Therapeutic Innovation & Regulatory Science: An Increasingly Global Approach

ANI Pharmaceuticals makes an offer to acquire Egetis Therapeutics as Egetis separately sells its priority review voucher for $190 million, Novartis exits its BrainTransporter deal with BioArctic 14 months after signing, and Ignite Proteomics’ Dr. Brian Corgiat on improving how tumors are tested after recurrence.

ANI Pharmaceuticals makes an offer to acquire Egetis Therapeutics, as Egetis separately agrees to sell its priority review voucher for $190 million.

Dr. Brian Corgiat makes the case for phosphoproteome testing—measuring what’s actively driving a tumor right now, not just static mutations.

How microgravity is opening new possibilities for drug R&D and manufacturing, a pharma funding roundup covers Boehringer Ingelheim’s up-to-$7 billion oncology licensing deal with Sino Biopharmaceutical and Nxera Pharma’s EP4 agonist deal with AbbVie, and CytoDyn’s Dr. Jay Lalezari on why Leronlimab isn’t just another repurposed drug.

As access to low Earth orbit expands, space-based research is opening possibilities in drug discovery, formulation, and manufacturing. In Part 1, the authors look at how microgravity changes biology and chemistry in ways that can’t be reproduced on Earth and where it fits from target discovery to life cycle management.

Boehringer Ingelheim licenses six preclinical oncology programs from Sino Biopharmaceutical in a deal worth up to $7 billion, while Nxera Pharma licenses its EP4 agonist program for inflammatory bowel disease to AbbVie for up to $1.37 billion.

Ignite Proteomics’ Dr. Brian Corgiat explains why tumors change over time—and why treatment must adapt to the current tumor, not the original.

Dr. Jay Lalezari, CEO and CMO of CytoDyn, discusses how Leronlimab’s unique CCR5-blocking mechanism has carried it from HIV, to Covid-19, to a promising, one-of-a-kind proof of concept in colorectal cancer.