The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
The number of participants from diverse populations the NIH hopes to attract to its new national research programme within five years
The Association of the British Pharmaceutical Industry has signed a five-year partnership to boost NHS innovation
The increase in per-person healthcare spending from 2007 to 2016 according to new report published in Health Affairs
The number of people expected to be diagnosed with Alzheimer’s and related dementias by 2060, according to a new report from the US Centers for Disease Control and Prevention
The forecast market value of global influenza medications by 2025
FDA investigation into heart drug valsartan
The US Food and Drug Administration said it found an additional "unexpected impurity" in three lots of Torrent Pharmaceuticals' recalled valsartan drug. The agency began testing the recalled products and the pills that have not been recalled for the substance after it learned that Zhejiang Huahai Pharmaceuticals found NDEA in several batches of its valsartan active ingredient. Not all batches have been found to be contaminated.
Hospitals band together to make drugs
Intermountain Healthcare is teaming with the Mayo Clinic, HCA Healthcare and four others to form a non-profit company called Civica Rx to manufacture generic medicines. The effort is aimed at combating drug shortages and skyrocketing prices.
NHS to save 'hundreds of millions' in landmark drug ruling
A landmark ruling against two leading drug companies could save the NHS "hundreds of millions" a year. Novartis and Bayer were trying to stop NHS doctors from prescribing a cheaper treatment for a serious eye condition. Health bosses said the judgement in the High Court may reduce the power of companies to set prices.
UK public-private partnership to use AI to cut drug failure rate
Government-backed agency Innovate UK is backing the £1m project, which is a collaboration between two small tech businesses and the Medicines Discovery Catapult, a government-run initiative. The project will see Optibrium, which creates software to improve the efficiency and productivity of drug discovery, and Intellegens, a spin out from the University of Cambridge, which is focused on the specific form of AI called ‘deep learning’, work with Medicines Discovery Catapult over the next two years.
Drug major Sun Pharmaceutical Industries has received approval from the Australian health regulator Therapeutic Goods Administration for its speciality product ILUMYA (tildrakizumab), used for the treatment of adults with plaque psoriasis.
Source: Times of India
Mecillinam (injectable) and pivmecillinam (oral prodrug)
The US Food and Drug Administration has approved the investigational new drug applications for UTILITY therapeutics’ mecillinam (injectable) and pivmecillinam (oral prodrug). This enables the company to commence clinical development in the US for the treatment of complicated urinary tract infections and uncomplicated urinary tract infections.
Source: Business Wire
The European Commission has approved Mylan and Fujifilm Kyowa Kirin Biologics’ Humira biosimiar Hulio.
The decision allows use of Hulio for all of Humira’s (adalimumab) approved indications, including rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis and psoriasis.
Source: Pharma Times
Dabrafenib and trametinib
The National Institute for Health and Care Excellence has approved dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma. It has also been approved for use on the NHS. Drug company Novartis said the combination of dabrafenib and trametinib has been recommended as a treatment option for the treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following surgery.
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