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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options. 3D rendering of Antibody Drug Conjugate Molecules.

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Taysha Gene Therapies Receives Rare Pediatric Disease and Orphan Drug Designations for TSHA-105 for the Treatment of Epilepsy Caused by SLC13A5 Deficiency

The Pharma Data

The Rare Pediatric Disease Priority Review Voucher Program is intended to address the challenges that drug companies face when developing treatments for these unique patient populations. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside.

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Novartis announces new organizational structure

The Pharma Data

“With our portfolio of in-market medicines and up to 20 major pipeline assets that could be approved by 2026, Novartis is in a strong position to deliver above-peer-median sales and margin growth in the mid- and long-term.” Change in Global Drug Development (GDD) Leadership.

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Ionis highlights achievements, commercial strategy and technology advancements at Investor Day

The Pharma Data

The company’s commercial priorities are three-fold: (1) Initially focusing its commercial efforts on rare diseases within its prolific neurology and cardiology franchises (2) pioneer new markets where there are no available treatments (3) create new standards of care where there has been a lack of innovation to optimize patient care.

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Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

Happy 40 th Birthday, generic drugs: September 24 will mark the 40 th anniversary of the 1984 signing of the Hatch-Waxman Act, which created a formal pathway for the approval of generic drugs. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election.

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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Sponsors should plan to justify the inclusion of a psychotherapy component.”

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Fibrosis research: Advances and challenges 

Drug Discovery World

Fibrocor Therapeutics, a developer of novel therapeutics to treat fibrosis, recently appointed Piet Wigerinck as Chief Scientific Advisor. Wigerinck has taken four drugs (Prezista, Olysio, Jyseleca and Rekambys) to market. MT: What technologies are Fibrocor Therapeutics utilising to advance its drug development process?