Johnson & Johnson one-shot Covid vaccine gets nod from FDA advisory panel

Vaccine, along with those from Pfizer and Moderna, should provide US with more than enough supply to vaccinate every person

The battle against Covid-19 took a major step forward on Friday as the US moved closer to distributing its first one-shot Covid-19 vaccine, after an independent expert advisory panel recommended drug regulators authorize the Johnson & Johnson vaccine for emergency use.

The authorization would be a significant boost to the Biden administration’s vaccinations plans, making Johnson & Johnson’s vaccine the third available to the public. Janssen, Johnson & Johnson’s vaccine subsidiary, told a Congressional hearing this week that it expects to deliver 20 million doses by March and a total of 100m doses before the end of June.

Related: US vaccine distribution: track your state’s progress

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Blair says collaboration on Covid could have cut three months off crisis

Former prime minister tells the Guardian the world must be better prepared for the next pandemic

World leaders could have cut the length of the Covid outbreak by three months if they had collaborated on vaccines, testing and drugs, Tony Blair has claimed as he launched a report on preparing for the next deadly pandemic.

The former Labour prime minister urged the UK to take the lead in developing a new “health security infrastructure” that would ensure countries coordinate better in identifying emerging new threats as well as developing, testing and manufacturing vaccines and treatments.

Related: Vaccine passports: a threat to liberty or necessary safeguard? | Letters

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AstraZeneca and Moderna’s contrasting rewards for fighting Covid hardly seem fair

While Moderna is being hailed as a national saviour in the US, AZ’s only gain so far has been goodwill

Compare and contrast. AstraZeneca is currently producing Covid vaccines for no profit and still manages to get beaten up by opportunists in Brussels. Over in the US, Moderna is hailed as a national saviour while shouting from the rooftops about how its commercial prospects have been transformed by its own Covid vaccine.

Moderna’s full-year statement on Thursday was extraordinary. The company expects to generate revenues of $18.4bn (£13.1bn) year from deals it has signed to supply its vaccine, which is priced at $30–$36 a shot, so is definitely intended to produce a chunky profit margin. That revenue forecast is enormous. For comparison, AstraZeneca’s entire established portfolio – for cancer, cardiovascular, respiratory treatments and more – generated sales of $26.6bn last year.

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Moderna forecasts $18bn in sales of Covid vaccine this year

Better than expected revenues will push US firm founded in 2010 into profit for first time

Moderna expects to rake in $18.4bn (£13bn) of sales from its coronavirus vaccine this year, marking a huge turnaround in the fortunes of the US biotech firm.

The expected revenue is far higher than the $11.2bn predicted by analysts, and exceeds the $15bn in sales that its US rival Pfizer expects for the Covid-19 vaccine that it developed with Germany’s BioNTech.

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Sussex medicines firm takes production line abroad in white van to beat Brexit ban

UK assembly line at standstill as pharmaceutical company sets up in Amsterdam and plans EU expansion

A Sussex pharmaceutical company has told how it had to bundle a production line into a white van and take it to Amsterdam to beat a Brexit medicines ban.

The impromptu four-wheeled mission to the Netherlands has secured the supply of the asthma drug Ventolin for France, where the company, Mediwin, had a huge order book.

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Drug companies look to AI to end ‘hit and miss’ research

Technology that speeded the development of Covid vaccines has potential to transform the pharmaceutical industry

The hunt for new medicines has often been more like a game of roulette than high-end science. But now the pharmaceutical sector is on the cusp of a transformation, as it delves into cutting-edge technology to come up with new treatments for diseases such as cancer, rheumatoid arthritis and Alzheimer’s.

Artificial intelligence (AI) is set to improve the industry’s success rates and speed up drug discovery, potentially saving it billions of dollars, a recent survey by the analytics firm GlobalData has found. AI topped a list of technologies seen as having the greatest impact on the sector this year. Almost 100 partnerships have been struck between AI specialists and large pharma companies for drug discovery since 2015.

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German politicians counter AstraZeneca vaccine scepticism with show of support

Oxford Covid vaccine described in German media as ‘shelf warmer’ with only 17% of doses administered so far

Politicians in Germany are stepping out in support of the AstraZeneca vaccine as public scepticism around the Oxford-developed product is threatening to hamper Europe’s Covid-19 immunisation programme.

The vaccine, subject of an acrimonious tug-of-war between its British-Swedish manufacturer and the European commission last month, is now being described by German media as a “shelf warmer” as only around 17% of doses delivered to the country have been administered so far.

Related: A quarter of people in France, Germany and the US may refuse Covid vaccine

Related: AstraZeneca to build new Covid-19 vaccine facility in Germany

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Shell strategy looking like a bundle of compromises | Nils Pratley

Investors will get a vote on oil company’s plan to cruise down the middle lane

Shell billed its net-zero by 2050 plan as an “acceleration” of strategy, which was a generous self-assessment. In today’s Big Oil terms, the approach is a cruise down the middle lane – a tweak here and there, but nothing to frighten those shareholders still scarred by last year’s cut of two-thirds in the dividend.

The company plans to reduce oil output by only 1%-2% a year until 2030, which compounds to an overall reduction of about 15% in the period. BP opted for 40% cut in oil and gas by 2030. Including gas, Shell’s production may be flat.

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AstraZeneca says vaccine against new Covid variants may take six months

Anglo-Swedish pharmaceutical firm’s profits rise to $7.4bn as main business ‘remains strong’

AstraZeneca has said it could take between six and nine months to produce Covid-19 vaccines that are effective against new variants of the coronavirus.

The company’s vaccine, developed jointly with scientists at the University of Oxford, remains effective against at least one variant of the virus, first discovered in Kent, England, but preliminary findings in a small-scale trial prompted South Africa to limit its use while it ascertains its efficacy.

Related: AstraZeneca to develop vaccines for new Covid strains in 6-9 months as sales hit $27bn – business live

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Lonza to Divest Specialty Ingredients Business to Bain Capital and Cinven for $4.7B

Shots:

  • Bain Capital and Cinven to acquire Lonza’s specialty ingredients business and operations for an enterprise value of $4.7B. The transaction is expected to close in H2’21
  • The divestiture will allow Lonza to refocus its business as a pure-play partner to the healthcare industry
  • Lonza’s specialty ingredients business provides microbial control solutions for Professional Hygiene and Personal Care products and offers the custom development and manufacturing of specialty chemicals and composites to support the electronics, aerospace, food and agrochemical industries

Click here ­to­ read full press release/ article | Ref: Lonza | Image: 24 News Update Blog

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A series of knocks: Oxford/AstraZeneca’s bumpy road to Covid vaccine confidence

From doubts about safety in older people to questions about variants, scientists have faced a battle to convince the public and regulators

The Oxford University/AstraZeneca vaccine against Covid has barely been out of the news from the moment the race to protect the world’s population from the novel coronavirus began. But not always in a good way.

Talented scientists at the Jenner Institute at Oxford University, led by Prof Sarah Gilbert, were incredibly quick off the mark in developing a potential vaccine, as soon as the virus in Wuhan had been sequenced and made globally available by Chinese scientists on 11 January. They were using an experimental but exciting approach they had tried in Mers (Middle East respiratory syndrome), caused by a similar coronavirus.

Pfizer/BioNTech

Related: Covid variants and vaccine resistance: all you need to know

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AstraZeneca set to weather Covid in better health than rivals

The Anglo-Swedish firm already had a strong lineup of cancer drugs when vaccine success gave it a further boost

Before the pandemic, AstraZeneca was highly regarded in the business and pharmaceutical world – seen as one of the UK’s best companies. Now, thanks to Britain’s successful vaccine programme, it is a household name.

The Anglo-Swedish firm, which publishes annual results on Thursday, has sprung to prominence as maker of one of the world’s first Covid-19 vaccines, approved for use in the UK, EU and India. Inevitably, headlines have followed. AstraZeneca has been the focal point of the vaccine supply wars between the UK and the EU and has, as part of that row, faced questions over the effectiveness of the jab in the over-65s.

Diabetes drug Farxiga has just been approved to treat heart failure in China and could become a mega-blockbuster

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Bezos is handing over fronting Amazon, but not his grip on his creation | Nils Pratley

The Amazon founder gains time for other projects, such as space and newspapers, while still making the big decisions

Jeff Bezos is stepping aside at Amazon – sort of. In fact, he is merely dropping one of his three job titles at thee online retailer. He will no longer be chief executive but will still be executive chairman. And, since he didn’t mention his status as “president” (whatever that involves), one assumes Bezos is keeping that bauble.

This “transition”, including the promotion of its web services boss Andy Jassy to be chief executive from the autumn, has been greeted as a very big deal. Let’s see. Its significance depends on how Bezos plays things. He gets formal leave to spend more time on other interests – everything from the Washington Post to rockets – but he was probably doing so informally anyway. Real change at Amazon may be hard to detect.

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GSK and CureVac sign £132m deal to develop multi-variant Covid vaccine

Companies hope to have next generation of vaccines against emerging variants by next year

GlaxoSmithKline and Germany’s CureVac have reached a €150m (£132m) agreement to develop a next generation of Covid-19 vaccines targeting new emerging variants in the pandemic.

The two companies said they they plan to work jointly to develop a vaccine that can address “multiple emerging variants in one vaccine”.

