Androgen

Spruce Biosciences Announces Topline Results from CAHmelia-203 in Adult Classic CAH and CAHptain-205 in Pediatric Classic CAH

Retrieved on: 
Wednesday, March 13, 2024
Biotechnology, Pharmaceutical, Health, GC, Obesity, Endocrinology, Clinical professor, Associate, Risk, Patient, GCS, Mayo Clinic, Androgen, Șaeș, CAH, Endocrine system, Safety, Workforce, Medical director, ACTH, Pharmaceutical industry

Preliminary pharmacokinetic analysis suggests that tildacerfont is cleared more rapidly in children than in adult CAH patients.

Key Points: 
  • Preliminary pharmacokinetic analysis suggests that tildacerfont is cleared more rapidly in children than in adult CAH patients.
  • 70% of patients with elevated baseline A4 values (16 of 23 patients) demonstrated an A4 reduction at week 4.
  • “The CAHptain-205 study results demonstrate safety and tolerability in pediatric CAH patients with weight-adjusted tildacerfont doses up to 200mg daily.
  • An archived copy of the call will be available on the events section of the company’s investor relations website for approximately 90 days.

BioCryst Presents New Real-world Data Showing Rapid, Substantial and Sustained HAE Attack Rate Reductions After Beginning ORLADEYO® (berotralstat) Treatment

Retrieved on: 
Friday, February 23, 2024
Incidence, AAAAI, Pharmacy, Attack, Expert network, Tranexamic acid, Prior, Effectiveness, Pharmacist, Washington Convention Center, University, Conditional sentence, Day, Lanadelumab, Safety, Androgen, HAE, History, Hereditary angioedema, Tolerability, Monitoring, Internal medicine, Walter, BioCryst Pharmaceuticals, Medicine, Disease, Ageing, Observational study, Poster, American Academy, Pharmaceutical industry

“These additional analyses of real-world use of ORLADEYO show that any person living with HAE has the potential to experience a rapid, substantial and sustained reduction in their monthly attack rate with ORLADEYO.

Key Points: 
  • “These additional analyses of real-world use of ORLADEYO show that any person living with HAE has the potential to experience a rapid, substantial and sustained reduction in their monthly attack rate with ORLADEYO.
  • These analyses present the overall attack rate progression and attack rate progression stratified by severity (i.e., number of attacks at baseline), prior prophylaxis and C1-INH level and function.
  • These findings further demonstrate that ORLADEYO can help maintain disease control in patients with lower baseline attack rates and further reduce attack rates in patients with more active disease.
  • Berotralstat Prophylaxis Reduces HAE Attack Rates Regardless of Baseline Attacks: Real-World Outcomes; Poster #012; Friday, February 23, 3:15-4:15 p.m.

Veru Reports Fiscal 2024 First Quarter Financial Highlights

Retrieved on: 
Thursday, February 8, 2024
Internet, Weight, COVID-19, Androgen, Weight loss, Mortality, Calendar, Investigational New Drug, Overweight, Trial of the century, Telehealth, Obesity, Telephone, Clinical trial, Government, Therapy, Patient, IND, Safety, Condom, Facial muscles, FDA, LaTeX, Pharmacy, FC2, Enobosarm, Pregnancy, Muscle weakness, Frailty, Female, Drug discovery, U.N, Death, Health, SARM, Cancer, NDA, Woman, Dietary supplement

MIAMI, FL, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for potentially higher quality weight loss, oncology, and viral induced acute respiratory distress syndrome (ARDS), today announced financial highlights for its fiscal 2024 first quarter and provided a business update.

Key Points: 
  • The clinical study is expected to begin in April 2024 with the topline clinical results from the trial expected in the end of the fourth calendar quarter of 2024.
  • To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call.
  • An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months.
  • A telephonic replay will be available on February 8, 2024 at approximately 12:00 p.m.

Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 21, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Medical Subject Headings, Marketing, CRPC, Agency, Survival, INN, Risk, Androgen, Fatigue, Learning, Woman, Docetaxel, Fracture, ATC, Male, Hormone, Hypertension, Capsule, International, Man, Disease, Neutropenia, Language, Prostate cancer, Cancer, Neoplasm, Cognitive disorder, Testosterone, Metastasis, Neutrophil, European Medicines Agency, Thought, Tablet, Growth, Select, Safety, Prostate, Memory, Anatomy, Seizure, IIA, Medical device

Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 21, Status: Authorised

BioCryst Presents New Real-world Data Showing Reduced Attack Rates in Patients with HAE with Normal C1-inhibitor Following Long-term Treatment with ORLADEYO® (berotralstat)

Retrieved on: 
Friday, November 10, 2023
Medicine, Anaheim Convention Center, SEM, Safety, BioCryst Pharmaceuticals, Attack, Month, Lanadelumab, Convention, American College, Androgen, Hereditary angioedema, HAE, Day, RESEARCH, Allergy, ACAAI, Pharmaceutical industry, Nightclub, Patient

These real-world observations suggest ORLADEYO can have a meaningful impact on the lives of people who have HAE with normal C1-INH.

Key Points: 
  • These real-world observations suggest ORLADEYO can have a meaningful impact on the lives of people who have HAE with normal C1-INH.
  • The company also announced a new post-hoc analysis from the APeX-S clinical trial that showed a sustained reduction in HAE attacks compared to patients’ self-reported baseline attack rates.
  • “The ability to compare patients’ treatment outcomes with their HAE attack rates at baseline is tremendously helpful to characterize the impact of a prophylactic therapy.
  • Patients who were treated with ORLADEYO experienced a sustained reduction in HAE attacks compared to their self-reported baseline attack rates, suggesting a reduction in disease burden and durable treatment effect.

Marius Pharmaceuticals Announces KYZATREX® (CIII testosterone undecanoate capsules) HERO Campaign, Empowering Men To 'Be the Hero of Your Life Again'

Retrieved on: 
Wednesday, December 6, 2023
WCS, Hypertension, Adolescence, Testosterone, HERO, Prevalence, Ageing, Testicular cancer, Hero, Hypogonadism, Patient, Prostate cancer, Health, Veteran, Cancer, SHBG, Site, Physician, Androgen, Overalls, Pharmaceutical industry

RALEIGH, N.C., Dec. 6, 2023 /PRNewswire/ -- Marius Pharmaceuticals , a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, today announces the launch of its KYZATREX® HERO campaign that aims to empower men to "Be the Hero of Your Life Again."

Key Points: 
  • RALEIGH, N.C., Dec. 6, 2023 /PRNewswire/ -- Marius Pharmaceuticals , a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, today announces the launch of its KYZATREX® HERO campaign that aims to empower men to "Be the Hero of Your Life Again."
  • KYZATREX is an oral prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions.
  • The advertising campaign seeks to educate patients who are appropriate candidates for treatment and their physicians on how KYZATREX can help men restore testosterone levels to reinvigorate their natural vitality.
  • In a clinical efficacy study of 127 hypogonadal patients, 96% of patients taking KYZATREX had normal testosterone levels at Day 90.

Astellas to Acquire Propella Therapeutics

Retrieved on: 
Wednesday, November 15, 2023
Acquisition, Research, Safety, Tissue, Patient, Date, Astellas Pharma, Prostate cancer, Androgen, Steroid, TSE, Cooley LLP, CYP17, Cancer, Pharmaceutical industry, Incorporated

TOKYO and PITTSBORO, N.C., Nov. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Propella Therapeutics, Inc. (President and CEO: William Moore, "Propella") today announced that Astellas, through a U.S. subsidiary, and Propella have entered into a merger agreement pursuant to which Astellas will acquire Propella. Propella is a privately held biopharmaceutical company that has leveraged a wholly owned proprietary platform that combines medicinal chemistry with lymphatic targeting to create new oncology drugs.

Key Points: 
  • TOKYO and PITTSBORO, N.C., Nov. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Propella Therapeutics, Inc. (President and CEO: William Moore, "Propella") today announced that Astellas, through a U.S. subsidiary, and Propella have entered into a merger agreement pursuant to which Astellas will acquire Propella.
  • Through the acquisition of Propella, Astellas will acquire PRL-02 (abiraterone decanoate), a next-generation androgen biosynthesis inhibitor being developed by Propella to treat prostate cancer.
  • Under the agreement, Astellas will pay approximately US$175million to acquire all of the outstanding common stock and equity interests in Propella.
  • Stifel, Nicolaus & Company, Incorporated is acting as exclusive financial advisor and Cooley LLP provided legal advice to Propella on this transaction.

