Sanofi has offloaded the French rights to a prolonged-release and divisible tablet formulations of lithium carbonate to Laboratoires Delbert.
Lead candidate AL001 is an ionic cocrystal of lithium for the treatment of Alzheimer’s and other neurodegenerative diseases and psychiatric disorders such as bipolar disorder, depression, and post-traumatic stress disorder (PTSD). Licensed from the University of South Florida, Alzamend expects to submit an IND for AL001 by the end of the 2Q21, and plans to pursue review under the 505(b)(2) pathway. Second candidate AL002 is a cell-based therapeutic vaccine in preclinical studies designed to elicit an immune response and prevent the build-up of plaque deposits in Alzheimer’s patients.
Intra-Cellular Therapies fought hard to secure its antipsychotic Caplyta an initial FDA nod in schizophrenia in late 2019. Early sales in the first half of 2020 were only in the single-digit millions, but one analyst sees an opportunity for more than $1 billion after a new clinical trial win.
Intra-Cellular Therapies (NASDAQ:ITCI) soars 74% premarket in reaction to positive topline results from its Phase 3 clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder.
The Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA) has announced that all strengths of Lithium carbonate tablets have been added to the list of medicines which must not be parallel exported from the UK. The additional restrictions came into place from 7th September 2020.
On 21st August 2020, the Department of Health and Social Care (DHSC) issued a supply disruption alert stating that Priadel®(Lithium carbonate) 200mg and 400mg modified-release tablets are being discontinued in the UK and remaining supplies of both strengths are expected to be exhausted by April 2021. The supply disruption alert details alternative licensed lithium brands which are available; Camcolit® is another brand of Lithium 400mg modified release tablets but there is no alternative brand available for Lithium 200mg modified release tablets. The full alert can be viewed here.
The Department of Health and Social Care (DHSC) have issued a supply disruption alert for Lithium carbonate (Priadel®) 200mg and 400mg modified release tablets
The initial public offer (IPO) by Neogen Chemicals, a leading manufacturer of bromine and lithium-based specialty chemicals, opens today. The IPO comprises an offer for sale (OFS) of 2.9 million equity shares, aggregating Rs 62.4 crore and fresh issue of 3.2 million equity shares aggregating Rs 70 crore in a price band of Rs 212 - Rs 215.
Alembic`s Generic Lithium Carbonate (300 Mg) Approved in US For Bipolar Disorder