Press review

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EMA cutting UK out of assessment contracts in preparation for Brexit

Country : Netherlands, U.S., UK

Keywords :
LONDON, 7 Sep (APM) - The European Medicines Agency (EMA) is cutting the UK out of its contracts seven months ahead of the country's exit from the EU, the Observer said on Sunday.
The paper said that UK drug regulator has won just two contracts out of 36 it bid for this year for EU drug assessments and the EMA has now said that this work is off-limits.
The situation is a stark contrast to 2016 when the UK was the lead assessor, known as the rapporteur, on 22 applications, and was joint lead or co-rapporteur on 19 multinational applications.
“We couldn’t even allocate the work now for new drugs because the expert has to be available throughout the evaluation period and sometimes that can take a year,” said a spokeswoman told the paper.

Government talks to drug companies about Brexit stockpiling

The UK government is in talks with drug companies about funding the extra costs of stockpiling and flying in vital medicines in the event of a no-deal Brexit, the Guardian reported on Thursday (APMHE 59596).
Health secretary Matt Hancock said the discussions were not a remnant of the so-called 'project fear' campaign against Brexit, but part of “responsible planning for a no-deal”.
Pro-Europe Best for Britain warned last week that Hancock’s plan to set aside six weeks’ worth of vital medicines for a no-deal would cost £2 billion.
Interviewed on BBC Radio 4’s Today programme, Hancock did not disclose how much the initiative would cost. But he revealed that the government was prepared to compensate pharmaceutical companies for the extra costs involved.

Novo to stock four months' worth of insulin in preparation for 'no-deal' Brexit

The UK's biggest insulin supplier Novo Nordisk has said it is building up a four-month stockpile to ensure that people with diabetes are not left without vital medications in the event of a no-deal Brexit, the Independent reported on Wednesday.
Novo supplies just over half of the UK’s insulin and says it is “significantly” increasing reserves as the prospect of the country crashing out of the EU without a deal draws closer. (APMHE 59541)

NHS to treat young cancer patients with 'game changer' drug

The National Health Service is to treat children and young people with an expensive new cancer drug which has the potential to transform how the disease is treated, the Guardian reported on Wednesday (APMHE 59548).
Simon Stevens, the NHS England chief executive, said that a deal has been done with Novartis for Car-T therapy Kymriah (APMHE 59548).
The list price of the drug is £282,000 per patient and treatment costs for the NHS could double that. In the United States, the total cost of the therapy can reach $1million, the paper said.

British people increasingly happy to share health data

British people are increasingly coming to terms with sharing their data with the NHS and believe artificial intelligence could improve the care they get, a report has found, The Telegraph said on Wednesday.
A report by KPMG found that more than half of British people would be happy to share their personal data with the NHS if it led to an improved service, with 56% saying they would be willing to share more.
In a sign of the changing perception of artificial intelligence, more than half said they believed it would have a positive impact on the health service.

Statins 'waste of time' for healthy elderly

Giving statins to the healthy elderly could be a waste of time, a study claims, the Daily Mail reported on Wednesday.
The research, involving 47,000 over-75s, found no evidence that these drugs make any difference to low-risk patients. Scientists said their results 'do not support the widespread use of statins' in this group.

Dutch group accuses Leadiant of price-gouging tactics

A Dutch non-profit is taking action against Leadiant Biosciences for dramatically raising the price of chenodeoxycholic acid (CDCA) to treat gallstones in a case reminiscent of Martin Shkreli’s tactics in the U.S., the Financial Times said at the weekend.
The paper said that the Dutch Pharmaceutical Accountability Foundation, which consists of Dutch doctors and health advocates, is set to file a claim with The Netherlands’ Authority for Consumers and Markets to probe Leadiant for abusing its monopoly for CDCA in the country.
The FT said that Leadiant increased the price of the drug from €300 a year to more than €150,000 since gaining full control of supplies and winning approval from European regulators for CDCA's use as a treatment for the rare disease cerebrotendinous xanthomatosis (CTX).

AI used to determine dose of experimental cancer drug combination

Researchers in Singapore are using artificial intelligence (AI) to continuously assess how well prostate patients respond to an experimental drug combination and to then adjust dosing when appropriate, the Daily Mail said at the weekend.
These dose changes reduced cancer markers in a patient's blood to their lowest ever levels, with CT scans also revealing the patient's tumours had not spread further, said the paper.
The drug regimen in the trial is a combination of ZEN-3694 and Pfizer/Astellas' Xtandi (enzalutamide).

Blood pressure drugs may be contaminated

The Daily Mail at the weekend reported on a warning from the U.S. FDA that several drugs used to treat high blood pressure may be contaminated with carcinogenic chemicals.
The agency announced the discovery of a potentially carcinogenic ingredient in valsartan in July, after the manufacturer brought it to their attention in June. (APMHE 58952)
Camber Pharmaceuticals voluntarily recalled the pills on 9 August due to a likely carcinogen known as N-nitrosodimethylamine (NDMA). 

Theranos to dissolve

U.S. blood-testing company Theranos is to dissolve, the FT reported on Wednesday.
The move comes after federal prosecutors filed criminal charges against Theranos founder Elizabeth Holmes and the blood-testing company’s former president, Ramesh "Sunny" Balwani, alleging that they had defrauded investors out of hundreds of millions of dollars and defrauded doctors and patients (APMHE 59554).

Bayer's shares fall further on fears Monsanto will destroy value

The FT reported that investors on Wednesday sent Bayer's shares down 2% on news the $63 billion Monsanto deal would boost earnings less than hoped (APMHE 59585).
It said that the reaction spoke volumes about investors' attitude to the June acquisition. The downgrade was the result of regulatory delays to the deal's completion, rather than serious problems. However, the jitters reflect that the Monsanto purchase, one of the biggest in German corporate history, will destroy value.
Shares in Bayer have fallen a fifth since May 2016, when news of the deal first leaked. The share price has been battered by a U.S. jury's verdict last month linking Monsanto's Roundup weedkiller to cancer.

Novartis sells part of Sandoz generics unit to Aurobindo

Novartis is selling its Sandoz U.S. generic dermatology and oral solids portfolio to Aurobindo Pharma in a deal valued up to $1 billion, said the FT on Thursday. (APMHE 59576)
The paper said that Vas Narasimhan has moved quickly to reshape the company since being appointed chief executive in February this year, previously selling a stake in a consumer health joint venture with GSK and announcing plans to spin off its Alcon eyecare unit.
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