Leuprorelin

Amide Technologies Announces Complex Peptide Manufacturing Platform, Raises $16.5M to Expedite Frontier Drug Discovery

Retrieved on: 
Thursday, December 14, 2023
Professional Services, Health, Other Professional Services, Other Health, Finance, Pharmaceutical, Biotechnology, Peptide, Dicarboxylic acid, SPPS, Acquisition, DNA, Liraglutide, Organization, Therapy, MIT, Velia, ITA Software, Dulaglutide, Flight, Leuprorelin, Protein, Multimedia, AFPS, Infection, Biology, FDA, General partnership, CIO, Drug design, Structural biology, Goserelin, Hand, Drug discovery, Ginkgo Bioworks, Doctor of Philosophy, Cancer, Diabetes, Type 2, Chemistry, Fine chemical, Amide

Amide Technologies , a biotech that synthesizes challenging peptides, announced today that it has begun commercializing its novel peptide manufacturing platform.

Key Points: 
  • Amide Technologies , a biotech that synthesizes challenging peptides, announced today that it has begun commercializing its novel peptide manufacturing platform.
  • New advances in structural biology, recombinant biologics, and AI-driven technologies have improved drug design and delivery methods, overcoming many previous pharmacokinetic behavior drawbacks of peptides .
  • “Amide delivers on complex peptide orders that other vendors refuse because peptide sourcing shouldn’t stand in the way of discovery,” said Amide CEO Mark Simon, PhD.
  • ITA Software founder and CEO Jeremy Wertheimer is an Amide co-founder and Board Member, alongside MIT Professor of Chemistry Brad Pentelute, PhD.

Astellas to Share New Data Across Hard-to-Treat Cancers During ESMO Congress 2023

Retrieved on: 
Sunday, October 15, 2023
Congress, Partnership, Senior, Cancer, Zolbetuximab, Astellas Pharma, Abstract, Brentuximab vedotin, Leuprorelin, GEJ, TSE, BCR, Patient, Oncology, ESMO, Quality of life (healthcare), Merck, Seagen, GLOW, Adenocarcinoma, European Society for Medical Oncology, Neoplasm, Prostate, HER2, Simple squamous epithelium, Research, Pharmaceutical industry

TOKYO, Oct. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will share new research results during the European Society for Medical Oncology (ESMO) Congress 2023 from October 20-24, showcasing the company's focus on making a meaningful difference for people living with hard-to-treat cancers. A total of 13 abstracts will be presented, highlighting data from two established medicines and one investigational therapy, across prostate, urothelial, and gastric/gastroesophageal junction (GEJ) cancers.

Key Points: 
  • Data include three late-breaking abstracts, underscoring Astellas' efforts to potentially redefine expectations for patients across its oncology portfolio
    TOKYO, Oct. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will share new research results during the European Society for Medical Oncology (ESMO) Congress 2023 from October 20-24, showcasing the company's focus on making a meaningful difference for people living with hard-to-treat cancers.
  • A total of 13 abstracts will be presented, highlighting data from two established medicines and one investigational therapy, across prostate, urothelial, and gastric/gastroesophageal junction (GEJ) cancers.
  • "At Astellas, we're working to change the course of cancer care, including through scientific advancements to address pressing unmet needs.
  • During ESMO, we will share updated data from two Phase 3 clinical studies, highlighting important clinical data of zolbetuximab in gastric and GEJ cancer patients whose tumors are CLDN18.2-positive."

Newron Appoints Margarita Chavez as Board Advisor

Retrieved on: 
Monday, October 2, 2023
Finance, Neurology, Consulting, Professional Services, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Santa Clara University School of Law, Abbott, XETRA, AGM, Leuprorelin, CNS, Medication, Silicon, Margarita, Santa Clara University, Patient, Initial public offering, BD, Pharmaceutical industry, Management, Newron Cup, Elagolix

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous (CNS) system, today announced that Margarita Chavez has been appointed as an advisor to the Board of Directors of Newron, bringing significant pharmaceutical business development (BD) and dealmaking expertise.

