US government gives Moderna $483m for COVID-19 vaccine

The US government has agreed to provide a whopping $483 million in federal funding to propel Modera’s coronavirus vaccine to FDA approval and ramp up production capacity.

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The award is something of a gamble, coming before data from an ongoing phase 1 trial of Moderna’s mRNA-1273 is available. Nevertheless it will allow the biotech to hire 150 new staff members, accelerate clinical development of the vaccine and start a phase 2 trial within weeks.

The Biomedical Advanced Research and Development Authority (BARDA) is effectively picking up the tab for both mRNA-1273’s development and pandemic-scale manufacturing – in other words tens of millions of doses – assuming it works as hoped in trials.

The National Institutes of Health is conducting the first trial of mRNA-1273, which is one of three coronavirus vaccines in clinical testing so far out of around 70 in development, according to the World Health Organization (WHO).

This week the NIH completed enrolment of 45 patients according to the study’s original protocol, which tested three doses of the vaccine (25 µg, 100 µg and 250 µg). They will be followed through 12 months, and the primary goal is to test the safety and reactogenicity of a two-dose schedule of the shot, along with preliminary data on immune responses.

It has now been decided to expand the trial with an additional six patient cohorts, looking at the same three dose levels in older subjects (aged 56 to 70) and elderly patients (aged 71 or above).

If that study is positive, Moderna will start its own phase 2 trial in the second quarter, and that could be followed by a phase 3 study in the autumn – which is breakneck speed for a vaccine development programme.

The 15 new hires will mainly be allocated to the manufacturing scale-up, and will allow it to expand production from two shifts a day for five days in the week, to three shifts a day all week long.

“We believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic”, said Moderna’s chief executive Stéphane Bancel.

Moderna is focused on development of vaccines based around mRNA, which present antigens to the body that instruct it to make antibodies against specific targets. So far the company has not brought any mRNA-based vaccines through development.

In the case of mRNA-1273, the vaccine instructs the body to make antibodies against a stabilised form of the Spike (S) protein found on the SARS-CoV-2 virus. Moderna made the vaccine based on the genetic sequence shared by Chinese authorities in early January.

At the moment a Chinese vaccine developed by CanSino Bio and the Beijing Institute of Biotechnology is the furthest along in trials – having already started phase 2 – but with BARDA’s support Moderna could gain ground quickly.

Inovio meanwhile has a DNA-based candidate called INO-4800 in a phase 1 trial involving 40 healthy volunteers which started earlier this month.

With global cases of coronavirus now well above two million and deaths heading towards 150,000 worldwide, reducing the time to having a vaccine is critical, to save lives and scale back the lockdowns that are hitting global economies hard.

“BARDA’s goal is to have a vaccine available as quickly as possible,” said the agency’s director Rick Bright.

“Preparing now for advanced stage clinical trials and production scale-up while phase 1 is underway could shave months off development of COVID-19 vaccines,” he added.

1,000 foreign firms mull production in India, 300 actively pursue plan as ‘Exit China’ mantra grows

These companies see India as an alternate manufacturing hub and have taken up their proposals across various levels of the government, including central government departments, Indian missions abroad and state industry departments

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KEY HIGHLIGHTS

  • 1,000 foreign firms are planning to shift manufacturing to India; in talks with authorities
  • 300 actively pursuing production plans in mobiles, electronics, medical devices, textiles
  • Proposals are at various levels — central government departments, Indian missions abroad, state industry departments
  • Government is making all-out attempt to hard-sell India as a manufacturing hub
  • Cost difference between India and South East Asia is 10-12 per cent

Amid chances of China possibly losing its tag of preferred manufacturing hub following coronavirus, around 1,000 foreign companies are engaged in discussions at various levels with the Indian authorities. At least 300 of these companies are actively pursuing production plans in sectors such as mobiles, electronics, medical devices, textiles and synthetic fabric, according to top government sources.

These companies see India as an alternate manufacturing hub and have taken up their proposals across various levels of the government, including central government departments, Indian missions abroad and state industry departments. “About 1,000-odd companies are currently engaged in discussion at various levels such as investment promotion cell, central government departments and state governments. Out of these companies, we are targeting 300-odd companies,” the official said.

