Generic drug

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, Acute coronary syndrome, Thrombolysis, Artery, Moyamoya disease, INN, Risk, ABCD2, ATC, Myocardial infarction, Bleeding, International, Blood, ASA, Brain, NIHSS, Language, Heart, TIA, Vitamin K, Vascular disease, Percutaneous coronary intervention, European Medicines Agency, VKA, Preventive healthcare, Tablet, ADP, Select, Chest pain, Aspirin, Patient, Anatomy, IIA, Atrial fibrillation, Generic drug

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
RNA, Medical Subject Headings, Non-small-cell lung cancer, Marketing, Malignancy, European Commission, Agency, INN, Risk, Histology, ATC, International, European, Lung cancer, Injection, Disease, Body surface area, Language, DNA, Cisplatin, Cancer, Asbestos, Inflammation, Folate, Enzyme, Select, Committee, Patient, Cell, Dehydration, Risk management, Anatomy, Medicine, IIA, CHMP, Generic drug

Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised

EQS-News: Health Canada approves FYB201/Ranopto® (Ranibizumab), a biosimilar to Lucentis®

Retrieved on: 
Saturday, December 30, 2023
NAMD, Quality of life, Partnership, Eye, Risk, Teva Canada, Retina, Paratriathlon, Blood, Visual impairment, AMD, VEGF, OECD, Genentech, Health Canada, Ranibizumab, NOC, Growth, Supervisory board, Patient, Generic drug

Press Release // December 07, 2023

Key Points: 
  • Press Release // December 07, 2023
    Munich, Amsterdam, Zug, Toronto – Formycon AG, Polpharma Biologics Group BV, Bioeq AG and Teva Canada Ltd. jointly announce that Health Canada has granted the “Notice of Compliance” (NOC) for Ranopto®1 (Ranibizumab), a biosimilar to Lucentis®2, for the treatment of several serious retinal diseases in Canada.
  • Mid 2021, Teva Pharmaceutical Industries Ltd. (“Teva”) entered into a strategic partnership for the exclusive commercialization of FYB201 in Canada, Europe and selected other countries.
  • Commercial launch by Teva Canada Ltd. is expected to start in the first quarter of 2024.
  • “The approval in Canada underlines the excellent work we have done together with our partners in the development of FYB201/Ranopto®.

EQS-News: Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration

Retrieved on: 
Saturday, December 30, 2023
Fresenius (company), Food, EMA, FDA, Biologics license application, Ulcerative colitis, Press release, Ustekinumab, Patient, Psoriasis, Biosimilar, BLA, Generic drug

Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration

Key Points: 
  • Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
    The issuer is solely responsible for the content of this announcement.
  • Press Release // November 30, 2023
    Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
    Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Biologics License Application (“BLA”) for FYB202, a proposed biosimilar candidate to Stelara®1.
  • FYB202 is a human monoclonal antibody that targets interleukin 12 and interleukin 23 for the treatment of immune-mediated disorders.
  • “The FDA file acceptance for our Stelara® biosimilar candidate FYB202 underlines the great expertise and capabilities of #TeamFormycon.

Aclaris Therapeutics Announces Patent License Agreement with Sun Pharma for Alopecia

Retrieved on: 
Tuesday, December 5, 2023
Sun Pharma, Alopecia areata, Therapy, Patent, Sun, Pattern hair loss, ACRS, AA, Generic drug

WAYNE, Pa., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drugs for immuno-inflammatory diseases, today announced an exclusive patent license agreement with Sun Pharmaceutical Industries, Inc. (Sun Pharma).

Key Points: 
  • WAYNE, Pa., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drugs for immuno-inflammatory diseases, today announced an exclusive patent license agreement with Sun Pharmaceutical Industries, Inc. (Sun Pharma).
  • Under the license agreement, Aclaris granted Sun Pharma exclusive rights under certain patents for the use of deuruxolitinib, Sun Pharma’s JAK inhibitor, or other isotopic forms of ruxolitinib, to treat alopecia areata (AA) or androgenetic alopecia (AGA).
  • Aclaris exclusively licenses the patents from a third party, and has separate contractual obligations under which it owes a portion of the consideration received from Sun Pharma.
  • “We are pleased to announce this patent license agreement with Sun Pharma, which represents our second out-license for this patent portfolio,” stated James Loerop, Chief Business Officer of Aclaris.

Hyloris announces US FDA approval for Podofilox Gel

Retrieved on: 
Monday, December 4, 2023
FDA, Brussels Stock Exchange, Health, New Drug Application, Podophyllotoxin, Patient, CGT, Generic drug

For the 12 months period ending December 2022, Condylox® Gel 0.5% had U.S. sales of approximately $9 million according to IQVIA Health.

Key Points: 
  • For the 12 months period ending December 2022, Condylox® Gel 0.5% had U.S. sales of approximately $9 million according to IQVIA Health.
  • Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: “This is the second product approval of the year in the U.S. supported by Hyloris, following our recent success with Maxigesic® IV.
  • We are excited to launch, with Padagis, the first generic version of Condylox® Gel in the US.
  • The availability of the generic Condylox® Gel reinforces Hyloris' mission to make a meaningful difference in the lives of patients by delivering innovative and accessible pharmaceutical solutions.

Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

Retrieved on: 
Wednesday, November 29, 2023
Rheumatoid arthritis, Pharmacokinetics, Patient, Safety, Trial of the century, Biosimilar, Generic drug

REYKJAVIK, Iceland, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).

