Jasper Therapeutics, Inc. (Nasdaq: JSPR) (“Jasper” or the “Company”), a biotechnology company developing novel antibody therapies and stem cell transplant conditioning agents targeting c-Kit, today announced, as part of an overall portfolio prioritization, that the Company will focus on the development of its lead product candidate, briquilimab (formerly known as JSP191), in chronic diseases and stem cell transplant for rare diseases. This portfolio includes a new program on chronic urticaria, along with the Company’s existing programs for lower-risk myelodysplastic syndrome (MDS), sickle cell disease, Fanconi anemia and severe combined immunodeficiency (SCID).
Based on preclinical and clinical studies showing inhibition of c-Kit signaling, depletion of mast cells in skin and lung and extended pharmacokinetics of subcutaneous dosing, the Company has prioritized rapidly starting a clinical study in severe chronic urticaria. In the meantime, while the Company does not have any near-term plans to initiate a Phase 3 study in AML/MDS, the Company will continue to work with the U.S. Food and Drug Administration, the transplant community and potential partners to explore development pathways and ensure briquilimab remains ready for a pivotal Phase 3 study in AML/MDS stem cell transplant.
Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, today announced preliminary unaudited fourth quarter and full year 2022 revenue and provided estimates for its 2023 guidance.
Preliminary Fourth Quarter and Full Year 2022 Highlights:
Preliminary unaudited revenue for the fourth quarter of 2022 is expected to be between $107.0 million and $108.0 million, up 12% sequentially and 29% year-over-year (at the midpoint of the range).
Preliminary unaudited revenue for the full year 2022 is expected to be between $382.7 million and $383.7 million, up approximately 38% over the full year 2021 (at the midpoint of the range).
Ended 2022 with over 275 U.S. sales territories.
“Our fourth quarter was successful and highly productive. We executed crisply across all five of our growth drivers and generated robust revenue growth,” said Drew Hykes, CEO of Inari Medical. “We presented important new data from both the CLOUT registry and the U.S. arm of our FLASH registry, the largest prospective thrombectomy trials ever conducted in DVT and PE. We also initiated the full market release of two new products while continuing our work to drive market expansion and uptake of our devices. Looking ahead, we remain fully committed to our mission of better outcomes for our patients while continuing to deliver sustained, premium growth.”
The preliminary unaudited revenue results described in this press release are estimates only and subject to revision, including as a result of completion of customary annual audit procedures, until Inari reports its full financial results for the fourth quarter and full year 2022 in our Annual Report on Form 10-K.
Full Year 2023 Revenue Guidance Inari is providing financial guidance for full year 2023 revenue of $470 million to $480 million, reflecting growth of approximately 23% to 25% over 2022. Further detail will be provided when Inari reports its financial results for the fourth quarter and full year 2022.
Mecbotamab vedotin (BA3011) Phase 2 part 1 interim results in PD-1 failure NSCLC continues to show strong antitumor activity in a highly refractory population with additional patients enrolled
BA3011 Undifferentiated Pleomorphic Sarcoma (UPS) Phase 2 part 2 of the potentially registrational study is being initiated; anticipate first patient dosed this quarter
BA3071 Phase 1 study ongoing with first two dose escalation cohorts completed; third cohort (70mg) on-going
CAB clinical programs continue to progress with multiple significant inflection points expected in 2023
Sotera Health Co. (SHC) soared 57% in premarket trading on Tuesday after the company said it will pay $408 million to settle more than 870 million legal cases in Illinois. Sotera owns Sterigenics, a medical sterilization company that is accused of running an industrial plant in Willowbrook, Ill.
Sesame has just been named the ninth major allergen in the U.S. by the FDA — but some companies have created a “workaround” that allows them to avoid removing sesame from their products.
The tiny seeds can cause a big reaction in some people who are highly allergic, according to experts.
Whether it’s sesame seeds on a bagel or sesame flour in baked goods, allergist and immunologist, Dr. Purvi Parikh shared with Fox News Digital that sesame as an ingredient can be life-threatening to some.
“It’s in so many foods,” said New York-based Parikh. “It’s often a subtle allergen that many people may not realize, but it can be life-threatening.”
Congress unanimously passed the FASTER Act in April 2021, which added sesame to the FDA’s list of major food allergens effective Jan. 1, 2023.
The nearly two-year wait allowed food brands and manufacturers the time to comply with the new law.
It requires clear labeling of sesame in food items, as well as any resulting fixes needed regarding existing manufacturing processes.
Congress, FDA recognize potential dangers of sesame
Jason Linde, senior vice president of government and community affairs for Food Allergy Research and Education (FARE), confirmed this window of time for brand compliance. He said he has long awaited recognition that some 1.6 million Americans suffer with this allergy.
