The Food and Drug Administration placed a temporary administrative stay Tuesday onits order last month requiring e-cigarette company Juul to pull its vape products from the US shelves.
The agency announced it stayed the initial June 23 order to allow time for additional review, but warned that the stay only temporarily suspends the ban — it doesn’t rescind it.
“The agency has determined that there are scientific issues unique to the JUUL application that warrant additional review,” the FDA said on Twitter.
However, the stay “does not constitute authorization to market, sell, or ship JUUL products,” the agency added.
The FDA issued the federal ban on Juul products in June because it said Juul’s parent company Altria submitted insufficient safety data.
The FDA initially issued the federal ban because the Juul company could not “demonstrate that marketing of the products would be appropriate for the protection of the public health.”AP
The health agency said at the time that the vaping company’s “applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”
The day after the ban, a federal appeals courtgranted a temporary stayof the FDA order while the court reviews the case. The temporary reprieve is set to last at least until July 12.
The Food and Drug Administration recently tried to take Juul vape pens off the shelf. This comes after public health officials say Juul is focusing on selling its nicotine products to high schoolers.
This decision was made after considerable pleas from government officials and public health institutes that say Juul is more focused toward selling its nicotine products to high-schoolers.
Juul currently faces a dozen lawsuits from different states who claim they focused more on their marketing campaign to young audiences and had a big role in the vaping epidemic.
According to Doctor Jayme Smith at Canton-Potsdam Hospital, that while Juuls could be banned, there are still other products available.
“Its important for our patients to understand that the FDA is targeting Juul right now, but there are other companies that are continuing to make e-cigarettes and vape pens, so you can continue to get that method of nicotine delivery, you don’t necessarily have to use Juul as specific,” said Smith, Canton-Potsdam’s Director of Behavioral Health Sciences.
A court granted Juul’s request for a stay on the ban, allowing the company to still the sell the products while an appeal is made on the decision.
Most recently, the FDA has required all nicotine and tobacco companies to slash down on harmful addictive substances and chemicals in their products.
Air France announced last week it will stop transporting nonhuman primates. The decision will create additional problems for biomedical research, which already faces increasing difficulty getting monkeys. Air France was the last major airline still carrying nonhuman primates as cargo, as other companies haveincreasingly refused to doso over the past 2 decades.
The policy change, announced on Twitter, is part of a “perfect storm” for biomedical research using monkeys, says Kirk Leech, executive director of the European Animal Research Association (EARA). China, a major exporter of primates for research and supplier of approximately 80% of the monkeys used for research in the United States until early 2020, banned trade in all nondomesticated terrestrial animals after the outbreak of COVID-19, drastically reducing the global supply of primates. Meanwhile, demand for monkeys has risen in recent years, with COVID-19 research adding to the crunch. And as airlines have dropped out, the dwindling supply of monkeys is often transported by chartered aircraft, raising costs and limiting availability.
Air France announced its decision quietly in a 30 June reply in French to another Twitter user’s now-deleted tweet, but Leech says the move had been expected for some time; EARA had already planned to tell researchers about the impending decision. The tweet said Air France’s ban would come into effect “as soon as its current contractual commitments with research organizations come to an end,” which Leech expects will be before the end of the year. Air France did not respond to Science’s request for comment.
People for the Ethical Treatment of Animals (PETA) celebrated the decision, saying in a written statement that “Monkeys will be spared enormous suffering, as the monkey transport trade has been dealt another blow.” The organization will now focus on Egyptair, a smaller airline that PETA says has flown up to 5000 monkeys through John F. Kennedy International Airport in New York City since March.
But EARA cautions Air France’s decision will further restrict crucial research that relies on nonhuman primates. Because monkeys are more closely related to humans than rodents, dogs, and other research animals, their immune systems and brains are better models for those in humans, says Peter Janssen, a neurophysiologist at KU Leuven who uses monkeys to study blindness and memory. That makes monkeys invaluable for neuroscientific work on illnesses such as Alzheimer’s disease as well as vaccine studies. Nonhuman primates are often the final species before humans in testing, and the U.S. Food and Drug Administration and the European Medicines Agency often require monkey studies of medicines before they will approve them. “Every [COVID-19] vaccine … was tested on nonhuman primates,” Leech says.
Air France had long refused to give in to pressure from animal rights groups, in part because a board member who had worked in the pharmaceutical industry had given fellow board members a tour of a Sanofi lab, convincing them monkey research was essential and done under humane circumstances, Leech says. The French government supported the airline’s stance as well. But as other companies dropped out, Air France was left as the lone target for protests.
