Endo

Endo Announces Approval of XCOPRI™ (cenobamate tablets) in Canada

Retrieved on: 
Thursday, June 29, 2023
Knight Therapeutics, Epilepsy, Seizure, Endo, Health Canada, Corona Labs Inc., OTC, Endo International, Pharmaceutical industry, Paladin

DUBLIN and MONTREAL, June 29, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that Paladin Labs Inc., an Endo operating company, received Health Canada's approval of XCOPRI™ (cenobamate tablets) for adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.

Key Points: 
  • DUBLIN and MONTREAL, June 29, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that Paladin Labs Inc., an Endo operating company, received Health Canada's approval of XCOPRI™ (cenobamate tablets) for adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.
  • "Many adults with partial-onset seizures are not able to control their seizures, even with the availability of many anti-seizure medications," said Livio Di Francesco, Vice President & General Manager of Paladin Labs Inc. "Paladin is dedicated to addressing unmet medical needs, and we are proud to achieve this approval—a milestone in epilepsy treatment."
  • Paladin Labs expects to launch XCOPRI™ in December 2023.

Bone Health Technologies to Present Clinical Data from Pivotal Trial of Wearable Treatment for Osteopenia in Post-Menopausal Women at Endo 2023

Retrieved on: 
Friday, June 16, 2023
ENDO, Osteopenia, Exercise, Finite element method, CT, Endocrinology, L1, Diet, Osteoporosis, Diagnosis, Bone fracture, Numerical methods for partial differential equations, Active, Vibration, Bone density, Woman, Saint Andrew's Society, Lumbar vertebrae, BHT, DXA, Compressive strength, Patient, Sham, Risk, PP, Menopause, Endocrine Society, Endo, FDA, Health, Precision diagnostics, Medical imaging, Dietary supplement

The double-blinded, sham-controlled study enrolled 126 postmenopausal women with low bone mass who were not on bone-active medications. The data being presented are strong evidence that supports the efficacy of the Osteoboost in reducing the decline of bone strength and bone density. The primary outcome measurement was the change in vertebral strength, as measured by Biomechanical Computed Tomography using finite element analysis. Per Protocol (PP) - subjects (those who used the device a minimum of 3 times per week throughout the year) in the Active Treatment group lost, on average, 0.48% bone strength, while those in the Sham group lost 2.84%, with a relative difference of 2.36% (P=0.014)-- an 82% reduction in the rate of bone strength loss. Additionally, CT measurement of vertebral bone density was conducted and showed a 1.68% relative benefit for those using the Osteoboost– an 85% reduction in loss of bone density (P=0.008) in the PP group. Zero serious adverse events were reported.

Key Points: 
  • CHICAGO, June 16, 2023 (GLOBE NEWSWIRE) -- Bone Health Technologies (BHT), a pioneer in health technologies for preventing and treating bone health diseases, is presenting pivotal trial data for Osteoboost, a novel treatment for low bone mass in postmenopausal women, at Endo 2023.
  • Bone Health Technologies has filed for Class 2 Prescription De Novo Approval with the FDA and was previously awarded Breakthrough Device Status.
  • The data being presented are strong evidence that supports the efficacy of the Osteoboost in reducing the decline of bone strength and bone density.
  • Bone Health Technologies is proud to have contributed to this groundbreaking study and will share findings with attendees at ENDO 2023.

Endo Launches PREVDUO™ (neostigmine methylsulfate and glycopyrrolate injection), the First and Only FDA-Approved Neostigmine-Glycopyrrolate Combination Pre-Filled Syringe

Retrieved on: 
Monday, June 12, 2023
Neostigmine, Bromide, Senior, Workflow, Endo International, Hospital, OTC, Endo, FDA, Health, RTU, Syringe, Pharmaceutical industry

"With two medications in one ready-to-use syringe, PREVDUO™ reduces complexity and increases efficiency for hospitals and healthcare providers."

