18 March 2019

NASA calls for new vaccinations to combat virus reactivation during spaceflight

Researchers from NASA’s Johnson Space Center have discovered that dormant herpes viruses reactivate during spaceflight, leading to an urgent need to develop counter-measures, including vaccination, to ensure the success of deep-space missions.

Currently only vaccinations are available for varicella-zoster virus (VZV), which causes chickenpox and shingles, but three further varieties of herpes were detected in astronauts tested by the team: herpes simplex virus (HSV), cytomegalovirus (CMV) and Epstein–Barr virus (EBV).

EBV and CMV are responsible for causing glandular fever, while HSV causes oral and genital herpes.

Senior author of the study Dr Satish Mehta said: “Our present focus is on developing targeted treatment regimens for individuals suffering the consequences of viral reactivation.”

This is especially important because, as noted by Mehta, “the magnitude, frequency and duration of viral shedding all increase with length of spaceflight,” meaning that although only six astronauts developed symptoms in the study, more astronauts could be at risk during deep-space missions to the Moon or Mars.

Based upon analysis of saliva, blood and urine samples collected before, during and following space-flight, of the 89 crew aboard Space Shuttle flights and the 23 on International Space Station missions, 61“shed herpes viruses in their saliva or urine samples.”

Mehta added: “These frequencies – as well as the quantity – of viral shedding are markedly higher than in samples from before or after flight, or from matched healthy controls.”

He explained: “During spaceflight there is a rise in secretion of stress hormones like cortisol and adrenaline, which are known to suppress the immune system.

“In keeping with this, we find that astronaut’s immune cells – particularly those that normally suppress and eliminate viruses – become less effective during spaceflight and sometimes for up to 60 days after.” The team found infectious VZV and CMV shed in body fluids up to 30 days following return to earth.

In addition to protecting astronauts during deep-space missions, Mehta argues: “This research has tremendous clinical relevance for patients on Earth too.

“Already, our spaceflight-developed technologies for rapid viral detection in saliva have been employed in clinics and hospitals around the world.”

Also, continued virus shedding on return to earth could cause serious risks to immunocompromised or uninfected people, such as new born babies.

19 March 2019

FDA expands label for Allergan’s antibacterial Avycaz

Dublin-headquartered Allergan has announced the US Food and Drug Administration (FDA) has approved its supplemental new drug application for Avycaz (ceftazidime and avibactam).

Thereby expanding the drug’s label to include treating paediatric patients with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

The company claims this is the first FDA approval for children with cIAI and cUTI in decades; the drug will now be available for patients over three months old. For cIAI, Avycaz is combined with metronidazole, whereas it is approved alone for cIAI.

Avycaz’s label expansion was based upon results from two active-controlled trials evaluating its safety and one pharmacokinetic study. The drug had similar safety results to trials into adult patients and there were no safety concerns.

The studies did not statistically analyse the clinical efficacy of the drug in paediatric patients, but the descriptive analysis of efficacy was consistent with the results of adult studies.

Allergan chief research and development officer David Nicholson said: “Difficult-to-treat gram-negative pathogens pose a significant health risk, particularly to the vulnerable and sensitive paediatric patient population with few options for treatment.

“As resistance rises among the gram-negative pathogens that cause these serious infections, the expanded label for Avycaz provides a safe and effective treatment option now for pediatric patients with cIAI and cUTI.

“These expanded indications in paediatric patients with infections, including infants and those at a particularly young age, address an unmet need among this vulnerable population and underscore Allergan’s efforts in anti-infective research.”

Avibactam, one of the active pharmaceutical ingredients (APIs) of Avycaz, is an antibacterial non-beta-lactam beta-lactamase inhibitor, which protect the other API ceftazidime against degradation by certain beta-lactamases.

Avycaz, which is being jointly developed with Pfizer, but Allergan holds commercial rights in North America for the combination therapy, was first approved by the FDA in February 2015 for the treatment of cUTI and CIAI. It was then approved in February 2018 for the treatment of adults with hospital-acquired pneumonia and ventilator-associated pneumonia.

15 March 2019

Germany partners with CARB-X to counter superbugs threat

Germany’s Federal Ministry of Education and Research (BMBF) has signed an agreement to support CARB-X in the early development of antibiotics, vaccines and diagnostics for drug-resistant bacteria.

Launched in 2016, CARB-X is a global non-profit partnership focused on antibacterial research and development (R&D) to fight the emerging global threat of superbugs.

As part of the agreement, BMBF will offer funding support of €39m over four years.

The German Ministry will also provide €1m to a consortium of the German Center for Infection Research (DZIF), the Federal Institute for Vaccines and Biomedicines (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM), which is set to join the CARB-X Global Accelerator Network.

Drug-resistant infections lead to approximately 700,000 deaths per year globally, including an estimated 33,000 in Europe and 23,000 across the US.

If the resistance continues to rise at current rates, deaths are expected to surge significantly within a generation.

CARB-X executive director Kevin Outterson said: “Drug resistance is one of the most urgent public-health and health-security threats facing the world today. We need political and scientific leadership, vision and sustained effort to win the race against superbugs.”

