Posts tagged with "FDA"

Skincare company Galderma sees opportunity in ‘Ozempic face’

June 24, 2024

Speedy weight loss from drugs used to fight obesity and diabetes has left some users looking gaunt and aged. The boss of Swiss skincare group Galderma thinks treatments for what has been dubbed “Ozempic face” could give the company a lift, reports The Wall Street Journal.

With millions of Americans taking blockbuster drugs like Ozempic and Zepbound to slim down—and more looking to get hold of them—the side effects of the popularity of the medications are rippling through the business world.

Investors are searching for winners and losers from weight-loss—also known as GLP-1 because of the appetite-suppressing gut hormone they mimic—in sectors ranging from medical devices to food to clothing.

Galderma Chief Executive Flemming Ornskov pitches the company, which houses skincare brands Cetaphil and Alastin, as a potential beneficiary of the weight-loss boom.

“If you have that kind of weight loss, not only do you have body transformation, but you also have facial transformation and they [users] are flocking to aesthetic treatments,” Ornskov said in an interview.

One of the downsides of obesity drugs is that some users have developed what they call “Ozempic face,” an aged appearance that leaves them with saggy skin on their faces. Doctors say the changes result from speedy weight loss, and the associated reduction in facial volume, and that the drugs themselves don’t target the face.

Fillers or longer-acting biostimulators, included in some of Galderma’s products, can help counter those side effects, Ornskov says. “Weight-loss products are rapidly changing aesthetics practices,” he added.

Analysts are also bullish on the demand potential of “Ozempic face” treatments for the Swiss company. The growing use of GLP-1s could help reinvigorate growth of the fillers market over the coming years, since they can address potential sagging and aging of facial skin resulting from the use of these drugs, Jefferies analysts wrote in a note to clients.

About 3.5 million patients use GLP-1 treatments in the United States, which has boosted demand for treatments to address the slimmed-down facial volume caused by weight loss, according to UBS estimates.

A recent Gallup poll showed 6% of the U.S. adult population—an estimated 15.5 million people—tried the drugs to lose weight. The poll was based on a survey of more than 5,500 people conducted in March.

Beyond products that target GLP-1 patients looking to rejuvenate their skin, Galderma sees growth potential in “injectable aesthetics,” or skin-smoothing injections. Demand is particularly high for neuromodulators, wrinkle-relaxing injections of botulinum toxin that Galderma sells under the Dysport brand. Dysport competes with AbbVie’s Botox.

“In the [United States], we have seen most of the growth comes from injectable aesthetics,” Ornskov said. Galderma expects its injectable-aesthetics products to continue to fuel growth domestically and everywhere else, its CEO said.

“We always wanted from the beginning a three-legged stool with three very strong and independent interlinked businesses,” Ornskov said. “By having this integrated story, we probably should be adding versus subtracting to our portfolio over time.”

The company expects to bolster its therapeutic dermatology business through the launch of nemolizumab, a drug for the treatment of skin disorder prurigo nodularis and for atopic dermatitis, a common type of eczema that causes itchy skin.

Galderma filed applications for both indications with the U.S. Food and Drug Administration and the European Medicines Agency, and expects to launch it in the United States next year. Analysts at Bank of America estimate the drug could reach $2.1 billion in annual peak sales.

Research contact: @WSJ

Supreme Court upholds access to mifepristone abortion pill in unanimous decision

June 13, 2024

On Thursday, June 13, the U.S. Supreme Court ruled in a unanimous decision that a group of anti-abortion doctors does not have any legal basis to challenge access to mifepristone, one of the two common drugs used in medication abortion.

As a result, access to mifepristone won’t change, reports The Hill.

The opinion, written by Justice Brett Kavanaugh, sided with the Biden Administration and Danco, the manufacturer of the branded version of mifepristone. It reversed a lower court decision that would have made it more difficult to obtain the drug, which is used in about two-thirds of U.S. abortions.

The ruling didn’t address the underlying regulatory or safety issues the plaintiffs raised, instead deciding the case only on standing. The justices found the conservative doctors in the lawsuit did not show they had personally been harmed by the government’s actions regulating mifepristone.

