Novartis Pharma AG continues to build up its radiopharmaceutical powerhouse and has expanded a peptide discovery collaboration with Peptidream Inc. in a deal worth up to $2.71 billion. Under the multi-program agreement, Kawasaki, Japan-based Peptidream will use its peptide discovery platform system technology to identify and optimize novel macrocyclic peptides against targets selected by Novartis for potential conjugation to radioligand therapies (RLTs) or other applications for both therapeutic and diagnostic purposes. Under terms of the deal, Novartis will pay Peptidream an up-front payment of ¥28.03 billion (US$180 million), and Peptidream is also eligible to receive up to ¥422.03 billion in development, regulatory and commercial milestone-based payments plus sales-based royalties.

Poseida, Astellas hit the road in convertibleCAR deal

Poseida Therapeutics Inc. is getting $50 million up front, with the possibility of earning up to $550 million more, in an early stage collaboration combining their respective cell therapy platforms. San Diego-based Poseida brings to the table its allogeneic CAR T platform while Astellas subsidiary Xyphos contributes its Accel technology, with the aim of developing a CAR T construct to form the basis of two convertibleCAR candidates against solid tumors. It’s the companies’ second deal, following an August 2023 agreement in which Astellas snagged rights for exclusive negotiation and first refusal to license Poseida’s allogeneic CAR T-cell therapy, P-MUC1C-ALLO1.

Nrx plans suicidal bipolar depression study despite phase II/III trouble

While Nrx Pharmaceuticals Inc.’s oral antidepressant NRX-101 failed, producing a not statistically significant 33% reduction in suicidality along with a 70% reduction in the symptoms of akathisia, the company said it plans to conduct a registrational study. Nrx said the sample size made the data fall short of significance. Akathisia is a side effect of antidepressants linked to suicide. The phase II/III randomized, prospective, double-blind study compared NRX-101, a combination of D-cycloserine and lurasidone, to lurasidone alone in those with suicidal treatment-resistant bipolar depression. The company’s stock (NASDAQ:NRXP) fell 27% on April 30, the day the news was announced, dropping another 18% by midday May 1, with shares going for about $2.12 each.

Debate over Orange Book device listings heard on multiple fronts

Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters citing device patents listed for combination products. This round targeted more than 300 of what the FTC called “junk patent listings” made by eight companies. The listings, which often claim the same patent for more than one product, cover inhalers and injectable and nasal spray devices used to administer asthma, chronic obstructive pulmonary disease, diabetes and obesity drugs. Meanwhile, the argument over whether device patents belong in the Orange Book is headed to court.

US FDA wary of impact of retirements on inspectional activities

The U.S. FDA’s senior managers often lament the lack of routine increases in taxpayer funding, and Michael Rogers, the associate FDA commissioner for regulatory affairs, reiterated those concerns during a May 1 webinar. Rogers said the agency’s field inspectorate may have to work through a “tsunami of announcements” from staffers looking to retire, a predicament he said will continue to be “a huge challenge” to overcome.

China’s CAR T market comes of age

BioWorld’s three-part series takes a deep dive into CAR T therapy development and investment in mainland China. The report examines the growing interest in CAR T therapy, an approach to cancer treatment designed to harness the power of the body’s immune system, looking at the rapid pipeline growth, investments and dealmaking, clinical trials and challenges surrounding patient access.

Also in the news

Aileron, Akari, Akili, Alnylam, Alumis, ALX Oncology, Alzheon, Amgen, Annovis, ARS, Arsenal, Atossa, Aurinia, Aurion, Avalyn, Avenacy, Barinthus, Bavarian Nordic, Bayer, Biora, Biorestorative Therapies, Bristol Myers Squibb, Cajal, CDR-Life, Chipscreen, Citius, Corcept, Creyon, Debiopharm, Discovery Therapeutics Caribe, Eagle, Editas, Eli Lilly, Emmecell, Epsilogen, Epygenix, Eton, Evotec, Foresee, G1, Genmab, Harmony, Immunesensor, Immunic, In8bio, Ingenium, Inmune, Leads Biolabs, Mannkind, Medicenna, Medison, Merck, Mindbio, Mission, Moleculin, Nacuity, Nanoviricides, Newron, NRX, Octapharma, Pepper, Peptidream, Pharmather, Polypid, Poolbeg, Quallent, Recce, Renovion, Repare, Replay, Rhythm, Sairiyo, Sandoz, Scenic, Shionogi, Soleno, Surf, Sutro, Terns, Tessellate, TFF, Trisalus, Ultragenyx, Vaxart, Veru, Wave, Xoma