Drug Development
The obesity market and Most Favored Nation drug pricing were among the topics de jour at the J.P. Morgan Healthcare Conference last week, while smaller biotechs sought to assure investors that their regulatory ducks are in a row; Novo Nordisk’s oral obesity pill got off to a hot start while the FDA delayed a decision on Eli Lilly’s investigational offering; and SpyGlass Pharma and AgomAb Therapeutics join the 2026 IPO club.
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Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
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Ahead of a scheduled Advisory Committee meeting this week, the FDA released favorable remarks about the Pfizer-BioNTech and Moderna COVID-19 vaccines for children under the age of five.
While a handful of companies have dominated the COVID-19 vaccine market in the U.S. and Europe, a number of biotechs are continuing to develop vaccines to use as booster shots.
The approval of AMX0035, which will be marketed under the brand name Albrioza, marks the first new ALS drug approved in Canada since 2018.
Genmab’s Phase II expansion cohort of the EPCORE NHL-1 clinical trial revealed that its investigational bispecific antibody epcoritamab induced a durable response in patients with LBCL.
CRISPR Therapeutics shared positive initial data from its Phase I COBALT-LYM trial of CTX130 for cancer which demonstrated safety and efficacy when used to target CD70.
For the second straight day, the FDA’s Cell, Tissue and Gene Therapies Advisory Committee voted unanimously to approve a bluebird lentiviral vector (LVV) gene therapy.
Cogent Biosciences shared its Phase II APEX clinical trial on bezuclastinib for patients with AdvSM and showed promise in treating the rare blood disorder.
AbbVie announced Friday that its investigational drug navitoclax, when used together with ruxolitinib, eases symptoms in myelofibrosis patients who had not yet been treated with a JAK inhibitor.
The European Hematology Association’s 2022 Hybrid Congress is in full swing in Vienna, Austria and will feature the newest and most promising developments in blood cancer research.
It was an extraordinarily busy week for clinical trial news and updates due to several prominent international conferences. Here’s a look at some of the highlights.