Taipei, Taiwan-based Foreseen Biotechnology Co. Ltd. scored a global licensing deal with Ipsen SA, of Paris, for antibody-drug conjugate FS-001. The drug takes aim at a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a critical role in tumor proliferation and metastasis, the companies said. Foreseen stands to bank up to $1.03 billion including the undisclosed up-front payment plus development, regulatory and commercial milestone rewards, along with tiered royalties on sales. Ipsen takes responsibility for phase I preparation activities, including submission of the IND application, and all subsequent clinical development, manufacturing, and commercialization work.

US FDA nixes Novo’s once-weekly insulin Awiqli with CRL

Following an advisory committee’s recommendation in May against approval, the U.S. FDA issued a complete response letter (CRL) to Novo Nordisk A/S for its once-weekly insulin icodec injection for diabetes, which is on the market as Awiqli in several other countries. In the CRL the FDA asked for more information related to manufacturing and the type 1 diabetes indication in which patients had higher rates of hypoglycemia than a comparator, but Bagsvaerd, Denmark-based Novo does not expect to fulfil the agency’s requests by the end of this year, delaying any hope for approval into 2025.

Kazia’s stock rockets on positive glioblastoma trial results

Kazia Therapeutics Ltd.'s stock shot up 248% on July 10 after the Sydney-based company reported that paxalisib showed a 3.8-month improvement in overall survival, a 33% improvement, for newly diagnosed unmethylated patients with glioblastoma (GBM) compared to the concurrent standard-of-care arm in the pivotal GBM-Agile phase II/III study. An oral brain-penetrant inhibitor of the phosphoinositide 3-kinase/Akt/mTOR pathway, paxalisib (formerly GDC-0084) was in-licensed from Roche AG unit Genentech, and Kazia has built the company around the molecule.

Is enforcement enough to address PBM issues?

Just a day after the U.S. FTC released an interim report on harmful pharmacy benefit manager (PBM) practices and appeared before a House subcommittee that encouraged the commissioners to take enforcement action, the agency reportedly was preparing to file suit against the country’s three largest PBMs over their practices in negotiating insulin and other drug prices. The report itself foreshadowed enforcement, noting that it was sharing “initial evidence about PBM and brand pharmaceutical rebating practices that urgently warrant further scrutiny and potential regulation.” But some health care experts wonder if going after PBM practices is enough, given the concentration and vertical integration in the field. Targeting specific practices is an “extremely modest” step in an urgent matter, Michael Abrams, managing partner of Numerof & Associates, told BioWorld.

Biomap sets new global ‘biocomputing’ hub in Hong Kong

Silicon Valley-based Biomap is setting up a new global biocomputing innovation hub, dubbed Biomap Innohub, in Hong Kong as the local government ramps up investment to build supercomputing prowess, Vicky Qu, senior vice president of Biomap, told BioWorld. The goal is to accelerate novel drug product development and commercialization with biocomputing, defined by Biomap as the use of artificial intelligence or machine learning in the life sciences, and attract global talent to the hub.

BIX 2024: From graveyard to breakthrough, MASH candidates on rise

Nonalcoholic steatohepatitis was renamed, for the first time in 34 years, to metabolic dysfunction associated steatohepatitis (MASH), but a name change is far from being the biggest development in the field, according to experts at Bioplus Interphex (BIX) Korea 2024. “The MASH field is changing from a notorious ‘development graveyard’ … due to Madrigal [Pharmaceutical Inc.’s] resmetirom gaining the first U.S. FDA approval for the condition,’” Hye-min Hur, Kiwoom Securities research analyst, said in Seoul, South Korea July 11. Now, the field is crowding with challengers, including Korean biopharmaceutical companies, looking to dethrone Madrigal’s resmetirom, U.S. FDA approved in March 2024 as Rezdiffra to treat the liver condition

Also in the news

Agomab, Almirall, Arcutis, Cargo, Cellular Origins, Clearside Biomedical, Context, Cosette, Curium, Ensol, Evotec, Flagship, Fortrea, Granza, Heparegenix, Ideaya, Io, Karolinska, Kazia, Longeveron, Mission, Neurosense, NMD, Nuvalent, Okyo, Oragenics, Perrigo, Pfizer, Pharmassêtx, Pint, Sanofi, Scenic, Skye, Skyhawk, Smartcella, Spine, Xylocor