Merck agrees $1 billion deal with Debiopharm for head and neck cancer drug

BERLIN (Reuters) – Germany’s Merck KGgA said on Monday it has agreed to pay Swiss biotech Debiopharm up to 900 million euros ($1.08 billion) to develop and commercialise Xevinapant for head and neck cancer.

Under the terms of the licensing deal, Merck will pay Debiopharm 188 million euros upfront and has agreed to further regulatory and commercial milestones worth up to 710 million euros, as well as royalties.

“This late-stage asset complements our Healthcare pipeline, which will be one of Merck’s key growth drivers in the coming years,” Chief Executive Stefan Oschmann said in a statement.

Xevinapant is currently in late-stage testing for previously untreated locally advanced squamous cell carcinoma of the head and neck, in combination with current standard of care.

Results of a mid-stage study found Xevinapant together with chemoradiotherapy cut the risk of death by 51% compared to the current standard of care, Merck said.

In February 2020, the U.S. Food and Drug Administration granted Xevinapant breakthrough therapy designation.

($1 = 0.8300 euros)

British Airways owner IAG calls for digital health passes

British Airways owner IAG has called for digital health passes “to reopen our skies safely” as it posted a record loss for 2020 due to Covid disruption.

British Airways plane interior

IAG posted an operating loss of €7.4bn (£6.5bn) for last year after the pandemic grounded many of its flights.

UK-focused airlines got a boost this week from government plans for travel markets to possibly reopen from mid-May, prompting a flood of bookings.

But uncertainty remains about what routes will be available.

The airline group – which also owns Iberia, Aer Lingus and Vueling – called for “a clear roadmap for unwinding current restrictions when the time is right.”

“We’re calling for international common testing standards and the introduction of digital health passes to reopen our skies safely,” said IAG’s boss Luis Gallego.

IAG said that the ongoing uncertainty and duration of the pandemic meant that it could not provide a forecast for future profits.

Laura Hoy, equity analyst at Hargreaves Lansdown, said: “There’s no getting around just how ugly IAG’s final results are.

“With the coronavirus crisis clearing the skies for over a year, it’s not unexpected to see IAG operating as just a shell of its former self.

“Management has responded in the only possible way – by securing new funding and slashing costs – but ultimately the group is at the mercy of the government’s travel restrictions.”

The government is in the process of talking to to G7 and other countries to try to build a consensus on how to allow more foreign travel.

Greek tourism minister Haris Theoharis told the BBC last week that early technical discussions were underway with UK officials about how a potential passport scheme might work.

Planes parked

The International Air Transport Association (IATA) also said this week that it expects its digital Covid Travel Pass will be ready soon.

The pass is an app that verifies a passenger has had the Covid-19 tests or vaccines required to enter a country. It also verifies they were administered by an approved authority.

Transport Secretary Grant Shapps said a review of how to return to international travel while managing risk from imported cases and virus variants would report on 12 April.

Capacity cut

IAG said that revenues last year sank by 69% from €25.5bn to €7.8bn amid the coronavirus-related restrictions on travel.

During 2020 it operated at a capacity of just 33.5% of the levels seen in 2019, and for January to March this year it expects capacity will drop to just 20% of pre-pandemic levels.

The airline group has been trying to boost its finances as it burns through cash in the pandemic.

Most recently, BA secured an extra £2.45bn through a UK government-backed loan and from deferring pension contributions.

Last October, IAG got shareholder backing for a €2.74bn rights issue, adding to savings made from 12,000 planned job cuts.

Despite the hefty losses, IAG has stuck to its plan to buy Spain’s Air Europa, announcing in January the price tag had halved to €500m, with payment deferred for six years.

Coronavirus: EU urged to adopt joint ‘vaccine certificates’

Greece and Austria are urging other EU states to adopt a common Covid vaccination certificate, which could help revive Europe’s stricken tourist industry this summer.

In a virtual meeting EU leaders are also discussing how to speed up vaccinations. The EU’s slow vaccine rollout has been widely criticised.

Greece and Israel already have digital vaccination certificates. 

But France and Germany are wary, as the data on infectiousness is incomplete

There are also concerns that enabling a vaccinated minority to enjoy foreign travel while others continue to face restrictions would be seen by many as discriminatory.

A further complication is the rapid spread of more contagious Covid variants – the English, South African and Brazilian forms. So it is more likely that people will need booster jabs to remain protected.

Greek Deputy Prime Minister Akis Skertsos told the BBC that a common digital certificate “is not discriminatory at all”. He argued that non-vaccinated tourists could also visit Greece this summer, but the procedure for them would be slower – they would have to be tested and might have to self-isolate on arrival.

