Generic drug

Alvotech and STADA add to strategic alliance through denosumab partnership

Retrieved on: 
вторник, июня 11, 2024
International Osteoporosis Foundation, Immunoglobulin G, Adalimumab, Patient, RANKL, CIS, Denosumab, Female, Osteoporosis, Commonwealth, Survival, Osteoclast, BAD, Partnership, RANK, Commonwealth of Independent States, Ustekinumab, Generic drug

The first product launched through the alliance was Hukyndra®, a high-concentration biosimilar to Humira® (adalimumab)

Key Points: 
  • The first product launched through the alliance was Hukyndra®, a high-concentration biosimilar to Humira® (adalimumab)
    REYKJAVIK, Iceland and BAD VILBEL, Germany, June 11, 2024 (GLOBE NEWSWIRE) -- Alvotech and STADA are strengthening their existing strategic alliance for high-quality, cost-effective biosimilars by extending their partnership to cover AVT03, a clinical-stage biosimilar candidate referencing the Prolia®/Xgeva® (denosumab) medicines for osteoporosis and cancer-related bone loss respectively.
  • Under the terms of the agreement, Alvotech will be responsible for development and manufacturing at its state-of-the-art facility in Reykjavik, Iceland.
  • Alvotech will also regain commercial rights from STADA to AVT06, a proposed biosimilar to Eylea® (aflibercept).
  • STADA’s Global Specialty Head, Bryan Kim, commented: “As European market leader with our teriparatide osteoporosis treatment, Movymia®, STADA sees a major opportunity to offer patients and clinicians a further treatment with denosumab.

CareDx Reiterates Position that it Does Not Infringe the ‘544 Patent, Injunction Motion is Irrelevant

Retrieved on: 
среда, мая 29, 2024
Biotechnology, Health, Surgery, Medical Devices, Patient, Caregiver, District court, Motion, Transplant, Court, Patent, Generic drug

The motion seeks to stop CareDx from using a prior AlloSure® process that Natera alleged infringed the ‘544 patent.

Key Points: 
  • The motion seeks to stop CareDx from using a prior AlloSure® process that Natera alleged infringed the ‘544 patent.
  • As CareDx informed Natera and the Court, since August 2023, CareDx has utilized a new AlloSure process that it believes does not infringe on the ‘544 patent.
  • The underlying validity of the ‘544 patent also remains subject to judicial review.
  • The ‘544 patent is the subject of post-trial motion practice in which, among other things, CareDx is seeking to invalidate that patent on the same grounds as the ‘724 patent.

Alvotech Reports Financial Results for First Quarter of 2024 and Provides a Business Update

Retrieved on: 
вторник, мая 21, 2024
Partnership, CTA, Patient, EBIDTA, Icelandic, Food, Movement, Clinical trial, FDA, EDT, Marketing, Ustekinumab, Food and Drug Administration, Absorption, Denosumab, Research, G&A, Biosimilar, Adalimumab, Webcast, Teva, Teva Pharmaceuticals, Generic drug

Gross margin in Q1 2024 increased to $17 million, by $40 million compared to the same period last year.

Key Points: 
  • Gross margin in Q1 2024 increased to $17 million, by $40 million compared to the same period last year.
  • Alvotech raises topline revenue guidance to $400-$500 million and tightens guidance for bottom line range for 2024 to $100-$150 million.
  • Management will conduct a business update conference call and live webcast on Wednesday May 22, 2024, at 8:00 am ET (12:00 pm GMT).
  • Alvotech will conduct a business update conference call and live webcast on Wednesday, May 22, 2024, at 8:00 am EDT (12:00 pm GMT).

Teva and Alvotech Announce SIMLANDI® (adalimumab-ryvk) Injection Now Available in the U.S.

Retrieved on: 
вторник, мая 21, 2024
Partnership, Patient, Uveitis, Prescription, Food, Rheumatoid arthritis, Johnson & Johnson, FDA, TEVA, Marketing, Ustekinumab, Psoriasis, Ankylosing spondylitis, Senior, Ulcerative colitis, Juvenile idiopathic arthritis, Hidradenitis suppurativa, Adalimumab, Teva, Teva Pharmaceuticals, Generic drug

“We are proud to make SIMLANDI available in the U.S. to patients and providers,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva.

