Regulation of tobacco by the U.S. Food and Drug Administration

Aziyo Biologics Provides Update on FDA Submission for CanGaroo® RM Antibacterial Envelope

Retrieved on: 
Monday, March 20, 2023
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SILVER SPRING, Md., March 20, 2023 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, provides an update on its submission to the U.S. Food and Drug Administration (FDA) for the CanGaroo® RM Antibacterial Envelope, the Company’s next-generation biomaterial envelope.

Key Points: 
  • SILVER SPRING, Md., March 20, 2023 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, provides an update on its submission to the U.S. Food and Drug Administration (FDA) for the CanGaroo® RM Antibacterial Envelope, the Company’s next-generation biomaterial envelope.
  • The device is intended to securely hold a cardiac implantable electronic device or neurostimulator, creating a stable environment when implanted in the body.
  • The CanGaroo RM Antibacterial Envelope contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope.
  • As previously announced, the Company submitted a 510(k) premarket notification for the CanGaroo RM Antibacterial Envelope to the FDA in April 2022 .

NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients

Retrieved on: 
Monday, March 20, 2023
Surgeon, Elective surgery, Spine, NUVA, NuVasive, Acquisition, Patient, Standard of care, SAN, LLD, Sinai Hospital, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, NSO, Food, Nursing, Medical device, S

The expanded clearance extends the clinical benefits of Precice to a wider range of patients.

Key Points: 
  • The expanded clearance extends the clinical benefits of Precice to a wider range of patients.
  • "Everyone faced with limb length discrepancy (LLD), especially pediatric patients, should have access to a non-invasive limb lengthening solution," said Pete Ligotti, leader of NuVasive Specialized Orthopedics (NSO).
  • As a division of NuVasive, NSO is focused on the design and innovation of disruptive orthopedic solutions for complex orthopedic reconstruction and limb lengthening.
  • "Precice has over a decade's worth of clinical data and has truly changed the standard of care for my patients," said Dr. John Herzenberg, director of pediatric orthopedics at Sinai Hospital.

Milla Pharmaceuticals Inc. and the Alter Pharma Group Announce Launch of a Generic Version of Magnesium Sulfate in Water for Injection, in Non-PVC, Single-Patient Use Containers by Their Partner Athenex Pharmaceutical Division (APD)

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Monday, March 20, 2023
Supply Chain Management, Retail, Health, FDA, General Health, Pharmaceutical, Biotechnology, Seizure, Central nervous system, Eclampsia, Paracetamol, Convulsion, Water, Magnesium sulfate, Multimedia, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Hospital, Sodium acetate, Acquisition, Patient, APD, Plasma protein binding, Injection, Pre-eclampsia, Infant, ANDA, ASHP, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, EU

View the full release here: https://www.businesswire.com/news/home/20230320005186/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230320005186/en/
    Alter Pharma #MakingAffordableMedicinesAvailableToAll Every day we ensure equal access to medicines and continuity of treatment for patients.
  • (Graphic: Business Wire)
    Magnesium Sulfate Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia.
  • This latest launch of Magnesium Sulfate Injection will help reduce the recent supply issues for the product experienced in the U.S.
  • This achievement marks the second ANDA commercialization for Milla Pharmaceuticals Inc. and the third for an Alter Pharma Group product in the U.S. market.

Voluntary Recall of One Lot of Kaytee® Wild Bird Food Birders’ Blend, 8 Lb. Bag, Due to Elevated Levels of Aflatoxin

Retrieved on: 
Saturday, March 18, 2023
Family, Retail, Other Consumer, Consumer, Seniors, Specialty, Pets, Food, CST, Regulation of tobacco by the U.S. Food and Drug Administration, Southeastern United States, GA, Safety

The affected wild bird product was packaged in clear plastic bags and shipped to ACE Hardware Distribution Centers in AL, FL, and GA, which service neighborhood hardware stores in the Southeastern United States.

Key Points: 
  • The affected wild bird product was packaged in clear plastic bags and shipped to ACE Hardware Distribution Centers in AL, FL, and GA, which service neighborhood hardware stores in the Southeastern United States.
  • Retailers who received the affected wild bird product have been contacted and asked to pull them from their inventory and shelves.
  • No adverse health effects have been reported with respect to the affected wild bird product at this time.
  • Consumers who have purchased the recalled wild bird product should return it to the place of purchase for a full refund.

The Law Offices of Frank R. Cruz Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Y-mAbs Therapeutics, Inc. (YMAB)

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Friday, March 17, 2023
Class Action Lawsuit, Professional Services, Legal, Neuroblastoma, Advisory Committee, Law, CNS, Suite, Patient, Court, Defendant, FDA, Therapy, Regulation of tobacco by the U.S. Food and Drug Administration, BLA, News, Food, Cryptocurrency, Pharmaceutical industry

On October 26, 2022, the FDA released its briefing document in advance of its Advisory Committee meeting to discuss the omburtamab BLA.

