NRX’S ZYESAMI PREVENTS CYTOKINE STORM IN PHASE IIB/III COVID-19 TRIAL

NRx Pharmaceuticals has reported that its investigational drug, Zyesami (aviptadil), statistically significantly prevented a steep surge in cytokines or cytokine storm in Covid-19 patients in a Phase IIb/III trial.

The trial’s prespecified goal was to analyse the change in cytokine level, as cytokines are linked to mortality in Covid-19 patients, NRx noted.

A rapid surge in interleukin 6, an inflammatory cytokine, may also cause lethal conditions such as acute respiratory distress syndrome.

The Phase IIb/III trial analysed Zyesami against placebo in critically ill Covid-19 patients with respiratory failure.

The drug’s effect was observed in a broad set of subjects with varying levels of disease severity and treated in tertiary care as well as community hospitals.

UK TO LAUNCH RESEARCH STUDIES TO DEVELOP LONG COVID THERAPIES

The UK Government has announced plans to commence a research programme comprising of 15 new studies to develop new therapies for long Covid and enhance diagnosis.

As per the National Institute for Health and Care Excellence guidance, long Covid is a condition in which signs and symptoms continue or develop after acute Covid-19.

The UK Government will provide funds worth $27.54m (£19.6m) through the National Institute for Health Research to aid researchers to assess long Covid in people with long-term effects.

The new programme will focus on understanding long Covid, assessing the efficacy of various care services and developing effective therapies such as drugs, rehabilitation and recovery to treat chronic symptoms.

REGENERON TO INVEST $1.8BN TO EXPAND FACILITIES IN NEW YORK

Regeneron Pharmaceuticals has plans to invest nearly $1.8bn to boost research, preclinical production and support sites at its Westchester County campus in Tarrytown, New York, US.

New York State Governor Andrew Cuomo announced the company’s strategies, which will create 1,000 full-time jobs in the Mid-Hudson Region in the coming five years.

To support Regeneron’s expansion in the state, Empire State Development has proposed tax credits of up to $100m under Excelsior Jobs Program if the company meets hiring targets.

Regeneron chose to expand in the Mid-Hudson region after analysing various potential locations in the tri-state area.

Cuomo said: “The continued growth of Regeneron here in New York is yet another indication that we are leading the way in the life sciences and attracting the jobs of tomorrow.

“Not only will this expansion further drive economic growth in the Mid-Hudson Region, but fuel lifesaving innovation and development that benefits the entire world.”

OCUGEN COMMENCES ROLLING SUBMISSION OF COVAXIN TO HEALTH CANADA

Ocugen has commenced the rolling submission to Health Canada for its Covid-19 vaccine candidate, COVAXIN, which is being jointly developed with Bharat Biotech International for use in the US and Canada.

COVAXIN is a purified and inactivated vaccine. Bharat Biotech developed the vaccine in partnership with the Indian Council of Medical Research’s National Institute of Virology.

The latest submission comes after Bharat Biotech reported positive data from Phase III clinical trial, which showed vaccine efficacy and safety in approximately 25,800 adult subjects.

The vaccine demonstrated an efficacy of 77.8% against mild, moderate and severe Covid-19 and offered increased protection against emerging B.1.617.2 (Delta) and B.1.351 (Beta) variants of SARS-CoV-2.

Under the Minister of Health’s interim order, the rolling submission process was suggested and accepted by Health Canada. This submission was changed to a new drug submission for Covid-19, which allows companies to provide safety and efficacy data and information when they are available.

RDIF AND SERUM INSTITUTE PARTNER TO PRODUCE SPUTNIK VACCINE IN INDIA

​​​​​​​The Russian Direct Investment Fund (RDIF) and Serum Institute of India (SII) have collaborated to manufacture the Russian Covid-19 vaccine, Sputnik, at the latter’s plant in India.

The manufacturing of the first batch of Sputnik doses is anticipated to begin in September, with plans to make more than 300 million doses of the vaccine in India annually.

SII has obtained cell and vector samples from the Gamaleya Center as part of the technology transfer and the cultivation process has commenced on receiving import approval from the Drug Controller General of India.

SINOPHARM AND SINOVAC TO DELIVER 550 MILLION VACCINE DOSES TO GAVI

Gavi, the Vaccine Alliance has signed advance purchase agreements (APAs) for a total of up to 550 million doses of Covid-19 vaccines from Sinopharm and Sinovac for supply through the COVAX facility.

As per the agreements, Sinopharm will provide a total of 170 million doses of its inactivated virus vaccine, BBIBP-CorV.

Sinopharm will deliver 60 million shots from July to October. Gavi also holds an option to buy additional 60 and 50 million doses in the fourth quarter of this year and the first half of next year, respectively.

As per the APA with Sinovac, the company will supply 50 million doses of its inactivated virus vaccine, CoronaVac, to Gavi from July to September.

Gavi also has an option to acquire another 150 million doses of CoronaVac in the fourth quarter of this year, as well as 180 million doses in the first half of next year.

This would take the number of doses to be supplied by Sinovac to a total of up to 380 million.