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Trial sets up wider use of Bayer's Nubeqa in prostate cancer

pharmaphorum

Bayer has the result it was hoping for in the phase 3 ARANOTE trial of Nubeqa in metastatic, hormone-sensitive prostate cancer (mHSPC), a key part of its plan to build the drug into a €3 billion-a-year blockbuster.ARANOTE compared Nubeqa (darolutamide) to placebo given with standard androgen deprivation therapy (ADT) and showed a significant improvement (..)

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Bayer expands global clinical program for darolutamide in prostate cancer

The Pharma Data

The new Phase III clinical study, ARASTEP, will investigate the efficacy of darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

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A USD 4.2 Billion Myovant/ Pfizer Deal; Audentes Therapeutics’ ASPIRO Trial Free to Proceed; First Generic of Drug for Severe Hypoglycemia Gets Approval; Teleflex Acquires Z-Medica

Delveinsight

Relugolix is a once-daily, oral gonadotropin-release hormone (GnRH) receptor antagonist. Audentes Therapeutics’ ASPIRO Trial Free to Proceed. The ASPIRO trial is a two-part, open-label ascending dose study, and is examining the safety and preliminary efficacy of AT132 in children with XLMTM younger than five years old.

Trials 52
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Bayer delivers on medical innovation fueling transformation of pharma business

The Pharma Data

Our leadership in cardiology, radiology and women’s health is recognized worldwide, and we are expanding our presence in oncology, working tirelessly to bring forward new approaches that can change the treatment paradigm for patients,” said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division.

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Scrutinizing the West Syndrome Market Space from Growth Perspectives

Delveinsight

It can be due to the previous existence of brain damage signs (psychomotor retardation, neurologic signs, radiologic signs, or other types of seizures) or on the basis of etiology that is characterized by a lack of previous signs of brain damage. There are many different causes of epileptic spasms.

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Women’s Health Clinical Trials: Clinical Innovations, Opportunities and Considerations

XTalks

In recent years, the landscape of women’s health clinical trials has begun to shift. Read on to learn more about the historical challenges, recent advancements, clinical considerations, and the future of women’s health clinical trials, as detailed by Medpace’s women’s health experts.

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Hypoxia-Inducible Factor-2 Alpha (HIF-2?) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors

The Pharma Data

The approval is based on results from the open-label Study 004 trial (N=61), where the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC. Advise patients of these risks and the need for effective non-hormonal contraception. WELIREG can render some hormonal contraceptives ineffective.