Sun Pharma Survey Reveals Americans with Mild-to-Moderate Acne Have Defeatist Attitudes About Treatment, Despite Self-Consciousness

Retrieved on: 
Thursday, November 2, 2023
FAAD, Knowledge, Union of Sales and Marketing Professionals, DO, Social media, Dermatology, Family, Hope, Skin care, Medical director, Skin, Doctor of Philosophy, Inflammation, Friends, Pimple, Acne, Androgen, Sun Pharma, Breakout, Hormone, Schizoid avoidant behavior, MMS, Marketing, Gland, Cosmetics, Birth control, Online shopping, MD

Among the 1,003 survey respondents ages 13-55, only three in 10 reported having seen a dermatologist, suggesting that many people with mild-to-moderate acne are missing out on effective treatments.

Key Points: 
  • Among the 1,003 survey respondents ages 13-55, only three in 10 reported having seen a dermatologist, suggesting that many people with mild-to-moderate acne are missing out on effective treatments.
  • Additionally, 60% of respondents said they "just have to deal with" their acne, and more than half (54%) expressed the opinion that acne is not preventable.
  • "Given the reported lack of control people seem to have over their acne, I find it especially troubling that so few consult a dermatologist.
  • For more information about the cause of acne, skin care tips, videos and more, please visit www.acnehormones.com/derm .

Veru Reports Clinical Data from the Discontinued ARTEST Study of Enobosarm, Novel Selective Androgen Receptor Targeting Agonist, in AR+ ER+ HER2- Metastatic Breast Cancer

Retrieved on: 
Monday, September 11, 2023
CDK, Clutch (eggs), Quality of life, Androgen, Enobosarm, Patient, Hematocrit, Pharmaceutical industry, Safety

MIAMI, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for metastatic breast cancer and for viral induced acute respiratory distress syndrome (ARDS), today announced clinical data from the discontinued Phase 3 ARTEST clinical trial of enobosarm monotherapy for the 3rd line or greater in the metastatic setting of AR+ER+HER2- breast cancer. Enrollment was discontinued in order to prioritize and focus the clinical development of enobosarm therapy earlier in the treatment sequence, the 2nd line metastatic setting, for AR+ER+HER2- metastatic breast cancer in the Phase 3 ENABLAR-2 (enobosarm +/- abemaciclib CDK 4/6 inhibitor) study. Data reported from the discontinued trial, which is based on an analysis of available data, may not be predictive of the results of larger, later-stage controlled clinical trials.

Key Points: 
  • “The clinical results from the ARTEST study provide promising scientific support and validation for the potential of enobosarm therapy in the ongoing Phase 3 ENABLAR-2 study.
  • The AR+ER+HER2- metastatic breast cancer patients enrolled in the Phase 3 ARTEST study were heavily pretreated.
  • On average, either enobosarm or the standard of care active control in ARTEST was given as 4th line treatment.
  • We are encouraged by these early results, and it appears to be the right decision to move and focus enobosarm’s clinical development earlier to the 2nd line metastatic setting for ER+HER2- metastatic breast cancer patients in the Phase 3 ENABLAR-2 study.”

Myelofibrosis Market Size and Trend Report 2023-2031: Projected $2.89 Billion Market by 2031 - MF Pipeline is Robust, with Plenty of Room for New Market Entrants - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 3, 2023
General Health, Pharmaceutical, Health, Oncology, Janus, PBF, Ruxolitinib, Androgen, Therapy, Primary myelofibrosis, Population Health Management, JAK, Epidemiology, Bone marrow, POLI, MF, Common, Clinical trial, Patent, WMH, Growth, Pharmaceutical industry, Medical device

The "Myelofibrosis Market Size and Trend Report including Epidemiology, Disease Management, Pipeline Analysis, Competitor Assessment, Unmet Needs, Clinical Trial Strategies and Forecast to 2031" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Myelofibrosis Market Size and Trend Report including Epidemiology, Disease Management, Pipeline Analysis, Competitor Assessment, Unmet Needs, Clinical Trial Strategies and Forecast to 2031" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report includes an assessment of the disease epidemiology and 10-year patient-based forecast (PBF) across the 8MM for marketed and late-stage pipeline therapies, with a launch date assessment by market for myelofibrosis (MF).
  • In 2028, Jakafi/Jakavi is set to come off-patent in the US, which will greatly decrease its total market sales.
  • The most promising candidates in Phase III and Phase IIb development are profiled
    Analysis of the current and future market competition in the global myelofibrosis therapeutics market.