Prednisone

On the Road to Halving Cancer: The 2023 Biotech Advancements Igniting Hope

Retrieved on: 
среда, сентября 20, 2023

VANCOUVER, British Columbia, Sept. 20, 2023 /PRNewswire/ -- USA News Group - Earlier this year, the US White House requested over $2.8 billion in funding from Congress for their  "Cancer Moonshot" initiative, an ambitious plan to slash cancer rates in half within the next quarter-century. Already, 2023 is brimming with encouraging progress in the biotech sector that is boosting our hope in the battle against cancer. Simplifying the jargon, this includes major breakthroughs in treatments that are prolonging the time before cancer worsens (known as progression-free survival or PFS) and increasing the rate at which patients respond positively to treatment (overall response rate or ORR). This inspiring progress has been led by companies like from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Eli Lilly and Company, ImmunoGen, Inc. (NASDAQ: IMGN), Merck &Co., Inc. (NYSE: MRK), and AstraZeneca PLC (NASDAQ: AZN).

Key Points: 
  • Already, 2023 is brimming with encouraging progress in the biotech sector that is boosting our hope in the battle against cancer.
  • The trial, known as BRACELET-1, tested a therapy that combines the company's drug, pelareorep, with a common cancer treatment, paclitaxel.
  • In fact, the risk of the disease getting worse was reduced by an impressive 71% compared to paclitaxel alone, through its progression-free survival (PFS).
  • For patients, this could mean more time to enjoy life without the burden of worsening symptoms.

aTyr Pharma Presents Efzofitimod Data Demonstrating Statistically Significant Improvements in Time to Relapse, FVC and Patient Reported Outcomes

Retrieved on: 
понедельник, сентября 11, 2023

SAN DIEGO, Sept. 11, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or the Company), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the results of a post-hoc analysis of data from its Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis. The analysis was presented in a poster at the European Respiratory Society (ERS) International Congress 2023, which is taking place September 9 – 13, 2023, in Milan, Italy. The poster is available on the Company’s website.

Key Points: 
  • 7.7% of patients in the 3.0 and 5.0 mg/kg efzofitimod group relapsed following steroid taper, compared to 54.4% in the placebo and efzofitimod 1.0 mg/kg group (p=0.017).
  • This is one of the few studies to demonstrate a steroid sparing effect of a drug associated with a significant improvement in patient outcome.
  • Dose dependent improvements in steroid burden, FVC and patient reported outcomes (PRO) were noted, though the study was not powered for efficacy.
  • These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone Approved in Japan for the Treatment of BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
четверг, августа 24, 2023

As previously reported, there was a statistically significant improvement in rPFS in the full intention-to-treat (ITT) population in the PROpel trial (n=796).

Key Points: 
  • As previously reported, there was a statistically significant improvement in rPFS in the full intention-to-treat (ITT) population in the PROpel trial (n=796).
  • In the ITT population, common adverse events (AEs) in patients who received LYNPARZA plus abi/pred were anemia (45.5%), nausea (28.1%) and fatigue (27.9%).
  • Despite various treatment options available, the prognosis for mCRPC remains poor, with limited treatment options for patients whose cancer progresses following initial treatment.
  • This combination is also approved in the U.S. for the treatment of adult patients with deleterious or suspected deleterious BRCAm mCRPC.

Merck Manuals Details What Patients Need to Know About Osteoporosis

Retrieved on: 
вторник, августа 15, 2023

RAHWAY, N.J., Aug. 15, 2023 /PRNewswire/ -- As we get older, our bone density and bone strength diminish. In some people, that decrease can lead to osteoporosis -- a condition in which a decrease in the density of bones weakens the bones, making breaks (fractures) more likely. In a new editorial from MerckManuals.com, Marcy B. Bolster, MD, Harvard Medical School, shares five things patients should know about osteoporosis as they get older.

Key Points: 
  • Bolster, MD, Harvard Medical School, shares five things patients should know about osteoporosis as they get older.
  • During menopause, a woman's estrogen levels decrease, which contributes to a drop in bone density, Bolster explains.
  • One of the most significant osteoporosis risk factors, Bolster says, is having a parent who has experienced a hip fracture.
  • The Bone Health and Osteoporosis Foundation recommends screenings for all females aged 65 and older and all men aged 70 and older.

Laekna, a Biotechnology Company in China, Listed on the Main Board of the Hong Kong Stock Exchange

Retrieved on: 
четверг, июня 29, 2023

HONG KONG, June 29, 2023 - (ACN Newswire) - A biotechnology company in China - Laekna, Inc. (stock code: 2105.HK), today listed on the Main Board of The Stock Exchange of Hong Kong Limited (the "Hong Kong Stock Exchange").

Key Points: 
  • HONG KONG, June 29, 2023 - (ACN Newswire) - A biotechnology company in China - Laekna, Inc. (stock code: 2105.HK), today listed on the Main Board of The Stock Exchange of Hong Kong Limited (the "Hong Kong Stock Exchange").
  • (2) Use for advancing the clinical development and approval of the other Core Product of the Company, LAE002.
  • The Hong Kong Offering also recorded an over-subscription, of approximately 5.81 times of the 6,373,000 shares offered.
  • The Company has established a number of global and regional partnerships with leading pharmaceutical companies, including Novartis and Innovent.