“We are hopeful that once coronavirus is in control, a lot of things will fructify into actual relocation. And India will emerge as an alternate manufacturing destination. Many countries like Japan, US and South Korea are over-dependent on China and that is now very apparent,” he added.

In a major push to domestic manufacturing, the Centre had in September last year slashed corporate tax to 25.17 per cent. For new manufacturers, the applicable tax was brought down to 17 per cent making it the lowest in South East Asia. Together with reduced tax rate and the roll-out of goods and services tax (GST), India hopes to attract sizeable foreign investment in the manufacturing sector.

It has now directed its focus on reducing the cost of production. With China in the firing line over its way of handling the deadly virus outbreak, major countries are expected to nudge their corporations to relocate production units out of China or set up new units at alternative locations.

Also read: Coronavirus: India plugs loophole in Chinese ‘opportunistic takeover’ of firms; govt nod must

In what appears to be early signs of possible changes in geopolitics, US President Donald Trump has questioned China over its response to the outbreak of the deadly virus. China had strongly protested Trump’s “China virus” remark but the American President has been lashing out at the country unabated.

On Saturday, the US President said during a White House briefing that the virus “could have been stopped in China before it started and it wasn’t, and the whole world is suffering because of it.”

Meanwhile, Japan has announced $2 billion financial aid for its companies to shift production out of China. Many more countries could follow Japan, which is expected to benefit India. “Now the world is rethinking its strategy of putting all eggs in one basket. A lot of interest is being shown by companies towards India,” says Guruprasad Mohapatra, Secretary in the Department for Promotion of Industry and Internal Trade(DPIIT).

“India is generally considered an attractive destination because of its market size and also India being a possible hub for exports in the region. That’s the reason FDI has been recording very impressive growth in the last 5-6 years,” he added.

While government is making all-out attempt to hard-sell India as a manufacturing hub it may find it an uphill task given that the production cost difference between India and South East Asian countries is about 10-12 per cent.

The government, however, sees large market size of India as a big plus for manufacturers. “If you manufacture mobiles in Vietnam, what do you do with them? You have to essentially export. You can’t sell there as there is no local market,” an official involved with the government’s Make-in-India initiative said.

He explained giving an example of mobile phones. “There is a huge market in India for mobile phones that cost less than $100. For mobiles costing $200 or more there is huge potential of export. So, from the 10-12 per cent (percentage cost difference between India and South East Asia), almost 6-7 per cent is negated or adjusted by India’s market itself. For the remaining 5-6%, a combination of state incentives and central incentives are there,” he added.

Israeli COVID-19 treatment with 100% survival rate tested on US patient

After one week, six critically ill patients in Israel survived. Four of them showed improvement in respiratory parameters.

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Israeli-based Pluristem has treated its first American patient suffering from COVID-19 complications under the country’s compassionate use program.

 
The news comes days after a report by the company showed that six critically ill coronavirus patients in Israel who are considered high-risk for mortality were treated with Pluristem’s placenta-based cell-therapy product and survived, according to preliminary data provided by the Haifa-based company.
In the US case, the patient was treated with the company’s PLX cell therapy at Holy Name Medical Center in New Jersey, where Pluristem is already running a Phase III critical limb ischemia study. Like the patients treated in Israel, this patient was critically ill with respiratory failure due to acute respiratory distress syndrome and was intubated in an intensive care unit for three weeks.

 

The company’s president and CEO, Yaky Yanay, said that although Pluristem is focused on a planned multinational clinical trial for the treatment of complications associated with coronavirus, it does hope to expand treatment under compassionate use in other countries at the same time.

 
Specifically, the US treatment was administered under the US Food and Drug Administration’s Single Patient Expanded Access Program, which is part of the US Coronavirus Treatment Acceleration Program – an emergency program aimed at getting treatments to corona patients as quickly as possible.
 
In Israel, the six patients were treated at three different Israeli medical centers for one week, also under a compassionate use program. They were suffering from acute respiratory failure and inflammatory complications associated with COVID-19. Four of the six patients also demonstrated failure of other organ systems, including cardiovascular and kidney failure.
 