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EU Covid incompetence leaves governments wanting vaccines, not excuses | Larry Elliott

Centralised approach was meant to underline Europe’s solidarity but has had opposite effect

The EU has made an almighty hash of procuring treatments for Covid-19. Vaccine centres are running short of supplies as a result. National governments want jabs rather than excuses for what has gone wrong. The search for scapegoats is on.

Stripped of the legal wrangling between Brussels and AstraZeneca, the protectionist plan to ban exports of drugs and the now-abandoned plan to close the border between Northern Ireland and the Republic, the EU has been incompetent – and no amount of bully-boy tactics can get away from that fact.

Related: How EU’s floundering vaccine effort hit a fresh crisis with exports row

But what really mattered was not price but speed and breadth of supply

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EU could block millions of Covid vaccine doses from entering UK

European commission says new mechanism will give national regulators power to refuse exports

Millions of doses of vaccines could be blocked from entering Britain from the EU within days, as part of Brussels’ response to a shortage of doses among its member states.

The European commission said a new authorisation mechanism would be established to give national regulators the power to refuse vaccine exports. The development will raise concerns over the continued flow of the Pfizer/BioNTech vaccine, for which the UK has a 40m-dose order.

Related: Coronavirus live news: Germany blocks use of AstraZeneca vaccine in over-65s; Portugal says situation is ‘terrible’

Related: Germany recommends Oxford Covid vaccine not be used on over-65s

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GameStop’s dizzying share price rise means it’s game over for the short-sellers | Nils Pratley

The retailer has gone from $19 to $33o thanks in part to amateurs taking on the hedge funds

If you find trading bitcoin insufficiently hair-raising, try GameStop. It is the Texas-based video games retailer that will be hard to out-do as the stock market story of 2021. The share price was $19 at the start of this month but reached $330 in mid-afternoon on Wednesday in New York. There have been a few downwards lurches along the way, but the overall direction has been unsustainably upwards.

It must be unsustainable because nothing of note has happened to improve GameStop’s commercial prospects so radically. Exciting Playstation and X-Box releases may lie around the corner, but the company is still a bricks-and-mortar retailer struggling in an online age. Instead, punting on GameStop has become a video game in itself.

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The EU’s vaccine bust-up with AstraZeneca is of its own making | Leo Cendrowicz

Slowness to sign up to and approve the vaccine may have caused delays, but Brussels feels the company is being less than cooperative

Last year AstraZeneca was heralded for its pioneering vaccine discovery. Yet today the British-Swedish pharmaceutical company is embroiled in a dispute with the European Union over claims that it is holding back vaccine deliveries for the bloc, while diverting supplies to Britain and other countries. But can AstraZeneca be blamed for the EU’s stuttering vaccine rollout, which is far behind Britain, the US and other countries?

Anger is certainly surging across the EU about the slow pace of vaccinations. The latest figures from Our World in Data reveal that just 2.1% of the EU population has received a vaccine, compared with 10.8% for the UK. The goal to vaccinate at least 70% of the EU’s population by this summer is wildly off – at the current pace, the bloc as a whole would reach only 15% by the end of September.

Related: Why has the EU been so slow to roll out a Covid vaccination programme? | Guntram Wolff

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EU Covid vaccines row: AstraZeneca boss reveals problems

Pascal Soriot has provided the deepest insight yet into supply issues

The chief executive of AstraZeneca has dismissed suggestions that the UK is being unfairly prioritised for Covid-19 vaccine doses, in a wide-ranging interview revealing “glitches” that have constrained production.

Pascal Soriot offered the deepest insight yet into a scientific process that has been dragged into the political sphere, as leaders in Brussels and several EU capitals voiced anger that Europe will not get the vaccine as quickly as hoped.

Related: AstraZeneca denies pulling out of talks as EU Covid vaccine row deepens

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EU means business over Covid vaccine exports, says Von der Leyen

Commission president says firms must deliver on orders after AstraZeneca warns of shortfall

The EU “means business”, Ursula von der Leyen has said, as the bloc doubled down on plans for tighter monitoring of vaccine exports to countries outside of the union, such as the UK.

Speaking at the World Economic Forum, the president of the European commission said the EU had invested billions and “companies must now deliver” to the 27 member states.

Related: EU threatens to block Covid vaccine exports amid AstraZeneca shortfall

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EU’s Covid vaccination debacle is down to institutional inflexibility

Supply delays underline there was no legal or economic justification for central planning

A storm is raging over the EU’s failure to have ordered more of the approved Covid-19 vaccines ahead of time. Stéphane Bancel, the CEO of the US pharmaceutical company Moderna, which gained approval for its vaccine shortly after Pfizer/BioNTech, claims that the EU has relied too much on “vaccines from its own laboratories”.

Did the European commission prioritise supporting its own pharmaceutical industry over protecting human lives? In fact, matters are not as simple as that. Contrary to what Bancel wants us to believe, the EU has actually ordered too little of its own vaccine. After all, the vaccine that is being administered most widely across the west was developed by a German company, BioNTech, and thus comes from the EU (though it was tested and partly produced in partnership with Pfizer in the US and with Fosun Pharma in China).

Related: The $2,000 stimulus cheques alone won’t work – the US needs better infrastructure

EU member states were wrong to entrust the European commission with the purchase of vaccines last summer

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Sector by sector: are British firms ready for post-Brexit trade?

Analysis: From retail to aviation to pharmaceuticals, we look at what will change from 1 January

After months of tortuous negotiations between the UK and the EU, a Brexit trade deal was agreed at almost the last minute. But how prepared are UK businesses for the significant changes that will come into force on 1 January? Are they happy with the terms of the agreement?

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‘Happy vaccine day’ at Welsh factory proudly preparing Oxford doses

Staff at Wockhardt in Wrexham buzzing at news of approval after working over Christmas

Most of the sprawling industrial estate on the edge of Wrexham was quiet. There was little sign of activity at the engineering firms or in the self-storage units or greasy spoon cafes.

But behind the wire fence of the Wockhardt UK plant, the laboratories and production lines were buzzing as scores of staff worked on the final part of the manufacture of the Oxford/AstraZeneca vaccine.

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‘I’ve never seen anything like it’: 2020 smashes records in global markets

From worst crash in a generation to record highs on news of a Covid vaccine, experts review the rollercoaster that was 2020

2020 has been the most remarkable year for the global financial markets. After the Covid-19 pandemic triggered the worst crash in a generation, unprecedented stimulus measures and vaccine breakthroughs have sent stocks roaring back to record highs.

In a year in which at least 1.7 million people died from coronavirus and unemployment soared in a global recession, world stock markets are ending 2020 up 13% – despite the latest surge in cases forcing further lockdowns this winter.

GUARDIAN: Stock markets in biggest fall since 2008 #TomorrowsPapersToday pic.twitter.com/1FX7ivVZZT

Related: As Airbnb’s shares go through the roof, we need to challenge the Big Tech monopoly | Will Hutton

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UK scientists trial drug to prevent coronavirus infection leading to disease

Exclusive: antibody therapy could confer instant immunity against Covid-19 to at-risk groups

British scientists are trialling a new drug that could prevent someone who has been exposed to coronavirus from going on to develop the disease Covid-19, which experts say could save many lives.

The antibody therapy would confer instant immunity against the disease and could be given as an emergency treatment to hospital inpatients and care home residents to help contain outbreaks.

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Servier to Acquire Agios’ Oncology Business for ~$2B

Shots:

  • Agios to receive ~$1.8B upfront in cash & ~$200M as regulatory milestones for Vorasidenib along with 5% royalties on sales of Tibsovo in the US from transaction close through the loss of exclusivity and 15% royalties on sales of vorasidenib in the US from first commercial sale through the loss of exclusivity
  • The acquisition is expected to close in Q2’21. The acquisition allows Servier to strengthen its product portfolio and drug development pipeline in oncology
  • The transaction includes the transfer of Agios’ oncology portfolio and associated employees, including its Tibsovo and pipeline and clinical programs, including vorasidenib

Click here ­to­ read full press release/ article | Ref: PRNewswire  | Image: Enzo Life Sciences

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Government ‘operated illegal buy British policy’ over Covid contracts

Other firms better placed to supply antibody tests, argues case against health secretary Matt Hancock

The government was operating an illegal “buy British” policy when it signed contracts with a small UK firm to supply Covid antibody tests, claim lawyers who have filed a case against the health secretary.

The Good Law Project said there were a number of other companies in a better position to supply antibody tests in June and August, when the Department of Health and Social Care (DHSC) agreed deals worth up to £80m with Abingdon Health without going out to tender.

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British American Tobacco wins approval to test Covid vaccine on humans

Treatment grown on tobacco plants gets US backing for clinical study

British American Tobacco has moved a step closer to producing a vaccine for coronavirus using tobacco plants, as it won approval in the US to begin testing on humans.

The company behind cigarette brands including Lucky Strike, Rothmans and Benson & Hedges said the US Food & Drug Administration had given it clearance to begin a clinical study with adult volunteers.

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Scheme to get Covid vaccine to poorer countries at ‘high risk’ of failure

Risk assessment documents say cost, delays and shortages could lead to billions not vaccinated until 2024

The global scheme to deliver Covid-19 vaccines to poorer countries faces a “very high” risk of failure, potentially leaving billions of people with no access to vaccines until as late as 2024, internal documents say.