Key Points: 
  • On October 26, 2022, the FDA released its briefing document in advance of its Advisory Committee meeting to discuss the omburtamab BLA.
  • On this news, Y-mAbs’s stock price fell $4.16, or 27.4%, to close at $11.01 per share on October 26, 2022, thereby injuring investors.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Trinity Biotech plc to Announce Fourth Quarter and Fiscal Year 2022 Financial Results

Retrieved on: 
Thursday, March 16, 2023
Research, Chemistry, Plasma, Serum, Regulation of tobacco by the U.S. Food and Drug Administration, Coronavirus, Glycated hemoglobin, Disease, COVID-19, Hemoglobin, Infection, Food

Certain statements made in this release that are not historical are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Key Points: 
  • Certain statements made in this release that are not historical are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
  • The words “estimate”, “project”, “intend”, “expect”, “believe” and similar expressions are intended to identify forward-looking statements.
  • Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market.
  • Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide.

Eton Pharmaceuticals Reports Fourth Quarter 2022 Financial Results

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Thursday, March 16, 2023
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DEER PARK, Ill., March 16, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the quarter ended December 31, 2022.

Key Points: 
  • DEER PARK, Ill., March 16, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the quarter ended December 31, 2022.
  • Eton reported fourth quarter 2022 product sales and royalty revenue of $3.5 million, representing 220% growth over the prior year and 9% growth over the third quarter of 2022.
  • The Company expects the sequential growth rate to increase in the first quarter of 2023 compared to the fourth quarter of 2022.
  • As previously announced, Eton Pharmaceuticals will host a its fourth quarter 2022 conference call as follows:

Paxlovid associated with lower risk of hospital admission

Retrieved on: 
Thursday, March 16, 2023
Kaiser Permanente, Hospital, Regulation of tobacco by the U.S. Food and Drug Administration, Risk, Immunity, Coronavirus, Vaccination, Doctor of Philosophy, COVID-19, Food, Death, Nirmatrelvir/ritonavir, Pfizer, Patient, Pharmaceutical industry, Lancet

PASADENA, Calif., March 16, 2023 /PRNewswire/ -- A Kaiser Permanente study confirms the benefit of nirmatrelvir-ritonavir, also known as Paxlovid, as an early-stage treatment to prevent hospitalization for people with mild to moderate COVID-19, regardless of prior immunity or age. The study was published March 15, 2023, in Lancet ID.

Key Points: 
  • Paxlovid is an oral therapeutic drug aimed at reducing the risk for severe outcomes of coronavirus infection.
  • In the study population, 7,274 people had received Paxlovid, and 126,152 had not received Paxlovid.
  • Effectiveness in preventing hospital admission or death within 30 days after a positive test was 80% for people who were dispensed Paxlovid within 5 days after symptom onset.
  • Within the subgroup of patients who were dispensed Paxlovid on the day of their positive COVID-19 test, effectiveness was 90%.

Glenmark receives acceptance from U.S. FDA on its IND application for GRC 54276 to proceed with a Phase 1/2, first-in-human clinical study of the molecule for the treatment of patients with advanced solid tumors and lymphomas

Retrieved on: 
Thursday, March 16, 2023
GRC, MD, Regulation of tobacco by the U.S. Food and Drug Administration, Trial of the century, Lymphoma, Patient, HPK1, FDA, Safety, Immune system, Cancer, Food, Pharmacokinetics, IND, Pharmaceutical industry

GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark.

Key Points: 
  • GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark.
  • HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle making it an attractive target for immuno-oncology.
  • By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient's own immune system to fight cancers.
  • "Now that the FDA has accepted our IND application, we look forward to initiating the ongoing Phase 1/2 study at the US sites.

Elevar Therapeutics to Present Clinically Supported Poster at AACR 2023 Demonstrating Rivoceranib as a Potent, and Most Selective, TKI for VEGFR-2

Retrieved on: 
Thursday, March 16, 2023
Progression-free survival, Poster, Society, AACR, Sorafenib, Therapy, Regulation of tobacco by the U.S. Food and Drug Administration, American Society of Clinical Oncology, American Association for Cancer Research, HCC, Congress, Neoplasm, Hepatocellular carcinoma, ESMO, Patient, TKI, Oncology, Orange County Convention Center, FDA, ASCO, Adenoid cystic carcinoma, European Society for Medical Oncology, ACC, Food, NDA, Liver cancer, Pharmaceutical industry

The poster, “Comparative biochemical kinase activity analysis identifies rivoceranib as the most selective VEGFR-2 inhibitor compared with other TKIs with known activity against VEGFR-2,” will be presented Tuesday, April 18.

Key Points: 
  • The poster, “Comparative biochemical kinase activity analysis identifies rivoceranib as the most selective VEGFR-2 inhibitor compared with other TKIs with known activity against VEGFR-2,” will be presented Tuesday, April 18.
  • Elevar in September 2022 announced during the annual Congress of the European Society for Medical Oncology (ESMO) that in its Phase 3 CARES 310 study , camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and improved overall response rate versus sorafenib, a standard first-line treatment for unresectable HCC.
  • The company intends to submit a New Drug Application (NDA) and Biologics License Application for the combination to the U.S. Food and Drug Administration (FDA) during the first half of 2023.
  • There are no currently approved therapies for ACC and the trial was the largest to date in ACC to show this level of effectiveness.