Alzheimer’s product is following a different playbook than Aduhlem, reflecting better data – and hard-earned lessons. Eisai estimates that 80-90% of veterans who are eligible for Leqembi treatment based on the FDA label would also fit the VA’s criteria.

China's just-concluded National Congress elected new senior government leadership, but shifting top-level policy priorities and a worsening wider operating environment mean observers are worried about continued growth and ongoing pressures on drug pricing.

PBM contracting and payer formulary placement for branded Humira signal headwinds for biosimilar versions in the US, according to participants in an IQVIA-sponsored panel.

Biden Administration praises Lilly for latest moves to improve affordability of insulin in private market and calls for other sponsors to follow suit. Lilly’s plan is also tactical, as manufacturers of highly-rebated drugs with serial price hikes face an increased rebate liability in Medicaid next year.

The drug pricing watchdog said in its revised report that Alzheimer’s therapy Leqembi (lecanemab) meets cost-effectiveness thresholds at $8,900-$21,500, below Eisai/Biogen’s $26,500 list price.

Some biotech leaders say IRA policies don’t feel consequential yet, though small companies could face impacts from R&D and M&A decision making at big pharmas.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

The route to market for Sarepta’s gene therapy candidate SRP-9001 for Duchenne muscular dystrophy has just got more complex after a U-turn by the US FDA. Its accelerated approval will now be scrutinized by outside experts – but the company remains confident in its data.

Novo Nordisk has been hit by a serious sanction in the UK after having been found to effectively pay pharmacists to promote Saxenda.

The US agency is reviewing two of the US biotech’s drug with decisions expected on its methotrexate product for ocular lymphoma by June and on the dry eye drug reproxalap in November, as Aldeyra mulls its marketing strategy for both.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Akeega, a combination of GSK’s PAPR inhibitor Zejula and J&J’s antiandrogenic drug Zytiga, has won a positive opinion from the CHMP in a lucrative first-line prostate cancer setting, hot on the heels of a broader approval for AstraZeneca’s blockbuster Lynparza.