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Bayer extends clinical development program for finerenone with Phase III study in patients with non-diabetic chronic kidney disease

The Pharma Data

In 2017, an alarming 1.2 The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. million people died from chronic renal disorder worldwide.

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Top 5 Scientific Resources in CNS Clinical Trials

Alta Sciences

Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking. Discover the challenges of driving simulation clinical testing.

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Article EMA Thank You EMA extends scientific advice pilot for high-risk medical devices

Agency IQ

Both the Medical Device Regulation (MDR; Regulation (EU) 2017/745 ) and In Vitro Diagnostic Device Regulation (IVDR; Regulation (EU) 2017/746 ) outline the role of these panels to provide “scientific and expert advice, contribute guidance and other relevant documents, and to identify emerging issues of concerns regarding medical devices and [IVDs].”

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Macrocyclization via Ring-Closing Metathesis in Drug Discovery & Process Chemistry

Drug Hunter

Recent Applications of Ring-Closing Metathesis in Drug Discovery and Development A selection of representative macrocycles in drug discovery where ring-closing metathesis has been applied to their synthesis are shown below, highlighting chemically diverse macrocycles from programs that have reached clinical development.

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J&J, Legend Biotech Launch Rolling Submission for CAR-T Therapy for Multiple Myeloma | 2020-12-22

The Pharma Data

Legend will receive $75 million from J&J as a clinical development-based milestone payment, per a 2017 collaboration pact.

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U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients

The Pharma Data

PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). PREVYMIS is administered once-daily as an oral tablet or as an injection for intravenous infusion.

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Evaluating Impurities in New Drugs to Prevent Delays in Development

The Premier Consulting Blog

Formally, both of these documents apply solely to marketing approval; informally, however, they are often used as general guidelines during clinical development to avoid obstacles that could result in extensive process changes, product reformulation, or safety qualification efforts. evaluating the safety of) impurities and degradants.