A study published by graduate students at MIT showed that a synthetic mRNA-based ‘programming language’ can control protein expression in gene therapy.
The FDA’s recent guidance on complex generics ‘increases clarity’ for Indian drugmakers targeting the US market, according to India Ratings and Research.
Rexahn Pharmaceuticals will combine its small molecule compound RX-5902 with Merck’s anti-PD-therapy, Keytruda, to evaluate its efficacy in patients with metastatic triple negative breast cancer.
A Swedish company’s combination gel and pump delivery system, Lecigon, has received regulatory approval for the treatment of patients with advanced Parkinson’s disease.
Ahead of the CPhI Worldwide in Madrid next week, Nemaura announced that it would be showcasing its newly developed 48-hour diclofenac transdermal patch and would be linking up with an unnamed global pharma company to develop three new products.
As previously reported, researchers have determined that ketamine has potential as a treatment for patients at imminent risk for suicide, and as a therapy for treatment-resistant depression.
In this first part of a two-part investigation, we look at how NDMA receptor antagonists, such as ketamine, could be poised to make a breakthrough in the treatment of depression – an area where the pharma industry has struggled to identify new targets...
A study at Washington University in St. Louis has shown a new way to deliver drugs to the brainstem in a non-invasive administration: microbubbles and ultrasound.
Impel Neuropharma announced the first participant have been dosed in a Phase I trial looking at safety and tolerability for the company’s intranasal olanzapine product.
Researchers from the Clinic for Special Children have developed a drug delivery catheter system that could reach a larger population of patients receive Biogen’s Spinraza treatment.
Lexaira Bioscience says its DehydraTECH platform has demonstrated significant improvements to the bioavailability of cannabinoids, and could be applied to other pharmaceuticals.
Frequency Therapeutics initiates a Phase I/II clinical trial for hearing restoration, using progenitor cell activator technology for the first time in adult patients.
Moderna Therapeutics has announced the opening of a state-of-the-art manufacturing site in Norwood, Massachusetts, built to advance their work in the messenger RNA (mRNA) platform, after announcing the plans for the site in 2016.
Cure Pharmaceuticals says it plans to apply its drug delivery technologies to Therapix Biosciences’ cannabinoid-based drug pipeline for non-pain indications.
Researchers from Harvard University have developed an insulin formulation using two ionic liquids they say could lead to the development of a pill for diabetics.
Oral tolerability concerns have prompted the US biotech to close Ph II clinical trial investigations of FLX-787 in amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT).
Sanofi Pasteur has teamed with Translate Bio to develop mRNA vaccines for infectious diseases, using a platform developed by subsidiaries of Shire plc.
SIGA is slated to receive FDA approval for the world’s first antiviral drug to treat smallpox – a milestone not reached in isolation, but in collaboration with several CROs, government agencies, and others.
The Centre for Process Innovation (CPI) has confirmed its role in a UK initiative to accelerate vaccine production and eliminate the need for cold-chain shipping.
Motif Bio plc has secured £10m ($14m) to support the potential commercialization of its lead candidate – iclaprim – which was granted FDA fast-track status in 2015.
A new partnership between Haselmeier and Common Sensing aims to develop smart connected monitoring and support solutions for users of injectable medicines.
Mayne Pharma has opened a new 126,000-square-foot oral solid-dose manufacturing facility to meet demand driven by new product launches – and new revenue stream from its CDMO business.
Pills embedded with sensor technology that verifies a patient has taken their medication can improve adherence and provide data on adverse effects, says Proteus Digital Health’s Nik Leist.
Almac Group has expanded its commercial packaging capabilities to meet a “significant increase” in demand for complex kit assembly as biopharma brings more advanced sterile and biological products to the market, says CDMO.
The US FDA has issued a recall of non-expired products marketed as sterile made by Coastal Meds after an investigation of the outsourcing facility found poor sterile production practices.
