Zydus Lifesciences

Sentynl Therapeutics Announces Global Acquisition of Zokinvy® (Lonafarnib) for Treatment of Hutchinson-Gilford Progeria Syndrome from Eiger BioPharmaceuticals

Retrieved on: 
Venerdì, Maggio 3, 2024
Sale, FDA, Mortality, Bankruptcy, Progeria Research Foundation, Progeria, Hearing, Zydus Lifesciences, Food, Lonafarnib, OTC, PRF, HGPS, Partnership, Doctor of Philosophy, Collection, Research, European, Disease, Patient, Eiger, United States bankruptcy court, Acquisition, PALO, DSM-IV codes, MBA, Therapy, Syndrome, PDPL, Pharmaceutical industry

SOLANA BEACH, Calif. and AHMEDABAD, India and PALO ALTO, Calif., May 3, 2024 /PRNewswire/ -- Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (Zydus Group), and Eiger BioPharmaceuticals, Inc. (OTC: EIGRQ), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for rare metabolic diseases, today announced the closing of the sale of Eiger's Zokinvy® (lonafarnib) program to Sentynl.

Key Points: 
  • Collectively known as progeria, HGPS and PDPL are ultra-rare, fatal, genetic premature aging diseases that accelerate mortality in young patients.
  • Since we first launched PRF in 1999, we have achieved tremendous progress in global awareness, breakthrough research, and treatment of progeria.
  • Under the terms of the acquisition, Sentynl acquired global rights to Zokinvy and will be responsible for its manufacture and commercialization.
  • For questions on continued access to Zokinvy, please contact the Sentynl Cares support team at 1-888-251-2800 Monday-Friday, 8 am-8 pm ET.

Zydus launches Mirabegron Extended-Release Tablets in the US

Retrieved on: 
Lunedì, Aprile 22, 2024
Biotechnology, General Health, Pharmaceutical, Health, Zydus Lifesciences, USP, Patient, Overactive bladder, USFDA, Mirabegron, Urinary incontinence, OAB, Generic drug

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market.

Key Points: 
  • Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market.
  • The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq® Extended-Release Tablets).
  • Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Tablets, 50mg imminently.
  • Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.

Assertio Holdings, Inc. Investors: Company Investigated by the Portnoy Law Firm

Retrieved on: 
Lunedì, Marzo 4, 2024
Acquisition, FDA, News, Food, Zydus Lifesciences, Suppository, ASRT

LOS ANGELES, March 04, 2024 (GLOBE NEWSWIRE) -- ​The Portnoy Law Firm advises Assertio Holdings, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT) investors that the law firm has initiated an investigation on behalf of investors that lost money on their Assertio stock. Assertio investors are encouraged to contact the firm to discuss their legal rights.

Key Points: 
  • LOS ANGELES, March 04, 2024 (GLOBE NEWSWIRE) -- ​ The Portnoy Law Firm advises Assertio Holdings, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT) investors that the law firm has initiated an investigation on behalf of investors that lost money on their Assertio stock.
  • Assertio investors are encouraged to contact the firm to discuss their legal rights.
  • The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
  • The Portnoy Law Firm represents investors in pursuing claims caused by corporate wrongdoing.

Assertio Holdings, Inc. Investors: Company Investigated by the Portnoy Law Firm

Retrieved on: 
Martedì, Febbraio 27, 2024
Acquisition, FDA, News, Food, Zydus Lifesciences, Suppository, ASRT

LOS ANGELES, Feb. 26, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Assertio Holdings, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT) investors that the law firm has initiated an investigation on behalf of investors that lost money on their Assertio stock. Assertio investors are encouraged to contact the firm to discuss their legal rights.

Key Points: 
  • LOS ANGELES, Feb. 26, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Assertio Holdings, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT ) investors that the law firm has initiated an investigation on behalf of investors that lost money on their Assertio stock.
  • Assertio investors are encouraged to contact the firm to discuss their legal rights.
  • The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
  • The Portnoy Law Firm represents investors in pursuing claims caused by corporate wrongdoing.

Assertio Holdings, Inc. Investors: Company Investigated by the Portnoy Law Firm

Retrieved on: 
Lunedì, Febbraio 5, 2024
ASRT, News, Suppository, FDA, Food, Zydus Lifesciences, Acquisition

​LOS ANGELES, Feb. 05, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Assertio Holdings, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT) investors that the law firm has initiated an investigation on behalf of investors that lost money on their Assertio stock. Assertio investors are encouraged to contact the firm to discuss their legal rights.

Key Points: 
  • ​LOS ANGELES, Feb. 05, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Assertio Holdings, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT ) investors that the law firm has initiated an investigation on behalf of investors that lost money on their Assertio stock.
  • Assertio investors are encouraged to contact the firm to discuss their legal rights.
  • The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
  • The Portnoy Law Firm represents investors in pursuing claims caused by corporate wrongdoing.

Assertio Holdings, Inc. Investors: Company Investigated by the Portnoy Law Firm

Retrieved on: 
Mercoledì, Gennaio 24, 2024
ASRT, Food, Acquisition, Suppository, FDA, News, Zydus Lifesciences

LOS ANGELES, Jan. 24, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Assertio Holdings, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT) investors that the law firm has initiated an investigation on behalf of investors that lost money on their Assertio stock. Assertio investors are encouraged to contact the firm to discuss their legal rights.

Key Points: 
  • LOS ANGELES, Jan. 24, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Assertio Holdings, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT ) investors that the law firm has initiated an investigation on behalf of investors that lost money on their Assertio stock.
  • Assertio investors are encouraged to contact the firm to discuss their legal rights.
  • The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
  • The Portnoy Law Firm represents investors in pursuing claims caused by corporate wrongdoing.

