BREXAFEMME, an oral, non-azole medication, is the first and only FDA-approved therapy for both the treatment of vulvovaginal candidiasis (VVC) and the reduction in the incidence of recurrent VVC.
Approval is based on pivotal Phase 3 CANDLE data demonstrating statistically significant superiority of ibrexafungerp over placebo for primary and key secondary endpoints.
Getlabs, the leader in providing nationwide infrastructure for remote health care delivery, and Sonora Quest Laboratories, Arizona's leading diagnostic testing laboratory, today announced that Getlabs' application programming interface (API) will be added to Sonora Quest's website. This integration allows patients to easily select and schedule an at-home sample collection when booking appointments through Sonora Quest's website, increasing the ease of access to vital health testing.
Patients booking labs through the Sonora Quest website can now select "home collection [let Getlabs come to me]" and schedule an appointment for in-home lab draws in Phoenix and Tucson metro areas at a time and location that is most convenient for them. A phlebotomist from Getlabs will arrive at the patient's scheduled time and location to collect a blood sample. Samples collected by Getlabs in Arizona are then sent to Sonora Quest's laboratories for testing, with results reported to the patient's ordering health care provider and in Sonora Quest's patient dashboard: sonoraquest.com/results.
Getlabs' API handles real-time scheduling and is fully HIPAA compliant, with personal information securely encrypted and protected, and only used for scheduling and care coordination. API integration into SonoraQuest.com makes the process seamless, letting patients more easily schedule their mobile appointment, receive appointment notifications and updates, and manage their appointments in their patient dashboard.
https://finance.yahoo.com/news/sonora-quest-streamlines-access-home-145300374.html
FDA Fast Track designation granted after presentation at the SITC 37th Annual Meeting demonstrating 69% objective response rate
Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation.
https://finance.yahoo.com/news/oncolytics-biotech-receives-fda-fast-123200369.html
The near year-long infant formula shortage in the United States that prompted the intervention of the White House is likely to "persist" until spring, according to Reckitt Benckiser, the maker of what is now the biggest brand in the market, Enfamil. Panicked parents had earlier this year emptied the baby formula aisles at supermarkets after former top U.S. manufacturer Abbott Laboratories in February recalled dozens of types of its Similac, Alimentum and EleCare formulas.
The products, made at a plant in Michigan, were pulled after complaints of bacterial infections. Supermarkets like Target and Walgreens Boots Alliance were forced to limit its sales, putting pressure on the Biden administration to address the crisis.
The White House in May took steps to address the shortage, invoking the Defense Production Act to help manufacturers obtain the ingredients needed to ramp up supply.
Supplies are yet to return to normal since the peak of the crisis in May and June, despite the U.S. making progress in replenishing stocks, said Robert Cleveland, Reckitt senior vice president, North America and Europe Nutrition.
"I suspect that will persist to some degree until the spring resets," he said. "When we talk about the crisis we talk about the condition of the shelves and how they appear to consumers, and how well that shelf meets their needs."
Rival manufacturer Perrigo Company Plc declined to comment, while Danone, maker of Aptamil, did not immediately respond to a request for comment.
Since the Abbott recall, share of Reckitt in the infant formula market has skyrocketed, making it the No.1 supplier in the United States.
The British company has yet to see its newfound popularity recede as Cleveland said its just over 50% of the market has "remained relatively unchanged" since earlier this year.
Its top position has been further boosted by the United States saying it will temporarily cover the cost of baby formula for low-income families dependent on government discounts in states contracted with the company.
Companies normally bid for state contracts to be the sole provider of baby formula for low-income families under the Women, Infants and Children (WIC) programme. In their bids, they offer a "rebate" in the form of discounts to the states.
The government's intervention, aimed at incentivising firms to boost supplies effectively covers that rebate.
Reckitt has said its formula factories are operating 24/7, and it was feeding more than 40% of all low-income WIC infants.
"Certainly at some point in the future, we expect they (the United States Department of Agriculture) will want to return the programme to normal," Cleveland said.
"What we're telling them is to give us enough notice - to put, essentially, a date on the calendar....don't try to shock the system by making it happen too quickly - give us time to adjust because we'll have to adjust our production, we'll have to adjust our distribution," he said.
By capitalizing on the long half-life of tumor targeting Quatramers™ combined with OmniTaur™-derived Picobodies™, the lead program, HSB-1940, is being developed to target PD-1
Picobodies are the smallest known antibody fragment, comprised of ultra-long CDR H3 sequences of 30-40 amino acids rich with cysteines that create tightly folded structures capable of binding recessed epitopes
Hillstream BioPharma, Inc. (Nasdaq: HILS) (“Hillstream”, the “Company”) today announced the development of proprietary targeted biologics, Knob Quatrabodies™ (HSB-1940) against PD-1. Hillstream signed separate collaboration agreements with a subsidiary of OmniAb, Inc. (Nasdaq: OABI) (“OmniAb”) and with Minotaur Therapeutics, Inc. (“Minotaur”) to advance Picobodies against novel, unreachable and undruggable epitopes in high-value validated targets starting with PD-1.
The technologies of Hillstream and Minotaur will be combined under a previously disclosed license from OmniAb to discover, develop and advance biotherapeutics against high-value validated targets. Picobodies are antibody “knob” domains comprised of cysteine-rich ultralong complementary determining region (CDR) H3 sequences of 30-40 amino acids, which have the potential to access challenging epitopes better than full size antibodies can.
https://finance.yahoo.com/news/hillstream-biopharma-announces-development-proprietary-134700747.html
