Stada Arzneimittel

Exelixis Announces First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, April 30, 2024
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Education, PFS, Abbreviated New Drug Application, European Patent Office, Experiment, Breast, NET, ASCO, RCC, Associate, Translation, European Medicines Agency, Hearing, PIN, Drug development, European Patent Convention, Metastasis, Conference, Liver disease, ADC, Stada Arzneimittel, Tablet, Baylor College of Medicine, Distinguishing, Therapy, NHT, Calendar, BIRC, Huntsman Cancer Institute, OS, Dean (education), Docetaxel, PKMYT1, Checkmate, Prostate cancer, ITT, EPO, USP1, University, PARP, Immunotherapy, Superior, PLK4, Patent, Royalty payment, Patient, Society, Acquisition, Translational research, Neoplasm, Share repurchase, Annual general meeting, Baylor University

Exelixis’ 2024 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 2.2% for both CABOMETYX and COMETRIQ effective on January 1, 2024.

Key Points: 
  • Exelixis’ 2024 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 2.2% for both CABOMETYX and COMETRIQ effective on January 1, 2024.
  • Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter ended March 31, 2024, Exelixis earned $39.6 million in royalty revenues.
  • In January, Exelixis announced the appointments of Mary C. Beckerle, Ph.D., and S. Gail Eckhardt, M.D., to the Exelixis Board of Directors, effective January 5, 2024.
  • Exelixis management will discuss the company’s financial results for the first quarter of 2024 and provide a general business update during a conference call beginning at 5:00 p.m.

NEXGEL Reports Full Year 2023 Revenue of $4.1 Million, an Increase of 99.7% Year-Over-Year

Retrieved on: 
Monday, April 1, 2024
Research, Growth, JV, Amazon, Health, Partnership, International, Webcast, ABBV, Foot, Acquisition, Cellulite, OTC, Marketing, Advertising, Stada Arzneimittel, Video game

Adam Levy, NEXGEL’s Chief Executive Officer, commented, “2023 was a record year for NEXGEL and transformational in many respects.

Key Points: 
  • Adam Levy, NEXGEL’s Chief Executive Officer, commented, “2023 was a record year for NEXGEL and transformational in many respects.
  • Our nearly 100% year-over-year revenue growth in 2023 was primarily driven by our branded products and contract manufacturing.
  • The increase in revenue was primarily due to sales growth in contract manufacturing of 166% and an increase in branded product revenue by approximately $427,000, or 52.4%, to $1.24 million.
  • For the fourth quarter of 2023, branded products revenue was $392,000, an increase of 104.2% year-over-year and 10.1% sequentially.

Alvotech Announces Expected Global Market Entry Dates for AVT04 Biosimilar to Stelara® (ustekinumab)

Retrieved on: 
Thursday, February 15, 2024
National health insurance, Food, Johnson & Johnson, European Economic Area, Biosimilar, Patient, EEA, Stada Arzneimittel, SPC

Market applications for AVT04 are currently pending in additional global markets, including in the U.S.

Key Points: 
  • Market applications for AVT04 are currently pending in additional global markets, including in the U.S.
    Market entry of AVT04 in Canada is expected in Q1 2024.
  • Market authorization for AVT04 in Japan is held by Alvotech’s commercial partner Fuji Pharma Co. Ltd., where the biosimilar will be marketed as Ustekinumab BS (F).
  • Alvotech’s commercial partner and market authorization holder for AVT04 in Canada is JAMP Pharma Group, where the biosimilar will be marketed as Jamteki®.
  • In the EEA, Alvotech’s commercial partner and market authorization holder for AVT04 is STADA Arzneimittel AG, where the trade name for AVT04 will be Uzpruvo®.

EQS-News: Federal Court of Justice (BGH) confirms additional payments for former shareholders of STADA Arzneimittel AG

Retrieved on: 
Thursday, February 8, 2024
Federal, SDK, BGH, Telephone, German, Federal Gazette, McKesson Europe, Bidding, Bain Capital, Stada Arzneimittel, News, Sale, EUR, Federal court, Security (finance)

Within the acceptance period (until the end of August 16, 2017), the bidder's offer was accepted by 63.76 % of STADA shareholders and within a further acceptance period (until September 1, 2017) by a further 0.11 % of STADA shareholders.

Key Points: 
  • Within the acceptance period (until the end of August 16, 2017), the bidder's offer was accepted by 63.76 % of STADA shareholders and within a further acceptance period (until September 1, 2017) by a further 0.11 % of STADA shareholders.
  • The bidder thus achieved a tender volume, including shares held by STADA, of approx.
  • In the opinion of the Bidder, the statute of limitations generally began at the latest at the end of 2017.
  • Former shareholders can register free of charge and without obligation at www.sdk.org/stada and will then receive all information on the proceedings.

European Patent Office Rules in Favor of Exelixis on Formulation Patent Covering CABOMETYX® (cabozantinib) Tablets

Retrieved on: 
Thursday, January 18, 2024
Pharmaceutical, Health, Oncology, European Patent Convention, Exelixis, EPO, European Medicines Agency, Tablet, Hearing, Patent, Stada Arzneimittel

Exelixis, Inc. (Nasdaq: EXEL) today announced it has successfully defended European Patent number EP2593090 (c-MET Modulator Pharmaceutical Compositions) against three opponents, STADA Arzneimittel AG, Teva Pharmaceutical Industries Ltd., and Generics (U.K.) Ltd. in a hearing before the Opposition Division of the European Patent Office (EPO).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced it has successfully defended European Patent number EP2593090 (c-MET Modulator Pharmaceutical Compositions) against three opponents, STADA Arzneimittel AG, Teva Pharmaceutical Industries Ltd., and Generics (U.K.) Ltd. in a hearing before the Opposition Division of the European Patent Office (EPO).
  • The three-member panel of the Opposition Division rejected all grounds of opposition, thus upholding the patent as granted.
  • The patent at issue, which expires on July 18, 2031, covers tablet formulations of cabozantinib, including the tablet formulation approved as CABOMETYX® (cabozantinib) tablets by the European Medicines Agency.
  • The decision is specific to the European patent at issue and is subject to appeal to the EPO Technical Boards of Appeal.