Key Points: 
  • "With two medications in one ready-to-use syringe, PREVDUO™ reduces complexity and increases efficiency for hospitals and healthcare providers."
  • Both neostigmine methylsulfate and glycopyrrolate have been approved in the U.S. as single, active ingredient drug products.
  • Neostigmine is always administered in conjunction with glycopyrrolate and, until now, its administration has required two syringes.
  • This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error—all of which support quality patient care.

Endo Launches PREVDUO™ (neostigmine methylsulfate and glycopyrrolate injection), the First and Only FDA-Approved Neostigmine-Glycopyrrolate Combination Pre-Filled Syringe

Retrieved on: 
Monday, June 12, 2023
Neostigmine, Bromide, Senior, Workflow, Endo International, Hospital, OTC, Endo, FDA, Health, RTU, Syringe, Pharmaceutical industry

"With two medications in one ready-to-use syringe, PREVDUO™ reduces complexity and increases efficiency for hospitals and healthcare providers."

Key Points: 
  • "With two medications in one ready-to-use syringe, PREVDUO™ reduces complexity and increases efficiency for hospitals and healthcare providers."
  • Both neostigmine methylsulfate and glycopyrrolate have been approved in the U.S. as single, active ingredient drug products.
  • Neostigmine is always administered in conjunction with glycopyrrolate and, until now, its administration has required two syringes.
  • This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error—all of which support quality patient care.

Endo Announces Agreement with MAIA Pharmaceuticals to Distribute Bivalirudin Injection in Ready-to-Use Vials

Retrieved on: 
Wednesday, May 24, 2023
MAIA, Partnership, Senior, Workflow, Endo International, Hospital, Patient, Corporation, OTC, Endo, FDA, Health, RTU, Corporate development, Pharmaceutical industry

"Hospital providers have told us what they need—ready-to-use medications that allow them to focus on patients rather than preparation," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo.

Key Points: 
  • "Hospital providers have told us what they need—ready-to-use medications that allow them to focus on patients rather than preparation," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo.
  • "Through this partnership with MAIA Pharmaceuticals, we are proud to answer that call with the only ready-to-use liquid format of bivalirudin."
  • "Like Endo, MAIA is laser-focused on delivering meaningful solutions to support healthcare providers as they deliver quality patient care," said Brian Cooney, Sr. Director, Corporate Development at MAIA Pharmaceuticals.
  • "We are pleased to partner with Endo to provide ready-to-use bivalirudin, which requires no reconstitution, no dilution and no mixing."

Endo Announces Agreement with MAIA Pharmaceuticals to Distribute Bivalirudin Injection in Ready-to-Use Vials

Retrieved on: 
Wednesday, May 24, 2023
MAIA, Partnership, Senior, Workflow, Endo International, Hospital, Patient, Corporation, OTC, Endo, FDA, Health, RTU, Corporate development, Pharmaceutical industry

"Hospital providers have told us what they need—ready-to-use medications that allow them to focus on patients rather than preparation," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo.

Key Points: 
  • "Hospital providers have told us what they need—ready-to-use medications that allow them to focus on patients rather than preparation," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo.
  • "Through this partnership with MAIA Pharmaceuticals, we are proud to answer that call with the only ready-to-use liquid format of bivalirudin."
  • "Like Endo, MAIA is laser-focused on delivering meaningful solutions to support healthcare providers as they deliver quality patient care," said Brian Cooney, Sr. Director, Corporate Development at MAIA Pharmaceuticals.
  • "We are pleased to partner with Endo to provide ready-to-use bivalirudin, which requires no reconstitution, no dilution and no mixing."

EDAP Announces First Quarter 2023 Financial Results

Retrieved on: 
Wednesday, May 17, 2023
Endometriosis, AUC, Prostate cancer, AUA, EDAP, Quality of life, EDT, MRI, Patient, Urology, Growth, Endo, EAU, Safety, Pharmaceutical industry

- Company to host conference call and webcast today, Wednesday, May 17that 8:30 am EDT -

Key Points: 
  • - Company to host conference call and webcast today, Wednesday, May 17that 8:30 am EDT -
    LYON, France, May 17, 2023 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today unaudited financial results for the first quarter ended March 31, 2023.
  • “After achieving record results in the fourth quarter of 2022, we continued to see growing demand through the first quarter of 2023, with our strongest Q1 revenue performance on record,” said Ryan Rhodes, Chief Executive Officer of EDAP.
  • The increase was driven by six Focal One units sold in the first quarter 2023 versus four units sold in the first quarter 2022.
  • A conference call and webcast to discuss first quarter 2023 financial results will be hosted by Ryan Rhodes, Chief Executive Officer, François Dietsch, Chief Financial Officer and Ken Mobeck, Chief Financial Officer of the U.S. subsidiary, today Wednesday, May 17th, 2023 at 8:30am EDT.

