FDA and NIH partner to understand ALS
The Critical Path for Rare Neurodegenerative Diseases (CP-RND) partnership was launched to develop breakthrough treatments for neurodegenerative diseases like amyotrophic lateral sclerosis (ALS).
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Developing an adaptive auto-synthesiser
EPR highlights the use of HPLC and FTIR in the creation of an auto-synthesiser that can flexibly perform critical actions such as quenching, purging and dosing reagents.
First patient dosed with HIV gene therapy
According to researchers, the CRISPR-based gene therapy, EBT-101, has the potential to change the future of HIV therapeutics.
EMA human medicines committee (CHMP) highlights, September 2022
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
GSK requires supplier sustainability compliance from 2023
New climate responsibility for the GSK supply chain will come into force from 2023, helping the biopharmaceutical giant to achieve their aspirational environmental targets.
Evusheld COVID-19 therapy approved in EU
Evusheld becomes first and only long-acting antibody combination available for both prevention and treatment of COVID-19 in Europe.
EMA approves biosimilar interchangeability in EU
Biosimilar medicines can now be interchanged with their reference medicine or an equivalent biosimilar, says European Medicines Agency (EMA).
Green HPLC method enables antipsychotic determination
EPR highlights a green high performance liquid chromatography (HPLC) method that successfully determined four common antipsychotics in formulation.
First bispecific antibody approved in EU to combat leading causes of vision loss
Roche’s Vabysmo® (faricimab) has been approved in Europe as a four-monthly treatment for wet age-related macular degeneration and diabetic macular oedema.
Zuranolone shows promise as episodic treatment for depression
Phase III data shows most major depressive disorder patients treated with zuranolone had minimal or mild depressive symptoms after a year.
Lonza expands HPAPI manufacturing suite
Lonza’s HPAPI multipurpose suite in Visp, Switzerland now includes enhanced capability for antibody-drug conjugate (ADC) payload production.
AbbVie’s Skyrizi® shows long-term efficacy in psoriatic arthritis
Similar rates of skin improvement at week 100 indicate Skyrizi® (risankizumab) has consistent long-term efficacy in psoriatic arthritis patients.
Novartis’ Kisqali® provides “unparalleled survival benefit” in breast cancer
A pooled exploratory analysis shows Kisqali® plus endocrine therapy adds a year to overall survival of patients with aggressive form of breast cancer.
Takeda to invest €300 million in plasma-derived therapy production
Investing in a new production facility and carbon net-zero emissions warehouse in Lessines, Belgium, Takeda aims to expand access for rare and complex chronic disease treatments.
Checkpoint inhibitor combination shows promise in Merkel cell carcinoma
Dual checkpoint inhibitor blockade could be a promising first-line and salvage therapeutic option for advanced Merkel cell carcinoma, say researchers.