The funding provided to CARB-X is part of Germany’s €500m R&D budget intended for efforts against antimicrobial resistance over the coming ten years.

BMBF will support CARB-X’s strategy to back R&D projects of companies and scientific institutions worldwide to address antibiotic resistance.

German Federal Research Minister Anja Karliczek said: “The growing number of pathogens being no longer responsive to lifesaving therapies puts the lives of millions of people worldwide at risk.

“Resistant pathogens spread globally. Thus, combatting them takes joint international collaborative actions, such as CARB-X. This is why the German Federal Ministry of Education and Research will support CARB-X with up to €40m.”

CARB-X is supported by multiple other organisations, including the US Biomedical Advanced Research and Development Authority (BARDA), Wellcome Trust and the National Institute of Allergy and Infectious Diseases (NIAID).

Including the latest funding support, the partnership currently has up to €480m to support the on-going 35 projects in six countries.

14 March 2019

Stanford researchers identify drug that can mitigate chemotherapy side effects

Researchers from the Stanford University School of Medicine have discovered that AMPK activators, which include metformin for type 2 diabetes, could mitigate the cardiac side effects of chemotherapy drug trastuzumab.

Trastuzumab, which is more commonly known as the branded product Herceptin, is approved and commonly used for HER2-positive breast cancer. However, one of the common side effects of the drugs is cardiac dysfunction, which can lead to heart failure.

The Stanford team used blood from three healthy participants and seven breast cancer patients, including five who had experienced cardiac dysfunction following treatment with trastuzumab, to derive stem cells from white blood cells, which they used to create into cardiomyocytes.

They applied trastuzumab drug to the heart cells, and discovered“it changes the way the heart cells consume energy,” according to lead author of the study and director of Stanford Cardiovascular institute Joseph Wu. The cells of those breast cancer patients who had not suffered the cardiac side effects were not affected by trastuzumab, whereas cells of those who had suffered cardiac dysfunction contracted less vigorously.

AMPK activators were then applied to the cells; they responded by consuming more glucose and contracting more vigorously.

Wu said: “We could use this method to find out who’s going to develop chemo-related toxicity and who’s not. And now we have an idea about the cardioprotective medications we can give them.”

They believe testing the drugs on cells in the lab could “significantly cut the cost of drug development, providing better and more affordable drugs to the population.”

His team now plans to conduct a similar follow-up study of patients who were taking metformin for diabetes while also receiving trastuzumab treatment for breast cancer. If they find that patients taking metformin had fewer cardiac side effects, they hope to conduct a clinical trial to see if combining the two medicines produces the same results.

The study was funded by the National Institutes of Health, the Japan Heart Foundation, and a Stanford translation research and applied medicine grant.

13 March 2019

Irish scientists secure EU funding for Parkinson’s research project

The Royal College of Surgeons in Ireland (RCSI) has been awarded a grant for a new research project that seeks to improve scientific understanding of Parkinson’s disease and lead to the development of more effective treatments.

The €7m award from the Innovative Medicines Initiative (IMI), a partnership between the European Union and the European pharmaceutical industry, will be used to gain better insights into Parkinson’s by studying the brain cell damage associated with the disease. This information is expected to facilitate more effective treatments.

During the three-year research study, the team will focus on the mitochondrial malfunction in Parkinson’s patients. Mitochondria are linked to cell death and neurodegeneration.

Though evidence on the role of mitochondria in the disease is available, no effective therapies have been created based on this information, noted RCSI.

The project, dubbed PD-MitoQUANT, will be coordinated by Royal College of Surgeons in Ireland (RCSI).

In addition to RCSI, the project comprises 13 partners, including Teva Pharmaceutical Industries, Lundbeck, and UCB. It will bring together academic experts, SMEs, pharmaceutical firms from the European Federation of Pharmaceutical Industries and Associations, as well as patient advocacy organisation Parkinson’s UK.

PD-MitoQUANT coordinator and RCSI Centre for Systems Medicine director professor Jochen Prehn said: “This project will join forces with top scientists in academia and industry to bring a fresh look on how we identify and test novel drugs for the treatment of this devastating movement disorder.”

Existing therapies do not improve all Parkinson’s symptoms. In addition, the treatments cannot stop, slow, reverse or prevent disease progression over time.

The researchers hope that systematic understanding of the disease obtained during the new project will allow improved tools for the early stages of drug development.

RCSI Research and Innovation director professor Raymond Stallings said: “Research that informs improved treatments for patients is at the core of RCSI’s mission to lead impactful research that addresses Irish and international health challenges such as Parkinson’s.”

Statistics from Parkinson’s Foundation reveal that more than ten million people are affected by the neurodegenerative disease globally. Incidence of the disease increases with age.

13 March 2019

Brussels aims to attract UK pharma business post-Brexit

The Brussels Capital Region has launched a major campaign to attract UK-based pharmaceutical and life sciences organisations after Brexit.

Pharmaceutical businesses based in the British region will require a new European base for their operations, once the UK has left the EU.

Brussels will host an event on 19 March targeting these businesses, providing attendees with an insight into the Belgian capital and the benefits of being based both in London and Brussels.

