Welcome to the latest edition of the Life Sciences Voice Top Five Newsletter, your source for the top developments in the life sciences industry! This week we take a look at FDA delaying Eisai & Biogen’s submission plans for its Alzheimer’s drug, Abbvie’s acquisition of Cereval Therapeutics, FDA & CDC’s investigation into counterfeit botox injections, and other top news! Eisai and Biogen’s Plans for Leqembi Delayed by FDA Eisai and Biogen face setbacks in their plans to bring their Alzheimer’s disease drug, Leqembi, to patients as promised with the FDA demanding additional data for its ..read more

A new commercial player for rare diseases has entered the market with the approval of X4 Pharmaceuticals’ first medicine, mavorixafor. Xolremdi is now the first medication approved by the FDA to treat WHIM, a rare condition characterized by a combination of primary immunodeficiency and chronic neutropenic disease brought on by an over-signaling of the CXCR4 pathway. After a decade-long development process, the FDA authorized mavorixafor’s use in patients aged 12 and above who suffer from WHIM syndrome, which includes warts, hypogammaglobulinemia, infections, and myelokathexis. According to a s ..read more

The add-on medication for schizophrenia developed by Newron Pharmaceuticals was shown to reduce both positive and negative symptoms, as well as the severity of the condition, in patients who were participating in phase 2/3 research. Evenamide, which might be coupled with a line of care such as clozapine for those with chronic conditions who do not react to current medications, is now being developed by an Italian biotech company in an effort to bring forth the first therapy for schizophrenia in decades. As stated in a press release, the primary objective of the study was to demonstrate improve ..read more

The Food and Drug Administration (FDA) has just greenlighted Pfizer’s gene therapy for a rare genetic bleeding disorder called hemophilia B which causes patients to bleed easily for longer periods of time and also bruise easily. The spontaneous and heavy bleeding caused by the disease can be the aftermath of an injury or surgery. The disease is caused by the absence or insufficient levels of a protein factor called IX in the blood. Proteins in the blood containing this factor are responsible for sealing wounds and stopping bleeding by helping the blood clot. The typical course of action in the ..read more

Harmony Biosciences has successfully acquired Epygenix along with its late-stage epilepsy drug for a $35 million upfront payment and an additional $600 million contingent on certain conditions being met. The drug acquired under this deal will join two other existing late-stage candidates in Harmony’s pipeline, including EPX-100 and another one meant to treat children suffering from a rare epilepsy condition called Lennox-Gastaut syndrome. EPX-100 is at the heart of these late-stage pipelines and is meant to treat Dravet syndrome in both adults and children. Company investors, analysts, and obs ..read more

The Alternative Methods Advancement Project (AMAP) by Charles River Laboratories (CRL) is an initiative aimed at reducing reliance on animal testing and finding alternatives to the conventional model. The initiative is built on the principles of reduction, replacement, refinement, and responsibility. The 4R approach will dictate how the company proceeds with developing strategic innovations and efforts needed to replace animal testing. The goal is to come up with alternatives without compromising the safety and efficacy of research products. The initiative outlines three key steps. Firstly, th ..read more

Bristol Myers Squibb has invested $65 million in Repertoire Immune Medicines, betting on its strategy for immune system reset. The agreement grants BMS the ability to collaborate with Repertoire on tolerating vaccines for up to three autoimmune illnesses, with potential future payments of up to $1.8 billion. Formed in 2022, Repertoire is a biotech company established by Flagship that relies on immunological synapse mapping technologies. The company believes it can identify disease-driving epitopes and use them to produce off-the-shelf medicines by examining T-cell receptor-epitope combinations ..read more

AriBio has achieved a crucial milestone in the development of its preclinical oral agent AR1001 with the recent authorization from the European Medicines Agency (EMA) for the Phase III clinical trial, known as POLARIS-AD (AR1001-ADP3-US01), aimed at treating early Alzheimer’s disease. AriBio, headquartered in South Korea and with offices in the U.S., is a biopharmaceutical company dedicated to advancing innovative therapies for neurodegenerative diseases, notably Alzheimer’s disease. This approval from the EMA adds to the previous authorizations granted by the US Food and Drug Administration ..read more

The FDA has halted a phase 1 trial of Neumora Therapeutics’ treatment for schizophrenia after preclinical investigations uncovered instances of convulsions in rabbits who had been administered the drug. Thus far, 30 healthy adult participants have got doses of NMRA-266, identified as a positive allosteric stimulator of the M4 muscarinic receptor, within the single and multiple increasing dose phase 1 study. Neumora emphasized that no participant showed any signs of convulsions. The biotech company stated that it is actively working with the FDA to address the issue and will provide further inf ..read more

Within the context of AbbVie’s $8.7 billion acquisition of Cerevel Therapeutics is now enjoying its turn in the limelight. Avapadon was brought to the forefront by Cerevel, when the company announced the successful completion of a phase 3 Parkinson’s disease study. This news also provided a slight lift to AbbVie as the company tries to conclude an agreement centered on another asset. Emraclidine, Cerevel’s midphase schizophrenia drug, was the focal point of attention when AbbVie announced the plan to acquire the biotech company around the end of the previous year. However, tavapadon provides t ..read more