Key Points: 
  • Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous (CNS) system, today announced that Margarita Chavez has been appointed as an advisor to the Board of Directors of Newron, bringing significant pharmaceutical business development (BD) and dealmaking expertise.
  • It is intended that Margarita Chavez will be nominated for election to the Board of Directors at Newron’s next Ordinary Annual General Meeting (AGM) of Shareholders in spring 2024.
  • Margarita Chavez brings to Newron over 20 years of dealmaking expertise and leadership in the pharmaceutical industry.
  • Ulrich Köstlin, Chairman of the Board of Directors of Newron, commented: “We are delighted that Margarita will be supporting us with her vast international dealmaking expertise as a Board advisor and we are convinced that she will as of the AGM 2024 significantly strengthen our Board of Directors as new member.

EQS-News:  Newron appoints Margarita Chavez as board advisor

Retrieved on: 
Monday, October 2, 2023
Santa Clara University School of Law, Abbott, XETRA, AGM, Leuprorelin, CNS, Silicon, Margarita, Santa Clara University, Patient, Initial public offering, Ordinary, BD, Management, Newron Cup, Elagolix

Margarita Chavez, former Managing Director at AbbVie Ventures, to be nominated for election to the Board of Directors at the Ordinary AGM 2024

Key Points: 
  • Margarita Chavez, former Managing Director at AbbVie Ventures, to be nominated for election to the Board of Directors at the Ordinary AGM 2024
    Milan, Italy, October 2, 2023 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous (CNS) system, today announced that Margarita Chavez has been appointed as an advisor to the Board of Directors of Newron, bringing significant pharmaceutical business development (BD) and dealmaking expertise.
  • It is intended that Margarita Chavez will be nominated for election to the Board of Directors at Newron’s next Ordinary Annual General Meeting (AGM) of Shareholders in spring 2024.
  • Margarita Chavez brings to Newron over 20 years of dealmaking expertise and leadership in the pharmaceutical industry.
  • Ulrich Köstlin, Chairman of the Board of Directors of Newron, commented: “We are delighted that Margarita will be supporting us with her vast international dealmaking expertise as a Board advisor and we are convinced that she will as of the AGM 2024 significantly strengthen our Board of Directors as new member.

European Medicines Agency Validates Type II Variation for Astellas' XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence

Retrieved on: 
Wednesday, September 13, 2023
Senior, Astellas Pharma, Type 2, Food, European Medicines Agency, MFS, Cancer, BCR, Leuprorelin, Type, EMA, Patient, Risk, FDA, Recurrence, Death, Regulation of tobacco by the U.S. Food and Drug Administration, Safety, MPH, PSA, Disease, Metastasis, TSE, Prostate cancer, Medical imaging, Pharmaceutical industry, MD

TOKYO, Sept. 12, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI® (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy.

Key Points: 
  • These patients, particularly those with rapidly rising PSA levels, need new therapeutic approaches.
  • Detailed results from the trial were presented as a plenary session during the 2023 American Urological Association Annual Meeting on April 29.
  • The overall safety profile was consistent with the known safety profile of each of the medicines.
  • Astellas has already reflected the impact from this acceptance in its financial forecast of the current fiscal year ending March 31, 2024.

Royalty Pharma Reports Second Quarter 2023 Results

Retrieved on: 
Tuesday, August 8, 2023
Acceleration, Net, Pressure, University, Civil service commission, Astellas Pharma, Chronic lymphocytic leukemia, Vertex, Calendar, Aplastic anemia, DPP, GAAP, Leuprorelin, Sale, Ulcerative colitis, Psoriasis, Gilead, EBITDA, Acquisition, European Commission, Patient, Risk, Metastasis, Cystic fibrosis, Growth, Johnson & Johnson, California Miramar University, FDA, Sacituzumab govitecan, Regulation of tobacco by the U.S. Food and Drug Administration, Death, Food, Ivacaftor, Pfizer, Talazoparib, Bank, Video game, Music, Vaccine, Pharmaceutical industry, Real estate, Cryptocurrency, Berotralstat, Apalutamide, Nusinersen, Elexacaftor/tezacaftor/ivacaftor, Adjustment, Guselkumab, Ibrutinib

