Syntegra collaborates with US NIH to increase access to Covid-19 data

19January | Covid-19

Syntegra and the US National Institutes of Health (NIH) have collaborated to expand access to the largest set of Covid-19 patient records using the former’s AI-enabled synthetic data technology.

Through its Covid-19 Therapeutic Accelerator, the Bill and Melinda Gates Foundation is backing the partnership between Syntegra and the NIH.

The NIH will be able to provide far less restricted access to the largest available repository of patient-level Covid-19 electronic medical records using Syntegra’s synthetic data engine.

In addition, it can help in rapidly expanding the reach and usage of this data in driving Covid-19 insights, as well as setting the basis for increasing data access to life science researchers in other major fields of disease understanding and drug and device development.

Syntegra’s data engine will be a major component of the National COVID Cohort Collaborative.

It will validate the production of a non-identifiable synthetic version of the complete dataset which has over 2.7 million screened people, including over 413,000 Covid-19 patients, and 2.6 billion rows of data.

This public-private collaboration includes over 70 contributing healthcare organisations.

Syntegra founder and CEO Michael Lesh said: “The promise of ‘big-data’ and precision medicine won’t be fulfilled unless we can share data siloed throughout the healthcare system while guaranteeing patient privacy. With the Covid-19 pandemic, there has never been a time when rapid, low burden access to patient-level data, at scale, was more urgent."

19January | drug development


Clinical-stage biopharmaceutical firm Aruvant Sciences and Lonza have entered a strategic long-term manufacturing agreement for the former’s one-time investigational gene therapy for sickle cell disease (SCD), ARU-1801.

The gene therapy will be developed for Aruvant’s upcoming pivotal trial.

Designed to tackle the limitations of present curative treatment options, ARU-1801 has unique characteristics that permit it to be given with reduced intensity conditioning.

The investigational lentiviral gene therapy is currently under analysis as a one-time potentially curative treatment for SCD in the Phase I/II MOMENTUM study. The trial is now enrolling subjects.

According to preliminary clinical data, engraftment of ARU-1801 and amelioration of SCD is achievable with a single dose of low-intensity chemotherapy.

Aruvant chief technology officer Palani Palaniappan said: “We are partnering with Lonza, one of the world’s leading cell and gene therapy manufacturing organisations, to help us manufacture our gene therapy ARU-1801, a potential cure for sickle cell disease that can be given with one low dose of chemotherapy."

19 january | vaccines


The Drug Regulatory Authority of Pakistan (DRAP) has granted emergency use authorisation (EUA) to China National Pharmaceutical Group’s (Sinopharm) Covid-19 vaccine.

Reuters reported that the latest development comes after the country approved Covid-19 vaccine developed by AstraZeneca and Oxford University.

According to the Pakistan Health Ministry, the country is holding discussions with various vaccine manufacturers.

The two Covid-19 vaccines have been granted conditional authorisation.

A DRAP spokesman said that the vaccines were analysed for their safety and quality and the authorisation will be reviewed on a quarterly basis for further safety, efficacy and quality data.

Pakistan Health Minister Faisal Sultan said that the country could obtain “in the range of tens of millions” of vaccine shots as part of an agreement signed with Cansino Biologics in China.

At present, Cansino’s Ad5-nCoV Covid-19 vaccine candidate is concluding Phase III clinical trials in Pakistan.

Sultan added that preliminary data from the trial of the vaccine is expected in mid-February.

18 january | safety


Norway has raised concerns about Pfizer’s Covid-19 vaccine safety after 29 elderly people with serious underlying health conditions have died after receiving the shot.

Bloomberg noted that even though it is not clear when the deaths happened, the country has inoculated as many as 42,000 individuals and concentrated on those at higher risk of contracting Covid-19, which includes the elderly.

The media company quoted the Norwegian Medicines Agency as saying in a written response that until 15 January, only Pfizer’s vaccine was available in Norway, and “all deaths are thus linked to this vaccine.”