“Under Article III of the Constitution, a plaintiff’s desire to make a drug less available for others does not establish standing to sue,” Kavanaugh wrote.

The drug will remain available to people up to the tenth week of pregnancy and will still be available through the mail. The decision is a victory for the Biden Administration’s efforts to maintain access to abortion, but it also is a victory for the Food and Drug Administration’s authority to regulate drugs.

Leading up oral arguments, pharmaceutical companies and FDA law experts urged the court not to second-guess the agency’s expertise and side with the plaintiffs. A ruling against the administration could have undermined the entire drug approval process, they argued.

“We are pleased with the Supreme Court’s decision in this incredibly important case. By rejecting the Fifth Circuit’s radical, unprecedented and unsupportable interpretation of who has standing to sue, the justices reaffirmed longstanding basic principles of administrative law,” said Abigail Long, a spokesperson for Danco. “The decision also safeguards access to a drug that has decades of safe and effective use.”

Still, mifepristone remains illegal in the more than a dozen states that ban abortion.

The case centered on whether federal regulators overstepped their authority by loosening restrictions to make mifepristone easier to access. The FDA first approved mifepristone in 2000 for abortion up to seven weeks of pregnancy, but then made a series of changes in 2016 and 2021.

Those changes included increasing the gestational age at which mifepristone can be used to up to ten weeks of pregnancy, allowing the medication to be mailed to patients, lowering the dosage, allowing telehealth prescribing, and permitting providers other than physicians to prescribe the drug.

The FDA has repeatedly found that mifepristone is safe and that a medication abortion regimen that includes mifepristone and a second drug, misoprostol, is a safe and effective alternative to surgical abortions.

Research contact: @thehill

First human with Neuralink brain chip can play video game by ‘telepathy’

March 22, 2024

On March 20, the first human to have a Neuralink computer chip surgically implanted in his brain demonstrated how he uses his thoughts to move a computer cursor around a screen to play online chess and toggle a music stream on and off, reports the New York Post.

Noland Arbaugh, a 29-year-old man who is paralyzed from the shoulders down due to a diving accident eight years ago, joined a livestream alongside a Neuralink engineer on X to show the public how the brain-computer interface tech works.

“It’s all being done with my brain. If y’all can see the cursor moving around the screen, that’s all me, y’all,” he said while the livestream showed his cursor moving across an online chess game. “It’s pretty cool, huh?”

The chip contains 1,000 electrodes—programmed to gather data about the brain’s neural activity and movement intention and send that data to a Neuralink computer for decoding to transform the thoughts into action.

Arbaugh explained that he simply imagines the cursor moving where he wants it to go and it does.

“Basically, it was like using the Force on the cursor and I could get it to move wherever I wanted. Just stare somewhere on the screen and it would move where I wanted it to, which was such a wild experience the first time it happened,” he said, referencing Star Wars.

The quadriplegic became the first human test subject of the chip developed by the Elon Musk-owned company when a robot surgeon plugged the implant into his brain at the end of January.

He said the surgery was “super easy” and he was released from the hospital a day later with no cognitive impairments since.

“It’s crazy, it really is. It’s so cool. I’m so friggin’ lucky to be a part of this,” he said. “Every day it seems like we’re learning new stuff and I just can’t describe how cool it is to be able to do this.”

Before receiving the chip, Arbaugh would need another person’s help to play online chess and video games like Civilization VI. “Now I can literally just lie in bed and play to my heart’s content,” he said—at least until the battery of his rechargeable chip dies.

The brief, nine-minute video stream posted on Neuralink’s X account is the closest look the human tech startup has shared with the public. The company, founded in 2016, has mostly kept information about its technology and human trials under wraps—prompting calls for greater transparency.

The U.S. Food and Drug Administration greenlit human trials of the brain chip last year after the company did hundreds of tests on animals—and faced backlash from animal rights groups in the process.

Neuralink has not disclosed how many people will be enrolled in the six-year trial or where the trials will be held. It also has not registered its study on a government website logging medical trials involving human test subjects, according to Wired.