Greece and Cyprus have agreed to admit Covid-negative Israeli tourists this summer – those who can prove their status with the Israeli “green” digital certificate. 

Chart showing vaccine doses per 100 people in countries with the highest total vaccinations

Greek Tourism Minister Harry Theocharis said a similar deal could be reached with the UK. However, the UK government has not yet approved any vaccination certificate, nor has it given the go-ahead for foreign holidays.

Greek tourism slumped disastrously last year because of the pandemic. Its revenues fell to €4bn (£3.5bn; $5bn), from €18bn in 2019, Reuters news agency reports. Tourism makes up about a fifth of the Greek economy, employing one in five workers. 

Austrian Chancellor Sebastian Kurz tweeted that “we’re advocating a digital Green Pass, like Israel’s”.

“That should allow you to prove, on your mobile phone, that you’ve been tested, inoculated or have recovered [from Covid]. Our goal: to avoid a lengthy lockdown and finally enable freedom to travel again in the EU, and freedom to enjoy events and cuisine.”

As some EU countries now struggle with a third wave of the virus there are tensions over unilateral border restrictions. Germany is the latest to have received a complaint from the European Commission, since it imposed new police checks on the Czech and Austrian borders.

The Commission – the EU executive – has been under fire over its vaccine procurement strategy. It got into a row with AstraZeneca, because the Anglo-Swedish drug firm fell far short of the first-quarter delivery target.

The Commission still aims to get at least 70% of adults vaccinated in the bloc by mid-September. But so far, the total vaccinated is below 5%.

The EU is desperately seeking ways to increase vaccine supplies and improve its ability to track new variants, BBC Europe correspondent Kevin Connolly reports. But it is pursuing policies that might pay off in months or years, when voters want answers in days or weeks, he says.

Johnson and Johnson vaccine: FDA finds the single-shot jab safe

A review by US regulators of the single-shot Johnson & Johnson coronavirus vaccine has found it is safe and effective.

It paves the way for it to become the third Covid-19 vaccine to be authorised in the US, possibly within days.

The vaccine would be a cost-effective alternative to the Pfizer and Moderna vaccines, and can be stored in a refrigerator instead of a freezer.

Results from trials were released by Johnson & Johnson last month.

The Belgian company Janssen, which is owned by the pharmaceutical giant, said its data showed the product was highly effective against severe disease.

It comes as Ghana became the first country to receive coronavirus vaccines through the Covax vaccine-sharing initiative.

The briefing document published by the US Food and Drug Administration (FDA) gives more detail on the data submitted by Janssen to the regulator. The FDA concludes that the Johnson & Johnson vaccine has “known benefits” in reducing both symptomatic and severe illness.

Results from vaccine trials conducted in the US, South Africa and Brazil found its efficacy against the worst outcomes of the virus was “similarly high” but overall protection was lower in South Africa and Brazil, where virus variants have become dominant.

Data showed it was more than 85% effective at preventing serious illness, but only 66% effective overall, when moderate cases were included, when considering cases at least 28 days after vaccination.

Notably, there were no deaths among participants who had received the vaccine and no hospital admissions after 28 days post-vaccine.

An external committee of experts will meet on Friday to recommend whether the FDA should authorise the vaccine, possibly adding to a coming surge in vaccine availability in the US.

A White House official said the administration anticipated distributing at least three million doses of the Johnson & Johnson vaccine next week, should it receive emergency authorisation from the FDA.

The company says it plans to deliver 20 million doses in total by late March, in line with an agreement to supply the US with 100m doses by the end of June.

Which countries have ordered the Johnson & Johnson jab?

  • UK – 30m doses
  • EU – 200m doses
  • Canada – 38m doses
  • Covax nations – 500m doses

Not only will the vaccine require fewer doses than its two-shot Pfizer and Moderna counterparts, it will also require fewer vaccine appointments and medical staff as a result.

Over 65 million Americans have already been vaccinated and about 1.3 million doses are being administered across the country each day. 

New cases, hospitalisations and deaths from Covid-19 in the US have all been on the decline over the past few weeks.

Top public health experts, however, continue to warn that mutations of the virus can still threaten progress.

Coronavirus: Republic of Ireland extends restrictions to 5 April

The Republic of Ireland is to continue at its highest level of Covid-19 lockdown restrictions until at least 5 April.

The widely expected decision to maintain Level Five was taken at a cabinet meeting on Tuesday.

But primary schools will re-open on Monday for the four young youngest ages groups, the equivalent of primaries one to four.

Final year secondary students will also return then.

Other pupils and students will resume their schooling in a phased manner over the coming weeks along with pre-school childcare.

On Tuesday, 45 further coronavirus-related deaths were reported, four of them in January, taking the country’s total to 4,181.