The Covax scheme has been beset by a number of issues, including a shortage of doses of approved vaccines, and a decision by India’s Serum Institute, which was initially earmarked to supply Covax, saying it would prioritise supplying India first.

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Ministers would be wise to play for time before ordering Sizewell C | Nils Pratley

Dashing ahead with a nuclear power station that’s modelled on Hinkley Point C would be reckless

This is the government’s problem as it reopens talks on a proposed nuclear power station at Sizewell C in Suffolk: it is contemplating ordering a replica of Hinkley Point C before the Somerset original has produced a single megawatt of electricity.

That is not a small point. Developer EDF’s pre-Hinkley version of its European pressurised reactor at Flamanville in Normandy is about a decade behind schedule. What’s more, EDF wants UK taxpayers or bill-payers to bear more of the construction risks at Sizewell, a less-than-compelling offer when you remember that Flamanville is also €9bn (£8.2bn) over budget.

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AstraZeneca shares slump after it agrees $39bn Alexion buyout

Britain’s biggest drugmaker offers 45% premium for shares of US rare diseases specialist

AstraZeneca shares fell sharply after it agreed to a $39bn (£29bn) takeover of the US rare diseases specialist Alexion, the biggest deal in its history if it goes ahead.

Investors sold off shares in the Anglo-Swedish drugmaker over fears it was paying too much for Alexion in the stock-and-shares deal. The offer price of $175 a share represents a 45% premium on Alexion’s closing price before the deal was announced. To finance the deal, AstraZeneca has secured a $17.5bn bridging loan.

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Deal or no deal: how life will look for key industries after Brexit

Companies are praying a trade agreement can be struck, but must prepare for talks to fail. Which will be most affected?

The scene is set for a showdown, and the future of the UK economy is at stake. Will Britain secure a free trade deal with the EU? Or will the prime minister choose to sail into uncharted waters, not only stepping outside the single market and customs union, as the UK will be even under a deal, but adding the tariffs and border checks that come with a no-deal Brexit?

Armed with a determination to end the transition period on 31 December, Boris Johnson is poised to force British businesses to sell their goods and services across the EU without any of the benefits that a deal offers, and with only a few days’ notice. Here we assess the impact on some of the worst-hit industries of securing a deal – albeit a slimmed-down one – compared with the alternative.

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Can the UK deliver on the Covid vaccine rollout? | Stephen Buranyi

The challenge of delivering vaccines on this scale are hard, but are firmly within the world of logistics, engineering, and politics

The UK has become the first country to approve one of the coronavirus vaccines that the entire world has been desperately waiting for. And on Tuesday it delivered the first dose, to 90-year-old Margaret Keenan in Coventry. We should be very pleased about this. But, as with every other stage of the pandemic, the final stretch brings a new set of unprecedented challenges. The world is watching as the UK becomes the first test case of our collective ability to manufacture, ship, and deliver an entirely new class of vaccines, on a scale and speed that no previous vaccination drive in history has ever approached.

The thing everyone knows about the Pfizer-BioNTech vaccine is that it needs to be extremely cold. The mRNA that makes up the vaccine payload is the same stuff your cells use to send short-lived genetic instructions. It’s a messenger that isn’t supposed to stick around, as temporally fragile as a Snap on Snapchat. The vaccine is happiest at -70C, and after thawing can be kept at between 4C and -8C – the temperature of a regular fridge – for just five days before it degrades. Most logistics providers aren’t set up to ship at -70C, and while university labs and large hospitals generally have some -70C freezers, GP surgeries and smaller centres do not. The temperature for shipping and storage has been identified as one of the biggest challenges in getting this vaccine out.

The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.

Stephen Buranyi is a writer specialising in science and the environment

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Covid vaccines offer chance for big pharma to improve its image

They make life-saving medicines, but no one likes them. Could this year be a turning point?

Never before has the world awaited a new medicine with such bated breath. A vaccine for Covid-19 has the potential to unlock society and save millions of people from death and serious disease, and the hero of the hour is an industry that is often regarded with disdain.

“Traditionally and historically, public trust in pharma has been comparable to the trust they put in their broadband provider,” said Alex Davies, a healthcare PR expert at Hanover Communications, which counts many drug companies as clients.

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Boston Scientific to Divest BTG’s Specialty Pharma Business for ~$800M

Shots:

  • Boston Scientific signs an agreement with Stark International and SERB SAS to sell its BTG specialty pharma business for $800M in cash. The transaction is expected to close in H1’21
  • The agreement includes the transfer of 5 facilities & ~280 employees globally. This transaction will help the BTG specialty pharma business enhance its potential as a fully integrated specialty pharmaceuticals platform
  • Boston Scientific acquired BTG for ~$3.7B in 2019. The divested products include life-saving antidotes used in hospitals & emergency care settings, including CroFab, DigiFab & Voraxaze

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Barron’s

The post Boston Scientific to Divest BTG’s Specialty Pharma Business for ~0M first appeared on PharmaShots.

How does the Pfizer/BioNTech vaccine work and who will get it?

Covid vaccine with an efficacy of almost 95% has been authorised by the UK medicines regulator

The Pfizer/BioNTech Covid vaccine, which has an efficacy of almost 95%, has been authorised by the UK medicines regulator, making the UK the first western country to license a vaccine against the disease. The UK has 40m doses of this vaccine on order.

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Different age groups may get different Covid vaccines, experts say

Oxford/AstraZeneca planning new trial of lower-dose jab to see how well it works in older people

Concerns around the efficacy of the Oxford University/AstraZeneca coronavirus jab in older people could lead to different age groups being given different vaccines, experts have said.

The partners announced last week that the vaccine had a 70% efficacy overall. For most trial participants – given two full doses, spaced a month apart – the efficacy was 62%, but for 3,000 participants mistakenly given half a dose for their first jab, the efficacy was 90%. No participants, regardless of dosing, developed severe Covid or were hospitalised with the disease.

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BioNTech’s Covid vaccine is a triumph of innovation and immigration | Hans-Werner Sinn

Pioneered by a Turkish-German couple, its significance exceeds its practical value

The world took note when the German startup BioNTech announced its breakthrough in the development of a new type of vaccine to combat Covid-19. After testing tens of thousands of people, BioNTech’s vaccine has been shown to be 95% effective in providing protection for those who would otherwise have been infected. The company was the first to apply for emergency use authorisation for a coronavirus vaccine in the US and it has announced it will soon take similar steps in Europe.

Antiviral vaccines are usually made with devitalised viral materials fabricated outside the body but BioNTech has pursued a new method of injecting genetically modified RNA into the patient. This prompts the patient’s cells to produce a characteristic protein of the relevant Sars-CoV-2 virus themselves, enabling the body’s immune system to build up an effective response before it encounters the real virus.

Related: Uğur Şahin and Özlem Türeci: German ‘dream team’ behind vaccine

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Here’s how to tackle the Covid-19 anti-vaxxers | Will Hanmer-Lloyd

Do not demonise. To optimise the vaccine rollout, all of us must show respect to those who are unsure about inoculations

  • Will Hanmer-Lloyd is a behavioural strategist

The Covid-19 vaccines, which are up to 95% effective, have the potential to save millions of lives in the UK and many more around the world.

Yet creating the vaccines is just the first step. We now need to produce them as quickly as possible, work out the logistics of distribution and administration and – most importantly – ensure as many people as possible take them. And as the history of vaccines shows, that is not as easy as some might assume. You only have to look at the fall in uptake of the measles, mumps and rubella (MMR) vaccine after it was falsely linked with autism.

Related: Vaccine results bring us a step closer to ending Covid, says Oxford scientist

Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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A vaccine revolution | podcast

Results from clinical trials have shown that the world has three apparently highly effective vaccines for Covid-19. With the race now on for regulatory approval, production and distribution, is the end of the pandemic within reach?

After a gruelling year of successive waves of Covid-19 infections and national lockdowns there has been a burst of good news this month, with three separate vaccine candidates performing extremely well in clinical trials.

First, Pfizer and Moderna announced that their vaccines were testing at an efficacy of around 95%. Then came the news that the AstraZeneca vaccine (the one pre-ordered in bulk by the UK government) was hitting 90%. It marks not just a new phase in the Covid-19 pandemic but potentially a revolution in vaccine technology itself.

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Why AstraZeneca’s reward for Covid vaccine is a share price slump | Nils Pratley

Despite the promising trial data, a viable – and profitable – vaccine is still some way off

The stock market is cruel. AstraZeneca’s reward for unveiling promising data for its “vaccine for the world”, developed in partnership with Oxford University, was a 3.8% fall in its share price. No gratitude there – just a decline of roughly £4bn in the company’s value.

Investors have to react somehow, but the strong response looks odd. AstraZeneca, remember, has pledged to distribute the vaccine at cost during the course of pandemic. For the purposes of that pledge, it’s a little vague who decides when the pandemic is over. But it has always been reasonably clear that AstraZeneca won’t make profits from the initial orders that have been received from governments and international bodies. So the day when the company can move to a for-profit model (with supplies to poorer nations remaining at cost) is still some way off.

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The Guardian view on coronavirus and vaccine scepticism: time to act | Editorial

Plans for mass immunisation against Covid-19 are developing fast, but concerns must be addressed

In the 1960s, academics studying rumours drew inspiration from epidemiology. They noted how such stories spread through communities, “infecting” some individuals while others seemed immune, and how more resistant populations could stop their spread.