The agency added: “There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed. All the reported deaths related to ‘elderly people with serious basic disorders’.”

Norway Health Minister Greg Hunt told reporters in Melbourne that Australia is waiting for critical information on this issue from Pfizer, health authorities, as well as from the government.

Earlier, the country signed an agreement to acquire ten million doses of the vaccine.

Last December, the US Food and Drug Administration (FDA) started investigating around five allergic reactions that occurred after individuals received Pfizer and BioNTech’ Covid-19 shot in the country.

Meanwhile, Pfizer is set to cut the supply of its vaccine to Europe for a brief period to advance its production capacity, the company and the Norwegian Institute of Public Health noted.

18 january | approvals


Brazil has granted approval to AstraZeneca and Chinese firm Sinovac Biotech’c Covid-19 vaccines for emergency use, allowing the country to begin inoculation as cases surge.

Brazilian health regulator Anvisa approved the vaccines citing a rise in cases, as well as the absence of options for Covid-19 treatment, Bloomberg reported.

Anvisa director Meiruze Freitas said that even though government technicians said they require more information about the vaccine, its benefits surpass the risks.

The media company quoted Freitas as saying: “We must continue monitoring the vaccines to capture adverse effects that were perhaps not seen in trials.”

Health Minister Eduardo Pazuello said in a press meet in Rio de Janeiro that the government would not do a ‘photo op’ vaccination.

Pazuello added that after a ‘symbolic delivery’ of vaccines to states on 18 January, the vaccination programme will begin on 20 January with delivery based on locations which are at higher risk, in a bid to provide more doses.

Initially, the elderly, Brazil’s local population and healthcare staff will receive the vaccines.

15 January  | vaccines


The US FDA has approved the supplemental New Drug Application (sNDA) for Pfizer’s Xalkori (crizotinib) for treating paediatric patients aged one year and above and young adults with anaplastic lymphoma kinase (ALK)-positive relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL).

The latest development derives from results of Study ADVL0912, which showed Xalkori treatment resulted in an objective response rate of 88%.

The multicentre, single-arm, open-label study enrolled 121 patients aged between one and 21 years and included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least one systemic treatment.

Furthermore, Xalkori’s safety profile in ALK-positive ALCL in children and young adults was observed to be similar to those in patients suffering from ALK-positive and ROS1-positive metastatic NSCLC.

Pfizer Global Product Development Oncology chief development officer Chris Boshoff said: “We are proud to deliver the first biomarker-driven therapy for children and young adults with ALCL. Xalkori offers a meaningful new treatment option for young patients with relapsed or refractory ALK-positive ALCL."

In brief

Switzerland authorises Moderna’s Covid-19 vaccine

The Swiss Agency for Therapeutic Products, Swissmedic, has authorised the Moderna’s Covid-19 vaccine in Switzerland. The authorisation, as per the ordinary approvals procedure, comes after a rolling submission of data and the totality of scientific evidence submitted by Moderna.

CohBar, NIAID to assess CB5064 Analogs for Covid-19 treatment

CohBar and the US National Institute of Allergy and Infectious Diseases (NIAID) have signed a non-clinical evaluation agreement to analyse CB5064 Analogs for treating Covid-19 related Acute Respiratory Distress Syndrome (ARDS). The company is developing its CB5064 Analogs as a potential treatment for ARDS. The programme demonstrated positive results in acute lung injury models.

Codagenix and SII begin dosing in Phase I Covid-19 vaccine trial

Biotechnology firm Codagenix and SII have dosed the first patient in Phase I clinical trial of a single-dose, intranasal Covid-19 vaccine, COVI-VAC. Developed with Codagenix’s Synthetic Attenuated Virus Engineering (SAVE) platform, the vaccine can potentially provide a safe, live attenuated form of SARS-CoV-2 that could stimulate a robust immune response and long-term cellular immunity against the virus.