For his part, Arbaugh said, he signed on to try the implant because he “wanted to be a part of something that I feel like it’s going to change the world.”

But he admitted that being the first-ever human to get the chip implanted in his brain has not come without its challenges, without elaborating.

“It’s not perfect. I would say that we have run into some issues,” he told those watching the livestream. “I don’t want people to think that this is the end of the journey. There’s a lot of work to be done. But it has already changed my life.”

Research contact: @nypost

Over-the-counter birth control pill to be available within weeks on retail shelves

March 5, 2024

Birth control pills will be available without a prescription on retail shelves for the first time ever in the United States this month, reports The Wall Street Journal.

The over-the-counter (OTC) contraceptive pills—branded as Opill and made by health-product company Perrigosoon will become the most effective birth-control method available without a doctor’s visit.

The drug represents a milestone that reproductive activists have pursued for decades—and comes as women’s fertility is at the center of a national conversation on abortion and in vitro fertilization

Walgreens and CVS have said they will offer the abortion pill mifepristone by later this month. “Opill will be available at CVS.com and through the CVS Pharmacy app in late March,” spokesperson Matt Blanchette wrote in an email on Friday, March 1.

“This is a[n] historic breakthrough,” said Dana Singiser, co-founder of the nonprofit Contraceptive Access Initiative, which supported the Food and Drug Administration’s OTC approval of the pill last year. “Without a prescription this becomes a game changer for people who can’t afford to go to doctor’s visits or hourly workers who need to take time off to schedule appointments.”

Dublin-based Perrigo has shipped its Opill to major U.S. retailers and expects it to be widely available by the end of the month. The company said it would sell a one-month pack for $19.99 and a three-month pack for $49.99.

Opill, which uses the hormone progestin to suppress ovulation, was shown to be 98% effective at preventing pregnancy when used as directed, beating out other over-the-counter methods, such as condoms and spermicide. Other prescription methods that require a doctor’s visit, such as intrauterine devices, are more effective.

Perrigo also will sell its product on its website, including a six-month pack for $89.99. The company said it would ship the pills in discreet packaging to online buyers.

Research contact: @WSJ

FDA to allow Florida to import prescription drugs in bulk from Canada

January 8, 2024

The Food and Drug Administration said on Friday, January 8, that it will allow Florida to buy prescription drugs directly from wholesalers in Canada—a move that is intended to lower the cost of prescription drugs for residents in the state, reports NBC News.

Prescription drugs are often much cheaper outside the United States, and some states—including Florida, Vermont and Colorado—have urged the federal government to allow them to import drugs from other countries.

The FDA already permits individuals to buy prescription drugs from Canada under certain circumstances.

The push to allow states to do so has been in the works for years. In 2019, the Trump Administration announced preliminary plans to import drugs from Canada, asking states to come up with proposals on how to do so safely. In 2021, President Joe Biden issued an executive order directing the agencies to work with states on the importation plans.

The FDA’s new policy will allow Florida to purchase prescription drugs in bulk. The medications will be made available to its residents through various state-run health care programs, such as Medicaid.

Meredith Freed, a senior policy analyst with KFF’s Program on Medicare Policy, said it’s unclear when Florida will begin importing the drugs.

Florida must meet certain requirements, such as testing the drugs to ensure they are not counterfeit and relabeling the drugs to be consistent with FDA-approved labeling, Freed said.

The state will also be required to submit a quarterly report to the FDA that includes information about the imported drugs, cost savings, and any potential safety and quality issues under the new policy, according to the agency.

The plan is only authorized for two years from the date the agency is told about the first drug importation shipment, according to the FDA. The agency has the authority to extend the authorization for an additional two years at a time.

Florida’s Agency for Health Care Administration has previously estimated that Canadian drug imports will save the state $150 million annually if enacted.

Stephen Ubl, the president and CEO of the Pharmaceutical Research and Manufacturers of America, the drug industry’s trade group, called the FDA’s decision “reckless.”

“Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” said Ubl, who has previously issued statements opposing the importation plan. (To be eligible for importation, the FDA has said that the prescription drugs must be approved by regulatory authorities in Canada.)

