Generic drug

Samsung Bioepis Releases Second Quarter 2024 US Biosimilar Market Report

Retrieved on: 
Monday, April 8, 2024
Filgrastim, IRA, Trastuzumab, Pegfilgrastim, ASPS, Growth, Patient, Adalimumab, ASP, Market access, WAC, Medicare, FDA, CMS, Inflation, Economics, Food, Generic drug

The 5th edition explores some IRA implications on biosimilars along with latest price trends, biosimilars market share

Key Points: 
  • The 5th edition explores some IRA implications on biosimilars along with latest price trends, biosimilars market share
    INCHEON, Korea, April 08, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today released its Second Quarter 2024 Biosimilar Market Report , which includes the latest Average Sales Price (ASP) information of all biosimilars and reference products available in the US market.
  • This fifth-edition of the Samsung Bioepis Quarterly Biosimilar Market Report delves into some implications of the Inflation Reduction Act (IRA) with respect to biosimilars, as well as the biosimilars market share and price trends.
  • “Over the past year, we have strived to provide the US market with the latest biosimilar insights through our report, and we are grateful for the positive reception from our readers,” said Thomas Newcomer, Vice President, Head of Market Access, US, at Samsung Bioepis.
  • As of February 2024, adalimumab biosimilar market share has reached 4%, increasing 2% compared to the previous quarter.

Sol-Gel’s Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® Cream

Retrieved on: 
Monday, April 1, 2024
Cream, Psoriasis, Abbreviated New Drug Application, NESS, Partnership, District court, Patient, Nevoid basal-cell carcinoma syndrome, Dermatology, Patent, IQVIA, FDA, Sol–gel process, Food, Generic drug

On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA.

Key Points: 
  • On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA.
  • Annual market sales for Zoryve Cream, 0.3% were approximately $95 million in the 12 months ended in January 2024, as measured by IQVIA.
  • Should its ANDA for Roflumilast Cream, 0.3% be approved by the FDA, Padagis believes that its product may be entitled to 180 days of generic market exclusivity.
  • Submissions such as Padagis’s Roflumilast Cream, 0.3% ANDA demonstrate the historic value of Sol-Gel’s partnership with Padagis.

Pharmazz Inc. and Dr. Reddy's Laboratories have entered into a licensing agreement to market Centhaquine (Lyfaquin) as a resuscitative agent for hypovolemic shock in India

Retrieved on: 
Friday, March 22, 2024
Cardiac output, U.S. FDA, Internal bleeding, Partnership, System, Patient, Research, Trauma, Diarrhea, Hypovolemic shock, Mortality, Gastrointestinal bleeding, Manuscript, Laboratory, Blood volume, Standard of care, DRUGS, Clinical trial, Resuscitation, Safety, DCGI, Phase, Vomiting, Blood, FDA, Food, Shock (mechanics), Emerging market, Generic drug

Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI).

Key Points: 
  • Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI).
  • As per the agreement, Dr. Reddy's has received exclusive rights to market and distribute Centhaquine in India.
  • For patients with hypovolemic shock, I believe Dr. Reddy's is the best partner for Pharmazz to market Centhaquine, an innovative, first-in-class novel resuscitative agent, in India."
  • U.S. FDA clearance of our Phase III IND is an important milestone for Pharmazz and the potential future treatment of hypovolemic shock patients.

Innovations in Small Molecule Drug Delivery and Formulation, 2024 Research Report - Collaborating with CDMOs to Intensify R&D Activities - ResearchAndMarkets.com

Retrieved on: 
Thursday, April 4, 2024
Health, Other Science, Research, Pharmaceutical, Science, Biotechnology, Molecule, Nanocarriers, Exosome, Toxicity, Solubility, Cancer, Ligand, Generic drug

The "Innovations in Small Molecule Drug Delivery and Formulation" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Innovations in Small Molecule Drug Delivery and Formulation" report has been added to ResearchAndMarkets.com's offering.
  • Small molecules, which are the leading drug class across indications, face several issues that threaten their drug delivery efficacy.
  • While the small molecule drug development pipeline remains a leading therapeutic class, it is essential to intensify R&D to improve drug delivery approaches.
  • This analysis of the latest advances in small molecule drug delivery covers developments in organic, inorganic, and carrier-free small molecule drug delivery systems (DDSs) as well as developments in formulations for improved patient adherence and targeted small molecule delivery.

Teva and mAbxience Announce Strategic Global Licensing Agreement for Oncology Biosimilar Candidate

Retrieved on: 
Thursday, April 4, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, TEVA, Partnership, Business, Patient, CGMP, Good manufacturing practice, Business development, Doctor of Philosophy, Biosimilar, Fresenius (company), Teva, Generic drug

Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications.

Key Points: 
  • Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications.
  • Biosimilars show promising potential in providing more cost-effective alternatives to existing oncology therapies, thereby addressing a critical need in global oncology care.
  • The licensing agreement covers multiple global markets, including in Europe and the United States, signaling a major step in mAbxience’s global expansion strategy, and supports a key element of Teva’s Pivot to Growth strategy, announced in 2023, to expand its biosimilar pipeline through business development and strategic partnerships.
  • Under the terms of the licensing agreement, mAbxience will leverage its expertise in biosimilar development and its state-of-the-art, current Good Manufacturing Practice (cGMP)-approved facilities in Spain and Argentina, to develop and produce the biosimilar product.