Key Points: 
  • “We are proud to make SIMLANDI available in the U.S. to patients and providers,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva.
  • “Biosimilars create opportunities for cost savings across the healthcare system, and SIMLANDI’s launch now offers the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. market.
  • Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure.
  • Humira is a registered trademark of AbbVie Biotechnology Ltd. Stelara is a registered trademark of Johnson & Johnson.

Court Dismisses Exact Sciences’ ‘781 Patent Infringement Claim Against Geneoscopy

Retrieved on: 
среда, мая 22, 2024
Other Health, Other Science, Pharmaceutical, Research, Legal, Oncology, Medical Devices, Professional Services, Science, Practice Management, Managed Care, Medical Supplies, General Health, FDA, Biotechnology, Surgery, Patent Law, Health, Patient, Risk, Patent, Exact sciences, Colorectal cancer, Blood, Complaint, Dicarboxylic acid, CRC, Court, RNA, Physician, District court, Generic drug

Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the United States District Court for the District of Delaware dismissed Exact Sciences' claim of infringement regarding United States Patent No.

Key Points: 
  • Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the United States District Court for the District of Delaware dismissed Exact Sciences' claim of infringement regarding United States Patent No.
  • The Court’s ruling concluded that the allegations did not support a claim that Geneoscopy has infringed, or currently is infringing, the ‘781 patent.
  • At this stage of the litigation, the Court did not address, nor was it asked to determine, whether the ‘781 patent is valid or enforceable.
  • Geneoscopy has separately petitioned the United States Patent and Trademark Office (USPTO) to institute an inter partes review challenging the patentability of the ‘781 patent.

Exelixis Announces Settlement of CABOMETYX® (cabozantinib) Patent Litigation with Cipla Limited and Cipla USA

Retrieved on: 
понедельник, мая 20, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Justice, Patent, Food, Agreement, Tablet, District court, FTC, Generic drug

Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a Settlement and License Agreement (Agreement) with Cipla Ltd. and Cipla USA, Inc. (collectively Cipla).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a Settlement and License Agreement (Agreement) with Cipla Ltd. and Cipla USA, Inc. (collectively Cipla).
  • This settlement resolves two patent litigations brought by Exelixis in response to Cipla’s Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of CABOMETYX® (cabozantinib) tablets prior to the expiration of the applicable patents.
  • 23-287), filed on March 16, 2023, relates to Cipla’s ANDA for a 60 mg cabozantinib dosage strength.
  • Additionally, in accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Exelixis and Cipla regarding CABOMETYX patents pending in the U.S. District Court for the District of Delaware.

Global Pharmaceutical Excipients Market Analysis, Competitive Landscape and Forecasts, 2024- 2033 - ResearchAndMarkets.com

Retrieved on: 
вторник, мая 14, 2024
Health, Pharmaceutical, Excipient, Prevalence, Growth, Conditional sentence, Research, Competitive landscape, Administration, Drug development, API, Safety, Generic drug

The "Global Pharmaceutical Excipients Market: Focus on Application, Formulation, Functionality, Product, Region, and Competitive Landscape - Analysis and Forecast, 2024- 2033" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Pharmaceutical Excipients Market: Focus on Application, Formulation, Functionality, Product, Region, and Competitive Landscape - Analysis and Forecast, 2024- 2033" report has been added to ResearchAndMarkets.com's offering.
  • The global pharmaceutical excipients market is witnessing robust growth due to the increasing demand for pharmaceutical formulations and rising focus on drug delivery systems.
  • Additionally, stringent regulatory requirements and the emphasis on product quality are shaping the competitive landscape of the pharmaceutical excipients market.
  • What are the major opportunities for existing market players and new entrants in the global pharmaceutical excipients market?

