Press review

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Deaths related to opioid fentanyl drugs rise by nearly a third in England and Wales

LONDON 10 Aug (APM) - Deaths caused by opioid painkiller fentanyl rose by nearly 30% in England and Wales last year, The Guardian reported, quoting figures from the Office for National Statistics.
On Monday, the paper reported statistics showing that the rate of deaths from drug poisoning in general in England and Wales has remained steady at 66.1 deaths per 1 million people (3,756 deaths). However, fatalities involving the synthetic opioid fentanyl were up 29%. There were 75 deaths in 2017, up from 58 in 2016, it noted.
The news comes amid a worldwide crackdown on opioid drugs as deaths from addiction and abuse increase.
U.S. president Donald Trump has previously blamed drug companies for fuelling the crisis.
Earlier this week, Insys Therapeutics agreed a $150 million settlement to halt U.S. Department of Justice (DoJ) investigations into alleged shady marketing tactics used by former employees to push an opioid painkiller known as Subsys (APMHE 59266).

Republican congressman and Innate Immunotherapeutics investor charged with insider trading

U.S. Republican congressman Chris Collins has been charged with insider trading over shares in Australian biotech Innate Immunotherapeutics while picnicking on the White House lawn last summer, the Financial Times reported on Thursday. (APMHE 59285)
It is alleged that Collins was at the congressional picnic on 22 June last year when he received an email from the chief executive of Innate, Simon Wilkinson, informing him of a study showing that a multiple sclerosis drug - MIS416 - had failed.
After learning of the failure, the congressman telephoned his son, Cameron, who subsequently sold his Innate shares, it is alleged, the FT said. Dumping the stock before the trial results were made public saved the Collins family roughly $570,900 in losses, according to the indictment.
Collins denied the allegations after he was charged on several counts of securities fraud by the U.S. Attorney’s Office for the Southern District of New York, the paper added.
Collins has branded the claims “meritless” and said that he would “mount a vigorous defence in court”.
Meanwhile, on Thursday Innate said the company is not under investigation, and stressed that Collins had retired as a director in May this year.

Odds of no-deal Brexit are 60-40, says trade secretary

Britain is odds-on to crash out of the European Union without a deal, the UK's trade secretary Liam Fox warned in the Sunday Times (APMHE 59214).
Fox put the chances of a no deal departure at “60-40”, squarely blaming the “intransigence” of the European Commission, the paper noted.
It said he accused Eurocrats of harbouring a “theological obsession” with EU rules rather than “economic wellbeing”, which would lead to “only one outcome”.
The news will come as a blow to many in the pharma and life sciences sector, who have been calling (APMHE 58921) for a trade deal to be finalised since Brexit was first voted through in 2016.
Still, The Times reported on Monday that the prime minister's office said it remains confident Britain can negotiate a good deal with Brussels.

Fresenius Kabi launches legal battle to stop use of its drugs in death sentence

German drugmaker Fresenius Kabi is suing to halt a planned execution in Nebraska, which it believes will include two of its drugs - muscle relaxant cisatracurium and potassium chloride.
According to The Guardian on Wednesday, the state plans to use these drugs alongside sedative diazepam and powerful narcotic painkiller fentanyl citrate.
Fresenius said it believes it is the source of the cisatracurium and potassium chloride drugs in the lethal cocktail, which it claims the U.S. state obtained illegally for the execution. The company is asking a federal judge to issue an order either temporarily or permanently blocking the state from using the injectable medications, The Guardian noted.
It quoted the firm as saying in its civil complaint: “While Fresenius Kabi takes no position on capital punishment, Fresenius Kabi opposes the use of its products for this purpose and therefore does not sell certain drugs to correctional facilities."
It added: “These drugs, if manufactured by Fresenius Kabi, could only have been obtained by defendants in contradiction and contravention of the distribution contracts the company has in place and therefore through improper or illegal means.”
The lawsuit was filed on Tuesday evening, claiming the state was planning to use two of its drugs on 14 August to put to death convicted killer Carey Dean Moore. If carried out, the execution would be Nebraska’s first in 21 years and its first ever lethal injection.

Novo Nordisk's shares slip after warning on U.S. price cuts

Novo Nordisk's shares slipped by nearly 5% as it warned of continued U.S. pricing pressures, the Financial Times reported on Wednesday (APMHE 59245).
Pricing pressures in the U.S. for diabetes drugs - particularly insulins - have become a running issue for Novo (APMHE 58150). Earlier this year, it was reported in local Danish media that the company could lose up to 3,000 staff as part of a cost-cutting initiative to deal with continued U.S. pressures (APMHE 58436).
The FT noted that while negotiations with pharmacy benefit managers and managed care organisations are progressing for the Danish biopharma, it is expecting average prices after rebates “to be lower compared with the levels in 2018”, which it added is “predominantly due to basal insulin pricing”.
Novo reconfirmed its guidance for 2018, with sales growth still expected to be between 3% and 5% and operating profit growth still expected to be between 2% and 5%, both measured in constant currencies, the FT added.