Friday’s move comes as the federal government continues to negotiate with major drug companies on the cost of the ten costliest drugs in the United States as part of a provision in the Inflation Reduction Act. The negotiated prices won’t go into effect until 2026.

An analysis published Thursday from the Commonwealth Fund, a research group that studies health care issues, found that the U.S. prices for the ten drugs were three to eight times higher compared to other countries of similar size and wealth.

Research contact: @NBCNews

The FDA says Ozempic might block your intestines

October 12, 2023

Ozempic, the über-popular injectable diabetes drug, has had to update its potential side-effect warnings to include intestinal blockage, reports Futurism.

As CBS News first disclosed, the Ozempic label change reflects updates posted last week by the Food and Drug Administration—which acknowledged that some users experienced a condition known as “ileus,” which involves a blocking of the intestines.

The FDA stopped short, however, of saying that semaglutide, the active ingredient in Ozempic—as well as Wegovy, its counterpart prescribed for weight loss—was the cause of the condition.

“Because these reactions are reported voluntarily from a population of uncertain size,” the FDA pointed out in its update published last week, “it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”

Of the two semaglutide injections and Mounjaro, which affects the body in a similar way but uses the drug tirzepatide as its active ingredient, Ozempic is the last to reflect on its label that ileus has occurred in some of the drug’s users, CBS notes.

This latest label update follows an early August lawsuit from a Louisiana woman, who claims that the drugmakers behind the popular diabetes shots didn’t do enough to warn consumers about its “severe” gastrointestinal side effects.

In the suit, the woman alleges that Ozempic and Moujnaro both caused her to vomit so much that she lost teeth.”As a result of using… Ozempic and Mounjaro,” the suit reads, “Plaintiff was caused to suffer from severe gastrointestinal events, which resulted in, for example, severe vomiting, stomach pain, gastrointestinal burning, being hospitalized for stomach issues on several occasions including visits to the emergency room, teeth falling out due to excessive vomiting, requiring additional medications to alleviate her excessive vomiting, and throwing up whole food hours after eating.”

In a statement to Fierce Pharma, a spokesperson for Ozempic and Wegovy maker Novo Nordisk said that these kinds of GI issues “are well-known side effects” of taking GLP-1 agonists, the class of drugs to which semaglutide belongs.

“For semaglutide,” the Danish company continued, “the majority of GI side effects are mild to moderate in severity and of short duration.”

Although ileus or intestinal blockages weren’t mentioned in that suit, these label updates could serve to protect Novo Nordisk and Eli Lilly, the maker of Moujnaro, from legal action—and, hopefully, will be taken into account by patients when weighing whether to take the increasingly-popular injections.

Research contact: @futurism

Cosmetics companies take a page from precision medicine’s playbook

July 25, 2023

The power of genomics is already being harnessed to develop therapies customized to a patient’s biological makeup. Now, it’s being applied to cosmetics, reports Axios.

L’Oreal is teaming up with Google life sciences spinout Verily to create a 10,000-person study to understand the biological, social, and environmental factors behind skin and hair health.

The knowledge can help the French conglomerate to “lead the future of precision beauty the same way they’re doing precision medicine, or precision health in the pharma industries,” Guive Balooch, L’Oreal’s global managing director of Augmented Beauty and Open Innovation, recently told Axios.

It’s a nascent market, but reflects a broader trend of the melding of health, wellness, and beauty industries; and tapping real-world medical data, said Laura Leeb, a partner at Strategy& Germany, part of PwC.

Among the industry and technical factors contributing to this development, Axios notes, are the following:

L’Oreal says that its goal is to create “a longitudinal biological, clinical, and environmental view” of what drives change in the features of skin and hair; and to create algorithms to match people and skin care products. It wants to develop new technologies and tele-diagnosis tools with sensors and AI.

The study will draw on participants’ selfies, as well as details about beauty and sleep routines over time. A smaller cohort of at least 1,000 patients also will give more intensive samples—such as tissue and hair samples. And part of the study will be devoted to advancing skin and hair health for people with Black skin tones.