The event will also offer an opportunity for the attendees to meet industry trade bodies.

This initiative has secured support from the Brussels’ regional government and regional trade associations, plus industry bodies.

Brussels Capital Region State for Foreign Trade Secretary Cécile Jodogne said: “With increasing uncertainty on what the final relationship will look like, we have extended our programme of events with an additional one on 19 March 2019 focusing entirely on those British and international pharmaceutical and life sciences businesses looking for certainty.

“The only way to guarantee this is to establish a base of operations within the EU and, as the Brexit deadline bears down upon us, there are multiple reasons why businesses should act now to guarantee this presence in the EU.”

The European Medicines Agency (EMA) was one of the first UK-based regulators to leave, leading to the loss of 900 jobs. The EMA evaluates medicines across the EU but had to relocate to Amsterdam as regulation must be done in a member state.

Jodogne added: “Every year over 500 clinical trial applications are submitted by the biopharmaceutical industry in Belgium. Applications are being processed and approved quickly before over 170,000 patients participate in Phase II and III trials.

“This is especially important as getting recognition for your medicine or medical technology by one European agency, means it’s recognised across Europe.”

Brussels’ campaign comes amid rising uncertainty around the UK leaving the EU with a formal agreement.

UK Prime Minister Theresa May’s Brexit withdrawal plan was initially rejected by the parliament by a margin of 230 votes on 15 January, increasing concerns among the UK and European pharma industry.

The withdrawal deal was again rejected on 12 March by a majority of 149 votes. The MPs are now set to vote on whether the UK should leave without a deal and, if that is approved, on whether Brexit should be delayed.

12 March 2019

Biogen to sell biologics production site to Fujifilm for $890m

US-based Biogen has signed a share purchase agreement to sell its biologics manufacturing site in Hillerød, Denmark to Japanese tech company Fujifilm for a cash consideration of up to $890m.

Fujifilm has decided to retain the approximately 800 employees currently working at the Hillerød site.

The Hillerød site consists of a 90,000L biologics production facility with assembly, labelling and packing capabilities, quality control laboratories and warehouses.

The site produces cell culture derived biologics and is expected to boost the capacity and capabilities of Fujifilm.

The facility will become Fujifilm’s fourth biopharmaceutical contract development and manufacturing site.

Fujifilm chairman and CEO Shigetaka Komori said: “This significant investment demonstrates our continued commitment to grow the Bio CDMO Business and become an industry leader by combining resources of Biogen Hillerød and Fujifilm.”

Biogen will also sign manufacturing services agreements with Fujifilm, as part of the proposed deal.

After the closing of the transaction, Fujifilm will use the Hillerød site to manufacture commercial products for Biogen, including very active relapsing multiple sclerosis drug Tysabri and additional third-party products.

Biogen will continue to operate its manufacturing facilities at Research Triangle Park (RTP), North Carolina in US and Solothurn in Switzerland, which is scheduled to begin operations by the end of 2020.

Biogen CEO Michel Vounatsos said: “As we continue to diversify our portfolio across multiple modalities and bring online our state-of-the-art manufacturing facility in Solothurn, Switzerland, we believe that we have enhanced our manufacturing capabilities and capacity for biologics with this transaction.”

Subject to customary closing conditions and regulatory approvals, the transaction is scheduled to be concluded around August this year.

Earlier this month, Biogen entered into an agreement to acquire UK-based gene therapy firm Nightstar Therapeutics for a cash consideration of $800m.

12 March 2019

Microsoft unveils new platform to boost therapeutics production

Technology giant Microsoft has unveiled a new platform that will leverage cloud and machine learning to improve gene and cell therapy manufacturing.

Developed under the company’s Station B project, the end-to-end platform will allow scientists to efficiently and predictably engineer living cells.

Microsoft partnered with Princeton University in the US, and Oxford Biomedica and Synthace companies in the UK, to develop and test the Station B platform.

Princeton University researchers are set to pilot the platform for exploring the formation of biofilms, bacterial layers that build up on surfaces and lead to various problems, including human diseases.

The team intends to study genetic constructs in order to understand and devise methods to disrupt biofilms or improve their sensitivity to antibiotics.

Under the collaboration with gene therapy company Oxford Biomedica, Microsoft Station B platform will be used to identify genetic and environmental combinations that would facilitate more productive manufacturing processes.

This is expected to help the company in significantly lowering the costs of gene therapies, which are currently quite expensive.

Oxford Biomedica will provide large data sets for analysis through the Microsoft Azure intelligent cloud platform.

In turn, Microsoft will leverage its cloud computing and machine learning technologies to create in silicomodels and new algorithms to support the next generation of cell and gene delivery technology.

Oxford Biomedica chief business officer Jason Slingsby said: “The collaboration with Microsoft Research will harness our rich data resources to offer greater insights into the biological processes required to enhance quality and optimise yields of lentiviral vectors.

“Our goal is to enable faster, cheaper and more reliable manufacture of high quality next-generation cell and gene therapies to allow more patients to benefit.”

The agreement will give Synthace access to Microsoft’s machine learning, cloud infrastructure and systems biology expertise to enhance the production of new biological materials and therapeutics.

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