Press review


FDA head Hahn defends regulator after criticism and sacking of spokesperson

LONDON, 4 Sep (APM) - The FT on Monday said that after eight months into his tenure as head of the U.S. Food and Drug Administration, Stephen Hahn is trying to "press the reset button" after he gave a press conference that included misleading information, requiring him to spend several days correcting the record.
Last week, Hahn removed his Trump-appointed spokesperson Emily Miller from her job after just 11 days. Her sacking followed, what the paper described, as a bungled press conference when Hahn overstated the benefits of convalescent plasma, which has been given emergency use authorisation for coronavirus.
In an interview with the FT, Hahn hit back at critics who said he is approving coronavirus treatments too quickly because of pressure from Donald Trump who has been accused on mishandling the U.S. response to the pandemic.
"Science and data drive our decisions," he said. "We have terrific, terrific scientists, doctors, nurses, pharmacists. They make the decisions on the ground . . . and they're science driven. We need to make sure that the American people know that and have confidence in that."
As head of the FDA, he has found himself caught between a president who wants to move faster on drug approvals, and public health experts who accuse Trump of abandoning scientific rigour in favour of speed, the FT said.
The paper said that in a few weeks' time, Hahn might have to make the most difficult choice of his career and one of the most sensitive decisions in public health history: whether to grant fast-track authorisation for a coronavirus vaccine
If he does, it could help start to turn the tide against the pandemic, stimulate the economy and hand Donald Trump a pre-election boost. But he could also end up contributing to growing scepticism among Americans about the safety of vaccines in general, and even end up harming people's health in the long run.

U.S. health agency experts cast doubt on plasma for Covid-19

The FT on Wednesday said a split has developed among leading U.S. government scientists over the benefits of using convalescent plasma to treat coronavirus.
A panel of experts convened by the National Institutes of Health said there was insufficient evidence to support its use. It quoted the panel as saying: "There are currently no data from well-controlled, adequately powered randomised clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of Covid-19."
The finding contradicted the U.S. Food and Drug Administration, which recently awarded emergency use authorisation for convalescent plasma to treat coronavirus in hospital patients and cast doubt on a treatment backed by Donald Trump. (APMHE 68641)
"This is what I've been looking to do for a long time. This is a great thing," the U.S. president said after the FDA authorised the treatment.

Pfizer warns on risk of fast-tracking Covid-19 vaccines

The chief executive of Pfizer has warned about the reputational risks of fast-tracking a Covid-19 vaccine, as governments put pressure on pharmaceutical companies to deliver an inoculation to bring the pandemic to an end, the FT reported on Thursday.
Albert Bourla said the U.S. pharma would never submit any vaccine for authorisation before it felt it was safe and effective.
"Pfizer last year had its 170th anniversary. It's a long institution and I don't plan to reduce its reputation in a year or two," the FT quoted him as saying.
Bourla said he understood that people may be "sceptical" about vaccines. "They are sceptical because there's so much politicised science right now," he said in a press conference of the International Federation of Pharmaceutical Manufacturers and Associations. "This is the worst situation for society."
His comments come as the U.S. government appears to be preparing to distribute a vaccine ahead of the presidential election in November.
The head of the U.S. FDA Stephen Hahn told the FT in an interview that he is willing to "fastback a vaccine", but will not do so at President Trump's request. The director of the U.S. Centers for Disease Control and Prevention has also written to states asking them to speed up approval for vaccine distribution sites to have them ready by 1 November.
Pfizer is at the Phase III stage of trialling a vaccine candidate developed in conjunction with its German partner BioNTech.

Pfizer aims to submit Covid-19 vaccine results to FDA by October

Pfizer said it could have results from its late-stage coronavirus vaccine trial available as early as October, the Mail reported on Thursday.
Its chief executive Albert Bourla said during a call sponsored by drug industry group International Federation of Pharmaceutical Manufacturers & Associations that 23,000 volunteers have been enrolled in the Phase III trial, which began in July.
The New York-based drug company said if data show the vaccine is safe and effective, it will file for approval, along with its German partner BioNTech, immediately.

Top U.S. health official prepares for pre-election vaccine

The FT on Wednesday said Robert Redfield, described by the paper as the top U.S. public health official, has called on state governors to speed up the opening of new vaccine distribution centres as the federal government presses ahead with plans to launch an immunisation against Covid-19 before the election.
Redfield, the director of the Centers for Disease Control and Prevention (CD), has written a letter asking governors to waive requirements that might slow down the granting of permits for the new facilities, which will be tasked with distributing vaccines to health providers.
"The normal time required to obtain these permits presents a significant barrier to the success of the urgent public health programme," Redfield wrote in a letter sent to governors on 27 August, which has been seen by the FT.
"CDC urgently requests your assistance in expediting applications for these distributions and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1," he added.

GSK and Sanofi start Covid-19 vaccine trial

The UK's press widely covered the start of human trials of GlaxoSmithKline and Sanofi's Covid-19 protein-based vaccine candidate. (APMHE 68760)
GSK's chief executive Emma Walmsley has described beating the coronavirus as the company's primary aim, The Times says on Friday.

J&J says coronavirus candidate vaccine prevents severe illness in hamsters

Johnson & Johnson's coronavirus vaccine candidate prevented severe illness in a small group of hamsters, the Mail reported the healthcare giant as saying on Thursday.
In the pre-clinical study, vaccinated animals lost less weight and had less virus in their lungs and other organs than unvaccinated animals.
J&J plans to begin Phase III testing in the second half of September in more than 60,000 volunteers, the Mail added.