Verily says it can use its technology to discover the links between external factors that people are exposed to over their lifetimes, skin aging, and biology of the skin.

For example, air quality and sleep can both affect skin aging, but it’s not known exactly how much either actually contributes to the phenomenon and why.

“There have been lots of cohorts done for health like diabetes,” Balooch said. “Skin has been, in my opinion, a place where there should be more.”

This is a much more consumer-focused task than Verily typically focuses on, said Amy Abernethy, a former principal deputy commissioner at the FDA who’s president of product development and chief medical officer at Verily.

“But if you ask the question, ‘How does the science influence things that are meaningful to us?’ It’s exactly the same task.” Abernethy said. “It’s a pretty remarkable dataset that L’Oreal is intending to build to inform what precision beauty should look like.”

L’Oreal and Verily have worked together before—unveiling a handheld makeup applicator at this year’s Consumer Electronics Show that makes it easier for someone with limited mobility to apply cosmetics.

However, there are ethical questions: Any consumer data collection, particularly at the level precision medicine requires, raises privacy concerns. Verily and L’Oreal officials say they are following the same cybersecurity protocols that might regulate any other health care project.

For now, none of the development requires FDA approval because L’Oreal is focused on a consumer market, including care for the aging; and conditions like eczema, atopic dermatitis, and acne.

The companies said they hope the study will inform future studies into biomarkers for more serious skin conditions.

And while the idea is intriguing, there are reasons to be skeptical about how meaningful its findings will be, Robert Pearl, a plastic and reconstructive surgeon, Stanford University professor and former CEO of The Permanente Medical Group told Axios.

“I think there’s so much that exists, even in medicine itself, where we can develop what I think of as precision beyond significance,” Pearl said. For instance, a person who learns they have a slightly higher lifetime risk for heart attack would still be offered the same solutions in terms of diet, exercise, and cholesterol, he said.

“It might be a very good tool to sell the product, to market the product,” Pearl said. “It’s gonna sound great but the question really is, will it make much difference?”

Research contact: @axios

Biden signs executive order to expand free birth control access

June 26, 2023

On Friday, June 23, President Joe Biden signed an executive order aimed at expanding free access to contraception on the eve of the one-year anniversary of the Supreme Court’s Dobbs ruling, reports Axios.

This is Biden’s third reproductive health-related executive order since Roe v. Wade was overturned last June by the court —and the first not to address abortion access.

Jennifer Klein, director of the White House Gender Policy Council, told reporters that the order does not impose a deadline by which agencies must act, but that it shows how the executive branch is prioritizing the issue, per The Hill.

 The order directs the Treasury, Labor, and Health and Health and Human Services departments to consider new guidance to ensure that private health insurers cover all contraceptives approved by the Food and Drug Administration without cost-sharing.

These departments also must take action to “improve access to affordable over-the-counter contraception, including emergency contraception.”

HHS must evaluate how to improve coverage and payment of contraceptives for Medicare beneficiaries—particularly women of reproductive age with disabilities. The department also must consider encouraging federally-supported health care services to expand contraception availability through new guidance, technical assistance, and training resources.

What’s more, Biden is directing the Education Department to “convene institutions of higher education to share best practices and ways to make sure that students understand their options for accessing contraception,” per a White House fact sheet.

FDA advisers last month unanimously endorsed making daily birth control pills available over-the-counter for the first time. A final decision from the agency is expected to come at some point this summer.

Under federal law, health plans are encouraged, but not required, to cover over-the-counter birth control without cost-sharing. However, at least 13 states though require insurers to cover over-the-counter contraceptive methods, such as the morning-after pill.

While the Dobbs decision struck down federal protections on abortion, a concurring opinion from Justice Clarence Thomas suggested that the Supreme Court should revisit similarly-established cases, such as those guaranteeing access to contraception.

Research contact: @axios

One-third of consumers can’t find a plant-based dairy product they like, survey finds

April 25, 2023

One-third of consumers say they have not found a plant-based dairy product that they want to drink, according to a survey by Singapore-based ingredients provider Ofi.

