Syncope

Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals") launches MOTPOLY XR™ (lacosamide) extended-release capsules C-V, the first, and only once-daily formulation of lacosamide

Retrieved on: 
Monday, February 26, 2024

MOTPOLY XR is approved for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.

Key Points: 
  • MOTPOLY XR is approved for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.
  • MOTPOLY XR is bioequivalent to Vimpat® (lacosamide) film-coated tablets, C-V and provides a new once-daily option at equivalent doses.
  • "MOTPOLY XR marks a major milestone for Aucta as our 1st branded pharmaceutical product to enter the US market.
  • To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Curis Announces Initial Combination Study Data from its TakeAim Lymphoma Study

Retrieved on: 
Tuesday, December 12, 2023

LEXINGTON, Mass., Dec. 12, 2023 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced initial combination study data from its TakeAim Lymphoma trial including 5 primary CNS lymphoma (PCNSL) patients.

Key Points: 
  • LEXINGTON, Mass., Dec. 12, 2023 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced initial combination study data from its TakeAim Lymphoma trial including 5 primary CNS lymphoma (PCNSL) patients.
  • "We are very pleased with the initial emavusertib/ibrutinib combination data from the TakeAim Lymphoma study.
  • As of October 12th, the TakeAim Lymphoma trial has enrolled and treated 19 Non-Hodgkin Lymphoma (NHL) patients, with a combination of emavusertib and ibrutinib; with emavusertib doses ranging from 100 mg to 300 mg BID.
  • These data underscore the potential of emavusertib to re-sensitize patients to BTKi therapy, marking a significant advancement in Non-Hodgkin Lymphoma treatment.

Physician identifies types of fainting and when to seek medical attention

Retrieved on: 
Tuesday, September 12, 2023

LOMA LINDA, Calif., Sept. 12, 2023 /PRNewswire-PRWeb/ -- Roughly three in four Americans have fainted or know someone who has fainted, according to a national survey by Syncope Trust and Reflex Anoxic Seizures. Syncope, the medical term for fainting or passing out, is a temporary loss of consciousness and could indicate an underlying cardiac condition.

Key Points: 
  • Syncope, the medical term for fainting or passing out, is a temporary loss of consciousness and could indicate an underlying cardiac condition.
  • In anticipation of October's Sudden Cardiac Arrest (SCA) Awareness Month, Contactor describes types of fainting, what fainting may signal about your heart health, and why you should seek medical attention directly after experiencing an episode to find out.
  • The most common type of syncope is vasovagal: fainting from a sudden drop in heart rate and blood pressure.
  • Contractor warns to seek medical attention after any fainting episode, even if you suspect the cause was fatigue, heat, dehydration, or an emotional response.

Danco Statement on Filing of Cert Petition, September 8, 2023

Retrieved on: 
Friday, September 8, 2023

Danco remains confident in the safety and effectiveness of Mifeprex® under the 2023 REMS that currently governs its use.

Key Points: 
  • Danco remains confident in the safety and effectiveness of Mifeprex® under the 2023 REMS that currently governs its use.
  • The changes in 2016 and 2021—approved by FDA after careful analysis—have expanded the availability and use of Mifeprex®, providing crucial individual and public health benefits.
  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use.
  • The frequency of adverse reactions varies between studies and may be dependent on many factors including the patient population and gestational age.

Danco Statement on 5th Circuit Ruling, August 16, 2023

Retrieved on: 
Thursday, August 17, 2023

NEW YORK, Aug. 16, 2023 /PRNewswire/ -- The Fifth Circuit panel's decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges.

Key Points: 
  • NEW YORK, Aug. 16, 2023 /PRNewswire/ -- The Fifth Circuit panel's decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges.
  • Danco remains confident in the safety and effectiveness of Mifeprex® and committed to making the drug available as broadly as possible.
  • Danco will continue to be at the forefront of this fight, working closely with the reproductive rights community and pharmaceutical industry, as this case moves forward.
  • Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000.

Amneal Launches Authorized Generic for Xyrem® (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter

Retrieved on: 
Monday, July 3, 2023

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 4 mcg/mL (200 mcg/50 mL and 400 mcg/100 mL) is a generic version of Precedex® Injection.