Their insights have in turn been taken up by health professionals. Hearsay can be useful, helping to catch disease outbreaks. It can also be deadly. Though vaccine hesitancy is as old as vaccines themselves, it has risen sharply in many countries in recent years. Unfounded scare stories about the safety of immunisation programmes have contributed to growing scepticism and outright refusal, with fatal consequences. In her new book Stuck: How Vaccine Rumours Start – and Why They Don’t Go Away, Prof Heidi Larson notes the paradox: we have better vaccine science, more safety regulations and processes than ever before, yet a doubting public.

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UK faces calls to drop opposition to patent-free Covid vaccines

Request will be made at WTO meeting in order to allow mass production of treatments

The UK will be asked to reconsider its opposition to waiving intellectual property rights for Covid-19 vaccines and treatments at a World Trade Organization meeting on Friday, a move that would allow mass production of treatments and inoculations against the disease and could significantly shorten the length of the pandemic, campaigners say.

India and South Africa have proposed that WTO member states be allowed to waive patents and other intellectual property (IP) rights on any treatments and tools related to Covid-19 until the end of the pandemic, including for the Moderna and Pfizer/BionNTech vaccines that are expected to be approved for use in the coming weeks.

Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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Pfizer Covid-19 vaccine has 95% efficacy and is safe, further analysis shows

Among first 170 Covid cases in trial, eight had received vaccine and 162 were in placebo group

The Pfizer/BioNTech vaccine against Covid-19 performs even better than previously thought, with 95% efficacy, equalling the early results from Moderna on Monday, according to an analysis of the final data from their trials, which paves the way for regulators to grant an emergency licence and vaccination campaigns to begin.

The news will excite scientists, public health experts and politicians. Pfizer/BioNTech say they also have the necessary safety data that regulatory bodies require, and will submit the vaccine for emergency approval within days to the US Food and Drug Administration and other regulators around the world.

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Standing ovation: Spike Lee to direct musical about Viagra

The director’s next project after Da 5 Bloods is based on a 2018 Esquire article and will be co-written by Kwame Kwei-Armah

Spike Lee is to direct a musical about the impotence medication Viagra, it has been revealed.

According to Deadline, the film will be Lee’s next project after Da 5 Bloods and American Utopia, and is based on a 2018 Esquire article headlined All Rise, which chronicled the discovery and marketing of the drug (called sildenafil citrate). Lee is co-writing the script with British playwright Kwame Kwei-Armah, current artistic director of the Young Vic, and the music is by songwriters Stew Stewart and Heidi Rodewald (who previously collaborated on the stage musical Passing Strange, filmed by Lee in 2008).

First And Foremost, I Thank Ms. Jacquelyn Shelton Lee. I Thank My Late Mother For As She Would Say Taking “My Narrow, Rusty Behind” Dragging, Kickin’ And Screamin’ To The Movies When I Wuz A Nappy Headed Kid Growing Up In Da Streets Of Da People’s Republic Of Brooklyn. I Did Not Want To See Corny People Singin’ And Dancin’. I Instead Wanted To Play With My Friends On Da Block, Stoop Ball, Stick Ball, Punch Ball, Soft Ball, Basketball, 2 Hand Touch, Tackle Football, Coco Leevio, Johnny On Da Pony, Hot Peas And Butter, Crack Top, Down Da Sewer And Of Course-Booty’s Up. All The Great New York City Street Games That Might Be Sadly Lost Forever. My Father, Bill Lee, Jazz/Folk Bassist, Composer HATED HollyWeird Movies, Henceforth And What Not, Me Being The Eldest Of 5 Children I Became Mommy’s Movie Date. She Was A Cinefile. Thank You Lawdy She Didn’t Listen To My Ongoing Complaints About Musicals. So Finally Going Into My 4th Decade As A Filmmaker I Will Be Directing A DANCIN’, ALL SINGIN’ MUSICAL Spike Lee Joint And I Can’t Wait. My Moms Has Been Waiting TOO!!! And Dats Da Rodgers And Hammerstein Truth, Ruth.

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Warren Buffett makes big investment in US pharmaceutical firms

Berkshire Hathaway bought $5.7bn worth of shares in four companies in third quarter

The investment company run by billionaire investor Warren Buffett bet $5.7bn (£4.3bn) on pharmaceutical companies during the third quarter of 2020, as the sector takes centre stage in the fight against the coronavirus pandemic.

Berkshire Hathaway bought shares in drug companies AbbVie, Bristol-Myers Squibb, Merck and Pfizer between July and September, according to filings with the US regulator.

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Easier distribution may make Moderna’s vaccine much more valuable | Nils Pratley

While Pfizer/BioNTech’s version requires -75C storage, Moderna’s could be easier to roll out

A second coronavirus vaccine candidate was always likely to struggle to match the excitement of the first, at least in stock market terms. Sure enough, Moderna’s promising trial results merely added to the generally bullish mood in markets without generating the same sense of wild relief, and 5% rise in the FTSE 100 index, that Pfizer and BioNTech achieved a week ago.

But, actually, the key difference with Moderna’s version looks significant. It’s the fact the company says its vaccine can be transported and stored for up to six months at -20C and will then remain stable for 30 days at fridge temperatures. By contrast, Pfizer and BioNTech spoke about -75C in storage and then only five days of stability in conventional fridges.

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It’s the ‘vaccine hesitant’, not anti-vaxxers, who are troubling public health experts | Gaby Hinsliff

To make vaccination work, we must reach out to the naturally cautious – a bigger proportion than you might assume

Lydia Guthrie is not very daring by nature. A psychotherapist and mother of two from Oxford, she couldn’t be persuaded into bungee jumping for all the money in the world, and even shudders at skiing. “I’m very risk averse and a bit of a coward. I can’t even watch horror films.” Yet nonetheless, earlier this year she volunteered to be injected with an experimental Covid-19 vaccine as part of a clinical trial in the city, a partnership between the university, the NHS and drug company AstraZeneca.

Like all the guinea pigs, she doesn’t yet know if she got the real thing or the meningitis vaccine used as a dummy. She had a headache afterwards and felt exhausted for a couple of days, but has never regretted taking part. She trusts the university’s ethics panel, having encountered it through her own degree research, and was also swayed by gratitude towards the city’s John Radcliffe hospital, where she had her own children. “If it hadn’t been for the NHS we might all have died. I feel I owe them.”

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Speedy work on Covid gives the vaccine industry a shot in the arm

Pfizer was first with the news, but biotech firms, governments, banks and NGOs are all involved in the search for a jab to prevent coronavirus infectionThe leading candidate to become the world’s first Covid-19 vaccine, developed by the US pharmaceutical company Pfizer and Germany’s BioNTech, had its genesis in late January 2020. Uğur Şahin, chief executive of the Mainz-based biotech, read about coronavirus in the Lancet and worried that the outbreak could grow into a pandemic.

Şahin summoned colleagues to tell them that the company would shift its focus from cancer treatments to finding a vaccine for the deadly virus. It would use a method based on mRNA, whereby a stetch of genetic material from the coronavirus is injected into the body, resulting in human cells producing its so-called spike protein. This in turn triggers an immune response. Pfizer stepped in to help with development and distribution costs.

‘Here in the US, a recent poll showed that more than half of people said they wouldn’t take a Covid-19 vaccine’

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BioNTech chief rejects Trump claim it delayed Covid vaccine news

Exclusive: Ugur Şahin says he and Pfizer CEO received results night before announcement

The scientist behind the BioNTech/Pfizer coronavirus vaccine has defended his company from Donald Trump’s accusation that it deliberately delayed news of its rapid progress until after the election, saying “we don’t play politics”.

BioNTech, a German company, and the US pharmaceutical giant Pfizer announced on Monday that their jointly developed vaccine candidate had exceeded expectations in the crucial phase 3 vaccine trials, proving 90% effective in protecting people from coronavirus infections.

The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

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Pfizer chief sold $5.6m of shares on day Covid vaccine was announced

Pfizer said sale of shares by Albert Bourla was automated under plan set up in August

Pfizer’s chief executive sold shares in the company worth $5.6m (£4.2m) on the day the drugmaker announced that its Covid-19 vaccine was more than 90% effective in protecting people from transmission of the virus, triggering a surge in the company’s stock.

Albert Bourla sold 132,508 shares at $41.94 a share, equivalent to 62% of his shareholding in Pfizer, according to filings with the US Securities and Exchange Commission (SEC). This is close to the $41.99 peak the share price hit on Monday.

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Mini-nuclear plants may be an experiment worth exploring

Roll-Royce gave an eye-catching pitch but the economics of nuclear power needs further inspection

An energy white paper is in the offing, so consider Rolls-Royce’s pitch for the wonders of small modular reactors (SMRs) a piece of last-minute lobbying. After all, it is clear already that more nuclear, in combination with more offshore wind capacity, is likely to be judged a central way to meet the UK’s targets for cutting carbon emissions.

It’s an eye-catching pitch. “A domestic energy solution for the first time in a generation, with a product that is engineered, designed and manufactured in the UK,” as Tom Samson, the chief executive of the nine-member Rolls-led UK SMR consortium puts it. So not one of those mammoth £20bn-plus French-led and Chinese-backed Hinkley Point C constructions.

