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How Are Regulatory Factors Impacting Biosimilars

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In today's Pharmaceutical Executive Daily, AbbVie licenses a portfolio of pain compounds from China's Haisco Pharmaceutical in a deal worth up to $745 million, the FDA grants full approval to Filspari as the first and only approved treatment for focal segmental glomerulosclerosis, and Pharmaceutical Executive speaks with Deepak Prakash of Identiv on how RFID and real-time tracking are building operational visibility in clinical trials.

AbbVie entered a global licensing deal with Haisco worth up to $715 million to expand its pain pipeline with several assets.

FDA has fully approved Travere’s Filspari for focal segmental glomerulosclerosis, making it the first approved therapy for the rare kidney disease and expanding its role beyond IgA nephropathy.

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, touched on Tecvayli plus Darzalex Faspro reducing the risk of disease progression or death by 83%, and what that signals for patients.

Thomas Newcomer of Samsung Bioepis discusses how certain classes of drugs don’t have enough biosimilars in development and the impact that this can have in the coming years.

Identiv’s VP of healthcare discusses the impact of new technology and data collection on trial design.

In today's Pharmaceutical Executive Daily, the FDA issues a second complete response letter for Replimune's RP1 in advanced melanoma, Regeneron and Telix Pharmaceuticals announce a radiopharmaceutical collaboration worth up to $2.1 billion, and Pharmaceutical Executive speaks with Matt Holms of Citeline on improving patient experience and real-world evidence integration in clinical trials.

Replimune received a second FDA complete response letter for RP1 in advanced melanoma, raising questions about the viability of its oncolytic immunotherapy program.

Regeneron and Telix have entered a radiopharmaceutical collaboration worth up to $2.1 billion in milestones, combining antibody-based targeting with isotope delivery to develop next-generation precision oncology therapies.

Citeline’s VP of commercial, patient engagement, and recruitment discusses how clinical trial design must adapt to modern issues.

In today's Pharmaceutical Executive Daily, China approves Amgen's tarlatamab for previously treated extensive-stage small cell lung cancer, a large study identifies genetic predictors of GLP-1 weight loss efficacy and side effects, and Pharmaceutical Executive speaks with Phenomix CEO Mark Bagnall on the complex realities of GLP-1 usage that many patients don't anticipate.

Ken Banta and Andy Milligan explore how life sciences leaders can rebuild relevance, consistency, and trust in today's complex and cost-focused era of healthcare.

New studies from 23andMe suggest genetic variation may modestly influence GLP-1 weight-loss response and side effects.

China approved Amgen’s tarlatamab for previously treated small cell lung cancer, expanding access to the bispecific immunotherapy.

The Phenomix CEO discusses recent data that suggests that patients may not be prepared for the side effects and unexpected costs of GLP-1s.
