“Previous to the law, [sesame] was just labeled as a spice or natural flavor,” Linde, who is based in the Washington, D.C. area, told Fox News Digital in an interview.
“So, you never knew what you were going to get, but thankfully, we passed this bipartisan law,” he said.
The FDA is requiring clear labeling of sesame in food items.Getty Images
With the FDA and the government backing FARE’s efforts, Linde said he expected U.S. brands and manufacturers to respect the law, as well as customer sensitivity to sesame.
But some major food brands, along with “Big Bread” — major U.S. bread suppliers — reportedly skipped over legal accommodations as the Jan. 1 deadline approached, Linde said.
Instead of ensuring the removal of all traces of sesame from products sold to the public — which would necessitate the suppliers clearing appropriate facilities and factory lines of the seed — some major food brands such as Wendy’s, Olive Garden and Chick-fil-A have added more sesame to their menu items instead, said Linde.
This serves as an “economic shortcut” for brands to explicitly label that there is sesame in their products instead of pushing — and funding — clean manufacturing lines, said Linde.
Popular food brands respond to issue
Olive Garden revealed that its suppliers have added less than 2% more sesame flour to their breadsticks due to “the potential for cross-contamination at the bakery,” the company said in a statement to Fox News Digital.
“We have updated our allergen guide accordingly and are sharing this information with our guests,” Olive Garden said.
Olive Garden is one major chain that has added more sesame to its menu.Icon Sportswire via Getty Images
Wendy’s has reportedly added sesame flour to its buns, which the brand credits to a “frequently” evolving menu, in a statement sent to Fox News Digital.
“We take food safety and allergen matters very seriously,” the company said in the statement.
“Like others in the restaurant industry, Wendy’s nutrition and allergen information was updated recently to include sesame, where applicable, in advance of the January 1, 2023, effective date of the FASTER Act,” the statement also said.
Chick-fil-A told Fox News Digital that the brand “did not want” a recipe change for sesame flour to be added to its white and multi-grain brioche buns — but that its bread suppliers found it necessary to do so.
Wendy’s nutrition and allergen information was updated recently to include sesame.Getty Images
“We were informed of the need for this recipe change by our bread suppliers, who are unable to guarantee with certainty that their production lines for our white bun and multi-grain brioche bun are sesame-free,” the company wrote in a statement.
“This is a nationwide issue that is impacting multiple restaurant brands across the country,” the company’s statement also said.
“It’s also important to note that unfortunately, there are no sesame-free bread suppliers that could consistently supply Chick-fil-A’s bread volumes,” the statement also noted.
A Chick-fil-A spokesperson revealed in a second statement that the company cannot ensure sesame-free menu items due to shared production lines in supplier facilities.
It is an “industry-wide matter” as brands source from multiple suppliers across the nation, the spokesperson reiterated.
While sesame is most frequently found as an ingredient in baked goods such as cookies, crackers and breads, the baking industry is reportedly a major player in adding sesame to products, said Linde.
ABA is not responding, says Linde
Ahead of the news that sesame would be considered a major allergen, Linde revealed that the American Bakers Association (ABA) publicly ensured its ability to comply.
During a July 2021 episode of the podcast “Bake to the Future,” ABA regulatory expert Meaghan Meyer said that even though compliance with the FASTER Act is a complex matter for bakeries, she understands that it’s the “right thing to do.”
ABA regulatory expert Meaghan Meyer calls FASTER Act the “right thing to do.”Getty Images
“We understand the importance,” she said. “We understand that our consumers need it … and we have to adapt to that,” she said in her podcast appearance.
Meyer added that creating sesame-free operations is doable since ABA has “had the practice” and the experience.
“It’s going to push bakers to think more creatively and to definitely do deeper dives into their equipment design and their sanitation practices,” she also said at the time.
But the ABA has yet to crack down on clean lines as time has run out, Linde said.
And despite ongoing conversations in which FARE encouraged the ABA to “do the right thing,” Linde revealed that the association assumedly made an “economical decision.”
“They just decided that they would comply by taking, frankly, a regulatory shortcut,” he said.
Fox News Digital reached out to the American Bakers Association but did not hear back.
FDA weighs in on sesame issue
The FDA “does not support” the workaround from these brands, but they’re technically not disobeying the law, the agency said in a statement to Fox News Digital.
Sesame seeds covered bread.Universal Images Group via Getty
“While a practice of adding sesame and then declaring it on the label is not violative, it would make it more difficult for sesame allergic consumers to find foods that are safe for them to consume, a result that the FDA does not support,” the FDA said.
“Requirements for allergen labeling apply to both domestically produced and imported products. It is the responsibility of the companies to ensure that their products meet applicable FDA requirements.”