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UK security bill signals open door era for foreign takeovers is over

China’s ambition to build a nuclear plant in Essex will likely fail on national security grounds

The new national security and investment bill, aiming to give the government sweeping powers to block foreign takeovers and investments, will inevitably be viewed through the lens of China and new nuclear power plants in UK.

That is, indeed, one way to look at it. Even before the Huawei 5G saga and Beijing’s introduction of draconian security laws in Hong Kong, the mood had cooled on Chinese ownership of critical UK infrastructure.

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FTSE 100 recovers to highest level since June after vaccine unveiled

Promising clinical data from Pfizer and BioNTech help the index to a £28bn one-day gain

Optimism that a mass rollout of Covid-19 vaccines will lead to an economic recovery lifted stocks in London again on Tuesday, to their highest closing level in over four months.

London’s FTSE 100 index of blue-chip shares rallied by nearly 1.8% to finish at 6,296 points, the highest close since 23 June. This added £28bn to the index’s value, taking its gains so far this week to nearly £100bn after it surged 4.6% on Monday on news of a vaccine breakthrough.

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Pfizer and BioNTech could make $13bn from coronavirus vaccine

Johnson & Johnson and AstraZeneca pledged to make their vaccines available on a not-for-profit basis

The US drugmaker Pfizer and the German biotech firm BioNTech stand to bring in nearly $13bn (£9.8bn) in global sales from their coronavirus vaccine next year, which will be evenly split between the two companies, according to analysts at the US investment bank Morgan Stanley.

Pfizer’s half would be more than the US pharmaceutical group’s bestselling product, a pneumonia vaccine that generated $5.8bn last year.

Related: Pfizer and BioNTech’s vaccine poses global logistics challenge

Related: 6 key questions about the Pfizer/BioNTech Covid-19 vaccine

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Pfizer and BioNTech’s vaccine poses global logistics challenge

Europe and US create vast facilities for Covid-19 vaccine but poorer nations lack infrastructure say experts

Two vast football-pitch-sized facilities equipped with hundreds of large freezers in Kalamazoo, Michigan, and Puurs, Belgium, will be the centres of the huge effort to ship the coronavirus vaccine developed by US drug giant Pfizer and German biotech firm BioNTech, around the world.

Governments are scrambling to prepare for the rollout of the vaccine, which must be stored at -70C (-94F), after the announcement from the two companies that it was more than 90% effective and had no serious side-effects. The news sparked hopes of a return to normal life and a stock market rally, but now minds are turning to the practicalities of getting the vaccine quickly to populations across the world, in particular to the vulnerable people who need it most.

Related: 6 key questions about the Pfizer/BioNTech Covid-19 vaccine

The problem is particularly acute in the global south where many rural villages don’t even have a working vaccine fridge

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Global markets: winners and losers as Covid vaccine hopes send shares surging

But the news highlighted divergences in fortunes across sectors during the pandemic

The FTSE 100 posted its biggest one-day gain since March on Monday after the drug companies Pfizer and BioNTech said their prospective coronavirus vaccine was 90% effective.

The news jolted global stock market indices to record levels but it also highlighted the stark divergences in fortunes across sectors during the pandemic. Those companies who gained from people spending their work and leisure time at home were among the biggest losers on Monday, while the vaccine news offered some welcome relief to previously hard-hit sectors such as travel and events.

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Pfizer/BioNTech vaccine announcement is cause for cautious celebration

Interim trial results are encouraging as scientists welcome news

It is not yet the end of the pandemic, but the announcement by Pfizer/BioNTech that their vaccine has been 90% successful in the vital large-scale trials has got even the soberest of scientists excited.

These are interim results and the trial will continue into December to collect more data. The two companies – a tiny German biotech with the big idea and the giant pharma company Pfizer with the means to develop it – have not yet published their detailed data, so it is all on trust. And yet, nobody is suggesting the results have been over-egged. It looks as though the vaccine not only works, but works better than anyone hoped.

Related: Covid-19 vaccine candidate is 90% effective, says Pfizer

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BioNTech’s Covid vaccine: a shot in the arm for Germany’s Turkish community

Couple who set up and run firm are children of long-maligned ‘guest workers’ from Turkey

When the German biotechnology company BioNTech picked a street called An der Goldgrube or At the Goldmine in the western city of Mainz for its headquarters, the couple behind it could not have predicted how prophetic the address would turn out to be.

The company’s shares shot up 23.4% on Monday morning after the Covid-19 vaccine it is developing with the US pharma giant Pfizer became the first candidate worldwide to show positive results in phase 3 trials, the crucial final stage of testing.

Related: Covid-19 vaccine candidate is 90% effective, says Pfizer

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What has Pfizer’s Covid vaccine trial found and is this a breakthrough?

Early results from phase 3 trial look promising but there are still many questions to be answered

Pfizer and the German biotech company Biontech said on Monday that they had had encouraging early results from a phase 3 clinical trial of their coronavirus vaccine. The trial is assessing how well the vaccine works in preventing humans from becoming infected. Although details are scant, the news is positive.

Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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Global stock markets surge after Pfizer Covid vaccine news

FTSE 100 jumps as Pfizer and BioNTech report coronavirus vaccine is 90% effective

Global stocks have surged after the drug companies Pfizer and BioNTech announced that their coronavirus vaccine was 90% effective in tests, giving hope that economies around the world can soon return to normal.

The FTSE 100 soared on Monday by 5.5% to 6,242 points, up 332 points, its highest since mid-August. Most of the increase happened immediately after the vaccine announcement was first reported just before midday in London.

Related: Global stocks hit record high on Biden victory and Covid-19 vaccine news – business live

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Future market for Covid vaccines ‘could be worth more than $10bn a year’

Analysts estimate revenue generated, assuming an annual jab at an average price of $20

The future market for Covid-19 vaccines could be worth more than $10bn (£7.6bn) in annual revenues for pharmaceutical companies, according to industry experts, even though some drugmakers have pledged to provide their vaccines on a not-for-profit basis during this pandemic.

The calculations by analysts at Morgan Stanley and Credit Suisse assume people will need to be vaccinated every year, similar to the traditional flu jab, with an average price of $20 for a Covid-19 vaccine dose. Prices range from $3 a dose to $37.

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Ipsen’s UK MD on adapting business to COVID-19

Since entering the pharmaceutical industry as a graduate trainee in the late 1990s, Asad Mohsin Ali’s career has taken him across the business from Novartis, MSD and Tesaro, before joining global biopharma Ipsen. He tells us how the company has responded to COVID and how he’d like to see the UK industry grow in the future.

As managing director, Ipsen UK & Ireland, Ali heads up one of Ipsen’s three global hubs, as well as chairing a UK & Ireland Site Steering Committee overseeing 900 people.

“My primary goal on joining Ipsen UK&I was to incorporate and elevate the talents of our Specialty Care organisation, but also the 900 colleagues in the UK and Ireland, to ensure we bring maximum value to patients and healthcare systems,” Ali tells pharmaphorum.

Ipsen UK&I’s culture is based on the principle, “One Ipsen” he says.

“Being “One Ipsen” means acting together on what matters most to our patients, customers and our employees.”

As COVID-19 disrupted the world, the pharmaceutical industry was urged to respond quickly – primarily by ensuring continuity of medicines for patients.

“The level of response required by industry, the impact to business and the duration of the crisis have surpassed the extent of a lot of business contingency plans,” Ali says. “Government responses and restrictions put in place to contain COVID-19 have changed over time. So, businesses like Ipsen UK&I have had to stay agile, adapt and re-group to deal with the changes, whilst ensuring a strong crisis management team is in place, and the right subject matter experts advising on our approach.”

“Changes in treatment patterns and patient journeys – companies need to understand how some of the changes will be long-term; not just about how patients can be safely re-introduced to the healthcare system, remote consultation and treatment will be more widely used.”

Ipsen UK&I recognised early on there would be no “one size fits all” way of working, says Ali. “For our manufacturing site in Wrexham, which is classified as critical workers, not much has changed except for the need to have less people on site with more PPE. But for our field-based team, the transition to fully home-based working with limited external interactions it has been a complete change that required a lot more adaptation.”

The company also focused on providing wellbeing resources to employees such as virtual yoga, an online wellbeing hub, a network of Mental Health and Wellbeing Ambassadors and an Employee Assistance Programme.

“We implemented a COVID-19 volunteering policy, which enabled our employees to go back into the NHS or carry out volunteer work for local community groups for one day per week fully paid,” Ali says.

Going remote

With COVID-19 anticipated to change how pharmaceutical companies engage with healthcare professionals, Ipsen UK&I is preparing for a more remote and virtual healthcare system. Prior to the pandemic, 95% of all the company’s UK customer facing teams’ interactions took place in person at NHS hospitals.

“Overnight this became unfeasible so we invested a significant amount of time on how we could optimise remote interactions.  This took many forms, from instant messaging to full video-based interactions with interactive e-materials. We have learned that the way our customers interact with their patients has shifted significantly and maybe permanently, so this in turn will drive how they want to interact with us.”

Indeed, more virtual patient engagement across the board means that services and products allowing remote engagement will thrive.

“Changes in treatment patterns and patient journeys – companies need to understand how some of the changes will be long-term; not just about how patients can be safely re-introduced to the healthcare system, remote consultation and treatment will be more widely used.”

The pharmaceutical industry can also expect to face challenges with innovation and funding, Ali says.