Key Points: 
  • REYKJAVIK, Iceland, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).
  • The study, which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult subjects, met its primary endpoints.
  • In the last twelve months up to October 2023, combined worldwide revenues from sales of Simponi and Simponi Aria were nearly $2.2 billion [1].
  • Alvotech’s current portfolio of 11 products and product candidates includes one launched product, one approved biosimilar and four biosimilar candidates in clinical studies, including AVT05.

Growth Opportunities in Biosimilars Market - Global Forecast to 2028: Leveraging AI, PD, and Omics Biomarkers with Focus on the Middle East and Africa - ResearchAndMarkets.com

Retrieved on: 
Monday, December 18, 2023
Biotechnology, Health, Pharmaceutical, Technology, Artificial Intelligence, Biosimilar, Patient, Safety, Element, Patent, Neurology, Environment, Generic drug

The "Growth Opportunities in Global Biosimilars Market, Forecast to 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Growth Opportunities in Global Biosimilars Market, Forecast to 2028" report has been added to ResearchAndMarkets.com's offering.
  • This study presents overall market and segment-wise revenue forecasts for the global biosimilars market.
  • It highlights key growth opportunities for biosimilar market participants based on the trends, evolution of business models, and strategic imperatives for various stakeholders.
  • This report identifies key growth opportunities to increase biosimilar uptake and innovations and compete for newer therapy areas, such as neurology and oncology.

Los Angeles Weight Loss Surgeon, Dr. David Davtyan, Thrilled for New FDA Approved ReShape Lifesciences® Next-Generation Lap-Band® 2.0 FLEX

Retrieved on: 
Tuesday, December 26, 2023
School, UCLA, Bariatric surgery, Multimedia, Weight loss, FDA, Surgeon, Inland Empire, Obesity, Food, Kia, Patient, PMA, Adjustable gastric band, FLEX, Medical school, Generic drug

BEVERLY HILLS, Calif., Dec. 26, 2023 /PRNewswire-PRWeb/ -- Dr. David Davtyan, a renowned surgeon and pioneer in weight loss surgery, is delighted to announce the FDA approval of ReShape Lifesciences' groundbreaking Lap-Band® 2.0 FLEX. Dr. Davytan was one of the first surgeons in the United States to offer the Lap-Band procedure and leads The Weight Loss Surgery Center of Los Angeles, a prestigious medical weight loss clinic in Beverly Hills. Dr. Davytan has dedicated his career to helping patients battle obesity through various surgical procedures. The enhanced Lap-Band® 2.0 FLEX development effort was physician-led, including input from Dr. Davtyan, with the goal of improving the patient experience. Compared to the current Lap-Band, the Lap-Band® 2.0 has a new feature called FLEX Technology, which acts as a relief valve, allowing larger pieces of food to more easily pass through the narrowed passage created by the band. This minimizes discomfort caused by the passage of large food pieces through the stoma. The Lap-Band® system has long been considered the safest and most durable weight loss option for obese patients. It is particularly ideal for those who are opposed to medically managed weight loss and prefer an anatomy-preserving surgery. Using this latest advancement, The Weight Loss Surgery Center of Los Angeles looks forward to continuing their mission of transforming lives through cutting-edge, safe and effective weight loss procedures.

Key Points: 
  • Dr. David Davtyan and his team at The Weight Loss Surgery Center of Los Angeles are looking forward to offering this innovative solution to their patients.
  • BEVERLY HILLS, Calif., Dec. 26, 2023 /PRNewswire-PRWeb/ -- Dr. David Davtyan , a renowned surgeon and pioneer in weight loss surgery , is delighted to announce the FDA approval of ReShape Lifesciences' groundbreaking Lap-Band® 2.0 FLEX.
  • Dr. Davytan was one of the first surgeons in the United States to offer the Lap-Band procedure and leads The Weight Loss Surgery Center of Los Angeles, a prestigious medical weight loss clinic in Beverly Hills.
  • Kia, The Weight Loss Surgery Center of Los Angeles, 877-923-7546, [email protected] , https://weightlosssurgeryla.com/
    View original content to download multimedia: https://www.prweb.com/releases/los-angeles-weight-loss-surgeon-dr-david-...

Pharmaceutical Excipients Industry Analysis 2024-2033 Featuring International Flavors & Fragrances, Ashland, DuPont, BASF, and More

Retrieved on: 
Saturday, December 23, 2023
Research, Administration, Growth, Excipient, Prevalence, Conditional sentence, Competitive landscape, Drug development, API, Generic drug

The global pharmaceutical excipients market is witnessing robust growth due to the increasing demand for pharmaceutical formulations and rising focus on drug delivery systems.

Key Points: 
  • The global pharmaceutical excipients market is witnessing robust growth due to the increasing demand for pharmaceutical formulations and rising focus on drug delivery systems.
  • Excipients play a crucial role in drug development by enhancing the stability, bioavailability, and overall efficacy of active pharmaceutical ingredients (APIs).
  • Additionally, stringent regulatory requirements and the emphasis on product quality are shaping the competitive landscape of the pharmaceutical excipients market.
  • With the pharmaceutical excipients market poised for continuous expansion, stakeholders are strategically focusing on partnerships, acquisitions, and product development to gain a competitive edge in this dynamic and evolving industry.