There have been 216,300 positive cases identified after an additional 575 were identified.

The Irish government has decided to take a cautious approach to easing its lockdown, arguing that its aim is the long-term suppression of the virus.

Its vaccination programme is several weeks behind Northern Ireland’s and has been hampered by supply issues and the relatively late authorisation of the AstraZeneca vaccine by the European Medicines Agency.

But the Republic of Ireland is near the top of the EU league in vaccinating people, once the injections arrive in the state.

While around a third of the population north of the border has had its first injection, just over 4% in the Republic have got their jab, although slightly more people south of the border have had their second dose.

Dublin vaccine centre
image captionThe Republic’s vaccination programme is several weeks behind efforts in Northern Ireland

Taoiseach (Irish Prime Minister) Micheál Martin said it was “critically important” that people do not let down their guard, but he acknowledged the country was “physically and mentally exhausted” by restrictions.

“Essentially, to open up our country safely, we need to keep the numbers of new infections low and accelerate the vaccination programme in line with improving supply,” he explained.

Addressing the nation on Tuesday, he said by the end of April more than 40% of people over 18 will have had a first vaccine dose and up to 82% by the end of June.

Mr Martin said non-Covid health and social care services would resume “over the coming weeks” and there would be a review ahead of 5 April.

By this date, the government will decide either to continue with the lockdown or ease restrictions for industries such as construction.

Last week, Mr Martin suggested in a newspaper the current restrictions could last until the beginning of May.

With more than 90% of current Covid cases linked to the highly-transmissible UK variant the government has decided on caution.

Last weekend, the first three cases of the Brazilian variant were recorded.

Eleven cases of the South African variant were reported at the start of January, but none since then.

By Shane Harrison
BBC News

Covid in Scotland: Drones to carry Covid samples

Drones are being used to carry Covid-19 samples and test kits in some parts of Argyll and Bute – in what has been described as a UK first.

Drone
image captionA three-month project has started following a trial last year

Following a trial last year, the project has been expanded, with medical cargo now being carried up to 40 miles (64km).

Flights from Mull, Clachan-Seil and Lochgilphead to Lorn and the Islands Hospital in Oban have been authorised.

NHS staff will be able to request drone deliveries.

The drones can carry a payload of up to 3kg (2lbs) and cover distances faster than they can be by road. Some of the road journeys also involve a ferry crossing.

Drone operator Skyports has been given permission by the Civil Aviation Authority for the flights.

View from a drone
image captionThe NHS in Argyll and Bute said the drones would be used in some of the region’s hardest to reach areas

Skyports said deliveries – which are being done for the Argyll and Bute Health & Social Care Partnership – were the first of their kind in the UK.

The service will initially operate between Lorn and Islands Hospital in Oban, Mid-Argyll Community Hospital in Lochgilphead, Easdale Medical Practice in Clachan Seil and the Mull and Iona Community Hospital in Craignure.

Both a scheduled service and an on-demand service will be run, with orders able to be placed by NHS staff through an online system developed by digital consultants Deloitte.

The Swoop Aero drones will be controlled from an operations centre in Oban and fly automatically along predefined routes. 

Skyports said communication between the drone and the ground control station will be provided by Vodafone’s 4G network and satellite communications to ensure connectivity coverage is provided at all times.

The project has been funded by a joint initiative between the UK Space Agency and the European Space Agency.

Drone
image captionNHS staff have been offered scheduled and on-demand services

Stephen Whiston, head of strategic planning for Argyll and Bute Health and Social Care Partnership, said the aim of the project was to improve services for patients and clinicians in “some of our most remote and island communities”. 

He added: “This three-month project working with Skyports will provide critical evidence on the real benefits this technology can bring to the NHS not only in Argyll and Bute but across Scotland.”

Skyports chief executive Duncan Walker said: “Using drone deliveries within supply chains can create significant time and cost savings. 

“This initiative is a natural progression from our recent trials with the NHS in Scotland as we scale our operations, supporting a wider network of hospitals and medical practices as they continue to respond to the Covid-19 pandemic.”

Mr Walker said it was hoped the initiative would bring permanent drone medical flights a step closer.

Covid: US on verge of exceeding 500,000 deaths

The US is on track to top 500,000 deaths from Covid-19 – the most for any country in the world – on Monday.

It comes just over a year after the first infection of the novel coronavirus, first detected in China, was recorded on the US west coast.

The grim milestone will be marked by a candle-lighting ceremony and moment of silence at the White House. President Joe Biden will also deliver remarks.

More than 28.1 million Americans have been infected – another global record.

The number of Americans who have had the coronavirus is nearly double that of second-highest India (11 million) and Brazil (10.1 million). Brazil has recorded the second-largest death toll at 244,000 while Mexico is in third with 178,000.