“While the pressure on healthcare systems is at an all-time high, industry innovation is keeping apace, with industry pipelines indicating over 7,000 medicines are currently in development. Products launched by companies will enter a very different launch environment in the mid-term. This will impact on all aspects of launch preparation.

“For HCPs, innovations or technologies that reduce the number of patients that come into hospital for treatment are key; and for patients, innovations (remote consultation, self-care devices or therapies) that empower them to manage their treatment independently are just as important.”

UK industry potential

The UK represents 3% of the global pharmaceutical business, but Ali believes its importance is underplayed.

“With some of the best talent, academic institutions, scientific infrastructure and of course the one-of-a-kind NHS, the UK could play an even greater leadership role than it does currently. Given the UK is home to a large proportion of biotech start-ups across Europe, it has great potential to lead the way in innovation and medicine development with the right investment and recognition.

“What I’d like to see is a clear recognition of what value the pharma industry brings to the UK economy and an understanding of the very high standards we operate with. Without this our public reputation will continue to be mediocre as it has been for the last few decades.”

For Ipsen UK&I it will be focusing efforts on several underserved disease areas across Oncology, Neuroscience and Rare Disease.

“My ambition is to unlock this potential and lead the way in adding value in these areas to our customers and their patients,”Ali says.

About the interviewee

Asad Mohsin Ali Asad Mohsin Ali joined Ipsen in September 2018 as managing director, UK & Ireland, bringing more than 20 years of experience in the pharmaceutical industry. Since entering the industry as a graduate trainee in the late 1990s Asad has worked in big pharma (with Novartis and MSD) and biotech (with Tesaro), and now mid-sized biopharma with Ipsen UK&I. Over 22 years he has held a range of positions – in sales, marketing, portfolio management, strategy, value and access, and latterly in general management

The post Ipsen’s UK MD on adapting business to COVID-19 appeared first on .

Oxford Covid vaccine works in all ages, trials suggest

Vaccine being trialled by Oxford University and AstraZeneca offers hope for all age groups

One of the world’s leading Covid-19 experimental vaccines produces an immune response in both older and young adults, raising hopes of a path out of the gloom and economic destruction wrought by the novel coronavirus.

The vaccine, developed by the University of Oxford, also triggers lower adverse responses among elderly people, said the British drug maker AstraZeneca, which is helping to manufacture the vaccine, on Monday.

Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

Related: At 75, I’ve volunteered for a Covid vaccine trial. It could set people free

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Boots to offer 12-minute Covid testing service within weeks

Pharmacy chain says £120 cost will be one of cheapest private tests available

Boots is to offer a coronavirus testing service it says can return results from swab tests in only 12 minutes.

The pharmacy chain said the LumiraDx devices, which are able to quickly process swab tests to give customers same-day results, will be rolled out in selected stores over the next few weeks.

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Boots bosses ‘encouraged’ staff to work at head office despite UK government advice

Emails show senior managers ‘expecting’ attendance at Nottingham HQ despite big spike in local cases

Boots told staff they were “encouraged” to come in to its headquarters in Nottingham, where Covid-19 infection rates are the highest in England, even after the government advised people to work from home where possible.

Employees said messages from senior managers – seen by the Guardian – indicated they were expected to be at their desks for at least part of the week. Boots verified the messages, including one from its UK boss, Seb James, but denied that staff were put under any implicit pressure to be in its Nottingham office.

Tier one – medium

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Boots chain reports 30% sales drop at retail sites in UK

Profit margin fall, blamed on Covid-19 effects, drags global firm to $3m quarterly loss

Sales at Boots slumped nearly 30% in the three months to the end of August as shoppers stayed away from town centres and picked up health goods at supermarkets instead.

Over the three-month period, the UK retailer has lost share in every market in which it operates, except for beauty. Shoppers shunned its stores and opted to pick up pain relief, shampoo and soaps at the same time as their groceries, driven by fears of catching Covid-19.

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Johnson & Johnson pauses Covid vaccine trial over participant’s ‘unexplained illness’

Company is unclear about whether patient was receiving vaccine or placebo in 60,000-patient study

Johnson & Johnson has paused its Covid-19 vaccine trial due to an “unexplained illness” in a participant, the company confirmed.

The pharmaceutical giant was unclear if the patient was administered a placebo or the experimental vaccine, and it’s not remarkable for studies as large as the one Johnson & Johnson are conducting – involving 60,000 patients – to be temporarily paused.

Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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Demand surges for Regeneron drug that Trump claims ‘cures’ Covid-19

Doctors say patients are seeking to participate in drug’s trials as Regeneron’s stock soar after president touts treatment

Doctors are reporting a spike in enquiries by patients for an experimental Covid-19 drug cocktail after Donald Trump called the Regeneron Pharmaceuticals drug “a blessing from God” that is a “cure” for the virus.

Two doctors involved in the trial of the drug told Reuters that more patients are asking to participate in the drug’s trials, though medical experts have pointed out the drug, REGN-COV2, is still too early in its trial period to confirm that it can help treat Covid-19.

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Provider of Trump Covid drug is president’s golf friend

Link to drug company boss raises questions about ‘cure’ claims and exclusive access

New questions have emerged over the circumstances in which Donald Trump was given an experimental antibody drug cocktail produced by a golfing acquaintance to treat his coronavirus infection.

As Trump wrongly hailed his treatment – which included a drug called REGN-COV2 produced by Regeneron – as a “cure”, it emerged that the company’s chief executive, Leonard Schleiffer, is a member of the Trump National golf club in Briarcliff Manor, New York, and had met the president in May to talk about drugs his company was developing.

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NHS coronavirus tests threatened by Roche supply chain glitch

Pharmaceutical firm reports ‘significant drop in processing capacity’ of reagents, kits and swabs

Concerns have been raised over the supply of vital testing materials for a range of conditions, including Covid-19, following a supply chain problem with the pharmaceutical company Roche.

On Tuesday, Roche said it had experienced a “very significant drop” in its processing capacity due to a problem with its Sussex distribution centre, the only one in the UK. It has been reported that the shortage includes vital reagents, screening kits and swabs.

Related: UK government ‘thwarting independent labs’ efforts to step up Covid-19 testing’

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GSK tells UK staff: turn off Covid test-and-trace app while at work

Drugs company says infection controls at some of its sites are so secure the app is not needed

The pharmaceuticals firm GlaxoSmithKline has told staff to switch off the contact tracing function that allows the NHS test-and-trace app to monitor the spread of Covid-19 while at work in case it is “disruptive” to business, the Guardian has learned.

GSK, which is among the companies working on a vaccine for Covid-19, sent the instruction to employees at its research and development labs and some of its manufacturing sites.

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UK doing more than most to help poor get Covid vaccine, study finds

Campaign scoring countries for global access efforts calls for more British transparency

The UK is doing more than most countries to support access to Covid vaccines for the poorest populations in the world, but it is not transparent enough about the deals it is doing at home, according to an international aid organisation launching a tracker.

The One campaign has given countries and pharmaceutical companies scores for the efforts they have made to ensure the poorest get vaccines. In the vaccine access test no country or company scores green, the top rating, classed as aiding global access to vaccines.

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Pharmacies in England pause online flu jab bookings as demand soars

Boots, LloydsPharmacy and Well Pharmacy report unprecedented take-up and many chemists run out of stock

Pharmacies across England are struggling to keep up with the demand for the flu vaccine, pausing online bookings and limiting it to those most in need.

The country’s three largest pharmacy chains – Boots, LloydsPharmacy and Well Pharmacy – have all reported unprecedented demand after a government vaccination campaign to reduce the pressure on the NHS during a second wave of Covid-19.

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From the archives: How Boots went rogue – podcast

We are raiding the Audio Long Reads archives and bringing you some classic pieces from years past, with new introductions from the authors.

This week’s article: Britain’s biggest pharmacy used to be a family business, dedicated to serving society. Now, many of the company’s own staff believe that its relentless drive for profit is putting the public at risk. By Aditya Chakrabortty

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Medical cannabis companies cleared for London stock market

Regulator agrees to float of UK firms but recreational suppliers still banned

Medicinal cannabis companies have been cleared by the UK’s financial regulator to float on the London Stock Exchange but firms that sell marijuana to recreational users will still be banned.

The Financial Conduct Authority said businesses that grow and sell recreational cannabis, even in countries such as Canada where it is legal, cannot list in London because of the Proceeds of Crime Act. Income from the sale of cannabis and cannabis oil outside the UK could constitute “criminal property” under the act, because it covers conduct abroad that would constitute a crime if it happened in the UK.

Related: Cannabis capitalism: who is making money in the marijuana industry?

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Oxford Covid-19 vaccine is still possible this year, says AstraZeneca chief

Pharmaceutical firm’s boss says 2020 deadline possible if regulators move fast

AstraZeneca’s coronavirus vaccine could still be available by the end of the year, or early next year, according to the company’s chief executive, Pascal Soriot, despite clinical trials being paused after a volunteer fell ill.

AstraZeneca and Oxford University, which are jointly developing the vaccine and testing it on 50,000 to 60,000 people around the world, halted trials on Wednesday to investigate the “potentially unexpected illness” of one participant.

Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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Oxford Covid vaccine trial suspension: what happens next?

Tests have been paused after a UK volunteer became ill. How will it affect the search for a cure?

