Press review

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Canopy Growth wins UK's first medical cannabis bulk import licence

Country : Denmark, Germany, U.S., UK

Keywords :
LONDON, 18 Oct (APM) - The world's largest publicly traded cannabis company, Canopy Growth, will be the first to be allowed to import medicinal cannabis in bulk into the UK, the Financial Times reported on Wednesday
The company's pharmaceutical division - Spectrum Therapeutics - told the FT that it had been granted a licence by the Home Office that will allow it to import cannabis from Canopy's distribution facility in Germany. It also told the FT that the licence allows it to import from a 430,000 sq ft greenhouse in Denmark and to store it in its Buckinghamshire facility.
Currently, patients in need of medical cannabis, which was legalised last November, can wait up to three months for specialist wholesalers to be granted an import licence and transport the product to the UK. Licences are granted on a prescription-by-prescription basis only.
Paul Steckler, managing director of Canopy's European business, said the Home Office licence and Canopy's ability to store the drug in bulk will mean that it could send cannabis products out the next day, as it does in Germany where medical cannabis has been legal since 2017.

Ban on exports of erectile dysfunction medicine Caverject

The UK government has banned drug wholesalers from exporting erectile dysfunction medicine overseas in an attempt to combat shortages in the UK, The Times reported on Thursday.
A ban has been imposed on exporting Caverject, the brand name for alprostadil, which is taken by men for whom Viagra does not work. It means the drug will have to be given to patients in Britain rather than sold abroad for a higher profit.
It is only the second time the Department of Health and Social Care has taken such extreme action after banning the export of 27 types of medication earlier this month, including all hormone replacement therapy drugs, epipens and some blood thinning pills.
Caverject, which is produced by Pfizer, has been beset by shortages and last year the company notified its Irish suppliers of a two-month shortage due to "global supply constraints".
It is thought that the dearth has been worsened by people stockpiling in anticipation of supply problems caused by a no-deal Brexit. Last year Pfizer supplied 270,000 doses of the drug to Britain.

Indivior's shares rise as it boosts guidance for second time

London-listed drug maker Indivior has raised its guidance for this year's earnings for a second time following the strong performance of a drug used to treat opioid addiction, sending shares up sharply on Tuesday, the Financial Times reported.
The group on Tuesday said it now expects net profit to be in the range of $160 million to $190 million, up from earlier guidance of $80 million to $130 million. It projected net revenue in the range of $750 million to $790 million, from $670 million to $720 million previously, the paper said.
Indivior said the primary driver of the raised guidance was the outperformance of Suboxone, which is used for patients seeking to beat opioid addiction and has been facing competition from cheaper "generic" alternatives.
"We cannot be certain how long this benefit will last and hence we continue to prudently manage the additional cash flow this is providing us," said chief executive Shaun Thaxter.
Shares rose more than 13% in early trading on Tuesday, but are still nearly 50% lower for the year. Indivior had already raised guidance for the financial year in July, again citing the outperformance of Suboxone.
Suboxone has been at the centre of a U.S. justice department probe into an alleged fraudulent marketing scheme to boost prescriptions of the flagship treatment, the FT added.

CRISPR/Cas9 gene editing used to treat sickle cell disease

The Times on Monday covered the results of a trial that showed CRISPR/Cas9 gene editing techniques could treat sickle cell disease, an inherited condition where red blood cells, which should be circular, adopt a crescent shape, leading to clogged blood vessels and damaged organs.
CRISPR/Cas9 techniques were used to alter the DNA of a U.S. patient called Victoria Gray, causing her body to produce foetal haemoglobin, a substance that has been show to reverse the symptoms of SCD.

UK scientist claim EU’s Clinical Trial Directive harms academic research

The Sunday Telegraph picked up comments from two senior scientists warning about the impact of the EU’s Clinical Trial Directive on academic research.
Angus Dalgleish, professor of oncology at the University of London, and Professor Keith Lewis, director of science and technology consultancy Sciovis, published a joint report on the directive, which was introduced to simplify and harmonise the administrative provisions governing clinical trials in Europe.
The report states: "Patients suffer from directives. The Clinical Trial Directive was put forward in the spirit of harmonisation but was, in fact, a mechanism to make trials so horrendously expensive that only Big Pharma could afford to get their products registered.
"This conveniently made it extremely difficult for smaller companies and generics to compete. Unfortunately, at a stroke, this killed clinical academic research into innovative treatments that could be applied rapidly to the clinic."
The article did not mention the pending Clinical Trials Regulation, which is intended to replace the directive.