Not only had all the patients survived one week later, according to Pluristem, but four of them showed improvement in respiratory parameters and three of them are in the advanced stages of weaning from ventilators. Moreover, two of the patients with preexisting medical conditions are showing clinical recovery in addition to the respiratory improvement.
Shortly after the preliminary data was published, Dr. Jason McCarthy, a senior managing director covering the biotechnology industry at Maxim Group praised Pluristem’s efforts: “Pluristem shows the COVID-19 world the first clinical data for stem cells,” he wrote. “Pluristem is initially evaluating its cell therapy under compassionate use authorization in Israel and is also the first company to dose COVID-19 patients, as well as produce the first set of early stage data.”

Study Suggests Intermittent Social Distancing Could Become Necessary Against COVID-19 Until 2022

Social distancing has become the new norm in the attempt to prevent the spread of COVID-19, and that norm could become a mainstay of life for the next couple years, a new study suggests.

Based on predictions of recurring outbreaks of COVID-19 in coming years, a study published in Science, and first reported by STAT, suggests that intermittent social distancing may be necessary into 2022. That recommendation is based on the absence of other solutions to the disease, for which there is currently no treatment nor vaccine.

“Additional interventions, including expanded critical care capacity and an effective therapeutic, would improve the success of intermittent distancing and hasten the acquisition of herd immunity,” the researchers said in the study abstract. “Even in the event of apparent elimination, SARS-CoV-2 surveillance should be maintained since a resurgence in contagion could be possible as late as 2024.”

There have been more than 600,000 people diagnosed with COVID-19 across the United States and more than 24,000 disease-related deaths, according to the Johns Hopkins University coronavirus tracking map. Social distancing, as well as stay-at-home orders, have become a mainstay of preventing the spread of infection and overwhelming hospital systems.

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The suggestion of the need for intermittent periods of social distancing was the crux of a research project from Harvard University’s T.H. Chan School of Public Health.

“With no pharmaceutical treatments available, interventions have focused on contact tracing, quarantine and social distancing. The required intensity, duration and urgency of these responses will depend both on how the initial pandemic wave unfolds and on the subsequent transmission dynamics of SARS-CoV-2,” the researchers said.

Over the course of the study, the research team points to a number of factors that could play a role in the way COVID-19 continues to impact society over the next few years, including seasonal activity, herd immunity and other factors.

“The total incidence of COVID-19 illness over the next five years will depend critically upon whether or not it enters into regular circulation after the initial pandemic wave, which in turn depends primarily upon the duration of immunity that SARS-CoV-2 infection imparts,” the researchers said and added that social distancing strategies could reduce the extent to which SARS-CoV-2 infections strain health care systems.

However, the researchers also acknowledged that social distancing practices, even intermittently, will likely result in negative economic, social and educational consequences.

“Our goal in modeling such policies is not to endorse them but to identify likely trajectories of the epidemic under alternative approaches, identify complementary interventions such as expanding ICU capacity and identifying treatments to reduce ICU demand, and to spur innovative ideas to expand the list of options to bring the pandemic under long-term control. Our model presents a variety of scenarios intended to anticipate possible SARS-CoV-2 transmission dynamics under specific assumptions. We do not take a position on the advisability of these scenarios given the economic burden that sustained distancing may impose, but we note the potentially catastrophic burden on the healthcare system that is predicted if distancing is poorly effective and/or not sustained for long enough,” they said.

AZ, Lilly join efforts to develop drugs for COVID-19

AstraZeneca and Eli Lilly have joined the ranks of drugmakers around the world trying to repurpose existing drugs for use in severely-ill COVID-19 patients as the number of cases worldwide approaches 2 million.

 

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A trial of Lilly’s JAK inhibitor Olumiant (baricitinib) – approved to treat rheumatoid arthritis – is due to start later this month in the US, and will be extended to include sites in Europe and Asia later, with results due in the next two months.

It will be an additional arm of the Adaptive COVID-19 Treatment Trial (ACTT) led by the National Institute of Allergy and Infectious Diseases (NIAID), which is also testing Gilead’s former Ebola candidate remdesivir.