Mylan to review options as North American sales fall

Meanwhile, Mylan is also feeling the pressure from the U.S. market. The FT reported on Wednesday that the firm's board is “actively evaluating a wide range of options” as it believes its global strengths are being overlooked and undervalued by U.S. public markets, amid a sharp drop in North American quarterly sales. (APMHE 59254)
The generic drugmaker’s shares dropped 4.5% in pre-market trading after the board announced the formation of the strategic review committee to “unlock the true value of our one-of-a-kind platform”, the paper noted.
The statement came as Mylan reported a 5% drop in revenue to $2.81 billion for the three months to June 30, with a 22% slide in segment net sales for its biggest market, North America. The company credited that to “significantly lower volume” for existing products, including EpiPen

AstraZeneca/ Merck's selumetinib granted EU orphan status

AstraZeneca and Merck & Co’s MEK 1/2 inhibitor selumetinib has been granted orphan designation in Europe as a treatment for the rare, incurable paediatric condition neurofibromatosis type 1 (NF1), The Times reported on Saturday (APMHE 59210).
It had already been given the same status by the U.S. Food and Drug Administration, the paper noted.

Surge in Scottish deaths linked to Xanax

New data show a surge in deaths in Scotland linked to Pfizer's Xanax (alprazolam), a benzodiazepine tranquiliser used to treat anxiety and panic disorders, The Guardian reported on Sunday.
It quoted experts as saying the rise in prescription drug use across the UK could be fuelling a hidden crisis affecting millions, as Scottish government data show a dramatic rise in deaths linked to these tranquilisers.
Xanax is not available on the NHS and can only be obtained on a private prescription in the UK. It is usually sourced from the internet or other illegal suppliers, The Guardian added.
The number of deaths increased from a handful between 2007 and 2015, to two in 2015, 24 in 2016 and 99 last year. Deaths linked to benzodiazepines generally went from 192 in 2015 to 431 in 2016 and 555 last year, the paper said.

CQC wants to tackle loophole exploited by websites selling prescription-only drugs

England's Care Quality Commission (CQC) has called for a change in the law to let it take action on websites selling prescription-only drugs, The Times reported on Monday.
Current rules mean the CQC can only inspect sites if the doctors they use to prescribe medicines are contracted by companies in England.
An investigation by the BBC's Panorama programme has found that many avoid CQC regulation by employing doctors through companies in Romania. 

GSK names new chief financial officer

GlaxoSmithKline has named HSBC’s Iain MacKay as the company’s new chief financial officer, both the FT and the Daily Telegraph reported on Tuesday. (APMHE 59226)
He will oversee a £1.7 billion restructuring programme over the next three years that aims to achieve annual savings of £400 million a year, said the papers.
The Times said MacKay is the latest in a string of senior hires that chief executive Emma Walmsley has made since replacing Sir Andrew Witty last year.
Other recent appointments include Luke Miels to run GSK’s pharmaceutical division, and Hal Barron as chief scientific officer and head of R&D.

Senior pharmacists warns of potential drug shortages in Ireland due to Brexit

Ann Marie Horan, of the Irish Pharmacies Union, has called for drugs to be stockpiled to minimise disruption to Ireland’s medicines supply due to Brexit, The Times said on Wednesday.
“We as pharmacists are on the frontline so we are the people who will have to explain to our patients, ‘you know we can’t get your drug’, and that’s such a horrible, horrible thought,” said Horan.
She added that the medical community must continue to put pressure on the government to prevent a medicines shortage in the event of a no-deal Brexit.

Brexit could lead to drug shortages, says AZN exec

A senior AstraZeneca executive has said patients in the EU may not be able to receive vital medicines from the UK if the company does not successfully prepare for a no-deal Brexit, the Guardian reported on Tuesday.
Ad Antonisse, the company’s Dutch external affairs director, told an official Dutch government website that it was going to have to test medicines in both the UK and the EU to ensure they could cross the border in all Brexit scenarios.
He conceded that AZN could not guarantee it would succeed, and emphasised that EU citizens could be at risk because many of its drugs are manufactured and quality-tested in the UK.
“If we do not prepare well for Brexit, patients in the EU may no longer be able to receive their medicines. Just because production happens to happen in the United Kingdom.”

Children with ADHD missing out on treatment

A new study has shown that may children with attention deficit hyperactivity disorder (ADHD) are not accessing treatment, both The Times and the FT said on Tuesday.
The study, led by Oxford University and published in Lancet Psychiatry, found that while 5% of UK children have the condition, only one in 10 of these are being given drugs to control it.
Researchers said the lag may be due to underdiagnosis of the condition and to unfounded fears among the public that it is inappropriate to give children treatments such as Ritalin (methylphenidate).
Overprescribing in children was not supported by the study’s findings, said the FT.
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