Endo Announces Launch of Argatroban Injection Through Premier's ProRx® Private-Label Program

Retrieved on: 
Monday, April 17, 2023
Senior, Endo International, Fluphenazine, USP, Hospital, Adrenaline, OTC, Endo, FDA, Pharmaceutical industry

DUBLIN, April 17, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its Par Sterile Products business has begun shipping argatroban injection to healthcare providers through Premier's Premier ProRx® private-label program, a guaranteed supply for hospitals and health systems.

Key Points: 
  • DUBLIN, April 17, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its Par Sterile Products business has begun shipping argatroban injection to healthcare providers through Premier's Premier ProRx® private-label program, a guaranteed supply for hospitals and health systems.
  • Argatroban is on FDA's essential medications list and has experienced intermittent supply issues in the broader market.
  • "We're proud to now provide a third product through the reliable Premier ProRx® supply channel."
  • Endo also supplies its Adrenalin® (epinephrine injection, USP), Vasostrict® (vasopressin injection, USP) and fluphenazine decanoate injection, USP products to Premier's hospital customers through the Premier ProRx® private-label program.

Endo Announces Launch of Argatroban Injection Through Premier's ProRx® Private-Label Program

Retrieved on: 
Monday, April 17, 2023
Senior, Endo International, Fluphenazine, USP, Hospital, Adrenaline, OTC, Endo, FDA, Pharmaceutical industry

DUBLIN, April 17, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its Par Sterile Products business has begun shipping argatroban injection to healthcare providers through Premier's Premier ProRx® private-label program, a guaranteed supply for hospitals and health systems.

Key Points: 
  • DUBLIN, April 17, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its Par Sterile Products business has begun shipping argatroban injection to healthcare providers through Premier's Premier ProRx® private-label program, a guaranteed supply for hospitals and health systems.
  • Argatroban is on FDA's essential medications list and has experienced intermittent supply issues in the broader market.
  • "We're proud to now provide a third product through the reliable Premier ProRx® supply channel."
  • Endo also supplies its Adrenalin® (epinephrine injection, USP), Vasostrict® (vasopressin injection, USP) and fluphenazine decanoate injection, USP products to Premier's hospital customers through the Premier ProRx® private-label program.

Endo Launches Authorized Generic Version of Noxafil® (posaconazole) Oral Suspension

Retrieved on: 
Monday, April 3, 2023
Par, Partnership, Senior, Posaconazole, Endo International, AG, OTC, Endo, Merck & Co., Merck Sharp & Dohme Federal Credit Union, Pharmaceutical industry, Merck

DUBLIN, April 3, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping the authorized generic (AG) version of Merck's Noxafil® (posaconazole) 200 mg/5 mL oral suspension in the U.S.

Key Points: 
  • DUBLIN, April 3, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping the authorized generic (AG) version of Merck's Noxafil® (posaconazole) 200 mg/5 mL oral suspension in the U.S.
    "Our partnership with Merck underscores our reputation as an industry-leading supplier," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo.
  • "This newly available Noxafil® AG dosage form is the latest addition to our generics portfolio—providing patient access to high-quality, lower-cost treatment options."
  • Endo subsidiary Endo Ventures Limited entered into an exclusive U.S. supply and distribution agreement with a subsidiary of Merck & Co., Inc. of Rahway, N.J. allowing Par to launch and distribute an authorized generic version of the product.
  • The agreement also included the authorized generic version of Noxafil® delayed-release tablets, 100 mg, which launched in 2019.