One of the volunteers in the UK has become ill and it is crucial that the researchers find out whether this could be related to the vaccine. This is not uncommon in vaccine trials – and in fact it is said to be the second time it has happened with this vaccine . Very large trials are essential to pick up any rare side-effects. Something that affects one in 10,000 people, for instance, will probably not be detected in the early trials of just a few thousand.

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GSK and Sanofi to start human trials of potential Covid-19 vaccine

World’s largest vaccine makers to begin testing on people in US with eye on rollout in early 2021

GlaxoSmithKline and Sanofi are to start testing their protein-based Covid-19 vaccine on humans for the first time, following promising results in earlier studies.

GSK, the world’s largest vaccine maker, and the French drugmaker Sanofi joined forces in April to work on an effective treatment to halt the devastating pandemic.

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AstraZeneca expands Covid-19 vaccine deal as final trials begin

UK drugmaker and Oxford Biomedica to produce more of potential coronavirus product

AstraZeneca has expanded an agreement with Oxford Biomedica to scale up production of its potential Covid-19 vaccine, as the race continues to find an effective prevention for the deadly virus.

Under the supply agreement, the Oxford-based cell and gene therapy firm said it would produce tens of millions of doses of AstraZeneca’s potential vaccine, AZD1222, for 18 months, which could be extended by a further 18 months into 2023.

Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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AstraZeneca starts Covid-19 antibody drug trial in UK

Volunteers are receiving doses of drug, which has potential both as a vaccine and a treatment

The pharmaceutical group AstraZeneca has started a clinical trial of a drug to help prevent and treat Covid-19, with the first volunteers already receiving doses.

The company, which is separately developing a potential Covid-19 vaccine together with scientists at Oxford University, said the drug, known as AZD7442, is a combination of two monoclonal antibodies.

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Oxford University Covid-19 vaccine firm denies Trump talks

AstraZeneca says it has not discussed ‘emergency use authorisation’ with the US

The company manufacturing the Oxford University coronavirus vaccine has denied it is in talks with the Trump administration about fast-tracking its vaccine for emergency use ahead of November’s presidential elections.

With both Russia and China pressing ahead with inoculations involving experimental vaccines yet to pass final efficacy and safety trials, the Trump administration has become increasingly frustrated with the Food and Drug Administration (FDA), which the president has tried to suggest is slowing approval of a vaccine for “political reasons”.

Related: Covid vaccine tracker: when will we have a coronavirus vaccine?

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Purdue Pharma escaped serious charges over opioid in 2006, memo shows

A justice department document shows prosecutors recommended the OxyContin face wire fraud and money-laundering charges

A Department of Justice internal memorandum obtained by the Guardian shows that government prosecutors found evidence that executives at the drugs giant Purdue Pharma may have committed multiple crimes, including wire fraud and money laundering, to boost sales of its billion-dollar OxyContin opioid.

The document comes to light as a new claim by US states for $2.2tn for harm from the drugmaker’s alleged role in America’s opioid epidemic was disclosed on Monday as part of Purdue’s bankruptcy proceedings.

Related: Activists see Purdue bankruptcy case as last chance to call Sacklers to account

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UK agrees deals for 90m doses of two potential coronavirus vaccines

Government secures early access to those being developed by Novavax and Janssen

The UK government has reached agreements it says will give British citizens early access to 90m doses of two more potential Covid-19 vaccines.

The vaccines are being developed by the US biotech company Novavax and the pharmaceutical business Janssen, which is owned by Johnson & Johnson and has its headquarters in Belgium.

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The Guardian view on Brexit bureaucracy: tied up in red tape | Editorial

Businesses already struggling with the fallout from Covid-19 will be forced to deal with a mountain of new bureaucracy in the middle of a deep recession

The government did not quite achieve the Brexit breakthrough it was seeking on Friday, when there was hope that a fast-tracked trade agreement with Japan might be reached. But it seems likely that a deal, essentially replicating one signed by the EU and Japan last year, will be done by the end of the month. Some kind of morale booster for Britain’s battered and bruised businesses would certainly be welcome.

As the clock runs down to the end of the transition period on 31 December, ministers are no longer bothering to offer the false hope of a relatively frictionless trade agreement with the EU. Even a Canada-style free trade deal will mean a vast infrastructure of compliance and checks: permits for lorry drivers to enter Kent, huge customs clearance centres and tracking apps are all in the mix. The government estimates that, from 2021, there will be over 400m extra customs checks a year on goods going to and from the EU.

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Trump has no problem letting billionaires profit off the pandemic | Robert Reich

The president thinks that as long as they buoy the stock market, they’re helping the US economy – and that’s pure rubbish

Since the start of the pandemic, American billionaires have been cleaning up. As more than 50 million Americans filed for unemployment insurance, billionaires became $637bn richer. Facebook’s Mark Zuckerberg’s wealth has ballooned 59%. Amazon’s Jeff Bezos’s, 39%. Walmart’s Walton family has added $25bn.

Big drug company CEOs and their major investors are doing nicely, too. Since the start of the pandemic, Big Pharma has raised prices on over 250 prescription drugs, 61 of which are being used to treat Covid-19.

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Up to 750,000 UK Covid test kits recalled due to safety concerns

Products made by diagnostics firm Randox removed from care homes and individuals

the Up to 750,000 unused coronavirus testing kits manufactured by diagnostics company Randox have been recalled from care homes and individuals due to concerns about safety standards.

At the beginning of the coronavirus crisis, the Department of Health and Social Care (DHSC) is understood to have operated a haphazard policy for obtaining testing kits and it faced criticism for the purchase of millions of kits that turned out to be significantly less effective than originally claimed by pharmaceutical companies.

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Covid-19: Gilead Sciences urged to study drug that showed promise with cats

Activists are calling on the pharmaceutical firm Gilead Sciences to study a drug for the treatment of Covid-19 that showed promise in curing cats of a coronavirus.

The drug, called GS-441524, is chemically related to remdesivir, an antiviral also made by Gilead, and one of the only treatments to successfully shorten the duration of Covid-19 recovery.

Related: US secures world stock of key Covid-19 drug remdesivir

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Return to work: a sector-by-sector look at the plans of England’s major employers

Companies can return to work from 1 August, but many employers are making their own plans

Major companies in England have been told that, from 1 August, they can discuss with workers whether it is safe to return to work. Up until now, the government had asked all employees to work from home where possible.

In addition, the advice in England to avoid public transport is being scrapped. However, some of the largest office occupiers in the country do not appear to be in a rush to return to their workplaces, with many waiting for the end of the school summer holidays at the start of September. And some will be waiting until 2021 at the earliest before they consider asking homebound employees to return to their offices. Here we take a sector-by-sector look at some major employers and their working plans.

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Coronavirus: UK signs deal for 60m doses of potential vaccine

GlaxoSmithKline and Sanofi Pasteur could supply vaccine by early next year if it is successful

The government has signed a deal with the pharmaceutical firms GlaxoSmithKline (GSK) and Sanofi Pasteur for 60m doses of a potential Covid-19 vaccine.

If the vaccine proves successful, the UK could begin to vaccinate priority groups, such as frontline health and social care workers and those at increased risk from coronavirus, as early as the first half of next year, the Department for Business, Energy and Industrial Strategy said.

Related: Coronavirus vaccine tracker: how close are we to a vaccine?

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UK must ensure medicines replenished for Covid-19 second wave

The trade committee urged ministers to develop “parallel supply chains” as a solution

Britain needs to ensure its stockpile of medicines is replenished to deal with a second wave of coronavirus and any shocks to a supply chain dominated by China and India, the trade committee warned in a report released today.

The cross party committee said the pandemic had revealed that 70% of the active ingredients used in pharmaceuticals in the UK are made in China – while India manufactured “virtually all” the paracetamol in British shops.

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AstraZeneca signs deal worth up to £4.7bn for cancer treatment

Pharmaceuticals company buys global rights to new technology from Japan’s Daiichi Sankyo

Drugmaker AstraZeneca could pay up to $6bn (£4.7bn) for the global rights to a new Japanese cancer treatment.

The Anglo-Swedish pharmaceutical company said it would pay $1bn (£800m) up front to its partner Daiichi Sankyo.

Related: Covid-19 is Big Pharma’s chance to impress. But who’ll do best?

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Covid-19 is Big Pharma’s chance to impress. But who’ll do best?

AstraZeneca and GSK both release results this week. But picking winners in the sector may be complicated

It was the press announcement heard around the world: a potential Covid-19 vaccine from the University of Oxford and pharmaceutical company AstraZeneca had not only been “tolerated” by patients, but “generated robust immune responses against the Sars-CoV-2 virus in all evaluated participants”. The project will now proceed to all-important phase 3 trials in Brazil and South Africa to test if it actually stops infection.

For a global population that has seen its movement curtailed and its health threatened, it was a welcome dose of good news. It is also a large feather in the cap for AstraZeneca, whose boss, Pascal Soriot, will unveil financial results for the first half of 2020 on Thursday.

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‘Major’ breakthrough in Covid-19 drug makes UK professors millionaires

Synairgen’s share price rises 540% on morning of news of successful drugs trial

Three professors at the University of Southampton school of medicine have this week made a “major breakthrough” in the treatment of coronavirus patients and become paper millionaires at the same time.