Cyprium Therapeutics, a Fortress Biotech Subsidiary Company, Completes Asset Transfer of CUTX-101 Copper Histidinate Product Candidate for Treatment of Menkes Disease, to Sentynl Therapeutics, a Wholly-owned Subsidiary of Zydus Lifesciences Ltd.

Retrieved on: 
Mercoledì, Dicembre 6, 2023
Fortress Biotech, Menkes disease, Agreement, FDA, NDA, Zydus Lifesciences, Therapy, Cyprium, Assumption, Safety, Pharmaceutical industry

MIAMI, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary company, today announced that it executed an Assignment and Assumption Agreement (the “Agreement”) with Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based specialty pharmaceutical company wholly owned by the Zydus Lifesciences Ltd., in which, Cyprium completed the transfer of its proprietary rights and assigned its FDA documents pertaining to CUTX-101, Copper Histidinate product candidate for the treatment of Menkes disease, to Sentynl.

Key Points: 
  • Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101.
  • “We are pleased to complete the CUTX-101 asset transfer with Sentynl.
  • Cyprium has made progress with the CUTX-101 rolling NDA submission, and we expect that Sentynl will complete the filing in 2024.
  • The transfer of the CUTX-101 program to Sentynl will result in a reduction in Cyprium’s development-related spend, while potentially expediting commercialization upon FDA approval.

United States Transdermal Patch Market Report 2023: Dosage, Price & Clinical Trials Insights to 2029 - Focus on Opioid, Cardiovascular Diseases, Neurological Disorders, and Hormonal Therapy - ResearchAndMarkets.com

Retrieved on: 
Giovedì, Novembre 23, 2023
Medical Devices, Health, Gastritis, Brown University, Transdermal patch, Research, Indication, Chronic pain, Parkinson's disease, Pain management, Buprenorphine, University of California, Davis, Pregnancy, Patient, FDA, Alzheimer's disease, Opioid use disorder, Zydus Lifesciences, University, Cancer, Communication, Pain, Growth, Nerve, DSM-IV codes, Generic drug, Pharmaceutical industry, Adhesive, Birth control

The "US Transdermal Patch Market, Dosage, Price & Clinical Trials Insight 2029" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "US Transdermal Patch Market, Dosage, Price & Clinical Trials Insight 2029" report has been added to ResearchAndMarkets.com's offering.
  • With the rapid approvals of transdermal patches lately, the FDA has also marked itself as an important player in the US market of transdermal patches.
  • The FDA provides a detailed communication on the requirements of an ideal transdermal patch, and patches that meet these are allowed entry in the regional market.
  • US Transdermal Patch Market, Dosage, Price & Clinical Trials Insight 2029 Report Highlights:
    US Transdermal Patch Market Opportunity: > US$ 5 Billion By 2029
    Commercially available Patches In US Market: > 25 Patches
    Ongoing Clinical Trials Of Transdermal Patches in US: > 40 Patches
    US Transdermal Patch Clinical Trials Insight By Company, Indication & Phase

Zydus receives USFDA approval for ZITUVIO™ to treat adult patients with type 2 diabetes mellitus

Retrieved on: 
Venerdì, Ottobre 20, 2023
FDA, DPP-4, Food, USFDA, Diabetes, Nitrosamine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, Exercise, Tablet, Type, Zydus Lifesciences, New Drug Application, Diet, MAT, NDA, Patient, Dietary supplement, Pharmaceutical industry, Sitagliptin

AHMEDABAD, India, Oct. 20, 2023 /PRNewswire/ -- Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as 'Zydus') today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ZITUVIO™ (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg.

Key Points: 
  • The approval of ZITUVIO™ is based on research, development, regulatory and manufacturing work performed by Zydus teams.
  • ZITUVIO™ has undergone quality testing for Nitrosamines and potential genotoxic impurities as per current USFDA standards.
  • "The ZITUVIO™ approval builds on Zydus' long-term commitment to offer healthcare professionals a new affordable treatment option in connection with diabetes management," said Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited.
  • "We are pleased to be able to receive such a milestone approval for Zydus.

Zydus appoints Mr. Punit Patel as President and CEO to lead its business operations in North America

Retrieved on: 
Lunedì, Ottobre 16, 2023
MCPHS University, Cardinal Health, CVS Health, Allied health professions, Zydus Lifesciences, Therapy, CVS Caremark, Doctor of Pharmacy, UnitedHealth Group, Health, Growth, Red Oak, Oklahoma, Red oak, Pharmaceutical industry, Pharmacy

AHMEDABAD, India, Oct. 16, 2023 /PRNewswire/ -- Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as 'Zydus') a discovery-driven, global lifesciences company announced the appointment of Mr. Punit Patel as President and Chief Executive Officer, Americas.

Key Points: 
  • AHMEDABAD, India, Oct. 16, 2023 /PRNewswire/ -- Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as 'Zydus') a discovery-driven, global lifesciences company announced the appointment of Mr. Punit Patel as President and Chief Executive Officer, Americas.
  • He will be responsible for the business operations of all Zydus entities in North America which include generics, injectables and specialty business, rare and orphan disease portfolio and also future forays into novel therapeutics.
  • Prior to his joining Zydus, Mr. Punit Patel was the President of Red Oak Sourcing, helming a multi-billion-dollar generic portfolio.
  • "We look forward to Punit joining our organisation," said Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd., "As a seasoned and successful business leader, Punit brings rich and varied experience in healthcare and pharmaceuticals to lead Zydus into the future.