Rafa has obtained the Food and Drug Administration’s clearance for its 10 mg midazolam auto-injector for the treatment of status epilepticus in adults.
The Midazolam 10 mg auto-injector is indicated for the treatment of status epilepticus, or prolonged seizures, in adults. As such, this new auto-injector can be used to treat seizures resulting from nerve agent exposure. According to the U.S. JPEO-CBRND, the auto-injector will replace the currently fielded convulsant antidote for the nerve agent diazepam autoinjector.
Rafa’s innovation resides in the use of an auto-injector to be administered intramuscularly to the thigh (can be administered through clothes as well), in a manner that does not require an intravenous line. This is a significant advantage in a field setting during an emergency when fast treatment reduces the likelihood of permanent damage that could result from a continuous seizure, the company said.
“We are proud of the FDA approval for this lifesaving product,” said Amir Levin, CEO of Rafa. “It is made in Israel and is meaningful news to the world of medical emergency solutions, thus strengthening Rafa’s key role in providing reliable products to armies, governments and first responders worldwide.”
The product is made at Rafa’s manufacturing site in Jerusalem and is already sold under EUA in other territories.
“The usability of the auto-injector has a significant medical advantage in its immediate treatment effect, as well as in reducing long-term damage,” said Roy Shay, head of emergency solutions at Rafa. “Clinical studies confirmed the correlation between early treatment of status epilepticus and a reduced risk of an ongoing and irreversible neurological damage. This product could assist in saving many lives around the globe.”
NACDS announces 2022 Total Store Expo showcase winners
The National Association of Chain Drug Stores has announced the winners of the 2022 Total Store Expo Product Showcase.
Products ranging from home health care to baby care and household products were on display in the Product Showcase on the exhibit floor — which provided increased visibility for suppliers to market their products to retailers.
Evaluated by the retail attendees, the winners of this year’s Product Showcase are:
Company: Xtreme Beauty International / OKAY
Name of Product: OKAY Baby Care
Company: E.&J. Gallo Winery
Name of Product: High Noon Seltzers Tailgate Pack
Cosmetics & Fragrances:
Company: Kiss Products
Name of Product: Kiss Falscara
Company: American Greetings
Name of Product: Magic Moments by American Greetings
Company: Liquid I.V.
Name of Product: Liquid I.V. Energy Multiplier — Yuzu Pineapple
Home Health Care:
Company: Gateway Genomics
Name of Product: SneakPeek Early Gender DNA Test
Household Products/Non-Edible Consumables:
Name of Product: LooLoo Touchless Toilet Spray
Company: GESKE Beauty Tech GmbH
Name of Product: SmartAppGuided Skincare Products
Pharmacy Operations Equipment and Services:
Name of Product: ScriptSave Personalized Wellness Healthcare
NACDS congratulated the winners of the 2022 Showcase and thanked the myriad participants whose new merchandising ideas and products made the event even more valuable for meeting attendees.
FDA gives Incyte approval for new Pemazyre indication
Incyte has received the Food and Drug Administration’s clearance for Pemazyre (pemigatinib), a selective fibroblast growth factor receptor inhibitor.
The medication is indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.
“The approval of Pemazyre represents an important treatment advancement for people living with MLNs with FGFR1 rearrangement who currently have limited treatment options,” said Hervé Hoppenot, CEO of Incyte. “These are complex hematologic malignancies with a range of presentations, and this approval highlights Incyte’s continued leadership and commitment to advancing care for patients with rare blood cancers.”
MLNs with FGFR1 rearrangement are extremely rare and aggressive blood cancers that may impact less than 1 in 100,000 people in the United States, the company noted.
“In patients with relapsed or refractory MLNs with FGFR1 rearrangement treated with Pemazyre in FIGHT-203, the high rate of complete response and complete cytogenetic response in patients with chronic phase disease and the high rate of complete cytogenetic response in patients with blast phase disease is clinically meaningful, especially in light of the lack of these specific responses with existing first-line treatments,” said Srdan Verstovsek, professor, department of Leukemia, division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and principal investigator for the FIGHT-203 study.
Pemazyre, a fibroblast growth factor receptor inhibitor, is the first targeted treatment approved for use in the United States for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.
Pemazyre also is indicated for the treatment of adults with relapsed or refractory previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on the overall response rate and duration of response. Continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial(s).
Nütrl launches cranberry vodka seltzers in variety pack
The Emerson Group announced that registration is open for Industry Day 2022. The event is slated to take place virtually on Oct. 12.
Guest speakers include: Scott Galloway, NYU professor; Jimmy Chang of Rockefeller Capital; Luca Silipo of Geodis; Indra Nooyi, author and former CEO of PepsiCo; Mindy McKnight, celebrated YouTuber; Colleen Lindholz of Kroger Health; Musab Balbale of CVS Health; Jostein Solheim of Unilever; and Wendy Liebmann of WSL.
Industry conversations include Walmart, CVS Pharmacy, H-E-B, Kroger, Amazon and WSL.
Fall is just around the corner and Premier Protein is the latest brand preparing for the season by announcing the return of a fan-favorite flavor, pumpkin spice.
The brand’s pumpkin spice protein shares are making a return with an even bolder flavor. In addition, it contains 160 calories, 20 g of protein, antioxidants vitamins E and C, and 1 g of sugar per serving, the company said.
Made without the use of artificial colors, Premier Protein’s pumpkin spice protein shakes are gluten-free and will be available for a limited time beginning later this month.