Almost two decades ago professors Ratko Djukanovic, Stephen Holgate and Donna Davis discovered that people with asthma and chronic lung disease lacked a protein called interferon beta, which helps fight off the common cold. They worked out that patients’ defences against viral infection could be boosted if the missing protein were replaced.

Epidemics of infectious diseases behave in different ways but the 1918 influenza pandemic that killed more than 50 million people is regarded as a key example of a pandemic that occurred in multiple waves, with the latter more severe than the first. It has been replicated – albeit more mildly – in subsequent flu pandemics.

Very proud of my husband’s efforts!!
He is the CSO of this company. He and has team have worked their socks off over the last 5 months to make this happen.

And the results are stunning! #COVID19 #Synairgen #SNG #clinicaltrials https://t.co/NThZDV1k0O

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GlaxoSmithKline makes bold move with £130m Covid-19 investment | Nils Pratley

GSK’s share price has been left standing by AstraZeneca’s high-risk success in cancer treatments

Monday’s most important vaccine news was the promising early data from the Oxford University and AstraZeneca coronavirus trial – “robust immune responses” is encouraging. But let’s not overlook other vaccine developments. The industry has been viewed for years as a dull subsector of the pharmaceutical business; now it is a whir of deal-making activity.

GlaxoSmithKline, already one of the world’s biggest vaccine makers, leaped into action by paying £130m for a 10% stake in German group CureVac, the company that briefly registered on President Trump’s radar (he suggested the US should buy the firm for its Covid-19 possibilities).

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GSK buys £130m stake in German coronavirus vaccine maker

Stake of 10% in CureVac is part of deal that could eventually be worth more than £800m

The British pharmaceutical company GlaxoSmithKline has bought a 10% stake in a German biotech company that is a key player in the global race for a coronavirus vaccine as part of a deal that could eventually be worth more than £800m.

GSK on Monday said it would pay £130m for the stake in CureVac. GSK will also make a separate payment of £104m that will fund research into CureVac’s development of messenger ribonucleic acid (mRNA) vaccines.

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UK government orders halt to Randox Covid-19 tests over safety issues

Care homes and members of public told to immediately stop using firm’s kits

The UK government has instructed care homes and members of the public to immediately stop using coronavirus testing kits produced by a healthcare firm after safety problems were discovered.

Randox was awarded a £133m contract in March to produce the testing kits for England, Wales and Northern Ireland without any other firms being given the opportunity to bid for the work.

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The pelvic mesh scandal makes it clear: doctors must declare any funding | Margaret McCartney

We need a public register to show if healthcare professionals are in the pay of industry – or more patients will suffer

It was never “just women’s problems”. After decades of having their suffering dismissed, many patients will have been relieved about the publication of the Independent Medicines and Medical Devices Safety Review yesterday. Led by Julia Cumberlege, the review has spent two years investigating three medical interventions: pelvic mesh, used in prolapse surgery, which resulted in chronic, life-changing pain for many women; Primodos, a hormonal pregnancy test, used up until 1978; and sodium valproate, an epilepsy treatment. The latter two have both been linked with birth defects.

Related: Denial of women’s concerns contributed to decades of medical scandals, says inquiry

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Activists see Purdue bankruptcy case as last chance to call Sacklers to account

The family behind the firm that made OxyContin denies wrongdoing – but numerous cases against them have been halted while a court deliberates

With most Americans transfixed for months by the election, Donald Trump’s impeachment, the coronavirus and economic catastrophes and anti-racism protests, the nation’s opioids crisis risks becoming “the forgotten epidemic”.

But millions of people continue to struggle with painkiller addiction or recovery efforts amid the Covid-19 pandemic, while billions of dollars and – as important to many – a sense of justice are at stake in huge legal battles still raging between opioid victims and “big pharma”.

Related: What does Purdue Pharma’s bankruptcy filing actually mean?

Related: House of pain: who are the Sacklers under fire in lawsuits over opioids?

Related: ‘I don’t know how they live with themselves’ – artist Nan Goldin​ takes on the billionaire family behind OxyContin

Related: Sackler family members face mass litigation and criminal investigations over opioids crisis

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Jonathan Sackler, joint owner of opioid maker Purdue Pharma, dies aged 65

  • Former pharmaceutical executive died of cancer on 30 June
  • Sackler was named as defendant in key opioid lawsuits

Jonathan Sackler, one of the owners of Purdue Pharma, the maker of the controversial opioid prescription painkiller OxyContin has died, the company confirmed on Monday.

Sackler died on 30 June, according to a court filing. He was 65 and the cause of death was cancer.

Related: House of pain: who are the Sacklers under fire in lawsuits over opioids?

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Watchdogs warn pharmacies not to hike price of face masks

Regulators also criticise sale of paracetamol and hand sanitiser at excessive costs

Two UK watchdogs have warned pharmacies they should not be overcharging customers for in-demand items including face masks, hand sanitiser and paracetamol.

With face masks compulsory on public transport and increasing numbers of people returning to work, these products remain in high demand but in a joint letter to businesses, the Competition and Markets Authority (CMA) and the General Pharmaceutical Council (GPhC) said this was not an opportunity to hike prices.

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Australian drugmakers hit by critical shortages at height of pandemic, inquiry hears

Evidence given to parliamentary committee sparks new calls to develop national capability to manufacture medicines and key supplies

Australian companies were “shocked” to experience price-gouging and had trouble accessing critical supplies to make medicines and personal protective equipment at the height of the pandemic, a parliamentary committee has been told.

It has prompted fresh calls for Australia to build up its ability to manufacture critical drugs “without reliance on opaque and fragile offshore supply chains”.

Related: Paracetamol and Ventolin limited to one per customer as Australia combats coronavirus hoarding

Related: Australia needs a national centre for disease control, peak doctors’ group says

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How will the world’s poorest people get a coronavirus vaccine? | Achal Prabhala and Kate Elder

Rich countries’ governments are putting all their trust in a marriage of markets and philanthropy called Gavi

Vaccines for Covid-19 are coming. Billions of dollars are flowing in, over 100 efforts are under way, and at least 13 leading candidates are already being tested on humans. But how will these vaccines reach the poorest people on the planet? This question haunts the fate of more than half the world’s population. It is the central question of our time. The failure to address this question in the past has resulted in millions of unnecessary deaths – and yet, some believe there is a simple answer. Ask pharmaceutical corporations about how they will ensure access to Covid-19 vaccines, and they say “Gavi”. Ask the wealthiest governments in the world what they are doing to ensure global equity, and they too say “Gavi”.

Gavi, the Vaccines Alliance, is a 20-year old public-private partnership that believes the marriage of markets and philanthropy will bring vaccines to everyone in the world. The numbers are impressive: every year, Gavi sends out 500 million vaccine doses against 17 different diseases. The sums of money pumped into Gavi are equally impressive. At the Global Vaccine Summit held earlier this month, Gavi raised a record-breaking $8.8bn. With £330m committed annually for the next five years, the British government is their single largest donor, alongside other wealthy countries and the Gates Foundation. At the summit, Gavi launched its newest initiative, a fund for future Covid-19 vaccines – the Covax Facility – which invites countries to invest in a wide portfolio of potential vaccines, pool their risk, and gain dedicated access to eventual products.

Related: UK plans £38m centre to start production of coronavirus vaccine

Related: Covid-19 vaccine may not work for at-risk older people, say scientists

Achal Prabhala is the coordinator of the AccessIBSA project, which campaigns for access to medicines in India, Brazil and South Africa. Kate Elder is the senior vaccines policy adviser at the Médecins Sans Frontières Access Campaign

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UK firms critical to public health protected from foreign takeovers

Legislation protects those needed in future pandemics who may be struggling now

The UK government has introduced legislation to protect businesses that are key to public health from foreign takeovers.

The changes give the government the power to protect companies that could be critical in helping the country in future health emergencies but which may be struggling to weather the coronavirus pandemic.

Related: Markets hit by coronavirus second-wave fears, as gold touches one-month high – business live

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Watchdog investigates possible overcharging for hand sanitiser in UK

Four unnamed stores suspected by competition regulator of profiteering during Covid-19 crisis

The competition watchdog is to investigate suspected profiteering by four pharmacies and convenience stores for over-charging shoppers for hand sanitiser during the coronavirus pandemic.

Stocks of hand sanitiser were among the first items the British public cleared off the shelves as the coronavirus pandemic took hold in the UK. The Competition and Markets Authority, which announced the investigations, has previously identified hand sanitiser as the product suffering the biggest price hike.

The coronavirus lockdown has prompted some of the UK’s most prominent companies to announce large-scale job losses. The aviation, automotive and retail sectors have been among the worst hit, as businesses adjust to dramatically reduced revenue projections.

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What on earth is the boss of AstraZeneca up to with his approach to Gilead? | Nils Pratley

Pascal Soriot heroically defended the company against Pfizer, but now he needs to calm his investors

It’s hard to keep AstraZeneca out of the headlines. A booming share price made the company the biggest in the FTSE 100 index last month, albeit Shell is now marginally in front again. More significantly, the group is in the vanguard of Covid-fighting efforts by helping Oxford University develop a vaccine and then, we hope, produce a successful product in massive volumes.

Now, though, comes something different: a Bloomberg report of an approach last month to Gilead of the US to create a new pharma giant. Nobody expects a deal to happen, it should be said. The proposal, if that’s what it was, seems to have been tentative and no talks are in progress now.

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