Hundreds of thousands of lives could be saved by giving patients with head injuries a £6 drug

According to new research, hundreds of thousands of traumatic brain injury deaths could be avoided by using a drug that costs £6, the Daily Mail reported on Monday.
London School of Hygiene and Tropical Medicine scientists tested transexamic acid (TXA) on almost 13,000 patients.
Results published in The Lancet journal found giving patients TXA within three hours slashed the number of fatalities by as much as 20%
The drug, which is already used to save the life of stab victims, stops bleeding in the brain by preventing the breakdown of blood clots.
Survival rates were almost a quarter higher in patients with mild and moderate traumatic brain injuries who were given TXA. But it provided no clear benefit in the most severely injured patients.
However, the largely encouraging results from the drug - to which the trial found no risky side-effects - have exciting implications for the advancement of medicine.
Professor Ian Roberts, who co-authored the study, said: "We already know that rapid administration of tranexamic acid can save lives in patients with life-threatening bleeding in the chest or abdomen such as we often see in victims of traffic crashes, shootings or stabbings.
"This hugely exciting new result shows that early treatment with TXA also cuts deaths from head injury. It's an important breakthrough and the first neuroprotective drug for patients with head injury."

J&J shrugs off legal woes

Mounting concern over more than 100,000 court claims it is defending in the U.S. did not stop Johnson & Johnson from raising its full-year profit forecast on Tuesday, The Times reported on Wednesday.
The healthcare group beat Wall Street's third-quarter forecasts thanks to strong sales of cancer and psoriasis drugs, but it did not comment in depth on the torrent of litigation.
J&J, valued at $351 billion, is the world's largest health company. It is defending claims from about 15,000 women who allege that its talc products gave them cancer.
It also faces about 13,000 suits involving antipsychotic drug Risperdal, around 25,000 claims linked with its pelvic mesh devices and 2,000 claims linked to the opioid addiction crisis in the U.S.
On Tuesday, a Missouri appeals court overturned a $110 million verdict against J&J in a lawsuit by a woman who says she developed ovarian cancer after decades of using of its talc-based products for feminine hygiene.
J&J denies all the claims against it. The company was said to be involved in discussions with three major drug distributors about an $18 billion settlement with state and local governments over opioid claims, according to the Wall Street Journal.

Introduce compulsory licensing?

The FT on Wednesday carried a comment piece in which it said unaffordable medicines are a large and growing global problem. In the U.S., both President Donald Trump and many of his prospective Democratic opponents are looking for ways to bring prices down.
In the UK, the opposition Labour party has endorsed two potentially far-reaching ideas: override patent protection on excessively priced medicines and change the way pharmaceutical research and development is funded.
"Compulsory licensing to remove patent monopolies on drugs like the cystic fibrosis treatment Orkambi could immediately lower prices and expand patient access," the paper said.
Orkambi maker Vertex has been fighting the UK government's efforts to reduce its £105,000 list price since 2015 and rejected a £1 billion bulk purchase. Talks have lasted so long that the company destroyed nearly 8,000 packets of expired medicine. Rather than curbing innovation, the authorisation of generic competition after lengthy, failed negotiations would signal that authorities will robustly regulate prices and limit patients' waiting time for drugs.
The R&D proposals are potentially even more transformative. The traditional innovation model relies on potential profits to pull in private investment. This means market returns set R&D priorities. But this model fails to deliver innovation in many areas: antibiotics, rare diseases, outbreak-prone pathogens like Zika, and the neglected diseases of poverty, among others, the FT commented.
Public authorities can and should play a greater role in guiding R&D. The World Health Organization has influenced funders by producing priority lists for missing antibiotics and technologies to combat outbreaks. It makes eminent sense to expand to other disease areas, and to back priorities with government financing.
But public funds should not be given away lightly. Taxpayers already fund much of the discovery and early-stage development of new drugs, the riskiest part of the process. Companies often acquire candidate drugs after they have shown signs of success. Once they go on sale, the public pays again through the high prices enabled by monopolies.
"Placing conditions on public R&D grants could help ensure that products benefiting from taxpayer investment are affordable when brought to market," the paper said.

Research into disease emergencies

Imperial College London is to set up a research centre to respond to disease emergencies and analyse global health priorities, with funding from a Saudi foundation, the FT reported on Tuesday.
The Abdul Latif Jameel Institute for Disease and Emergency Analytics (J-Idea) aims to tackle health crises, for example when epidemics of infectious disease such as Ebola and Zika break out, as well as carrying out longer term research into the factors behind them, such as climate change and population movements, that make health emergencies more likely.
A donation of about £25 million from Community Jameel, the charity of the Jameel family who have made a fortune from their trading business in the Middle East, will enable Imperial to build J-Idea as part of its £100 million campaign to establish a new School of Public Health at its White City campus in west London.
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