Despite being hailed as a potential breakthrough for Alzheimer’s, the EMA will not fast-track lecanemab, underscoring differences with the FDA’s frequent use of accelerated pathways.
Eisai’s request for an accelerated assessment of its Alzheimer’s disease candidate lecanemab has been rejected by the European Medicines Agency, a blow to hopes of fast access to the treatment in the EU.
The drug has been tipped as a potential blockbuster for Eisai and its partner Biogen, but gaining full regulatory approval, then reimbursement and acceptance by physicians
Dr. Reddy's Laboratories preps for potential US tariffs, focusing on sustaining product supply and collaborating with customers on inventories. A recent US plant sale, the firm stressed, was unrelated to tariffs and underlines its openness to ‘make in the US’, where it launched 18 products in fiscal 2025.
In this week's episode: industry makes its case to Trump; Sarepta slammed by double blow; Chinese firms build obesity pipeline; Swiss biopharma staying strong; and Merck & Co looks to immunology and ophthalmology.
The Japanese drug maker is on track for three pivotal Phase III readouts and two regulatory submissions in 2025.
Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.
Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.
Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.
Workforce development will be essential to meeting president Trump’s goal to return biopharma manufacturing to the US.