Air France’s about-face will have the biggest impacts in the United States and Europe, the leading importers of primates—for research and for other purposes, such as conservation. The airline transports many monkeys from Mauritius, which in recent years has become one of the world’s main suppliers, having established breeding colonies of long-tailed macaques that were brought to the Indian Ocean island nation as pets but became an invasive species.
“Ultimately, the way to get around this problem is to breed them locally” in the countries where monkeys are needed, Leech says. But that would likely run into opposition as well, and it would take nearly a decade to build breeding colonies. In the meantime, “this shortage is going to drive out innovation from the sector,” Leech predicts.
As one of the most critical health problems, pain afflicts one in five adults in the world (1). Despite the efficacy of opioids in treating pain, opioid use disorder and overdose have motivated the development of nonopioid alternatives, such as other analgesics (2), electrical stimulation (3), and acupuncture (4) for pain management. Among these alternatives, analgesic nerve cooling offers an effective and reversible strategy to alleviate pain (5). On page 109 of this issue, Reeder et al. (6) report a miniaturized and implantable cooling system that integrates state-of-the-art microfluidic and flexible electronic technologies in a biodegradable platform for localized temperature control and precise pain relief.
Strategic collaboration with Medtronic to develop BackBeat Cardiac Neuromodulation Therapy™ as potential integrated hypertension treatment for cardiac pacemaker patients
Investors in $110 million Series D financing include Medtronic and Terumo as well as lead investor RTW Investments and founding investor Perceptive Advisors
Business combination with Health Sciences Acquisitions Corporation 2 (Nasdaq: HSAQ) (the “Business Combination”); upon closing, the common stock of the combined company is expected to be listed on Nasdaq under the ticker symbol “OBIO”; Business Combination is supported by $20 million in total forward purchase agreements and an up to $50 million backstop agreement
Business Combination and completed private equity financing are structured to ensure total gross proceeds of a minimum of $180 million, which is expected to fund the combined company into 2026 based on current plans and estimates
Biogen and Eisai’s follow-up to the Alzheimer’s disease treatment Aduhelm scored priority review under the FDA's accelerated review pathway, with a decision slated for Jan. 6.
The companies are hoping for a swift, positive review for their anti-amyloid therapy lecanemab, which would follow the controversial Aduhelm onto the market if the FDA gives its blessing. With an FDA application completed in May and the priority review, Eisai and Biogen have seen lecanumab's regulatory timeline cut from 10 months to six.
Eisai confirmed in an email to Fierce Biotech that the FDA is not planning on holding an advisory committee meeting for the lecanemab application at this time. Aduhelm was considered by a committee of the FDA's advisors, which recommended against approval. The FDA later granted the accelerated approval anyway.
When the applicaiton was submitted, Eisai said it was still moving forward with a request for accelerated review, a pathway that became a flashpoint in Alzheimer’s after the FDA approved Aduhelm last year. Later, the Centers for Medicare & Medicaid Services restricted coverage of the therapy to patients participating in approved clinical trials. That coverage decision applies to future monoclonal antibodies for the disease, including lecanemab.
Eli Lilly and Roche's Genentech both similarly have monoclonal antibodies in development for Alzheimer's. The former is seeking an accelerated review as well, while Genentech is waiting on a pivotal data read out expected in the fall rather than go the fast route now.
Ivan Cheung, Eisai's chairman and global president of the neurology business group, told Fierce Biotech in May that he's well aware of the public backlash that has followed Aduhelm. The company is hoping to gain "credibility and trust" by producing evidence to support clinical evidence as fast as they can, but the company remains committed to using—and “respecting”—the accelerated pathway, Cheung said.
Eisai, which is leading the partnership's regulatory process this time around, aims to turn the accelerated nod into a full one as soon as possible. An ongoing phase 3 study—if successful—could provide the efficacy evidence needed to support a full FDA nod.
In a Tuesday evening press release, the companies said they are using the accelerated review pathway once again “in an effort to streamline the submission process for the potential traditional approval” and to expedite patients’ access to the drug.
The phase 3 Clarity AD trial will delivery results on the primary endpoint this fall, the companies said, and it can be used as the confirmatory study to verify lecanemab’s clinical benefit. That key endpoint is the change from baseline on the Clinical Dementia Rating Scale Sum of Boxes, which measures the severity of dementia in Alzheimer’s disease and mild cognitive impairment.
If the results prove lecanemab's clinical benefits, Eisai will seek full approval in the U.S. within its 2022 fiscal year, which ends March 31, 2023.
Eisai’s CEO Haruo Naito called the FDA’s acceptance of the application “an important milestone” for people living with Alzheimer’s. Biogen’s outgoing CEO Michel Vounatsos similarly called it an important step towards the company’s vision of a future where patients have multiple options for treatment.
