly using the medication resulting in unintended pregnancy. Medical associations such as the American College of Obstetricians and Gynecologists for years have urged over-the-counter sales of birth control pills be allowedMore than 50 members of Congress in March 2022 called on FDA Commissioner Dr. Robert Califf to ensure the agency reviewed applications for over-the-counter birth control pills without delay. "Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system." Shrinking access to abortion across the U.S. in turn sparked renewed calls for expanded access to birth control to prevent unwanted pregnancies.

☆ FDA may allow birth control pill without prescription this summer as experts weigh data
▼ + stars: | 2023-05-09 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration could approve the sale of birth control medication without a prescription for the first time by this summer. The FDA approved prescription sales of HRA Pharma's birth control pill in 1973. Medical associations such as the American College of Obstetricians and Gynecologists for years have supported over-the-counter access to birth control without age restrictions. In March 2022, more than 50 members of Congress urged FDA Commissioner Dr. Robert Califf to review applications for over-the-counter sales of birth control without delay. "Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system."

☆ FDA commissioner praises Eli Lilly Alzheimer's treatment results
▼ + stars: | 2023-05-03 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

FDA Commissioner Dr. Robert Califf speaks at an event celebrating hearing aids being available over the counter at a Walgreens in Washington, D.C., Oct. 19, 2022. Food and Drug Commissioner Dr. Robert Califf praised results Eli Lilly announced Wednesday that a clinical trial showed its Alzheimer's treatment donanemab slowed progression of the disease. "We have to look at the data when it comes in before making a judgment, but if the data look as good as the press release — this is really, really exciting," the commissioner said. The antibody treatment also carries risks of brain swelling and bleeding that can be severe and even fatal in rare circumstances. Full-time civil servants who are prohibited from having financial conflicts of interest make those decisions, the commissioner said.

☆ A drug company abandoned a treatment for ‘bubble boy disease.’ After a 5-year fight, this little girl is about to get it
▼ + stars: | 2023-04-27 | by ( Elizabeth Cohen Lauren Mascarenhas | Elizabeth Cohen | Lauren Mascarenhas | ) edition.cnn.com time to read: +29 min

The Sulacks weighed their options: Have a transplant with a match that was less than ideal – far less – or wait for gene therapy to become available. The news release didn’t say anything else about the SCID gene therapy. Or was the company abandoning its plans for SCID gene therapy altogether? In February, 2021, the parents of more than 20 children who were waiting for the gene therapy treatment, including the Sulacks, wrote a letter to Gaspar. Insurance companies have sometimes balked at paying for gene therapy, which is typically given in one treatment.

☆ FDA commissioner says health misinformation is driving U.S. life expectancy down
▼ + stars: | 2023-04-11 | by ( Meg Tirrell | ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailFDA commissioner says health misinformation is driving U.S. life expectancy downDr. Robert Califf says in an interview with CNBC that better regulation is needed to combat health misinformation that's costing Americans years of life. He also weighs in on what the agency can do about drug pricing, where he wants to see the drug industry focus more, and new drugs for obesity.

☆ Health misinformation is lowering U.S. life expectancy, FDA Commissioner Robert Califf says
▼ + stars: | 2023-04-11 | by ( Meg Tirrell | ) www.cnbc.com time to read: +5 min

watch nowLife expectancy in the U.S. is between three and five years lower than the average in other high-income countries — and the gap comes in part from misinformation, Food and Drug Administration Commissioner Dr. Robert Califf said. He said there's a need for better regulation, including "specific authorities at FDA, FTC and other areas" to root out misinformation. Food and Drug Administration Commissioner Robert Califf testifies before a Senate Health, Education, Labor, and Pensions hearing to examine an update on the ongoing Federal response to COVID-19, at the U.S. Capitol in Washington, U.S., June 16, 2022. The FDA commissioner spoke about multiple topics including efforts to cut drug prices, a priority for the Biden administration and lawmakers from both parties in Congress. Incentives for researchCaliff is also encouraging the drug industry to consider investments in neglected areas of research.

☆ FDA approves over-the-counter sales of lifesaving opioid overdose treatment Narcan nasal spray
▼ + stars: | 2023-03-29 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration on Wednesday approved sales without a prescription of the nasal spray Narcan to reverse opioid overdoses, a decision that promises to significantly expand access to the lifesaving treatment. The FDA's decision means people will be able to buy the 4 milligram nasal spray in supermarkets, convenience stores, gas stations, vending machines and online. FDA Commissioner Dr. Robert Califf, in a statement, said the agency is encouraging the company to make the nasal spray available as soon as possible at an affordable price. The nasal spray must be administered as soon as an overdose is suspected. Two nasal spray devices typically come in a single package.

☆ FDA Hopes Revamp Will Help Prevent Baby-Formula, Food-Safety Problems
▼ + stars: | 2023-03-01 | by ( Kristina Peterson | ) www.wsj.com time to read: 1 min

WASHINGTON—A proposed reorganization of the U.S. Food and Drug Administration would help the agency anticipate and prevent some elements of the baby-formula recall and ensuing shortage that panicked parents of young children last year, the agency’s commissioner said in an interview. However, the highly consolidated market for infant formula could continue to pose problems if one of the handful of facilities making formula was to close again, Robert Califf said.