Other countries have incorporated safety measures
Creating sesame-free environments and offering clear labeling for consumers is accomplished “every day” in other countries, Linde said.
“Canada has labeled sesame for years,” he said. \
“And what we can’t understand is why a bakery in Toronto can somehow magically remove sesame, yet a bakery in Tennessee just can’t.”
He added, “It’s just disappointing and frustrating.”
The “bottom line” for these organizations, according to Linde, is that they just don’t want to spend the money on these production changes.
“It’s just that simple,” he said.
FARE is still “very hopeful” that these large brands and bakers will “demand changes” and recognize that sesame-free food items are attainable, Linde said.
“The easiest fix is for the bakers to realize they’ve made a strategic mistake and say, ‘We want to serve this community,’” he added.
We’re going to follow the spirit, intent and the letter of the law,” he continued.
“We’re going to clean our lines, like our colleagues do in Canada and in the EU and in Australia and in New Zealand. And we’re going to do the right thing.’”
A Canadian TV reporter suffered a frightening medical emergency during a live broadcast on Sunday, telling the station’s news anchor, “I’m not feeling very well right now.”
Jessica Robb, a reporter with CTV, was reporting to anchor Nahreman Issa from the field in Edmonton when she began stumbling over her words and having difficulty completing a sentence.
“Sorry, Nahreman,” Robb said in footage aired by TMZ on Monday. “I’m not feeling very well right now and I’m about to…..”
Robb’s words fade off and she can be seen starting to lose her balance on the air.
“We will make sure that Jessica is OK, and we’ll give you guys an update a little bit later,” Issa says back in the studio.
“On Sunday night, a very personal and vulnerable moment unfolded as I reported live on air,” Robb says in the statement. “Since then, it has been shared thousands of times, along with baseless theories about the cause.
Canadian TV reporter Jessica Robb suffered a frightening medical emergency while reporting from the field in Edmonton. She assured viewers on Monday that she’s fine.CTV News Edmonton
“To everyone who has reached out with supportive messages of well wishes and concern, thank you,” she wrote. “It has been overwhelming, and while I can’t get to all the messages, please know I’ve seen them and appreciate every single one.
“I have also received an overwhelming amount of harassment and hatred, tied to false theories about the reason for the incident,” Robb said. “While I will not share private medical information publicly, I can say that there is no cause for concern and that my understanding of my own medical background provides a reasonable explanation for what happened.
“I can, however, confirm that the situation was in no way related to the COVID-19 vaccine.”
The Biden administration is considering a nationwide ban on gas stoves — citing the harmful pollutants released by the appliances, according to a report.
The Consumer Product Safety Commission is mulling the action after recent studies showed emissions from the devices can cause health and respiratory problems, Bloomberg reported Monday.
“This is a hidden hazard,” CPSC Commissioner Richard Trumka Jr., told the outlet. “Any option is on the table. Products that can’t be made safe can be banned.”
Reports by groups including the American Chemical Society and New York University Law School’s Institute for Policy Integrity found gas stoves — which are used in about 40% of US homes while the remainder use various forms of electric cookers — emit pollutants like nitrogen dioxide, carbon monoxide and fine matter at levels deemed unsafe by the Environmental Protection Agency and World Health Organization.
The studies also linked gas stoves to respiratory illness, cardiovascular problems, cancer and other health conditions.
More than 12% of childhood asthma cases can be attributed to gas stoves, according to a report published last month by the International Journal of Environmental Research and Public Health.
“There is about 50 years of health studies showing that gas stoves are bad for our health, and the strongest evidence is on children and children’s asthma,” Brady Seals, a manager in the carbon-free buildings program at the nonprofit clean energy group RMI and a co-author of the study, told Bloomberg. “By having a gas connection, we are polluting the insides of our homes.”
A report last month found gas stoves contributed to 12% of childhood asthma cases.Getty Images
Short of barring the manufacture or importation of gas stoves, the CPSC could also impose emissions standards, Trumka said.
The agency is expected to open public comment on gas stove hazards later this year, he said.
Democratic Sen. Cory Booker of New Jersey and Rep. Don Beyer of Virginia sent a letter to the agency in December urging it to take action against the appliances, saying they are a “cumulative burden” on minority and low-income households.
The association that represents gas stove makers like Whirlpool contends that cooking on any type of stove produces harmful emissions.
“Ventilation is really where this discussion should be, rather than banning one particular type of technology,” said Jill Notini, a vice president with the Association of Home Appliance Manufacturers.
“Banning one type of a cooking appliance is not going to address the concerns about overall indoor air quality,” she added. “We may need some behavior change, we may need [people] to turn on their hoods when cooking.”
