Designing Cell Therapy Facilities: Leveraging Operational Simulations

Posted by Niranjan Kulkarni, Ph.D
On March 26, 2019

Cell therapies are emerging as an important class of next-generation medicines. As many novel treatments move through development to commercialization, manufacturers are challenged to construct optimal facilities for the production of cell therapies. Modeling and simulation at the earliest design stages have many benefits. The number of cell therapy treatments in development has exploded in […]

Biogen Halts Alzheimer’s Drug Trials

Posted by ISPE Boston
On March 22, 2019

Biogen and partner Eisai have announced the decision to discontinue the global Phase 3 trials designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. The decision to stop the trials is based on results of a futility analysis conducted by […]

Pfizer On Track to Acquire Gene Therapy Company

Posted by ISPE Boston
On March 22, 2019

Pfizer has acquired a 15% equity interest in French biotech Vivet Therapeutics and secured an exclusive option to acquire all outstanding shares. Vivet is a privately company dedicated to developing gene therapy treatments for inherited liver disorders with high unmet medical need. Pfizer and Vivet will collaborate on the development of VTX-801, Vivet’s proprietary treatment […]

VC Firm Launches $824 Million Funding Effort

Posted by ISPE Boston
On March 22, 2019

Cambridge-based Flagship Pioneering has announced that it has secured $824 million to support the growth of human health and sustainability companies originated by its Flagship Labs unit. The new capital pool will operate alongside more than $700 million in capital raised in late 2017 and 2018 that currently finances Flagship’s in-house innovation and company origination […]

Sage Therapeutics Wins FDA Approval of Drug for Postpartum Depression

Posted by ISPE Boston
On March 20, 2019

Sage Therapeutics, a biopharmaceutical company developing novel medicines to treat life-altering central nervous system disorders, has announced that the FDA has approved ZulressoTM (brexanolone) injection for the treatment of postpartum depression (PPD). Zulresso is the first and only medicine specifically approved to treat PPD, the most common medical complication of childbirth. Zulresso is expected to […]

Karuna Announces $68 Million Series B Financing

Posted by ISPE Boston
On March 20, 2019

Boston-based Karuna Therapeutics, focused on the treatment of neuropsychiatric disorders including psychosis in schizophrenia, psychosis in Alzheimer’s disease, and pain, has announced the completion of a $68 million Series B financing round, including the issuance of $5 million in shares upon conversion of debt into equity. KarXT, Karuna’s lead product candidate, is currently being evaluated […]

Biotech Supplier HPNE Leases Former Alexion Facility

Posted by ISPE Boston
On March 12, 2019

High Purity New England, a supplier of biotech equipment, has signed a lease for a substantial new building, formerly occupied by Alexion, where they will nearly quadruple their manufacturing footprint and expand their offices in northern Rhode Island. High Purity New England has seen a surge of growth in the past 6 years, having grown […]

Voyager Therapeutics and AbbVie Announce Collaboration

Posted by ISPE Boston
On March 6, 2019

Voyager Therapeutics and AbbVie have announced an exclusive, global strategic collaboration and option agreement to develop and commercialize vectorized antibodies for the potential treatment of Parkinson’s disease and other diseases (synucleinopathies) characterized by the abnormal accumulation of misfolded alpha-synuclein protein. The delivery of sufficient quantities of antibodies across the blood-brain barrier is one of the […]

Biogen to Acquire Gene Therapy Company Nightstar Therapeutics

Posted by ISPE Boston
On March 6, 2019

Biogen has announced plans to acquire Nightstar Therapeutics (NST), a clinical-stage gene therapy company based in London, UK. NSK is focused on adeno-associated virus (AAV) treatments for inherited retinal disorders. Under the terms of the proposed acquisition, Biogen will pay $25.50 in cash for each NSK share, representing a total transaction value of about $800 […]

Voyager Therapeutics and Neurocrine Biosciences to Collaborate on Parkinson’s Disease

Posted by ISPE Boston
On February 14, 2019

Cambridge-based Voyager Therapeutics and Neurocrine Biosciences and have announced the formation of a strategic collaboration focused on the development and commercialization of Voyager’s gene therapy programs for Parkinson’s disease and Friedreich’s ataxia, as well as rights to two programs to be determined. This collaboration combines Neurocrine Biosciences’ expertise in neuroscience, drug development and commercialization with […]

Page 1 of 1312 3 ›»