AZ meanwhile is planning to start a trial of its BTK inhibitor Calquence (acalabrutinib), which is currently used to treat various types of blood cancer, in coronavirus, and says it will be “the fastest launch of any clinical trial” in the history of the company.

The CALAVI trial will see if adding the drug to supportive care in hospitalised coronavirus patients will reduce mortality and the need for assisted mechanical ventilation, and is due to get started in the next few days in Europe and the US.

While the two drugs have different mechanisms, the purpose of testing in both cases is the same. This is to see if they can interrupt the exaggerated inflammatory response – sometimes referred to as a cytokine storm – that causes some people infected with the coronavirus to develop life-threatening respiratory distress.

Olumiant isn’t the first JAK inhibitor to be tested against the cytokine storm in COVID-19 patients. Earlier this month, Novartis and Incyte said they were starting a phase 3 trial of their JAK drug Jakafi/Jakavi (ruxolitinib) – used to treat blood cancers – in severe COVID-19 patients.

The aim is of the trial is to see if Jakafi treatment can lead to faster recovery times for COVID-19 patients with fewer requiring intensive care and mechanical ventilation, according to the drugmakers.

Other drugs being trialled to see if they can interrupt the runaway immune reaction include Roche’s Actemra (tocilizumab) and Sanofi/Regeneron’s Kevzara (sarilumab) – both interleukin-6 inhibitors.

Studies have suggested that IL-6 may play a role in driving the overactive inflammatory response in some COVID-19 patients, and Roche has already won approval in China for Actemra as an emergency treatment for coronavirus.

There are concerns however that all of these approaches could be risky, as dampening down the inflammatory response could put the brakes on the body’s efforts to eliminate the coronavirus infection.

The JAK inhibitors for example are known to inhibit interferon-alpha – a key cytokine in the fight against viral pathogens.

Lilly’s anti-Ang2 drug

Meanwhile, Lilly says it is also starting a phase 2 trial of LY3127804, an investigational antibody against angiopoietin 2 (Ang2), in pneumonia patients hospitalised with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome (ARDS).

Ang2 is known to be elevated in ARDS patients and Lilly wants to see if inhibiting it can reduce the progression to ARDS or the need for mechanical ventilation in COVID-19 patients. This trial will begin later this month in the US only, according to the company.

First study of Gilead’s remdesivir in COVID-19 reveals little

Two-thirds of coronavirus patients treated with Gilead’s antiviral drug remdesivir seemed to get a clinical benefit from the drug in a just-published study – but it’s still far too early to say if it is effective.

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That is the preliminary message from an analysis of remdesivir treatment given on a compassionate-uses basis to 53 patients who were hospitalised with COVID-19, published in the New England Journal of Medicine (NEJM).

The data found that 36 (68%) of the patients showed clinical improvement after 10 days’ treatment with remdesivir, although some experts have already said that limitations in the study make the findings almost impossible to interpret.

Among the problems are that the results come from a small, mixed population of patients whose COVID-19 symptoms were highly varied at the time Gilead’s drug was administered, with some requiring mechanical ventilation and others on non-invasive oxygen support, for example.

There was also no control group or randomisation, minimal follow-up, no testing of virus levels before and after treatment and missing data on eight of the 53 subjects enrolled into the study, according to some commentators.

Others said however that the results are simply a first step in deciding if remdesivir has a role to play in COVID-19 therapy and should be welcomed ahead of a controlled trial readout due later this month.

All told, seven patients in the trial died after a median of 18 days’ follow-up, and 10 didn’t have any change in their condition.

Gilead itself said in a statement that compassionate use data have limitations, adding that “multiple phase 3 studies are ongoing” to determine the safety and efficacy of remdesivir for coronavirus infections.

The drug has emerged as the front-runner among candidate therapies for COVID-19, and has been approved for compassionate use in the US, Europe and other countries as the pandemic gathers pace, with the number of confirmed cases approaching 2 million and around 120,00 deaths.

In an open letter published after the NEJM data came out, Gilead’s chief executive Daniel O’Day writes that “in studying remdesivir, the question is not just whether it is safe and effective against COVID-19 but in which patients it shows activity, how long should they receive treatment and at what stage of their disease would treatment be most beneficial.”