Key Points: 
  • Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 4 mcg/mL (200 mcg/50 mL and 400 mcg/100 mL) is a generic version of Precedex® Injection.
  • For full prescribing information, see package insert located here .
  • Nelarabine injection, 250mg/50mL (5mg/mL) is a generic version of Arranon® Injection.
  • Patients must be enrolled in the XYWAV and XYREM REMS to receive Sodium Oxybate Oral Solution.

Enanta Pharmaceuticals Announces Positive Data From a Phase 1 Clinical Study of EDP-323, an Oral, L-Protein Inhibitor in Development for the Treatment of Respiratory Syncytial Virus

Retrieved on: 
Tuesday, June 20, 2023

EDP-323, which received Fast Track designation from the U.S. Food and Drug Administration (FDA), is a novel L-protein inhibitor in development as a once-daily oral treatment for respiratory syncytial virus (RSV).

Key Points: 
  • EDP-323, which received Fast Track designation from the U.S. Food and Drug Administration (FDA), is a novel L-protein inhibitor in development as a once-daily oral treatment for respiratory syncytial virus (RSV).
  • Data from the Phase 1 study demonstrated favorable safety, tolerability, and PK supportive of once-daily dosing, with good exposure multiples, thereby supporting further clinical advancement of EDP-323.
  • “With the significant unmet need for effective antivirals to treat patients with RSV, we are pleased to report positive Phase 1 results for EDP-323.
  • Based on these positive data, Enanta plans to initiate a human challenge study evaluating EDP-323 by early fourth quarter of 2023.

Pyxis Oncology to Acquire Apexigen

Retrieved on: 
Wednesday, May 24, 2023

ET

Key Points: 
  • ET
    BOSTON and SAN CARLOS, Calif., May 24, 2023 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (“Pyxis Oncology”) (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, and Apexigen, Inc. (Nasdaq: APGN), a clinical-stage biopharmaceutical company focused on discovering and developing innovative antibody therapeutics for oncology, today announced a definitive agreement by which Pyxis Oncology will acquire Apexigen in an all-stock transaction for an implied value of $0.64 per Apexigen share.
  • Apexigen and Pyxis Oncology share a common vision of bringing innovative solutions to oncology patients.
  • Under the terms of the definitive merger agreement, Pyxis Oncology expects to issue approximately 4.4 million shares of its common stock to Apexigen stockholders to acquire Apexigen.
  • For each share of Apexigen common stock, Pyxis Oncology will issue 0.1725 shares of its common stock, par value $0.001 per share.

SCOTUS Issues Stay

Retrieved on: 
Saturday, April 22, 2023

NEW YORK, April 21, 2023 /PRNewswire/ -- We at Danco are gratified the Supreme Court has granted a stay, which keeps the approval of Mifeprex intact without any changes. This stay is an important step in maintaining access to medication abortion during the litigation. Danco stands by the well-established safety profile of Mifeprex and FDA's repeated and careful review of the data and literature in approving the drug and modifying the conditions under which it is available. We remain committed to working with healthcare providers, patients and state and federal governments to keep Mifeprex available and accessible.

Key Points: 
  • This stay is an important step in maintaining access to medication abortion during the litigation.
  • Danco: Gratified the Supreme Court has granted a stay, which keeps the approval of Mifeprex intact without changes.
  • Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000.
  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use.

-SCOTUS Issues Administrative Stay-

Retrieved on: 
Saturday, April 15, 2023

NEW YORK, April 14, 2023 /PRNewswire/ -- This afternoon, the US Supreme Court issued an administrative stay of the April 7 order from Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas.  This administrative stay, which runs until midnight on April 19, is a temporary measure that contemplates the Court ruling by then on applications from Danco and the federal government for a broader stay. 

Key Points: 
  • The administrative stay issued today stops Judge Kacsmaryk's order for the time necessary for the Supreme Court to rule on the requests for a full stay.
  • The administrative stay means that the approved status of Mifeprex remains unchanged, including the 2023 revisions to the REMS that allow for dispensing from certified pharmacies and by mail.
  • "It is temporary, but we look forward to the careful consideration we know the Court will give to these important issues.
  • "  Because of the Court's administrative stay, Mifeprex remains approved for use through 70 days' gestation and with the dosing regimen approved in 2016.