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In August, Novartis became the poster child of dodgy data when the US FDA accused the company of submitting a drug application with manipulated data and failing to inform regulators until after the product was approved. But how did this error occur, and what can be done to prevent it happening again? We take a look at the problem of manipulated data and what can be done to fix it.
Also in this issue, we examine the controversy surrounding the Dengue Fever vaccine as nations grapple with outbreaks and epidemics, find out how ‘evergreening’ and ‘thicketing’ tactics used to extend IP protection are undermining current patent systems, and take a look at a new method of attaching drugs to antibodies which could improve the stability and safety of targeted cancer treatment.
Plus, we explore the challenge of developing transplant rejection drugs, review the state of non-hormonal menopause treatments, round up key examples of multi-indication drugs, and take a look back at the research and innovations that have brought us one step closer to creating a Chlamydia vaccine.
In this issue
The problem of manipulated data In August, the FDA accused Novartis of submitting a drug application with manipulated data and then not informing regulators of the issue until a month after approval. According to the FDA, the company was aware of the issues two months before the FDA greenlighted Zolgensma. Abi Millar asks how this situation came about and what more can be done Read the article here.
Timeline: the dengue vaccine dilemma Pharma giant Sanofi has been mired in controversy in the Philippines after allegations that its dengue vaccine Dengvaxia, which had been used in a widespread school vaccination programme, was linked to the deaths of children. Since the vaccine’s ban the Philippines has declared a national dengue epidemic, creating a public health dilemma as infection rates soar. Chris Lo reports. Read the article here.
From evergreening to thicketing: exploring manipulation of the pharma patent system The drug patent system was created to reward pharma companies for innovation and ensure returns on investment, but increasingly companies are manipulating the system using techniques like ‘evergreening’ and ‘thicketing’ to extend exclusivity for drugs and prevent generic competition. What are the consequences of these manipulative practices on access and could the system be reformed to reduce this negative impact? Allie Nawrat finds out. Read the article here.
A safer ride: the latest innovation in targeted cancer treatment One downside of the antibody-drug conjugates used in oncology today is that the drug-carrying antibodies can shed much of their toxic cargo on the way to the tumour site. Now, German researchers have published their method for attaching drugs to antibodies with greater stability, potentially making this treatment much safer. Abi Millar finds out more. Read the article here.
Treading the line: the challenge of transplant rejection drugs Devising an anti-rejection strategy after a transplant requires a delicate balance between protecting the donor organ and minimising unnecessary suppression of the immune system. How do physicians strike the right equilibrium with the anti-rejection drugs available today, and could inducing immune tolerance revolutionise the post-transplant care of tomorrow? Chris Lo reports. Read the article here.
Treating menopause: at last a non-hormonal alternative? Despite the risk of breast cancer from long-term use of HRT to treat hot flushes, there are currently few non-hormonal options for managing bothersome menopause symptoms. However, new research has found that NK3 receptors have a role to play in causing hot flushes, sparking hope for a new treatment. Allie Nawrat reports. Read the article here.
Drug repurposing: the industry’s all-rounder medicines Drug repurposing has become a core approach to drug development due to its time and cost saving qualities. This has fuelled the development of all-rounder drugs that work for many indications and across disease areas. Allie Nawrat picks out some interesting examples of multi-indication drugs, which have been or are currently being repurposed for new indications. Read the article here.
One step closer to a Chlamydia vaccine Researchers from Danish SSI and Imperial College London have published promising results from the first clinical trials of a vaccine against chlamydia. This represents a significant step toward a preventative treatment for the world’s most common sexually transmitted bacterial disease. Allie Nawrat examines the history of chlamydia treatment and the next steps in the development of the vaccine. Read the article here.
Next issue preview
In the next issue of Pharma Technology Focus, we chart the development of flu vaccines, investigate the dangers of treating children using drugs that have not been studied or approved for paediatric patients, debate whether countries should look to repatriate active pharmaceutical ingredient manufacturing following contamination scandals in China and India.
Also, we profile the current state of pharma manufacturing in Ireland, examine the validity of research that links an imbalance in the gut microbiome to recurrent miscarriage, and take a look at the role of PR in the pharmaceutical industry,
Plus, we find out how Gavi, a Vaccine Alliance plans to support the immunisation of 300 million children against 18 diseases, and examine the problems with cancer trial design and administration.