He adds: “Many answers are needed, which is why we need multiple types of studies involving many types of patients.”

Seven trials of remdesivir are on the go, including two investigator-led Chinese studies, two phase 3 trials being run by Gilead in the US, Europe and Asia, and a National Institute of Allergy and Infectious Disease (NIAID) test in around 800 patients with a broad spectrum of symptoms.

The World Health Organisation is also carrying out the SOLIDARITY trial including remdesivir as well as other repurposed drugs namely generic antimalarials chloroquine/hydroxychloroquine, AbbVie’s HIV combination product Kaletra (lopinavir/ritonavir), and Kaletra plus Merck KGaA’s Rebif (interferon beta-1a)

A study called DisCoVeRy also began recently in Europe led by France’s public research body INSERM.

Originally developed as a potential Ebola treatment, remdesivir has shown in laboratory studies that it can inhibit SARS-CoV-2, the virus that causes COVID-19.

New drug targets

Meanwhile, researchers in China have published the structure of the main protease in SARS-CoV-2 in the journal Nature, and – using computer-aided drug design and high-throughput drug screening – identified compounds that can inhibit the enzyme in the lab.

Proteases are a common antiviral target because they are intimately involved in viral replication and transcription. After sifting through a library of more than 10,000 molecules the team from various Chinese research groups identified six particularly promising candidates for further study.

WHO: More than 70 COVID-19 Vaccines are in Development, Three in Clinical Trials

More than 2 million people have been diagnosed with COVID-19, and the pharmaceutical industry is pulling out all stops to find potential treatments and vaccines for the global pandemic. According to the World Health Organization (WHO), there are now more than 70 potential vaccines under development, with three already in clinical trials.

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The most advanced clinical trial is CanSino’s Adenovirus Type 5 Vector, Ad5-nCoV, which has been moved into Phase II. Ad5-nCoV is a genetic engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein, which intends to be used to prevent the disease caused by the novel coronavirus infection, the company said in its filing. Ad5-nCoV is built upon CanSino BIO’s adenovirus-based viral vector vaccine technology platform, which has also been successfully applied to develop the globally innovative vaccine against Ebola virus infection. 

Moderna has also begun human testing of mRNA-1273, its mRNA vaccine that encodes for a prefusion stabilized form of the Spike (S) protein found on COVID-19. Inovio also launched a Phase I trial for its vaccine candidate earlier this month. INO-4800 is a DNA vaccine candidate designed to prevent COVID-19 infection. Preclinical data showed promising immune response results across multiple animal models, the company said.

Those three candidates are the farthest along in development, but as the WHO data notes, multiple companies, as well as university research centers, are focused on developing a vaccine. Best estimates suggest that a vaccine will take up to 18 months to develop and launch, which puts earliest availability in early to mid-2021.

Earlier today, GlaxoSmithKline and Sanofi announced a collaboration to develop a vaccine candidate. The two companies will combine their technologies to develop an adjuvanted vaccine. Sanofi will use its S-protein COVID-19 antigen, which is based on recombinant DNA technology and GSK will boost the antigen with its pandemic adjuvant technology. In addition to that partnership, both companies have other vaccine programs in development for COVID-19. Sanofi teamed up with Translate Bio to develop a novel messenger RNA vaccine against the virus and GSK forged an agreement with China’s Innovax to provide its vaccine adjuvant technology in support of a potential vaccine against the pandemic.

Also this morning, NantKwest and ImmunityBio announced they are in active discussions with the U.S. Food and Drug Administration for vaccines and therapeutics to combat COVID-19. The companies aim to harness ImmunityBio’s second-generation adenovirus vaccine platform.

Other vaccine programs include an mRNA candidate under development by Pfizer and Germany’s BioNTech. Those two companies hope to enter the clinic this month. At the end of March, life sciences giant Johnson & Johnson announced it had discovered a vaccine candidate for COVID-19 and plans to begin human testing in September. Johnson & Johnson began developing a potential vaccine for COVID-19, the disease caused by the novel coronavirus, in January, as soon as the sequencing became available.

