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FDA approves Agios' oral leukaemia treatment Tibsovo

The oral leukaemia treatment Tibsovo (ivosidenib) produced by Massachusetts-based Agios Pharmaceuticals has been approved for treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with a defective IDH1 gene in the United States.

The FDA approved the Cambridge-based drug makers AML pill for use in treating the rapidly progressing bone marrow cancer. The National Cancer Institute at the National Institute of Health estimated that 19,520 people will be diagnosed with AML this year while 10,670 will die from the disease.

Top Ten most popular articles on Pharmafile.com this week

As we move into November, we bring you another run down of the top ten most popular articles on Pharmafile.com this week.

Novartis' has revealed the data behind the approval of its CAR-T therapy Kymriah as it became the first-ever such treatment approved by the FDA. Gilead entered the fray weeks later with its own approval, and the CAR-T space is now heating up. We delved into this area for an in-depth feature exploring the huge promise it presents.

Top Ten most popular articles on Pharmafile.com this week

It's been another packed week in the industry, with one of the biggest takeaways being that childhood obesity has rocketed up ten-fold over the last 40 years.

Another shocking discovery this week revealed that, of 103 UK companies, pharma giant GlaxoSmithKline was the worst in terms of criteria for good governance, according to a report by the Institute of Directors.

Strong IBS and constipation Phase 3 data sends Ardelyx shares rocketing 60%

Ardelyx has confirmed that its NHE3 inhibitor tenapanor met all its primary and secondary endpoints in the study of its treatment efficacy against irritable bowel syndrome and constipation (IBS-C). Based on the positive results the therapy has garnered, Ardelyx plans to file for US approval of the drug in the second half of 2018.

Harnessing the power of the immune system

Published on 09/10/17 at 10:55am

Dr Áine McCarthy, Senior Science Information Officer at Cancer Research UK, discusses the latest efforts to further understand the immunotherapies that have done so much for cancer treatment in recent years, and how they can be pushed to achieve even more.

China to accelerate drug approvals with overseas trial data

In a bid to speed up access to medicines for patients, China has revealed it intends to incorporate data from clinical trials conducted overseas into its approval process for new drugs, meaning international manufacturers and patients alike could face less delays in the world’s second-largest pharmaceutical market.

At least 40% of Afghanistan's medicine imported illegally, union claims

New damning allegations have arisen concerning Afghanistan’s pharmaceutical industry, as the Medicine Importers Union claims that at least 40% of the nation’s drug products are imported illegally.

Beyond the shocking figure, it is reported that a significant percentage of drugs in the country are of sub-par quality. The total sales of products imported into the country legitimately are estimated to be worth $700 million annually.

Gilead completes £11.9 billion Kite Pharma acquisition

Gilead has announced that it has completed its acquisition of Kite Pharma after the deal was announced on 28 August this year. Gilead now owns Kite Pharma via a transaction by its wholly-owned subsidiary Dodgers Merger Sub, valuing the company at $180 per share, or $11.9 billion.

AbbVie adds biologic production capability to Singapore facility

AbbVie has expanded the operational capability of its facility located at the Tuas Biomedical Park in Singapore with the addition of a biologics manufacturing facility. The move means the plant will now add the production of biological drugs to its repertoire in addition to small molecule active pharmaceutical ingredients (APIs).

Police raid French HQ of Merck KGaA over thyroid drug scandal

Police have raided the French headquarters of German drug manufacturer Merck KGaA over a scandal concerning its thyroid treatment Levothyrox, whereby more than 9,000 patients allege that the drug has caused a range of detrimental side-effects.

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