“People decades from now are going to be talking about this as a terribly historic milestone in the history of this country, to have these many people to have died from a respiratory-borne infection,” the nation’s top immunologist, Dr Anthony Fauci, told CNN on Sunday.

At least 90,000 more Americans are expected to be killed by 1 June, according to a recent projection from the University of Washington’s Institute for Health Metrics and Evaluation (IHME).

The IHME estimates that by late May, the virus will kill around 500 Americans per day – down from approximately 2,000 daily deaths now.

Hospital admission rates have fallen for 40 straight days, as approximately 1.6 million vaccinations are administered to Americans daily.

How is the US death toll being marked?

At the White House, President Biden will be accompanied by his wife Jill, as well as Vice-president Kamala Harris and her husband Doug Emhoff.

They will gather at the building’s South Portico for a candle-lighting ceremony, which will take place just after sunset. Mr Biden will also deliver remarks and a moment of silence will be held for the victims of the pandemic.

Mr Biden’s approach to the pandemic is different to his predecessor Donald Trump, who cast doubt on the impact of the deadly virus and was viewed as having politicised the wearing of masks and other measures to prevent the spread of the virus.

On 19 January, one day before Mr Biden took office, he held an event to mark 400,000 Americans dying of the disease.

“To heal, we must remember, and it’s hard sometimes to remember, but that’s how we heal,” he said from the Lincoln Memorial in Washington DC.

“Between sundown and dusk, let us shine the lights in the darkness along the sacred pool of reflection, and remember all whom we lost,” he said less than one month ago.

Source: BBC

Sanofi’s mRNA COVID-19 vaccine candidate not ready this year, CEO says

(Reuters) – A COVID-19 vaccine candidate developed by Sanofi and U.S. group Translate Bio “will not be ready this year,” the French drugmaker’s chief executive told Le Journal du Dimanche newspaper.

Clinical trials of this vaccine, which will be based on a technology known as mRNA — on which lean approved vaccines of Pfizer/BioNTech and Moderna –, are expected to start this quarter.

In December last year, Sanofi had said it was targeting “earliest potential approval” of the shot in the second half of 2021, following positive preclinical data.

“This vaccine will not be ready this year, but it could be of use at a later stage all the more if the fight against variants was to continue,” Paul Hudson was quoted as saying.

The CEO gave no other details. Officials at Sanofi were not available for comment.

The news could mark another blow for Sanofi, already embattled with a delay for another COVID-19 vaccine candidate it hopes to bring to patients and for which the company has teamed up with Britain’s GlaxoSmithKline.

The two groups stunned investors last year by warning their traditional, protein-based COVID-19 jab showed an insufficient immune response in older people, delaying its launch towards the end of 2021.

To appease critics, Sanofi said last month it had agreed to fill and pack millions of doses of the Pfizer/BioNTech vaccine from July.

Some 108 million people have been reported to be infected by the novel coronavirus globally and more than 2.4 million have died since first cases were identified in China in December 2019, according to a Reuters tally.

Countries worldwide have since the beginning of the year embarked on mass vaccination programmes, with mixed results, and are now confronted with the emergence of several variant strains which forces them to move even more quickly.

Facebook building smartwatch with health features

Facebook Inc is building a smartwatch that will let users send messages and also offer health and fitness features, The Information reported bit.ly/378YViU on Friday, citing people with direct knowledge of the device.

The social media giant plans to start selling the device next year, according to the report, a move that would mark its entry into a market currently dominated by Apple Inc and Huawei.

Facebook’s smartwatch will work via a cellular connection, letting users send messages through its services and also connect to the services or hardware of health and fitness companies, such as Peloton Interactive, according to the report.

Menlo Park, California-based Facebook has been foraying into the hardware sector in recent years, coming up with products including virtual reality headset Oculus and video chatting device Portal.

Facebook did not immediately respond to Reuters’ request for comment.

Source: Reuters Business Tech

South Africa turns to Johnson & Johnson Covid jab

The South African government has outlined its amended coronavirus immunisation plans. 

They were put on hold when a trial suggested that the AstraZeneca jabs which were due to be distributed were less effective against a local variant of the virus. 

Health Minister Zweli Mkhize said a Johnson and Johnson vaccine would be used to immunise health workers, even though it has yet to be approved in South Africa. 

He said it would be deployed as part of an implementation study. 

The minister said doses of the Pfizer vaccine had also been secured.

He added that the authorities were considering selling doses of AstraZeneca vaccine the country had bought.

“Why not sell the AstraZeneca … well it’s an option. We will consider it, … first our scientists must tell us what to do with it,” he told a news conference.