Earlier this month, the University of Pittsburgh reported that its vaccine candidate is producing antibodies specific to SARS-CoV-2 at quantities thought to be sufficient for neutralizing the virus. The researchers had already worked on vaccine development for SARS-CoV in 2003 and MERS-CoV in 2014, both viruses from the same family that causes COVID-19. 

Those are just a few of the more than 70 candidates under development. And, it’s likely that more companies and universities will add additional assets as time goes on.

GSK and Sanofi Join Forces to Develop a COVID-19 Vaccine

As the world continues to wait with bated breath for a vaccine against COVID-19, GlaxoSmithKline and Sanofi have joined forces to develop an adjuvanted vaccine for COVID-19.

The two companies are eying the second half of this year to begin clinical trials on their combined project and, if the vaccine meets expectations, the companies said it could be available for use in the second half of 2021. Terms of the collaboration have not yet been finalized, the companies said. Those terms, including financial, are expected to be completed sometime next week.

Under terms of the agreement that were announced, Sanofi will use its S-protein COVID-19 antigen, which is based on recombinant DNA technology to develop the vaccine candidate. The company’s technology has produced an exact genetic match to proteins found on the surface of the virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the company said. GSK will boost the antigen with its pandemic adjuvant technology. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people, GSK said.77b983c5-cd70-4cf6-bf0a-28b872b30e78

The companies have set up a Joint Collaboration Task Force, co-chaired by David Loew, Global Head of Vaccines at Sanofi and Roger Connor, President of Global Vaccines at GSK. The task force will seek to mobilize resources from both companies to look for every opportunity to accelerate the development of the candidate vaccine. In their announcement, both companies said they believe that global access to COVID-19 vaccines is a priority and both are committed to making any vaccine developed through the collaboration “affordable to the public and through mechanisms that offer fair access for people in all countries.”

Sanofi Chief Executive Officer Paul Hudson said this morning that no company can go it alone in the fight against COVID-19. He said that is why Sanofi is complementing its own expertise and resources with its peers at GSK. Hudson said the companies have the goal to create and supply sufficient quantities of vaccines that will help stop this virus.

“This collaboration brings two of the world’s largest vaccines companies together. By combining our science and our technologies, we believe we can help accelerate the global effort to develop a vaccine to protect as many people as possible from COVID-19,” GSK CEO Emma Walmsley said in a statement.

This partnership is not the first foray into developing a treatment and vaccine against COVID-19, a disease that has now infected more than 2 million people across the globe. Both companies have multiple candidates against the disease in hopes of providing more shots on goal.

Last week, GSK forged an agreement with China’s Innovax to provide its vaccine adjuvant technology in support of a potential vaccine against the pandemic. Innovax is developing its COVID-19 XWG-03 vaccine candidate technology, which is based on a series of truncated S (spike) proteins which will be screened during the pre-clinical testing and a lead candidate will be determined by immunogenicity data. The company also struck a deal with Vir Biotechnology to use that company’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options against COVID-19.

Sanofi teamed up with Translate Bio to develop a novel messenger RNA vaccine against the virus, and is also working with the Biomedical Advanced Research and Development Authority (BARDA) to advance a novel COVID-19 vaccine candidate. That agreement calls for Sanofi to initiate development of a recombinant, protein-based vaccine candidate against COVID-19. Sanofi is also working with its longtime partner Regeneron to assess the efficacy of rheumatoid arthritis drug Kevzara against COVID-19.

Med comms agency 90TEN acquired by Envision Pharma Group

90TEN has been acquired by Envision Pharma Group in a move its new parent company says will deepen and diversify its offering.

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The London-based healthcare communications agency (whose team are pictured above) will retain its brand, while bringing its behavioral science model to a range of Envision Pharma Group’s own communications solutions.

Envision Pharma Group’s CEO David Thompson said: “We’re delighted to welcome an award-winning healthcare communications consultancy into the Envision Pharma Group family.

“90TEN will add its expertise across new verticals for the group – in corporate communications and public relations, while extending Envision’s current footprint in patient engagement and medical communications with its behavioural science methodology.”

Envision Pharma Group said the deal would also enrich its global reach in medical affairs, while also providing 90TEN’s London-based team with significant geographical expansion opportunities.

