Fintel reports that on May 1, 2023, Cantor Fitzgerald maintained coverage of Pliant Therapeutics (NASDAQ:PLRX) with a Overweight recommendation.
Monday, May 1, 2023
Nanox.ARC Imaging System Receives FDA Clearance
Nano-X Imaging LTD.
Nanox.ARC
Nanox.ARC
Nanox.ARC presents high powered digital X-ray tubes for 3D tomosynthesis imaging
Nanox.ARC could help expand the availability of medical imaging
NANO-X IMAGING LTD ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the multi-source Nanox.ARC, including the Nanox.CLOUD, its accompanying cloud-based infrastructure. Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography on adult patients. Representing a major advancement in X-ray technology, Nanox.ARC is a multi-source digital 3D tomosynthesis system that utilizes novel, cold cathode X-ray tubes, which the Company intends to offer using an innovative pay-per-scan business model.
The FDA cleared Nanox.ARC for use in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicians, and has the potential to increase availability to medical imaging around the world, once approved by local regulatory authorities and deployed at scale.
The Company received 510(k) clearance to market its single-source X-ray device, known as the Nanox Cart X-Ray System, in April 2021. The multi-source Nanox.ARC has the ability to reconstruct a series of 2D projection images into a stack of tomograms (or slices) of the imaged object, forming a 3D visualization. This visualization reduces the effect of overlying structures and provides in-depth information on structures of interest.
https://finance.yahoo.com/news/nanox-arc-imaging-system-receives-124600793.html
Bausch Unit Applies to Trial Acme Treatment
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its dermatology business, Ortho Dermatologics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational IDP-126 (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) Gel with a Prescription Drug User Fee Act (PDUFA) action date of October 20, 2023. If approved, IDP-126 has the potential to be the first of its kind fixed dose triple combination treatment for acne vulgaris.
https://finance.yahoo.com/news/ortho-dermatologics-announces-u-food-120000549.html
Eagle Gets Compensation Code for Sedative from CMS
Byfavo1 is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that the Centers for Medicare & Medicaid Services (“CMS”) has established a unique, product-specific billing code for Byfavo®1 (remimazolam for injection), a short-acting sedative for procedures lasting 30 minutes or less. This new Healthcare Common Procedure Coding System (HCPCS) Level II code (“J-code”) is J2249 “Injection, remimazolam, 1 mg.” The J-code will be effective on July 1, 2023.
J-codes are reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for physician-administered drugs like Byfavo and are intended to simplify the claims submission and documentation process, facilitating access for patients.
https://finance.yahoo.com/news/eagle-pharmaceuticals-granted-unique-j-105000209.html
Kiromic Gets OK of IND to Initiate Phase 1 in Non-Small Cell Lung Cancer
Kiromic BioPharma, Inc. (NASDAQ: KRBP) (“Kiromic” or the “Company”), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, today announces that the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (IND) application to initiate a Phase 1 clinical trial to evaluate Deltacel (KB-GDT-01) for patients with non-small cell lung cancer (NSCLC).
Deltacel is the Company’s allogeneic, non-engineered, off-the-shelf Gamma Delta T-cell (GDT) therapy. Notably, Deltacel does not require the use of any viral vector as many other cell therapies do, which, among other advantages, allows for reduced manufacturing costs. Kiromic is seeking to address a significant unmet need by applying cell therapy to treat solid malignancies, which comprise 90% of all cancers, including NSCLC. Lung cancer is by far the leading cause of cancer death in the US, accounting for about 1 in 5 of all cancer deaths. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.
FDA Greenlights First Bi-Monthly Injectable for Schizophrenia, Bipolar 1 Disorder
Friday, the FDA approved Otsuka and Lundbeck’s extended-release injectable formulation of aripiprazole, now to be marketed as Abilify Asimtufii, for the treatment of schizophrenia or as maintenance therapy for bipolar I disorder.
Abilify Asimtufii is the first long-acting injectable for these indications that only needs to be administered once every two months, according to the companies. The new formulation is approved for use in adult patients.
Otsuka and Lundbeck supported Abilify Asimtufii’s FDA bid with data from the pivotal 031-201-00181 trial, which compared its efficacy with another aripiprazole formulation, the 400-mg once-monthly Abilify Maintena, in the same indications.
Pharmacokinetic analyses showed that a 960-mg, once-every-two-month dosing regimen induced similar plasma aripiprazole concentrations as the once-per-month version, Abilify Maintena.
As for safety, the study found that even at multiple doses, the 960-mg Abilify Asimtufii dose is generally well-tolerated and has a similar adverse event profile to Abilify Maintena.
These results validate the established safety and efficacy profile of the once-monthly aripiprazole injection, while also enabling the companies to offer new treatment options that provide patients with schizophrenia and bipolar I disorder more flexibility, Johan Luthman, executive vice president, Lundbeck Research & Development, said in a statement.
In its approved form, Abilify Asimtufii comes in 960-mg and 720-mg prefilled syringes, both of which are designed to deliver doses that lead to sustained plasma levels of aripiprazole. The drug is delivered by a healthcare professional through an intramuscular injection to the gluteal muscle.
Abilify Asimtufii’s label contains a warning for an increased risk of death for elderly people who are experiencing psychosis due to dementia and are being treated with antipsychotic drugs. The drug might also lead to stroke, neuroleptic malignant syndrome, uncontrolled body movements and metabolic problems.
Friday’s approval pits Otsuka and Lundbeck against Johnson & Johnson in the schizophrenia market. In September 2021, J&J subsidiary Janssen won FDA approval for Invega Hafyera (paliperidone palmitate six-month), its long-acting injection for schizophrenia designed to be administered twice a year.
Data from a Phase III non-inferiority study found that Invega Hafyera was just as effective as a three-month formulation of paliperidone palmitate. Another study, dubbed Route 6, showed that the six-month formulation can prevent relapses in over 90% of patients throughout one year of treatment.
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