Eisai has also initiated a submission for lecanemab in Japan, with the manufacturing and marketing approval request there expected during the fiscal year. But in Europe, the Eisai will wait for results from the Clarity study before filing an application for approval; that's also expected within the fiscal year.
Level 3, or "high," is now the top rung in terms of risk level and applies to places that have had more than 100 cases per 100,000 residents in the past 28 days. Level 2 and Level 1 are considered "moderate" and "low" risk, respectively.
All three new entries to Level 3 on Tuesday had previously been at Level 2.
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Sweden, renowned for its culture and natural beauty, is one of just a few European nations to even make it out of the 'high" risk list since the ratings overhaul. Along with Romania, it moved into the "moderate" risk list on June 21. This week, Romania remains at Level 2.
There were almost 115 destinations at Level 3 on July 5. Level 3 locations account for almost half of the roughly 235 places monitored by the CDC.
Level 4, previously the highest risk category, is now reserved only for special circumstances, such as extremely high case counts, emergence of a new variant of concern or health care infrastructure collapse. Under the new system, no destinations have been placed at Level 4 so far.
The village of Oia on Santorini island is a favorite tourist spot in Greece, which remains at the CDC's Level 3.
Francesco Riccardo Iacomino/Moment RF/Getty Images
Much of Europe has been stubbornly lodged at Level 3 for months with the summer travel season in full swing. As of July 5, the following popular European destinations were among those remaining at Level 3:
• France • Germany • Greece • Ireland • Italy • The Netherlands • Norway • Portugal • Spain • United Kingdom
Those aren't the only high-profile spots that find themselves at Level 3. Numerous other destinations around the world are among those in the "high" risk category, including the following:
• Brazil • Canada • Costa Rica • Malaysia • Mexico • South Korea • Thailand • Turkey
The CDC advises that you get up to date with your Covid-19 vaccines before traveling to a Level 3 destination. Being "up to date" means you have had not only the full initial vaccinations but any boosters for which you're eligible.
Level 2
Baalbek is a UNESCO World Heritage Site in Lebanon, which has moved up to the CDC's "moderate" risk category.
Luis Dafos/Moment RF/Getty Images
Destinations carrying the "Level 2: Covid-19 Moderate" designation reported 50 to 100 Covid-19 cases per 100,000 residents in the past 28 days.The CDC moved three places to this level on Tuesday:
• Jordan • Lebanon • North Macedonia
The move was not good news for the Middle East's Jordan and Lebanon, which had been at Level 1. For North Macedonia in Europe's Balkans, the move was in a positive direction, having previously been at Level 3.
There are 20 places in the "moderate" risk category this week.
In its broader travel guidance, the CDC has recommended avoiding all international travel until you are fully vaccinated.
Level 1
To be listed as "Level 1: Covid-19 Low," a destination must have had 49 or fewer new cases per 100,000 residents over the past 28 days. Just two little island destinations were added to the category on July 5:
• Saba • Saint Pierre and Miquelon
Saba, in the Caribbean, had been at Level 2. Saint Pierre and Miquelon, a French archipelago south of Newfoundland, Canada, had been at Level 3.
A few of the more popular places in the "low" risk category this week include Indonesia, India and the Philippines.
Unknown
The Hungarian Parliament is seen through the arches of Fisherman's Bastion in Budapest. The CDC warns against travel to places where the Covid-19 risk is "unknown."
Alexander Spatari/Moment RF/Getty Images
Finally, there are the destinations the CDC has deemed to be of "unknown" risk because of a lack of information. Usually, but not always, these are small, remote places or places with ongoing warfare or unrest. Four places were added to this category this week:
• Haiti • Hungary • Iran • Mozambique
Haiti, Iran and Mozambique had all been at Level 1 last week. Hungary, a favorite stop on the Eastern European travel circuit, had been at Level 3.
The CDC advises against travel to these places precisely because the risks are unknown. Other destinations in this category that typically draw more tourist attention include French Polynesia, Macau and the Maldives.
'Medical expert' weighs in on risk levels
Transmission rates are just "one guidepost" for travelers' personal risk calculations, according to CNN Medical Analyst Dr. Leana Wen.
We've moved into "a phase in the pandemic where people need to make their own decisions based on their medical circumstances as well as their risk tolerance when it comes to contracting Covid-19," said Wen, who is an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health.
There are other factors to weigh in addition to transmission rates, according to Wen.
"Another is what precautions are required and followed in the place that you're going and then the third is what are you planning to do once you're there," she said.