☆ Repeat of Baby-Formula Shortage Still Possible Under Revamped FDA
▼ + stars: | 2023-02-28 | by ( Kristina Peterson | ) www.wsj.com time to read: 1 min

WASHINGTON–A proposed reorganization of the U.S. Food and Drug Administration would help the agency anticipate and prevent some elements of the baby-formula recall and ensuing shortage that panicked parents of young children last year, the agency’s commissioner said in an interview. However, the highly consolidated market for infant formula could continue to pose problems if one of the handful of facilities making formula was to shutter again, Dr. Robert Califf said.

☆ U.S. FDA to restrict unlawful import of veterinary tranquilizer Xylazine
▼ + stars: | 2023-02-28 | by ( ) www.reuters.com time to read: +1 min

Feb 28 (Reuters) - U.S. health regulators on Tuesday issued an import alert for drug ingredients and products related to Xylazine, used largely as a veterinary tranquilizer but has been a drug of abuse, to restrict its unlawful entry into the United States. The Food and Drug Administration (FDA) said its move aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals. Under the alert, the FDA will do an entry review of evidence offered by importers if incoming Xylazine is properly labeled, not adulterated, and for legitimate use. Xylazine is approved by the FDA only for veterinary use and German drugmaker Bayer's (BAYGn.DE) animal sedative drug Rompun is among the drugs which are based on Xylazine. "The FDA remains concerned about the increasing prevalence of Xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue," FDA Commissioner Robert Califf said in the statement.

☆ FDA Proposes Overhaul in Wake of Baby Formula Shortage
▼ + stars: | 2023-02-01 | by ( Kristina Peterson | ) www.wsj.com time to read: 1 min

WASHINGTON—The head of the U.S. Food and Drug Administration proposed consolidating the leadership of the food side of the agency Tuesday, in response to criticism of its slow response to the baby formula shortages and other food safety concerns. The plan unveiled by FDA Commissioner Robert Califf reorganizes the overlapping food divisions by putting a single deputy commissioner in charge of food policy and regulation within the agency.

The Food and Drug Administration on Friday proposed easing blood donation guidelines for gay and bisexual men. Under current rules, the FDA allows donations from gay and bisexual men if they haven't had sex with another man for three months. In a draft proposal posted to the agency's website, the FDA said the new rules would allow anyone to donate blood — regardless of gender or sexual orientation — as long as they haven't engaged in certain sexual behaviors in the last three months. Blood donors who report having a new sexual partner or more than one sexual partner would be asked about their sexual activity over the last three months under the new guidelines. The FDA will not reach a final decision immediately.

☆ FDA proposal would allow gay men in monogamous relationships to donate blood
▼ + stars: | 2023-01-27 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Under the guidelines proposed on Friday, gay and bisexual men who are in monogamous relationships would be allowed to donate blood. The FDA had imposed a lifetime ban on men who have sex with men donating blood during the AIDS crisis in the 1980s. The agency had eased the ban in 2015, allowing gay and bisexual men to donate blood if they had not had sex in the previous year. The American Medical Association had criticized the FDA's restrictions on gay men donating as discriminatory. Those taking injections to prevent HIV would not be allowed to donate blood for two years following their most recent injection.

☆ FDA official overseeing food policy and response to resign in wake of baby formula shortage
▼ + stars: | 2023-01-26 | by ( Zoë Richards | Zoë Richards Is The Evening Politics Reporter For Nbc News. | ) www.nbcnews.com time to read: +2 min

Frank Yiannas, a top official at the Food and Drug Administration in charge of the agency's food policy and response office, announced Wednesday that he is stepping down from his role as deputy commissioner. His resignation comes days after Abbott Laboratories confirmed that the Justice Department was investigating the company over its Michigan baby formula plant. "Today, I informed Commissioner [Robert] Califf that I will be resigning my position as Deputy Commissioner for the Office of Food Policy and Response effective February 24 ," Yiannas tweeted. Yiannas' resignation announcement comes weeks after an expert panel issued a scathing report on its investigation of the FDA's processes and organizational structure for its foods program. That investigation, was ordered by FDA Commissioner Robert Califf in July, following growing criticism that the agency had mishandled the formula crisis after illnesses were reported.

☆ FDA proposes new lead limits for baby food to reduce potential risks to children’s health
▼ + stars: | 2023-01-24 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration proposed new limits Tuesday on lead in baby food, in an effort to reduce exposure to a toxin that can impair childhood development. The lead limits apply to processed food consumed by children younger than two years old. In a statement, FDA Commissioner Dr. Robert Califf said the limits would reduce lead exposure from these foods by as much as 27%. This would reduce exposure by 26%. Lead exposure through food among children ages 1 to 3 has declined 97% since the 1980s, according to the FDA.

☆ FDA Commissioner Denies Wrongdoing in Approval Process for Biogen Alzheimer’s Drug Aduhelm
▼ + stars: | 2023-01-11 | by ( Liz Essley Whyte | ) www.wsj.com time to read: +1 min

FDA Commissioner Robert Califf says a high level of interaction between agency officials and drug companies helps cut down on applications for drugs that don’t work. U.S. Food and Drug Administration Commissioner Robert Califf defended his agency’s decision to approve the Alzheimer’s drug Aduhelm, after an investigation by House Democrats found close cooperation between the drug’s sponsor and regulators. Findings released late last year from the then-Democratic-led Oversight and Reform Committee and the Energy and Commerce Committee faulted the FDA for holding an unusual number of meetings with Biogen Inc. while it weighed approval of Biogen’s Alzheimer’s treatment, Aduhelm, as well as for co-authoring with the company a briefing document presented to outside advisers. The FDA granted preliminary approval to Aduhelm in 2021, but Medicare officials refused to cover it routinely, dooming the company’s plans for profits.

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