The Medicines and Healthcare Products Regulatory Agency said in its latest Yellow Card monitoring of the coronavirus vaccine programme this week that of the 18.1 million people who had the Oxford vaccine in the UK, 30 people developed blood clots and seven had died as of March 24.
Country's biggest drug maker, Ranbaxy Laboratories Ltd on Wednesday said a US Appeals Court has ruled in its favour in the patent infringement case with Pfizer for cholesterol-lowering drug Atorvastatin (Lipitor).
The phase 3 trial is being implemented as part of Operation Warp Speed, a multi-agency collaboration led by the US Health and Human Services, which aims at accelerating the development and manufacturing of medical countermeasures for COVID-19 and delivering 300 million doses of an effective vaccine by January 2021.
A US court has ruled against Ranbaxy in its case for non-infringement and invalidation of two patents of its competitor Pfizer
Close on the heels of the UK high court delivering a mixed verdict on the patent case of cholesterol lowering drug, atorvastastin between Ranbaxy and Pfizer, a Norwegian court has given another mixed ruling.\n\n
These vaccines have not yet been approved by the World Health Organization
The government is hopeful of a speedy launch of single-dose COVID-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country's vaccination drive, sources said.
'Whoever owns the best chip industry will be the Saudi Arabia of the era of data,' predicts Rajeev Srinivasan.
China has given conditional approval for a single dose COVID-19 vaccine, touted to be a rival to Johnson & Johnson's one-jab shot cleared by the United States drug regulator on Sunday.
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The company has not yet revealed details about the unexplained illness but has stopped trials while doctors find out if the illness was caused due to the vaccine or was a coincidence.
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
Addressing a virtual Downing Street press conference, Boris Johnson acknowledged the divided views on lifting all lockdown restrictions to declare that his update does not imply that the pandemic "is over".
The British-Swedish pharmaceutical major and the UK's medicines regulator said that the vaccines produced by Oxford University in collaboration with AstraZeneca to protect against COVID-19 are safe.
Dr Reddy's Laboratories has succeeded in developing a copycat or generic version of Pfizer's Lipitor, the world's largest selling drug which has sales of over $10 billion.
'Covid patients have infected lungs and the pollutants will further damage it.'
'If you approached it with that level of aggression in 100 days, you would have vaccinated more than half of your country.' 'On a mass scale you will be able to eliminate that wave.'
'We're clear Covishield is not a problem. The UK is open to travel and we're already seeing a lot of people going from India to the UK, be it tourists, business people or students,' Alex Ellis, British high commissioner to India, said.
As states grapple with a shortage of coronavirus vaccines, the Centre on Thursday said that over two billion doses will be made available in the country in five months between August and December, enough to vaccinate the entire population.
'The Union government has discouraged state and local governments from imposing restrictions on their own.' 'That advice should be withdrawn,' asserts Mihir S Sharma.
The government said it had been evaluating the implementation of the decentralised model of vaccination since its launch on May 1 and that the decision to centralise it again was taken after detailed deliberations and following requests by some states, amid claims by the Opposition that the policy change was due to the Supreme Court's intervention.
Global pharma majors such as Novartis, Roche and Pfizer have secured 392 medicine patents in less than three years of India changing its patent laws to allow product patenting system for drugs in the country. While Swiss multinational Hoffmann La Roche leads the tally with 34 patent grants, Novartis AG and Pfizer Inc follow closely with 25 and 24 respectively.
'Mortality or hospitalisation has not increased in South Africa because of the new variant.' 'There is nothing to show so far that it is more infectious.' 'I am of the opinion that at the moment, there is no reason to panic.'
Pfizer has won a patent challenge in Denmark by India's largest drug-maker Ranbaxy Laboratories on atorvastatin, the active ingredient of the world's largest selling cholesterol drug, Lipitor, which has global sales of over $13 billion.
Multinational drug manufacturers such as Pfizer and DSM are increasingly getting into contract manufacturing alliances with emerging bulk drug makers in the country, bypassing established players such as Ranbaxy and Dr Reddy's.
Ajit Mishra, vice president, Research, Religare Broking, answers your queries.
COVAX, 'the global COVID vaccine equity scheme', has so far delivered 65 million doses to 124 countries and economies but it is dependent on countries and manufacturers honouring their commitments.
'Until the case load starts dropping, we will have to keep up the current level of prevention activities.'
'Nobody is attacking the company or the vaccine.' 'The concerns are about the process and the lack of transparency.'
Pfizer's blockbuster drug Viagra (sildenafil citrate), hitherto approved for use in treatment of erectile dysfunction, may soon acquire a new identity as a "life saving drug" in treating pulmonary arterial hypertension in children.
Bach's two-day visit to Tokyo is likely to bolster Japan's efforts to stage the Olympics, but will do little to assuage the concerns of a public deeply worried about the spread of the virus.
But, the process patent that existed previously had already allowed for a huge number of cheaper generics. Even so, within two months, Pfizer's Viagra had exceeded its own expectations by capturing 1.8 per cent of the market, worth around Rs 80 crore (Rs 800 million). It set an example and gave hope to other pharma companies to launch their products in India.
Some critics contend that Japan's rush to secure supplies is driven largely by a political desire to show the world it is fully committed to hosting the Games.
In another setback to India's biggest drugmaker Ranbaxy Laboratories Ltd, a court in Finland has prohibited it from marketing its generic version of Pfizer's cholesterol lowering drug Lipitor in the country.
On December 4 last year, the stock of the world's largest drugmaker, Pfizer, fell 10.6 per cent, wiping out more than $21 billion in market value in a single day.
'Ideally, the efficacy data of all the trials should be there in the public domain, and as soon as possible.' 'It is difficult to understand the reason behind the authorisation.'
This week, global drugmakers Pfizer and BioNTech said their COVID-19 vaccine candidate is 95 per cent effective, including in adults over 65 years of age.
Ranbaxy Laboratories Ltd on Tuesday said it has decided to discontinue all its 'Valdecoxib' formulations with immediate effect from Indian markets.
'A third wave is possible, but we must try to restrict it to a low level by adopting all personal protection and public policy measures to prevent viral transmission, while speeding up vaccination.'
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