Drivers of total royalty receipts in the second quarter of 2023 are discussed below, based on commentary from the marketers of the products underlying the royalties in the preceding quarter (as royalty receipts generally lag product performance by one calendar quarter).

Key Points: 
  • Drivers of total royalty receipts in the second quarter of 2023 are discussed below, based on commentary from the marketers of the products underlying the royalties in the preceding quarter (as royalty receipts generally lag product performance by one calendar quarter).
  • Royalty Pharma acquired a royalty interest in Trelegy in July 2022 and began receiving royalty receipts in the third quarter of 2022.
  • During the second quarter of 2023, Royalty Pharma began repurchasing its Class A ordinary shares and repurchased approximately four million shares for $134 million.
  • The weighted-average diluted Class A ordinary shares outstanding for the second quarter of 2023 was 606 million as compared to 607 million for the first quarter of 2023.

Royalty Pharma Reports First Quarter 2023 Results

Retrieved on: 
Tuesday, May 9, 2023
Asthma, Share repurchase, BioCryst Pharmaceuticals, Cohort, DPP, GAAP, Letermovir, Acquisition, Patient, Risk, Cystic fibrosis, Ageing, Ionis Pharmaceuticals, Psychiatry, Vertex, Cardiovascular disease, Aplastic anemia, Gilead, Bronchoconstriction, Growth, FDA, Calcitonin, Net, Pressure, Migraine, Psychosis, Schizophrenia, HER2, Cabozantinib, Leuprorelin, Psoriasis, Cytokinetics, Astellas Pharma, Progression-free survival, RCC, LVEF, Calendar, Exelixis, COVID, AstraZeneca, Sale, EBITDA, HCM, PureTech Health, Breast cancer, Generic drug, Bank, Video game, Pharmaceutical industry, Music, Bookkeeping, Ionis, Natalizumab, Sacituzumab govitecan, Ibrutinib, Salbutamol/budesonide, Elexacaftor/tezacaftor/ivacaftor, KarXT, Adjustment, Pfizer

As such, Royalty Pharma did not receive royalty receipts on Prevymis net sales in the first quarter of 2023 related to the fourth quarter of 2022.

Key Points: 
  • As such, Royalty Pharma did not receive royalty receipts on Prevymis net sales in the first quarter of 2023 related to the fourth quarter of 2022.
  • Drivers of royalty receipts in the first quarter of 2023 are discussed below, based on commentary from the marketers of the products underlying the royalties in the preceding quarter (as royalty receipts generally lag product performance by one calendar quarter).
  • Royalty Pharma acquired a royalty interest in Trelegy in July 2022 and began receiving royalty receipts in the third quarter of 2022.
  • Royalty Pharma will also receive 25% of Ionis’ mid-teens to low-20% royalty on net sales of pelacarsen, resulting in a mid-single digit royalty to Royalty Pharma.

XTANDI® (enzalutamide) plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

Retrieved on: 
Saturday, April 29, 2023
Confidence interval, PFE, Leuprorelin, Pfizer, Death, Astellas Pharma, TSE, NYSE, Risk, Metastasis, Prostate cancer, Dairy, Pharmaceutical industry

TOKYO and NEW YORK, April 29, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) announced today that XTANDI® (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; P

