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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.

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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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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.

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AHA News: Hormones Are Key in Brain Health Differences Between Men and Women

The Pharma Data

1, 2021 (American Heart Association News) — Medical science has come a long way since the days of “bikini medicine,” when the only time doctors managed a woman’s health differently than a man’s was when treating the parts of her body found under a bikini. MONDAY, Feb. It’s that they age differently.

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Patient-Reported Outcomes from the Positive Phase 3 monarchE Trial for Verzenio® at St. Gallen Virtual Congress 2021

The Pharma Data

The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints. had fatal outcomes.

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