Indeed, Food Dive reports, while milk alternatives, such as almond and oat, have become popular over the past decade; barriers remain for some consumers, including taste, mouthfeel, and affordability.

Still, nearly two-thirds of respondents (64%) said they purchased at least one plant-based dairy product each week—and the same numbers reported buying milk alternatives along with regular dairy. Health and nutrition were listed as the most important factors when deciding to buy them.

Conversely, while 82% of those surveyed said they use animal-free products at least once a month, 7% said they went back to dairy after they did not enjoy their first plant-based alternative.

The survey from Ofi—the producer of the ingredients such as coffee, edible nuts and dairy—asked more than 1,500 adults about their adoption of plant-based dairy. Interest is rising, as 63% said they expect to purchase more products during the next two years.

The survey results indicate there are key areas plant-based dairy producers should concentrate on when conceiving new products, particularly flavors and health benefits, said Sonali Dalvi, Ofi’s vice president of Innovation.

“This is a call to action to the food and beverage industry. You need a fresh, creative approach to flavor creation, color, and texture development to make products that captivate consumers,” Dalvi said in a statement.

Given consumers’ prioritization of nutritious and functional aspects when choosing a dairy alternative, Dalvi said there is potential for formulations made from ingredients such as cocoa, nuts, and spices that feature clean-label attributes.

Affordability and accessibility also provide a barrier to entry for some consumers, the survey indicated, as 57% of those who eschew plant-based dairy said the prices are a significant factor.

As Gen Z moves away from dairy milk, the leading plant-based dairy alternatives continue to grow their sales. Large consumer packaged goods companies like Nestlé, Chobani, and Danone have leaned into the dairy alternative category with new products in recent years.

Oat milk, one of the leading product categories, is projected to increase at a compound annual growth rate of 15.4% through 2028, according to Grand View Research.

The increase in consumer adoption of plant-based milks has resulted in more recognition for the category from federal regulators. In February, the FDA said plant-based milk products can can be labeled as “milk,” while recommending that producers add nutritional disclosures to their packaging to help consumers discern it from dairy milk.

Research contact: @FoodDive

FDA approves over-the-counter sales of lifesaving opioid overdose treatment Narcan nasal spray

March 30, 2023

On Wednesday, March 29, the Food and Drug Administration approved sales without a prescription of the nasal spray Narcan to reverse opioid overdoses—a decision that promises to significantly expand access to the life-saving treatment, reports CNBC.

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. Emergent BioSolutions, the manufacturer, has said Narcan should be available without a prescription by late summer.

In a formal statement, FDA Commissioner Dr. Robert Califf, noted that the agency is encouraging the company to make the nasal spray available as soon as possible at an affordable price.

Narcan reverses fatal overdoses by blocking the effect that opioids have on the nervous system. The nasal spray must be administered as soon as an overdose is suspected.

Two nasal spray devices typically come in a single package. The first dose should be administered in one nostril of the person suffering an overdose and then 911 should be called, according to the instructions. If the person is still unresponsive after two to three minutes, the second dose should be administered.

After the FDA’s decision, Walgreens said it will offer over-the-counter Narcan later this year in-store and online nationwide.

“Delivering access to this lifesaving medication that can reverse the effects of an overdose if administered in time is imperative and Walgreens is already working with suppliers to bring this OTC medication to shelves,” said Zoe Krey, a Walgreens spokesperson.

The FDA said in November that it was considering approving naloxone products, the generic name for medications that reverse opioid overdoses, for use without a prescription. The push to make naloxone easier to access is part of the agency’s efforts to fight the opioid crisis.

More than 564,000 people died from opioid overdoses between 1999 and 2020, according to the Centers for Disease Control and Prevention. The first wave of the epidemic began in the 1990s with prescription opioids, followed by an increase in deaths from heroin starting in 2010.

Deaths from synthetic opioids such as fentanyl have increased significantly since 2013. More than 71,000 people died from synthetic opioids in 2021—an 18% increase over the year prior, according to CDC estimates.

Research contact: @CNBC