Key Points: 
  • The most common adverse events in those treated with XTANDI plus leuprolide were fatigue, hot flush, and arthralgia and in those treated with XTANDI monotherapy were fatigue, gynecomastia, and arthralgia.
  • The MFS results from the EMBARK study demonstrate that this intervention with XTANDI plus leuprolide was statistically significant for patients with high-risk BCR."
  • Specifically, the XTANDI monotherapy arm demonstrated that treatment with XTANDI reduced the risk of metastasis or death by 37% versus leuprolide plus placebo (HR: 0.63; 95% CI, 0.46–0.87; P=0.0049), meeting its MFS endpoint.
  • Treatment with XTANDI plus leuprolide and XTANDI monotherapy reduced the risk of PSA progression by 93% (HR: 0.07; 95% CI, 0.03–0.14; P

Myovant Sciences Announces Corporate Updates and Financial Results for Third Fiscal Quarter 2022

Retrieved on: 
Thursday, January 26, 2023
Research, Prostate cancer, Food, Gonadotropin-releasing hormone, USPI, Scott Richter, Endometriosis, Hart–Scott–Rodino Antitrust Improvements Act, History, Sale, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, SG, Roivant Sciences, SPIRIT, ORGOVYX, New Drug Application, EMA, Woman, RWS, Shanda, United Kingdom, Type 2, TRX, Richter, Pain, Safety, PDUFA, R, NYSE, Type, Risk, European Medicines Agency, Calendar, Patient, Growth, Uterine fibroid, German–Soviet Commercial Agreement (1940), Leuprorelin, Video game, Fine chemical, Credit, Security (finance), Pharmaceutical industry, Health insurance, Medical imaging, Airline, Takeda, Accord, Pfizer

Third fiscal quarter 2022 net product revenues for ORGOVYX in the U.S. were $48.7 million, reflecting 12% sequential growth compared to the second fiscal quarter 2022.

Key Points: 
  • Third fiscal quarter 2022 net product revenues for ORGOVYX in the U.S. were $48.7 million, reflecting 12% sequential growth compared to the second fiscal quarter 2022.
  • Approximately 4,000 new patients started treatment with ORGOVYX in the third fiscal quarter of 2022, reaching approximately 26,000 cumulative patients since launch.
  • In December 2022, Myovant completed a New Drug Submission to Health Canada seeking marketing approval for ORGOVYX for advanced prostate cancer.
  • Third fiscal quarter 2022 net product revenues for MYFEMBREE in the U.S. were $10.5 million, reflecting 64% sequential growth compared to second fiscal quarter 2022.

Acer Therapeutics Announces Initiation of Two Investigator-Sponsored Trials of ACER-801 (Osanetant) in Men with Adenocarcinoma of the Prostate

Retrieved on: 
Thursday, January 5, 2023
Adenocarcinoma, Prostate cancer, ACER, Partnership, Acer, Testosterone, Therapy, MD, Prostate, Leuprorelin, Flash, University of Kansas Health System, ADT, Acquisition, Patient, University, Aircraft pilot, Oncology, Quality of life, Palliative care, VMS, Severity, Department of Medicine – University of Pamplona, Prostatectomy, Medical imaging, Osanetant

The POSH-MAP (Pilot of Osanetant for Severity of Hot Flashes in Men with Adenocarcinoma of the Prostate) and PORT-MAP (Pilot of Osanetant to Reduce Testosterone in Men with Adenocarcinoma of the Prostate) trials are being sponsored and conducted by The University of Kansas Cancer Center in partnership with Acer.

Key Points: 
  • The POSH-MAP (Pilot of Osanetant for Severity of Hot Flashes in Men with Adenocarcinoma of the Prostate) and PORT-MAP (Pilot of Osanetant to Reduce Testosterone in Men with Adenocarcinoma of the Prostate) trials are being sponsored and conducted by The University of Kansas Cancer Center in partnership with Acer.
  • Following the completion of treatment on day 28 participants will re-test hormone levels and report final patient outcome measures.
  • “However, the ability of NK3R antagonists to reduce testosterone to castrate levels in prostate cancer patients has not been evaluated to date.
  • ACER-801 is an investigational product candidate which has not been approved by FDA or any other regulatory authority.