Amgen, Inc.

Latigo Biotherapeutics appoints Tim Lugo as CFO and Beth Seidenberg, M.D., and Jim Tananbaum, M.D., to its board to advance non-opioid pain medicine development.

ESMO 2024 in Barcelona will feature discussions on cancer therapeutics, including anticipated presentations on bispecific antibodies and anti-TIGIT therapies. Other topics include radioligand therapies and synthetic lethality assets. Experts are optimistic about the potential of these therapeutic classes, despite past challenges.

Autolus Therapeutics' obe-cel, an autologous CAR-T cell therapy for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia, awaits FDA approval on November 16, 2024. The therapy targets CD-19 and has shown a 78% ORR in the FELIX study, with potential peak revenues of ~$300m. Despite a 25% share price drop, Autolus holds $700m in cash and has partnerships with BioNTech, Moderna, and Bristol Myers Squibb, positioning it for future growth.

Edwards Lifesciences and Meril Life Sciences dispute over Meril's importation of transcatheter heart valve systems for an industry conference, focusing on the Hatch-Waxman safe harbor. The Federal Circuit affirmed the lower court's decision, protecting Meril's conduct under the safe harbor. Edwards argued the court misinterpreted the term 'solely,' while Meril emphasized the relevance of each act's reasonable relation to FDA information submission. The Federal Circuit denied Edwards' motions, reiterating its prior holdings on the safe harbor's application.

Deepak Bhatt, a prominent cardiologist, discussed common pitfalls in interpreting clinical trial data at the ESC Congress 2024. His work, cited over 275,000 times, focuses on pivotal trials like REDUCE-IT and SCORED. Bhatt highlighted the 17-year lag between scientific discovery and its adoption into clinical practice.

FDA approves Pavblu (aflibercept-ayyh), a biosimilar to Eylea, for treating neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).