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By the Numbers: Construction and Design, 2021

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By the Numbers: Construction and Design, 2021


The 2021 Construction & Design package includes projects by construction phase, top architectural firms, top construction management companies, top design/build companies, top development companies and top general contracting companies.



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Moderna booster increases antibodies against Covid-19 variants, early data shows – ET HealthWorld

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Moderna booster increases antibodies against Covid-19 variants, early data shows – ET HealthWorld


Moderna booster increases antibodies against Covid-19 variants, early data showsModerna Inc said on Wednesday early human trial data shows that a third dose of either its current Covid-19 shot or an experimental new vaccine candidate increases immunity against variants of Covid-19 first found in Brazil and South Africa.

The booster shots, given to volunteers previously inoculated with Moderna’s two-dose vaccine regimen, also boosted antibodies against the original version of Covid-19, Moderna said.

The early data comes from a 40-person trial testing of both Moderna’s existing shot and a version developed to protect against the South African variant of Covid-19 called mRNA-1273.351.

Moderna is also studying a shot that combines both the new and existing vaccine.

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Natco files for patent waiver for arthritis drug to fight Covid-19 in Hyderabad – ET HealthWorld

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Natco files for patent waiver for arthritis drug to fight Covid-19 in Hyderabad – ET HealthWorld


Natco files for patent waiver for arthritis drug to fight Covid-19 in HyderabadIn the first instance of a pharma company taking the compulsory licencing (CL) route to launch a Covid-19 drug in India, Hyderabad-based Natco Pharma has filed for a CL to manufacture rheumatoid arthritis drug Baricitinib, under Section 92 of the Patents Act, 1970. The patent is owned by Incyte Holdings, with a license to Eli Lilly, which markets the drug under the Olumiant brand name.

In its application, Natco has cited the unmet medical needs due to the lack of supply and affordability in light of the grave and life-threatening national public health emergency, due to the Covid-19 second wave, as the main grounds for seeking the CL.

“The CL, if granted, will help in improving the accessibility and affordability of the drug, bringing its price down substantially”.

Under the World Trade Organisation TRIPS Agreement, compulsory licences are legally-recognised means to overcome barriers in accessing affordable medicines. Under the rules, governments allow a company to manufacture a patented drug without the consent of the innovator firm.

Analysts said Natco’s move puts pressure on the US drug maker. It has only two choices – either give a voluntary licence or sue Natco for the patent, which could result in a public backlash given the soaring Covid-19 case load and death toll in India.

Natco has applied for a CL at a time when India and South Africa have approached the WTO for a temporary suspension of intellectual property rights of pharma companies so that Covid-19 vaccines and other medicines can be accessible to poor countries.

Natco has urged the controller of patents to grant it a CL to manufacture and market Baricitinib, both as bulk API (active pharmaceutical ingredient) and finished dosage only for Covid-19 treatment in India till the pandemic prevails. It is also willing to pay a 7% royalty on net profits from Baricitinib sales to the patent-holder.

Making its case, Natco’s application said not only is Olumiant not manufactured in India, less than 9,000 tablets were imported in 2019 and 2020, at an average cost of Rs 3,230 per tablet.

Citing the pricing as a significant barrier, it said a 14-day regimen (one tablet a day) works out to approximately Rs 45,220 per patient, which most Indians can ill-afford.

Natco said it would structure its pricing at Rs 30 each for a 4mg tablet, which translates to Rs 420 for a 14-day course, Rs 20 for a 2mg tablet (Rs 280 for the regimen) and Rs 15 for each 1mg tablet, costing only Rs 210 for the entire 14-day therapy.

It also pointed out that the drug’s limited imports, which dropped from 8,870 tablets in 2019 to 8,385 tablets in 2020, would not be enough to cater the nearly 34 lakh Covid-19 patients in India. “The tablets of Olumiant imported through 2020 by Lilly would serve at best to meet the needs of only approximately 600 patients,” Natco said in its application, a copy of which was reviewed by TOI.

“It’s time India set up an independent committee of experts to consider and advice on compulsory licensing and use of other safeguards for Covid-19 medical products including medicines and vaccines’’, lawyer and IP expert, Leena Menghaney told TOI.

This is not Natco’s first battle for CL with a global pharma biggie. In 2012-13 it took on Bayer for cancer drug Nexavar and won India’s first ever successful compulsory license.





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Roche receives emergency use approval in India for its investigational Antibody Cocktail used in the treatment of Covid-19 – ET HealthWorld

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Roche receives emergency use approval in India for its investigational Antibody Cocktail used in the treatment of Covid-19 – ET HealthWorld


Roche receives emergency use approval in India for its investigational Antibody Cocktail used in the treatment of Covid-19Mumbai, 5 May 2021: Roche India today announced that the Central Drugs Standards Control Organisation (CDSCO) has provided an Emergency Use Authorisation (EUA) for Roche’s antibody cocktail (Casirivimab and Imdevimab) in India. This approval was based on the data that have been filed for the EUA in the United States, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union. This Emergency Use Authorisation will now enable Roche to import the globally manufactured product batches to India and will be marketed as well as distributed in India through a strategic partnership with Cipla Limited. The production process for this biologic medicine is very complex and Roche as one of the largest biologics manufacturers in the world was selected by its partner Regeneron to expand worldwide production capacity. Roche will do everything to ensure an equitable distribution across the globe, however initial local demand may far exceed the supplies the company will be able to provide.

The antibody cocktail (Casirivimab and Imdevimab) is to be administered for the treatment of mild to moderate coronavirus disease 2019 (Covid-19) in adults and pediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and who are at high risk* of developing severe Covid-19 disease. It could significantly help these high-risk patients before their condition worsens. On March 23 2021, Roche announced that a large phase III global trial (n=4,567) in high-risk non-hospitalised COVID-19 patients (“outpatients”) met its primary endpoint, showing that Casirivimab and imdevimab significantly reduced the risk of hospitalisation or death by 70% compared to placebo. Casirivimab and imdevimab also significantly shortened the duration of symptoms by four days.

‘With the increasing number of Covid-19 infections in India, Roche is committed to doing everything we can to minimise hospitalisations and ease pressure on healthcare systems. This is where neutralising antibody cocktails like casirivimab and imdevimab can play a role in the fight against COVID-19 and in treatment of high risk patients before their condition worsens. We are thankful to the CDSCO for granting an EUA for casirivimab and imdevimab. This outpatient treatment for Covid-19 will be complementary to the ongoing vaccination drive and support our fight against the pandemic in India’, said V. Simpson Emmanuel, Managing Director, Roche Pharma India.

Commenting on the partnership, Umang Vohra, MD & Global CEO Cipla said, “We are deeply committed to exploring all possible treatment options and being at the forefront in our fight against COVID-19. This partnership with Roche is a significant step in enabling access to promising treatments in furtherance to our purpose of ‘Caring for Life’.

Cipla will market and distribute the product in India by leveraging its solid distribution strengths across the country. The drug will be available through leading hospitals and Covid treatment centers.





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