Cheap steroids to be rolled out across NHS for Covid patients

The Telegraph on Wednesday reported that steroids, which cost £5 and cut the risk of dying from Covid-19 by a fifth, are to be rolled out across the National Health Service.
A study, which was coordinated by the World Health Organization and analysed by National Institute for Health Research (NIHR) at the University of Bristol, looked at patient mortality in a 28-day period after treatment. It found treatment with one of three types of corticosteroid led to an estimated 20% reduction in the risk of death.
The WHO will now issue new guidelines to include the use of steroids to treat critically ill Covid-19 patients, the paper said.
Researchers said it was equivalent to about 68% of critically ill patients surviving after treatment with the steroids, compared to approximately 60% surviving without them.
The results of the study, which involved the drugs dexamethasone, hydrocortisone and methylprednisolone, were published in the Journal of the American Medical Association on Wednesday. (APMHE 68754)
The Mail quoted NHS chief executive Sir Simon Stevens as saying: "Just as we did with dexamethasone, the NHS will now take immediate action to ensure that patients who could benefit from treatment with hydrocortisone do so, adding a further weapon in the armoury in the worldwide fight against Covid-19."
The story was also covered in the FT on Wednesday and The Times on Thursday.

Actemra offers severely ill Covid-19 patients hope in small study

The Mail online on Monday reported on a small study which has given hope that Roche's rheumatoid arthritis drug Actemra (tocilizumab) might help severely ill Covid-19 patients.
Seven patients given doses of the drug saw severe symptoms reduce such as fever and being able to come off of ventilators and oxygen therapy. The study was published in Proceedings of the National Academy of Sciences.
Scientists believe Actemra's anti-inflammatory properties can control the immune system's overreaction to the virus, the Mail added.
Actemra belongs to a class of drugs called interleukin-6 (IL-6) inhibitors that could help mitigate a dangerous overreaction to the virus by the body's immune system called a cytokine storm.
These so-called storms occur when the body does not just fight off the virus but also attacks its own cells and tissues. In cases of Covid-19, the disease caused by the virus, cytokine storms can trigger respiratory distress, which can lead to multi-system organ failure and death.

GSK starts Covid-19 antibody trial

The Times on Tuesday reported on GlaxoSmithKline's aim for an antibody coronavirus treatment to be available as soon as the first half of next year after starting a trial of 1,300 patients last week. (APMHE 68720)
The trial is in partnership with Vir Biotechnology, the Nasdaq-listed company in which GSK took a $250 million stake this year.
The study, called Comet-Ice, will investigate the safety and efficacy of the antibody therapy in preventing patients with mild or moderate Covid-19 needing hospital treatment. The first patient was given a dose last week and the trial could involve people in the UK.

Nestlé buys Immune

Nestlé agreement to buy food allergy specialist Aimmune Therapeutics in a deal worth $2.6 billion, was covered in the FT on Monday. (APMHE 68712)

AstraZeneca signs $15 million deal with Oxford Biomedica

AstraZeneca has signed a $15 million deal with an Oxford Biomedica to manufacture a Covid-19 vaccine, The Telegraph, Guardian and Mail reported on Tuesday. (APMHE 68729)
The pharma will pay Oxford Biomedica the sum upfront to reserve manufacturing capacity at its plant.
Oxford Biomedica could get an additional $35 million plus other costs until the end of 2021 under the new 18-month deal, The Telegraph added.

Pharma industry calls on UK to support medical research charities

More than 30 pharma companies and business groups have written to UK prime minister Boris Johnson urging the government to plug a £310 million financing gap faced by medical research charities that work closely with industry to fund and develop drugs, the FT reported on Tuesday
Companies at the forefront of Covid-19 drug development, including AstraZeneca, Novartis, Pfizer and Roche, wrote to Johnson on Tuesday to urge him to take "urgent action to preserve the vital contribution medical research charities make to life sciences in this country".
Since April, the charity research sector has been calling for the government to extend support packages it has offered to frontline charities, universities and businesses, at a time when coronavirus drug and treatment development has become a central tenet of political strategy around the world.
The letter, seen by the FT, said: "We recognise the government's clear drive to put R&D at the heart of the UK's economic and social recovery, but we have yet to see clarity in this around what this means for the future of charity funded research.
"By preserving charity-funded research in the short-term, government can help create high-quality research, innovation infrastructure and skills benefiting the UK economy in the longer term."
The FT said the letter marks the latest chapter in a series of pleas made by and on behalf of medical research charities ahead of major funding decisions due to be made in the autumn.

Millions of flu jabs could be delayed until December in the UK

Millions of flu jabs may not be offered until close to Christmas in the UK, despite fears of a winter crisis in the National Health Service (NHS), The Telegraph and Times reported on Monday.
Government ministers have promised "the biggest flu vaccination programme in history" to ensure the NHS can cope if it is hit by a "double whammy" of flu and Covid this winter, the Telegraph added.
They pledged to expand the programme to half the population, with healthy over 50s offered a jab, as well as pensioners, those with underlying health conditions and young children.
But now the paper is reporting that patients have been told it is likely that they will have to wait until December for the jab - despite the fact the flu season may well start earlier, and amid fears of a second wave of Covid.
The vaccination programme is due to start this month, with the most vulnerable patients prioritised first.
The Telegraph said it has seen government guidance, which says services aim to "extend the vaccine programme in November and December to include the 50-64 year old age group, subject to vaccine supply".



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