Press review


EpiPen shortage shows company and regulator failure

LONDON, 5 Oct (APM) - The Financial Times on Tuesday said a worldwide shortage of EpiPens shows twin corporate and regulator failings.
It said Mylan owns the rights to EpiPen but does not make the product. It gave that job to Pfizer, which it said seems to have "messed up".
In September 2017, the U.S. Food and Drug Administration sent a warning letter to Meridian Medical Technologies, a Pfizer subsidiary, saying it had identified "significant violations of current good manufacturing practice" at the Brentwood, Missouri plant where the EpiPens are made.
Trying to correct those faults helped create the shortage, said the paper.
EpiPens usually have expiry dates 12 months away. But now faced with shortages, the FDA and UK authorities say adult-use EpiPens can be used for four months beyond that date.

UK’s MHRA issues Brexit drug access warning

UK drug regulator the MHRA has warned that leaving the EU without a deal could mean UK patients will miss out on access to new medicines, the FT said on Thursday (APMHE 59995).
The paper reported on a consultation paper from the MHRA that acknowledges there would be “costs” to the pharma industry to cope with additional regulatory hurdles to sell drugs in the UK if it is no longer in the remit of the European Medicines Agency (EMA).
The MHRA said that companies may choose not to submit an additional application to the UK if it goes ahead with its own regulatory system.

Heart drug trials in UK halted because of Brexit

Clinical trials of a potential heart drug have been halted because of uncertainty over Brexit, The Times reported on Thursday.
Medical research company Recardio has suspended all trials in Britain because of “completely unresolved” questions about medicines regulation after Britain leaves the EU next year. (APMHE 59978)
Theresa May has said she wants the UK to remain part of the European medicines approval process, but with only six months before Brexit day, some in the pharmaceuticals industry believe that they cannot rely on the promise. Recardio is the first to state publicly that uncertainty over the future of medicines rules created a “significant risk” to its business.

Ian Read to step down as Pfizer CEO

The Times on Tuesday covered Pfizer's announcement that Ian Read is to step down as chief executive at the end of the year. (APMHE 59940)
It said that in an interview with The Wall Street Journal on Monday, Read said: “The company has come out of the abyss it was in and is really poised for growth. Given my age, it’s time for me to move on.”
Read is a 25-year veteran of Pfizer and will have been at the helm for eight years.

Mega-deals no longer necessary for Pfizer

Pfizer's enthusiasm for big strategic deals has been cooling, the FT reported on Wednesday.
In the decade to 2017, few big drug companies spent more on acquisitions than Pfizer and few made lower returns on investment, according to research firm EvaluatePharma.
Pfizer’s prospects depend on how well it copes with patent expiries as well as the political backlash against price increases.
But with up to 15 potential blockbusters, the pipeline looks promising. That gives new CEO Albert Bourla a chance to change the prescription. Pfizer does not need any more evidence that dealmaking can destroy value.

GSK to allow payments to doctors again

GlaxoSmithKline has eased restrictions on payments to doctors introduced after a bribery scandal in China, The Times said on Wednesday (APMHE 59964).
The UK pharma will allow payments to healthcare professionals who speak about the “new science behind selected GSK products, their associated diseases and clinical practice in promotional settings”.
GSK severely restricted these types of payments in 2013 after it was found guilty of paying doctors to prescribe drugs in China.

NHS to reimburse CAR-T Yescarta in adults with lymphoma

NHS England has agreed a deal with Gilead to reimburse CAR-T cancer therapy Yescarta (axicabtagene ciloleucel) for adult patients whose large cell lymphoma has returned or has stopped responding to previous treatment, the Daily Mail says on Friday. (APMHE 60016)
The paper said the deal means up to 200 adults a year will have access to the therapy, which is personalised and reprogrammes immune system cells to target cancer.
Clinical trials suggest the treatment, which would normally cost nearly £300,000 per person, could potentially cure around 40% of eligible patients, said the paper, referencing NHS England.

Court rules Fresenius can ditch $4.75 billion Akorn deal

Fresenius has won a rare court victory for a buyer seeking to back out of a deal after a U.S. court ruled it could terminate a $4.75 billion takeover of Akorn without any penalty, the FT reported on Tuesday.
A Delaware judge said the German healthcare group was entitled to end its merger agreement with Akorn because the U.S. drugmaker had made untrue statements about the state of its business during the deal negotiations.
Akorn's shares plunged more than 50% on Monday after the ruling to about $6, valuing the company at less than $800 million.

Injecting tumours with gangrene-causing bacteria could help fight late-stage cancers

Safety tests on a new type of “bacterial therapy” found that tumours which have become resistant to other treatments became necrotic and shrank when injected with bacterial spores, the Independent reported at the weekend.
University of Texas doctors used a strain of bacteria related to lethal hospital superbug Clostridium difficile, which had been modified to make it less harmful to humans.
Clostridium novyi-NT needs a very low-oxygen environment to survive; this means it will not develop in healthy tissue with a good blood supply, but dense, rapidly growing tumours are a perfect host.
“By exploiting the inherent differences between healthy and cancerous tissue, Clostridium novyi-NT represents a very precise anti-cancer therapeutic that can specifically attack a patient’s cancer,” said Dr Filip Janku, of the university’s Anderson Cancer Center.

Drug gives hope to women with morning sickness

A new morning sickness pill could save women from becoming so ill that they decide to terminate their pregnancies, campaigners have claimed, The Times reported on Wednesday.
Xonvea was launched in Britain yesterday to treat nausea and vomiting in pregnant women. In clinical trials, the drug was found to reduce nausea by two thirds and cut daily episodes of sickness from four to one.
Doctors have been reluctant to prescribe medication to control nausea in pregnant women after the thalidomide scandal, in which an antisickness drug caused severe birth defects.

Millions warned of severe side effects when coming off anti-depressants

Millions of people face severe side effects when trying to come off anti-depressants, a major review has concluded, the Daily Mail reported on Tuesday.
For years health officials have played down the difficulty of withdrawing from antidepressants, insisting side effects are ‘mild’ and last no more than a week or two.
But a review of medical evidence today shows 56 % of people experience withdrawal effects if they try to come off the drugs.
The worst-hit experience nausea, anxiety, insomnia and agitation, with many people put back on antidepressants as doctors mistake the symptoms for a relapse of depression itself.

Users exploiting loopholes to buy prescription drugs from Chinese online retailers

Some users of Chinese online retail giants Alibaba and are exploiting a loophole to buy prescription medicines, the FT said on Thursday.
The paper said searches for drugs such as Pfizer’s Zoloft and Celebrex resulted in dozens of listings from third-party vendors, bypassing laws that explicitly prohibit online sales of prescription drugs.

Nobel Prize recognises pioneers in cancer immunotherapy

There was wide coverage on Monday and Tuesday of the Nobel Prize for Medicine being awarded to cancer researchers James Allison, from the University of Texas, and Tasuko Honjo, from Kyoto University.
The pair were honoured for their separate work that led to the discovery of checkpoint inhibitors in the immune system, forming the basis of cancer immunotherapy research.
The story was covered in all major media outlets.



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