FDA releases guidance on gene therapy manufacturing
In an effort to support innovation in the development of gene therapy products, the FDA has released guidance to provide regulatory clarity for product developers.
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Survey finds 87 percent of pharmacists concerned about medicine supply post-Brexit
New findings reveal that the majority of pharmacists are worried about the supply of medicine to the UK after Brexit and believe their pharmacies will be impacted.
EC approves Mayzent® for secondary progressive multiple sclerosis
Mayzent (siponimod) has been approved by the European Commission (EC) for adults with secondary progressive multiple sclerosis (SPMS) based on the results of the EXPAND trial.
Protein engineering market predicted to be worth $3.9 billion by 2024
A report on the protein engineering market suggests it will grow at a CAGR of 12.4 percent, primarily due to protein-based drugs and pharmaceutical company development.
FDA to promote development of coronavirus diagnostics and countermeasures
The US FDA has revealed its action plan to aid in the development and advancement of diagnostics and medical countermeasures to combat the novel coronavirus 2019.
Class 2 medicines recall of LEO Laboratories Picato gels
LEO Laboratories is recalling its Picato (ingenol mebutate) gels from pharmacies and wholesalers over a possible risk of skin malignancies; the products must be returned to suppliers for credit.
EC approves ustekinumab to treat plaque psoriasis in patients age six to 11
The European Commission has granted marketing authorisation to Stelara (ustekinumab) to treat patients aged six to 11 with moderate to severe plaque psoriasis.
Rise in pharmaceutical applications to increase demand for mass spectrometers in Europe
Researchers predict that the market for mass spectrometers will be worth $1.9 billion by 2025 due to demand for faster and more accurate technology.
Two awards granted to recognise work in bioprocessing industry
The UK BioIndustry Association’s bioProcessUK conference saw two awards given to Sharon Grimster and Dr Sarah Goulding for their work in the bioprocessing sector.
CEPI announces three programmes to develop coronavirus vaccine
The CEPI has announced three respective projects with Inovio, the University of Queensland and Moderna, to develop a vaccine for the novel coronavirus, nCoV-2019.
Boris Johnson announces UK Global Talent visa for researchers
Boris Johnson, the Prime Minister of the UK, has announced a new Global Talent visa for researchers and scientists which will fast track those in certain fields.
AstraZeneca announces plan for zero carbon emissions by 2025
AstraZeneca’s new carbon emission plan includes a 100 percent electric vehicle fleet and a 50 million tree reforestation plan.
FDA approves Tepezza for the treatment of thyroid eye in adults
The US FDA approved Tepezza (teprotumumab-trbw), the first treatment for thyroid eye, on the basis of two trials in which the drug improved eye protrusion in patients.
Tiofarma admits role in illegal agreement causing fludrocortisone price hikes
The CMA has announced Tiofarma admits taking part in an anti-competitive agreement with Amilco and Aspen which resulted in huge price increase in fludrocortisone acetate tablets.
NRDL list could lead to increased access to innovative drugs in China
China has started to regularly update its National Reimbursement Drug List (NRDL) which could lead to new opportunities for innovative drug manufacturers to foray into the Chinese market, say researchers.