U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
пятница, августа 11, 2023

HORSHAM, Pa., Aug. 11, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food & Drug Administration (FDA) has approved AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test.1

Key Points: 
  • *, Medical Oncologist at BC Cancer – Vancouver and principal investigator of the Phase 3 MAGNITUDE study.
  • "All individuals diagnosed with prostate cancer should consider genetic testing, especially those from racial and ethnic minority groups who tend to have worse cancer outcomes.
  • This is imperative to close the racial and ethnic disparities in prostate cancer health outcomes."
  • "This milestone, which marks the approval of Janssen's third prostate cancer treatment, highlights the importance of advancing precision medicine approaches and genetic testing for the treatment of patients with BRCA-positive mCRPC."

Parent Project Muscular Dystrophy Publishes 15 Year Registry Report

Retrieved on: 
среда, августа 2, 2023

WASHINGTON, Aug. 2, 2023 /PRNewswire/ -- Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), is excited to announce the release of the 15 Year Registry Report. This report is the culmination of data provided by registrants in The Duchenne Registry, as well as collaborative work with expert clinicians and researchers over the past 15 years. The Duchenne Registry is the largest, most comprehensive patient-reported registry for Duchenne and Becker muscular dystrophy.

Key Points: 
  • WASHINGTON, Aug. 2, 2023 /PRNewswire/ -- Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), is excited to announce the release of the 15 Year Registry Report .
  • This report is the culmination of data provided by registrants in The Duchenne Registry , as well as collaborative work with expert clinicians and researchers over the past 15 years.
  • The Duchenne Registry is the largest, most comprehensive patient-reported registry for Duchenne and Becker muscular dystrophy.
  • Today, the result of this endeavor is The Duchenne Registry, the largest, most comprehensive registry for Duchenne and Becker muscular dystrophy and female carriers.

Catalyst Pharmaceuticals Acquires Exclusive North American License For Vamorolone for Duchenne Muscular Dystrophy from Santhera Pharmaceuticals

Retrieved on: 
среда, июля 19, 2023

CORAL GABLES, Fla., July 19, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), today announced the completion of its acquisition from Santhera Pharmaceuticals Holdings ("Santhera") of an exclusive license for North America for vamorolone, a potential treatment for patients suffering with Duchenne Muscular Dystrophy. The license is for exclusive commercial rights in the U.S., Canada, and Mexico, as well as the right of first negotiation in Europe and Japan should Santhera pursue partnership opportunities. Additionally, Catalyst will hold North American rights for any future approved indications of vamorolone.

Key Points: 
  • Early in Q1 2024, Subject to Regulatory Approval
    CORAL GABLES, Fla., July 19, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), today announced the completion of its acquisition from Santhera Pharmaceuticals Holdings ("Santhera") of an exclusive license for North America for vamorolone, a potential treatment for patients suffering with Duchenne Muscular Dystrophy.
  • Additionally, Catalyst will hold North American rights for any future approved indications of vamorolone.
  • Vamorolone is a promising best-in-class dissociative anti-inflammatory steroid treatment for Duchenne Muscular Dystrophy ("DMD").
  • Duchenne Muscular Dystrophy, or DMD, the most common form of muscular dystrophy, is a rare, fatal neuromuscular disorder characterized by progressive muscular dysfunction, leading to loss of ambulation, respiratory failure, and death.

Phase 3 Trial of ADCETRIS® (brentuximab vedotin) with Modified Chemo Regimen Shows Non-Inferiority with Unprecedented 3-Year Progression Free Survival of 94.9% vs Less Tolerable International Standard of Care in Advanced Classical Hodgkin Lymphoma

Retrieved on: 
вторник, июня 20, 2023

The data results of the HD21 study were presented in a late-breaking session at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 17.

Key Points: 
  • The data results of the HD21 study were presented in a late-breaking session at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 17.
  • 12-month post-treatment safety data were consistent with previously presented HD21 data results at the American Society of Hematology 2022 Annual Meeting.
  • Preservation of fertility potential was indicated by measurement of follicle-stimulating hormone (FSH) and was available for 597 patients.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Diurnal Ltd., a Neurocrine Biosciences Company, Presents Phase 3 Extension Study Data for Modified-Release Hydrocortisone in Patients with Congenital Adrenal Hyperplasia at ENDO 2023

Retrieved on: 
четверг, июня 15, 2023

Diurnal Ltd. developed this modified-release formulation of hydrocortisone, which has been specifically designed to replicate the natural circadian release of cortisol.

Key Points: 
  • Diurnal Ltd. developed this modified-release formulation of hydrocortisone, which has been specifically designed to replicate the natural circadian release of cortisol.
  • Current treatment guidelines recommend a target daily hydrocortisone dose of ≤25 mg (or equivalent dose of prednisone, prednisolone, or dexamethasone) in adult (fully grown) patients with CAH.
  • The post hoc analyses examined total glucocorticoid daily dose and 9:00 a.m. 17-hydroxyprogesterone (17-OHP) levels in patients treated with modified-release hydrocortisone in an open-label Phase 3 extension study.
  • Of the 71 patients who completed 24 months in the Phase 3 extension study at the time of the interim cut, 64 patients had 9:00 a.m. 17-OHP data for analysis.