Replikins’ genomic understanding of the Zika and Flaviviruses has led to the development of a trivalent vaccine for Zika, Dengue, and Japanese Encephalitis.
Using an experimental Internet of Things system that enables remote monitoring, the companies believe the multi-year project has the potential to change the way clinical trials are conducted.
Anti-LGBT legislation has prompted Braeburn Pharmaceuticals to reassess plans for a $20m facility in North Carolina, but will others in "the nation’s number one state for biomanufacturing" follow suit?
A new artificial intelligence-enabled solution redacts confidential information from clinical study reports with 99% accuracy in preparation for publication.
Sanofi Pasteur, the vaccines division of Sanofi, has launched a vaccine research and development project targeting the prevention of Zika virus infection and disease.
Crown Bioscience has announced the acquisition of PreClinOmics, an in vivo preclinical company specializing in early research in cardiovascular and metabolic diseases (CVMD).
With 320m monthly active users, Twitter could potentially serve as a new, unexploited resource to stimulate interest and enrollment in clinical trials.
Synexus has bought trial site network Research Across America (RAA) in a deal it claims will give its customers access to the US market and additional study participants.
Capsugel has come on leaps-and-bounds since it was spun-out from Pfizer, the firm says as it inks a deal with Pulmatrix to develop inhaled therapeutics.
Ennaid Therapeutics has announced it is developing therapeutic cures to help those that may become infected with the Zika Virus, and it may be available in less than four years.
Zika researchers are using animal models and epidemiological studies to try and determine if the virus causes birth defects and neurological disorders.
The US FDA has ordered CTI BioPharma to halt a Phase III trial of a cancer drug candidate after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest.”
Recipharm will invest €40 in serialization equipment to ensure it can comply with evolving track and trace regulations in the US, Europe and other markets.
AstraZeneca has reformulated roxadustat using materials sourced in China to make it eligible for fast track review through the country's new "green pass" process.
Indian drugmaker Strides Shasun has bolstered its generics manufacturing network by acquiring stakes in Kenya’s Universal Corporation and Australia’s Generic Partners Holdings.
MannKind has spoken about Receptor Life Science, a newly-formed company which last month licensed the Technosphere inhaled delivery platform from the struggling firm.
Sanofi Pasteur has launched a Zika vaccine project, levering its experience in developing vaccines for similar viruses, as the US government pushes for “intensified research.”
Incoming Indonesian government measures to attract foreign manufacturing joint ventures (JVs) could include a regulation to reduce API imports, Vincent Harijanto, committee head GP Farmasia said.
Ipca has received an FDA Warning Letter at three Indian API facilities, but says it awaits re-inspection after already rectifying issues highlighted in a 2014 Form 483.
Plans to centralise its manufacturing operations will optimise use of new technologies across Novartis’s divisions without resulting in any additional facility closures, the firm says.
More plants in China will close says a US-based analyst who predicts that some drugmakers' inability to comply with stricter quality rules will create an opportunity for those that can.
The recent tide of Warning Letters issued to Chinese API and finished formulation makers reflects an increase in regulatory oversight, the US FDA says.
Catalent will pursue strategic acquisitions and licensing in 2016, said VP Marketing & Strategy Elliott Berger, noting growth areas include complex delivery technologies and specialised logistics.
India’s CRO industry is playing catch-up to the generic and manufacturing sectors, according to the departing CEO of one of the largest players, Syngene.