90TEN’s chairman Paul Tanner said the move was an exciting milestone in his agency’s evolution.  “Envision Pharma Group will provide global support to accelerate our plans to extend into more markets and reach more audiences. Both companies share the same values, which is reflected in the similarities between our passionate, ambitious, and collaborative teams who are dedicated to improving patient outcomes.”

90TEN’s CEO Carole North added: “We’ve always said, if we partnered with another company it would have to be one that was the right strategic and cultural fit for 90TEN, celebrating everything that is 90TEN and the people who make it so successful. Envision Pharma Group embodies all of this and will allow us to retain our individuality, culture, and entrepreneurial spirit as we continue to deliver life-changing communications.”

90TEN will be managed from its London headquarters by the existing management team, which includes co-founders Paul Tanner and Carole North and managing directors Peter Impey and Alison Doughty.

The healthcare communications agency recently expanded its senior management team and currently employs around 70 members of staff. Their addition to Envision Pharma Group brings its total headcount to around 800 across 14 offices and four continents.

EMA clears compassionate use of Gilead’s remdesivir for COVID-19

The EU drugs regulator says Gilead Sciences’ antiviral drug remdesivir should be made available for people seriously ill with COVID-19, despite limited data on its efficacy.

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The EMA’s human medicines committee (CHMP) says the antiviral drug can be used on compassionate-use grounds for people with severe coronavirus complications, such as pneumonia, acute respiratory syndrome, multi-organ failure and death.

It developed its position on remdesivir after a request from EU member states Estonia, Greece, the Netherlands and Romania for guidance on the criteria that should be used for selecting patients for treatment who aren’t eligible to receive the drug in a clinical trial.

The aim is to set a level playing field across the EU for access to the drug, according to CHMP chairman Dr Harald Enzmann. Remdesivir has also been cleared for emergency use by the US FDA, although Gilead has been forced to suspend new applications after being inundated with requests.

“The CHMP encourages the company to make remdesivir available in a fair and transparent way to those Member States wishing to take part in international clinical trials or treat patients in compassionate use programmes,” said Enzmann.

The World Health Organization (WHO) recently described remdesivir as the best hope to treat COVID-19 until a vaccine becomes available.

The agency is putting the experimental drug through its paces in the SOLIDARITY megatrial along with generic antimalarials chloroquine/hydroxychloroquine, AbbVie’s HIV combination product Kaletra (lopinavir/ritonavir), and Kaletra plus Merck KGaA’s Rebif (interferon beta-1a).

Kaletra missed the mark in a small Chinese study, and for now there’s very little data on remdesivir, although the first trial of daily infusions with the drug in COVID-19 – by a research team in China – is due to report findings shortly.

Studies are also underway in the US, and another at 15 UK centres also got underway last week, including one in people with moderate symptoms and another in those who are in a serious condition.

There’s no guarantee the drug will actually work – there was disappointment when the Chinese scientists didn’t stop the trial early after an interim look at the still blinded data, which could suggest the drug is not working as well as hoped. Another Chinese study could generate results before the end of April.

Hope that it will be effective stems mainly from laboratory studies that suggest it can inhibit SARS-CoV-2, the virus that causes COVID-19, as well as other coronaviruses like SARS-CoV and MERS-CoV. It was originally developed as an Ebola treatment, but was found to be less effective than other antibody-based drugs in clinical trials and was abandoned.

Gilead has been ramping up production capacity for remdesivir, and its chief executive Daniel O’Day said at the weekend it now has 1.5 million doses, enough to treat around 140,000 people.  The company has also said it won’t enforce patents on the drug so generic drugmakers can produce it.

As remdesivir is given by infusion it is likely to be reserved for the most seriously-ill COVID-19 patients if it proves to be effective.

Gilead is one of four companies – along with Amgen, Genentech and Regeneron – that according to President Donald Trump have been asked to offer drug therapies to UK Prime Minister Boris Johnson, currently in intensive care after developing breathing difficulties following coronavirus infection.

Johnson is reportedly receiving oxygen support but does not need to use a ventilator, according to Downing Street.

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