British Columbia rejects Health Canada-approved antibody drug for Covid-19

British Columbia has rejected a Health Canada-approved antibody drug, bamlanivimab, for treating Covid-19 citing very limited safety data. Pharmaceutical company Eli Lilly developed bamlanivimab using AbCellera Biologics’ technology.

Algeria registers Russian Sputnik V vaccine against Covid-19

The Russian Direct Investment Fund has announced the registration of Sputnik V vaccine against Covid-19 by the National Agency of Pharmaceutical Products of People’s Democratic Republic of Algeria. Based on a human adenoviral vector platform, the Sputnik V vaccine uses two vectors for the two shots for inoculation.

15 january | approvals


The Serum Institute of India (SII) expects to soon receive World Health Organisation (WHO) emergency use authorisation for the Oxford University/AstraZeneca Covid-19 vaccine, produced for mid and low-income countries.

Reuters quoted SII chief executive Adar Poonawalla as saying at the Reuters Next conference: “The emergency use licensure from the WHO should be available and coming through in the next week or two, hopefully, because we have submitted everything.”

Poonawalla added that SII was aiming to initiate deliveries of the WHO-backed COVAX initiative by this month-end.

A single dose of the vaccine will cost $3 for low-income countries and sold to others at a ‘slightly higher’ rate.

The vaccine maker already sold 11 million doses to the Indian Government, which is planning to initiate the world’s largest mass vaccination campaign on 16 January.

Indian Prime Minister Narendra Modi will launch the rollout of the drive at a total of 3,006 session sites virtually.

In the first phase, the country intends to vaccinate around 300 million people.

Earlier this month, the Drugs Controller General of India approved Covid-19 vaccines of Serum Institute of India and Bharat Biotech for restricted use in emergency situations.

13 january | vaccines


The US FDA has accepted priority review of the Biologics License Application (BLA) of Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate, V114, for preventing invasive pneumococcal disease in adults.

The vaccine candidate has pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and also serotypes 22F and 33F.

The BLA and priority review status are backed by results from Phase II and Phase III clinical studies in the adult population. These include healthy adults and people at high risk, such as those with chronic medical conditions, HIV and aged 65 years and above.

Furthermore, additional studies in the BLA back V114’s usage in clinical settings, such as in co-administration with the quadrivalent influenza vaccine, as well as in sequential administration with PNEUMOVAX 23 and show identical performance among consecutive lots of V114.

Separately, a licensure application for V114 in adults is under review by the European Medicines Agency.

In brief

Bangladesh signs Covid-19 vaccine deal with Serum Institute of India

Bangladesh has entered into a deal with the Serum Institute of India (SII) to acquire 30 million doses of a potential vaccine being developed by AstraZeneca for Covid-19. Under the deal, Beximco will purchase five million doses of vaccine per month.

EC approves AstraZeneca and Merck’s Lynparza for two cancer types

AstraZeneca and Merck’s Lynparza (olaparib) has secured approval from the European Commission for prostate cancer and ovarian cancer treatments in the European Union. A subgroup analysis of the PROfound Phase III trial of Lynparza backs the prostate cancer approval.

Australia to acquire 40 million doses of Novavax Covid-19 vaccine

Novavax has signed a non-binding heads of terms document with the Australian Government to supply 40 million doses of its Covid-19 vaccine candidate, NVX-CoV2373. The vaccine candidate is currently in Phase III clinical trial in the UK.

AIIMS find ivermectin prophylaxis reduces infection in Covid-19 patients

A study by All India Institutes of Medical Sciences (AIIMS)-Bhubaneswar in the Indian state of Odisha found that two doses of potential drug ivermectin prophylaxis resulted in a 73% reduction in Covid-19 infection.

Regeneron to continue patient recruitment for Covid-19 trial

The independent data monitoring committee (DMC) has recommended the continuation of Regeneron’s UK-based RECOVERY trial analysing REGN-COV2 in hospitalised patients with Covid-19. Prior to this, DMC recommended holding enrolment for the REGN-COV2 antibody cocktail treatment trials for Covid-19 based on a potential safety signal and an unfavourable risk/benefit profile.