Coma

Crossject announces publication of clinical data on ZEPIZURE ® in Neurology and Therapy

Retrieved on: 
Giovedì, Maggio 30, 2024

ZEPIZURE®, based on the ZENEO® autoinjector and previously known as ZENEO® Midazolam, provides for needle-free delivery of midazolam with significant associated advantages.

Key Points: 
  • ZEPIZURE®, based on the ZENEO® autoinjector and previously known as ZENEO® Midazolam, provides for needle-free delivery of midazolam with significant associated advantages.
  • In addition, ZEPIZURE® enhanced the midazolam absorption during the first minutes post-injection, suggesting that seizure treatment may be efficient sooner.
  • The maximum blood concentration reached with ZEPIZURE® is not above that with Dormicum®, which is a good indication in terms of safety.
  • “The detailed clinical results published today in Neurology and Therapy on ZEPIZURE® are exciting, as they outline quick delivery of a life-saving medicine,” said Patrick Alexandre, CEO of Crossject.

scPharmaceuticals Inc. Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
Martedì, Maggio 14, 2024

BURLINGTON, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the first quarter ended March 31, 2024, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million for the first quarter of 2024, compared to $2.1 million for the first quarter of 2023.
  • Costs of product revenues were $1.8 million for the first quarter of 2024, compared to $0.6 million for the first quarter of 2023.
  • Research and development expenses were $2.7 million for the first quarter of 2024, compared to $2.1 million for the first quarter of 2023.
  • scPharmaceuticals reported a net loss of $14.1 million for the first quarter of 2024, compared to $11.2 million for the first quarter of 2023.

Anebulo Pharmaceuticals Reports Third Quarter Fiscal Year 2024 Financial Results and Recent Updates

Retrieved on: 
Mercoledì, Maggio 15, 2024

Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid toxicities that include acute cannabinoid intoxication (ACI) and unintentional cannabis poisoning (the “Company” or “Anebulo”), today announced financial results for the three months ended March 31, 2024, and recent updates.

Key Points: 
  • Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid toxicities that include acute cannabinoid intoxication (ACI) and unintentional cannabis poisoning (the “Company” or “Anebulo”), today announced financial results for the three months ended March 31, 2024, and recent updates.
  • Our decision to prioritize the development of an intravenous treatment for children is driven by multiple factors.
  • Our prior discussions with United States Food and Drug Administration have highlighted the need for an alternative formulation of selonabant for treating younger patients.
  • Net loss in the third quarter of fiscal 2024 was $1.7 million, or $(0.06) per share, compared with a net loss of $2.8 million, or $(0.11) per share, in the third quarter of fiscal 2023.

New US product, ORMALVI™ (dichlorphenamide) tablets, launches for Primary Periodic Paralysis (PPP) treatment

Retrieved on: 
Mercoledì, Maggio 8, 2024

We want to provide them with the support that they require to effectively manage their PPP.

Key Points: 
  • We want to provide them with the support that they require to effectively manage their PPP.
  • ORMALVI™ is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
  • Simply Stated: Research Updates in Periodic Paralysis - Quest | Muscular Dystrophy Association [online] Available at: https://mdaquest.org/simply-stated-research-updates-in-periodic-paralysis Accessed 23 Nov. 2023.
  • The impact of permanent muscle weakness on quality of life in periodic paralysis: a survey of 66 patients.

Recovering Patient Reunites with Penn Highlands DuBois Trauma Team Who Saved His Life

Retrieved on: 
Mercoledì, Aprile 24, 2024

He was transported to the Level II Trauma Center at Penn Highlands DuBois where the Trauma Team saved his life.

Key Points: 
  • He was transported to the Level II Trauma Center at Penn Highlands DuBois where the Trauma Team saved his life.
  • Richmond required extensive surgery,” explained Philip S. Vuocolo, MD, MHA, FACS, a board-certified acute-care and trauma surgeon at Penn Highlands General Surgery and Trauma Medical Director for Penn Highlands DuBois.
  • On April 23, 2024 during a meeting with the Trauma Team and emergency services personnel, they expressed gratitude to the team who saved his life.
  • “I am very thankful that we have such a skilled Trauma Team and Trauma Center in our region and I will never hesitate to travel from York to DuBois for my care.”
    Penn Highlands DuBois is accredited as a Level II Trauma Center by the Pennsylvania Trauma Systems Foundation.

scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection

Retrieved on: 
Mercoledì, Aprile 24, 2024

BURLINGTON, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that it has enrolled the first participant in the pivotal pharmacokinetic (PK) study of SCP-111 (furosemide 80 mg/mL), an investigational, low volume, pH neutral formulation of furosemide administered via an auto-injector.

Key Points: 
  • The auto-injector is being developed as a complement to the FDA approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility.
  • If approved, the Company believes the auto-injector also has the potential to meaningfully reduce manufacturing costs.
  • FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.
  • The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Avenacy Announces Launch of Desmopressin Acetate for Injection in the U.S. Market

Retrieved on: 
Lunedì, Aprile 15, 2024

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Desmopressin Acetate for Injection in the United States as a therapeutic equivalent generic for DDAVP® for Injection (Desmopressin Acetate) approved by the U.S. Food and Drug Administration.

Key Points: 
  • Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Desmopressin Acetate for Injection in the United States as a therapeutic equivalent generic for DDAVP® for Injection (Desmopressin Acetate) approved by the U.S. Food and Drug Administration.
  • Desmopressin Acetate for Injection is multi-indicated for patients with central diabetes insipidus, hemophilia A, and von Willebrand’s disease (Type I).
  • View the full release here: https://www.businesswire.com/news/home/20240415847399/en/
    Avenacy’s Desmopressin Acetate for Injection is available in two presentations: 4 mcg per 1 mL single-dose vials, and 40 mcg per 10 mL multiple-dose vials.
  • Avenacy will begin shipping Desmopressin Acetate for Injection to wholesale partners this week.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Mercoledì, Marzo 13, 2024

BURLINGTON, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023.
  • Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022.
  • Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022.
  • scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022.

Inspira™ Announces Program to Pioneer the Applicable Use of the INSPIRA™ ART100 Device for an Artificial Womb

Retrieved on: 
Mercoledì, Aprile 3, 2024

Ltd. (NASDAQ: IINN) (NASDAQ: IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, is delighted to announce the commencement of a program to explore the applicable use of the INSPIRA™ ART100 Device for an artificial womb for neonates in need of vital respiratory support.

Key Points: 
  • Ltd. (NASDAQ: IINN) (NASDAQ: IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, is delighted to announce the commencement of a program to explore the applicable use of the INSPIRA™ ART100 Device for an artificial womb for neonates in need of vital respiratory support.
  • Inspira aims to explore how this potential additional application of the INSPIRA ART100 device to provide neonates with vital respiratory support could replace the currently used mechanical ventilators.
  • "Inspira is dedicated to pushing the boundaries of medical technology to save and improve lives," remarked Dagi Ben-Noon, CEO of Inspira Technologies.
  • The Company's products have not yet been tested or used in humans and has not been approved by any regulatory entity.

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

Retrieved on: 
Martedì, Marzo 26, 2024

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.

Key Points: 
  • DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.
  • Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
  • Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
  • If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.