UroGen Pharma Files Patent Infringement Action Against Teva Pharmaceuticals

Retrieved on: 
Wednesday, April 3, 2024
Legal, Biotechnology, Pharmaceutical, Public Relations, Investor Relations, Health, FDA, Communications, Professional Services, The Orange Book, Drug discovery, Carcinoma, Patent, District court, Mitomycins, Orange Book, Food, Generic drug

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069 (“the ’069 patent”).

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069 (“the ’069 patent”).
  • Both patents are listed in the U.S. Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for JELMYTO® (mitomycin) for pyelocalyceal solution.
  • JELMYTO® is indicated for the treatment of adults with low-grade, upper tract urothelial cancer (“LG-UTUC”) and utilizes UroGen’s RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology.
  • “UroGen pioneered a significant breakthrough and remains at the forefront of transforming urothelial cancer treatment,” said Liz Barrett, President and CEO, UroGen.

Anda Pho Named President at Evite, the Leading Party Planning Authority

Retrieved on: 
Wednesday, March 27, 2024
Retail, Social Media, Communications, Bridal, Friends, Anda, Organization, POM Wonderful, Female, Human, Minecraft, Woman, The Walt Disney Company, Multimedia, Family, Generic drug

Evite, the world's leading digital platform for bringing people together, is celebrating a groundbreaking moment with the appointment of Anda Pho as its first-ever female President.

Key Points: 
  • Evite, the world's leading digital platform for bringing people together, is celebrating a groundbreaking moment with the appointment of Anda Pho as its first-ever female President.
  • Taking the reins in 2024, Anda leads a team of remarkable women executives, marking a significant milestone for the company and the event planning industry.
  • View the full release here: https://www.businesswire.com/news/home/20240327745156/en/
    Anda Pho, President of Evite Photo Credit: Evite
    Evite is the world's leading digital platform for bringing people together for life's celebrations.
  • "I'm incredibly excited to lead this talented team as we continue to build upon Evite's legacy," said Anda Pho, President of Evite.

HydrophilicCoating.Org Simplifies Purchasing of Hydrophilic Coating

Retrieved on: 
Friday, March 22, 2024
Engineering, Medical Devices, Health, Manufacturing, General Health, Other Manufacturing, Hydrophile, Plastic, Endoscopy, Catheter, Frustration, Communication, Generic drug

HydrophilicCoating.org is proud to announce the launch of its new website, offering a revolutionary approach to purchasing hydrophilic coatings for medical devices and consumer products.

Key Points: 
  • HydrophilicCoating.org is proud to announce the launch of its new website, offering a revolutionary approach to purchasing hydrophilic coatings for medical devices and consumer products.
  • Born from the frustrations of industry professionals, HydrophilicCoating.org prioritizes customer needs and simplifies the ordering process.
  • "After experiencing years of frustration working with traditional medical device coating companies, we saw the need for a better solution," said CEO Jason Scherer.
  • "Hydrophilic Coating was born from pure frustration overcharging on engineering formulations, delayed production runs, and lack of communication.

Dr. Reddy's Laboratories launches Versavo® (bevacizumab) in the UK

Retrieved on: 
Tuesday, March 19, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Ovarian cancer, Patient, Lung cancer, Bevacizumab, RDY, Cancer, Generic drug

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr.

Key Points: 
  • Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr.
  • Reddy’s”), a global pharmaceutical company, announced the launch of Versavo® (bevacizumab) in the United Kingdom (UK).
  • Versavo® is the first Dr. Reddy’s biosimilar product to be approved and launched in the UK.
  • Subsequently, Versavo® was introduced in other markets such as Thailand, Ukraine, Nepal, and Jamaica under the same brand name.

US Biosimilar Industry Projected to Surge With CAGR of 40% Through 2028: New Study Highlights Market Growth and Trends - ResearchAndMarkets.com

Retrieved on: 
Monday, March 18, 2024
Biotechnology, Pharmaceutical, Health, Competitive advantage, Conditional sentence, Incidence, Patient, Research, Cancer, Oncology, Ecosystem, Compound annual growth rate, FDA, Movement, Medicine, Ageing, Hook effect, Generic drug

The study delves into the complex ecosystem of the US Biosimilar market, identifying the critical factors that contribute to its projected Compound Annual Growth Rate (CAGR) of approximately 40% over the next five years.

Key Points: 
  • The study delves into the complex ecosystem of the US Biosimilar market, identifying the critical factors that contribute to its projected Compound Annual Growth Rate (CAGR) of approximately 40% over the next five years.
  • Key Insights from the Report:
    The cost-effectiveness of Biosimilar drugs is key to market growth as patients seek affordable alternatives to high-priced generic drugs.
  • The Competitive Edge in Biosimilars:
    The US Biosimilar market is characterized by a robust presence of both domestic and global pharmaceutical titans.
  • The research highlights the strategies employed by these entities to navigate the market dynamics and enhance their foothold within the industry.