Neurology

Eisai and Biogen report Leqembi’s MHRA approval for Alzheimer’s

Eisai and Biogen have announced the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) approval for Leqembi (lecanemab) for intravenous (IV) maintenance dosing once every four weeks to treat early Alzheimer’s disease.

Nilo Therapeutics raises $101m to develop neural circuit therapies

Nilo Therapeutics has been launched with $101m series A funding, led by The Column Group (TCG), DCVC Bio, and Lux Capital, with additional participation from the Gates Foundation and Alexandria Venture Investments.

AbbVie files NDA with FDA for tavapadon to treat Parkinson’s disease

AbbVie has filed a New Drug Application with the US Food and Drug Administration (FDA) for tavapadon, a selective dopamine D1/D5 receptor partial agonist that has been investigated as a once-daily oral treatment for Parkinson's disease.

Lilly secures EC approval for Kisunla to treat Alzheimer’s disease

Eli Lilly and Company (Lilly) has received the European Commission (EC) marketing authorisation for Kisunla (donanemab) to treat early symptomatic Alzheimer's disease in adults with mild cognitive impairment or mild dementia.

Leqembi approved in Australia to treat early Alzheimer’s

Swedish biopharma company BioArctic announced that Australia’s Therapeutic Goods Administration (TGA) has approved Leqembi (lecanemab) to treat early Alzheimer's disease in adults.

FDA grants breakthrough therapy status to Ionis ION582 to treat Angelman syndrome

Ionis Pharmaceuticals has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for ION582, an investigational antisense medicine designed to treat Angelman syndrome (AS).

Andelyn and Tern partner for gene therapy to treat CLN2 Batten disease

Andelyn Biosciences has collaborated with Tern Therapeutics to carry out advanced-stage Process Performance Qualification (PPQ) manufacturing of the former’s investigational gene therapy, TTX-381, to treat CLN2 Batten disease in children.

Leal Therapeutics raises $30m in Series A funding for neuro-metabolic therapies

Leal Therapeutics, a US-based biotechnology company, has secured $30m in a Series A funding round for advancing its neuro-metabolic therapies to treat neuropsychiatric and neurodegenerative disorders.

Santhera signs deal with Uniphar for GCC distribution of Agamree

Santhera has signed an exclusive agreement with Uniphar for the distribution of AGAMREE (vamorolone) in five Gulf Cooperation Council (GCC) countries, covering the United Arab Emirates, Saudi Arabia, Kuwait, Oman and Bahrain.