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 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 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.
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.
Swedish biopharma company BioArctic announced that Australia’s Therapeutic Goods Administration (TGA) has approved Leqembi (lecanemab) to treat early Alzheimer's disease in adults.
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 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, 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 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.
Cingulate, a biopharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead asset, CTx-1301 (dexmethylphenidate HCl), aimed at treating Attention Deficit/Hyperactivity Disorder (ADHD).
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