DHgate Releases 2023 IP Protection Annual Report

Retrieved on: 
среда, мая 8, 2024
ACG, DHgate.com, Conference, Ecology, American Apparel, AAFA, Wahl Clipper, Union, Database, Intellectual property, Clutch (eggs), Annual report, Generic drug

BEIJING, May 8, 2024 /PRNewswire/ -- DHgate, the global leading B2B cross-border e-commerce marketplace, has released its "2023 Intellectual Property Protection Annual Report". The report reveals key progress in intercepting infringing products, protecting brand rights, optimizing intellectual property protection systems, and enhancing merchants' awareness of intellectual property protection worldwide.

Key Points: 
  • DHgate has released an annual report highlighting their outstanding successes in combating IP infringement on their leading global cross-border e-commerce marketplace, with complaints decreasing by as much as 90% from many brands
    BEIJING, May 8, 2024 /PRNewswire/ -- DHgate , the global leading B2B cross-border e-commerce marketplace, has released its "2023 Intellectual Property Protection Annual Report".
  • The report reveals key progress in intercepting infringing products, protecting brand rights, optimizing intellectual property protection systems, and enhancing merchants' awareness of intellectual property protection worldwide.
  • DHgate was commended at the REACT Asia Annual Intellectual Property Protection Conference in 2023 by several parties, including the Wahl Clipper Corporation, an established century-old American grooming product brand, the well-known intellectual property protection organization Corsearch, and the Beijing Intellectual Property Protection Association.
  • Download the complete "DHgate 2023 Intellectual Property Protection Annual Report" at the following link:

Pharmacy Automation: Revolutionizing Healthcare with Cutting-Edge Solutions

Retrieved on: 
пятница, мая 3, 2024
Pharmacy, Key market, Hospital, RFID, Growth, Automation, Patient, Robotics, Radio-frequency identification, Ageing, Long-term care, Generic drug

BOSTON, May 3, 2024 /PRNewswire/ -- According to the latest BCC Research study, the demand for Pharmacy Automation: Technologies and Global Markets is growing from $7.8 billion in 2023 to $12.7 billion by the end of 2028, at a compound annual growth rate (CAGR) of 10.2% from 2023 through 2028.

Key Points: 
  • Applications: Inpatient Pharmacy Automation ensures accurate medication dispensing for hospitalized patients, while Acute-Care Settings prioritize fast dispensing.
  • Outpatient Pharmacy Automation supports community pharmacies, and Outpatient/Fast-Track Clinical Settings focus on quick dispensing in clinics.
  • This report on the Pharmacy Automation Technologies and Global Markets provides comprehensive insights and analysis, addressing the following key questions:
    What is the projected market size and growth rate of the pharmacy automation market?
  • The key factors driving the growth of the pharmacy automation market include rising prescription volumes in pharmacies, the surge in demand for automated packaging and labelling solutions, continuous need to reduce medicine errors, and increasing worldwide healthcare expenditures.

Global Recycled Concrete Market to Grow at a CAGR of 9.3% During Forecast Period 2023-2028

Retrieved on: 
вторник, апреля 30, 2024
Construction, Key market, MEA, Carbon, Natural Resources, CDW, Sand, Growth, Generic drug

BOSTON, April 30, 2024 /PRNewswire/ -- According to the latest BCC Research study, the demand for Global Recycled Concrete Market is growing from $11.1 billion in 2023 to $17.4 billion by the end of 2028, at a compound annual growth rate (CAGR) of 9.3% from 2023 through 2028.

Key Points: 
  • Product Type: Recycled concrete aggregates come in various forms: crushed stone for road construction, asphalt pavement debris for new asphalt mixtures, sand and gravel for concrete production, and cement concrete debris for various construction applications.
  • End Use: Recycled concrete aggregates find application in residential construction, industrial purposes such as infrastructure development and factory floors, and in infrastructure projects like roads and bridges.
  • This report on the Global Recycled Concrete Market provides comprehensive insights and analysis, addressing the following key questions:
    What is the projected market size and growth rate of the market?
  • The market is projected to grow from $10.3 billion in 2022 to $17.4 billion in 2028 at a compound annual growth rate (CAGR) of 9.3% during the forecast period.