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024
GEJ, Immunoglobulin A, GPRC5D, Government, Trastuzumab, Daiichi Sankyo, DME, BRCA, FDA, Spacecraft, Health, Haemophilia, Abiraterone acetate, Infection, PDE, Crohn's disease, CLVT, Drug discovery, Breast cancer, Breast, Data, Budesonide, AMD, PARP, Metastasis, PDE4, DXD, Safety, NSCLC, Health care, RSV, DR, AstraZeneca, EMA, CRISPR, Chronic obstructive pulmonary disease, Adenocarcinoma, Multiple myeloma, Civil service commission, Artificial intelligence, Patient, Stada Arzneimittel, Intelligence, CD3, Ulcerative colitis, SCD, Lung cancer, European Commission, Sickle cell disease, Gilead Sciences, Respiratory syncytial virus, Research, Diabetic retinopathy, Mirikizumab, COPD, COVID-19, Conditional sentence, Genentech, Thalassemia, Organization, Zolbetuximab, ADC, Pharmaceutical industry

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024
GEJ, Immunoglobulin A, GPRC5D, Government, Trastuzumab, Daiichi Sankyo, DME, BRCA, FDA, Spacecraft, Health, Haemophilia, Abiraterone acetate, Infection, PDE, Crohn's disease, CLVT, Drug discovery, Breast cancer, Breast, Data, Budesonide, AMD, PARP, Metastasis, PDE4, DXD, Safety, NSCLC, Health care, RSV, DR, AstraZeneca, EMA, CRISPR, Chronic obstructive pulmonary disease, Adenocarcinoma, Multiple myeloma, Civil service commission, Artificial intelligence, Patient, Stada Arzneimittel, Intelligence, CD3, Ulcerative colitis, SCD, Lung cancer, European Commission, Sickle cell disease, Gilead Sciences, Respiratory syncytial virus, Research, Diabetic retinopathy, Mirikizumab, COPD, COVID-19, Conditional sentence, Genentech, Thalassemia, Organization, Zolbetuximab, ADC, Pharmaceutical industry

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

NEXGEL Announces Partnership with STADA to Distribute and Commercialize Consumer Health OTC Products in North America

Retrieved on: 
Monday, December 11, 2023
Gel, Partnership, Stada Arzneimittel, OTC

LANGHORNE, Pa., Dec. 11, 2023 (GLOBE NEWSWIRE) -- NEXGEL, Inc. (“NEXGEL” or the “Company”) (NASDAQ: NXGL), a leading provider of medical and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogels for healthcare and consumer applications, today announced a partnership with STADA Arzneimittel AG (“STADA”), a European leader in consumer health, to distribute and commercialize consumer health OTC products in North America in 2024.

Key Points: 
  • LANGHORNE, Pa., Dec. 11, 2023 (GLOBE NEWSWIRE) -- NEXGEL, Inc. (“NEXGEL” or the “Company”) (NASDAQ: NXGL), a leading provider of medical and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogels for healthcare and consumer applications, today announced a partnership with STADA Arzneimittel AG (“STADA”), a European leader in consumer health, to distribute and commercialize consumer health OTC products in North America in 2024.
  • Adam Levy, CEO of NEXGEL, commented, “We are pleased to be partnering with STADA, a brand leader in the European markets.
  • The product launch is expected to be in mid-2024 and will provide North American consumers with an established European product.”

Alvotech Reports Financial Results for First Nine Months of 2023 and Provides a Business Update

Retrieved on: 
Tuesday, November 28, 2023
Omalizumab, European Economic Area, European Commission, Partnership, Food, Johnson & Johnson, Food and Drug Administration, BLA, Business analyst, FDA, EMA, Marketing, Absorption, Research, Civil service commission, European Medicines Agency, Gross metropolitan product, Committee, Patient, Safety, Stada Arzneimittel, Webcast, G&A, Biosimilar, CHMP, Pharmaceutical industry

Alvotech and JAMP Pharma also announced the receipt of a marketing authorization in Canada for AVT04.

Key Points: 
  • Alvotech and JAMP Pharma also announced the receipt of a marketing authorization in Canada for AVT04.
  • Product Revenue: Product revenue was $29.8 million for the nine months ended September 30, 2023, compared to $11.1 million for the same nine months of 2022.
  • Income tax benefit: Income tax benefit was $67.1 million for the nine months ended September 30, 2023, compared to $14.8 million for the same nine months of 2022.
  • Alvotech will conduct a business update conference call and live webcast on Wednesday, November 29 at 8:00 am ET (13:00 GMT).

Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy

Retrieved on: 
Tuesday, October 3, 2023
EEA, CET, Health care, EGFR, Medication, Glomerular filtration rate, Immunoglobulin A, Budesonide, Person, Proteinuria, Sustainability, European Economic Area, CALT, Risk, Kidney, United Kingdom, Stada Arzneimittel, Lancet, UPCR, MHRA, Disease, Pharmaceutical industry, IgA nephropathy

STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.

Key Points: 
  • STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.
  • Kinpeygo is an orphan medicinal product and the first and only treatment approved in the UK for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need.
  • Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
  • : +46 76 403 35 43, email: [email protected]
    The information was sent for publication, through the agency of the contact persons set out above, on October 3, 2023 at 09:20 a.m. CET.