Serum Institute gets nod to resume clinical trials of Oxford COVID-19 vaccine in India

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Serum Institute gets nod to resume clinical trials of Oxford COVID-19 vaccine in India

Besides, the drug regulating body of the country has told the Serum Institute to take extra care during screening, provide additional information in informed consent, and closely monitor participants for any adverse events during follow-up of the study

The DCGI has asked SII to submit details of medication used in accordance with the protocol for the management of adverse events

The Drugs Controller General of India (DCGI) has given permission to the Pune-based Serum Institute of India (SII) to resume the clinical trial of the Oxford/AstraZeneca COVID-19 vaccine in the country.

The DCGI has revoked its earlier order of suspending recruitment of any new volunteer for the Phase 2/3 clinical trial.

The DCGI has asked SII to submit details of medication used in accordance with the protocol for the management of adverse events.

Besides, the drug regulating body of the country has told the Serum Institute to take extra care during screening, provide additional information in informed consent, and closely monitor participants for any adverse events during follow-up of the study.

Last week, pharma giant AstraZeneca and the University of Oxford resumed the clinical trial of its COVID-19 vaccine AZD 1222 in the UK, following the confirmation by the Medicines Health Regulatory Authority (MHRA) that the trials were safe.

The human trials in the UK resumed few days after getting paused after a participant reported illness.

In India, Serum Institute is conducting Phase 2/3 human trials for the COVID-19 vaccine developed by the University of Oxford and AstraZeneca.

Consequently, the DCGI also directed SII to suspend the trial until further notice. The DCGI had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries. On September 11, the DCGI directed the SII to suspend any new recruitment in Phase 2/3 clinical trials till further orders.

Yesterday, SII submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, to the DCGI, requesting to restart enrolment in the clinical trial.

According to Tuesday's order issued by the DCGI, the DSMB, UK, recommended the investigators to recommence all immunisation in their clinical trials, subject to certain conditions. DSMB, India, has also recommended continuing the study and enrolment of the remaining participants in the clinical trial as per protocol subject to certain conditions.

The SII has submitted a revised participant information sheet, revised informed consent form, and an additional safety monitoring plan for the evolved participants.

The Pune-based firm on Tuesday submitted a summary of safety follow-up of seven days post first vaccination. SII assured that no serious adverse events were experienced by any of the participants until the date of the reporting. The reported adverse events were stated to be mild, resolved on their own, it added.

University of Oxford/AstraZeneca's potential coronavirus vaccine is among the frontrunners in the race towards a safe and effective vaccine that could put a dent in the global pandemic. The company launched its late-stage trials at the end of August. Officials from the World Health Organisation had previously hailed AstraZeneca's vaccine candidate as one of the most promising candidates, which are currently in development.

Serum Institute gets nod to resume clinical trials of Oxford COVID-19 vaccine in India

Palestinians fire rockets at Israel, wounding two, during White House ceremony
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Last Updated : Sep 16, 2020 07:44 AM IST | Source: Reuters

Palestinians fire rockets at Israel, wounding two, during White House ceremony

Palestinians, who seek an independent state in the occupied West Bank and Gaza view the U.S.-brokered deals between Israel, the United Arab Emirates and Bahrain as betrayal of their cause.

Reuters
Representative image
Representative image

Palestinian militants fired rockets from Gaza into Israel, wounding two people, on Tuesday at the same time as Israel and two Gulf Arab states signed normalisation agreements at the White House in Washington.

There was no immediate claim of responsibility for the attack from the Hamas Islamist-run territory.

Palestinians, who seek an independent state in the occupied West Bank and Gaza view the U.S.-brokered deals between Israel, the United Arab Emirates and Bahrain as betrayal of their cause.

Warning sirens sounded in the coastal cities of Ashkelon and Ashdod as Israeli Prime Minister Benjamin Netanyahu, U.S. President Donald Trump and the UAE and Bahraini foreign ministers held the signing ceremony on the White House lawn.

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Automated rocket alerts on TV screens in Israel during live broadcasts from Washington were a graphic reminder of on-going conflict along the restive Gaza border, even as Tel Aviv's city hall was lit up with the word "peace" in Arabic, Hebrew and English.

Israel's Magen David Adom ambulance service said paramedics treated two men for light injuries from flying glass in Ashdod, where a rocket exploded outside a shopping centre, blowing out storefront windows.

An Israeli military spokesman said two rockets were fired from Gaza and the Iron Dome anti-missile system intercepted one of them

In Gaza, which Israel blockades, citing security concerns, dozens of Palestinians rallied outside a U.N. office to condemn the normalisation deals shortly before the signing ceremony began.

"Palestine isn't for sale," protesters chanted.

Sami Abu Zuhri, a Hamas spokesman, said the Bahrain and UAE agreements would not bring Israel peace in the region.

"Peoples of the region will continue to deal with this occupation as their true enemy," he told Reuters, speaking from Turkey. Hamas did not claim responsibility for the rockets.

In the West Bank city of Ramallah, there was a small, muted protest at which 200 people gathered in a central square.

Some carried a banner reading: "The UAE-Israeli normalization agreement is a reward for the state of occupation and for settlements, and is a stab in the back of Jerusalem and of Palestine."

The normalisation agreements are the first signed between Israel and Arab states since the peace accords with Egypt in 1979 and Jordan in 1994.

"This is not peace, this is surrender in return for the continuation of the aggression," read a tweet posted on the Twitter account of the Palestine Liberation Organization. "There will no peace before Palestine is free."
First Published on Sep 16, 2020 07:20 am
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Serum Institute gets nod to resume clinical trials of Oxford COVID-19 vaccine in India

West Bengal CM to resume administrative meetings after Covid outbreak | Kolkata News - Times of India

West Bengal CM to resume administrative meetings after Covid outbreak

Mamata Banerjee
KOLKATA: Chief minister Mamata Banerjee is headed to North Bengal next week to resume her district administrative meetings, her first such visit since the Covid-19 outbreak in March.
September 11 was the last announced total lockdown in Bengal till September 20. The CM’s September 21-24 North Bengal tour is after that. Banerjee will leave for Siliguri on Monday and return on September 24.
Nabanna sources said the CM will hold an administrative meeting with DMs, SPs and officials of Alipurduar and Jalpaiguri districts on September 22 and meet officials of Darjeeling, Kalimpong and Cooch Behar the following day. Banerjee will stay at Uttar Kanya — the North Bengal branch secretariat — and would also hold meetings with North Bengal development minister Rabindranath Ghosh.
Apart from the administrative meetings, there would be some political meetings too. Sources said while most meetings will be virtual, the CM might have closed-door interactions with political leaders. Some functionaries of Gorkhaland Territorial Administration (GTA), Lepcha Welfare Board and Bhutia Welfare Board might meet her. All officials and leaders supposed to meet the CM personally have been directed to strictly follow Covid-19 protocols.
As there are inputs there might be agitation in the Hills before the assembly polls to put the Trinamool government on a sticky wicket, the CM is likely to speak to all stakeholders, including senior TMC leaders of North Bengal. Banerjee will try to take into confidence GJM leaders, including Binay Tamang, who runs the show at GTA.
It is expected that the CM might declare some new projects for the people of North Bengal. Worried over the condition of workers of closed tea gardens, Banerjee will speak to labour leaders.
With political violence increasing in Cooch Behar, the CM might stress on controlling violence there. The functioning of state universities would also be under the scanner. Banerjee is also expected to meet officials of North Bengal Medical College and Cooch Behar Medical College.

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    Ahmedabad: Onion price may touch Rs 100/kg by end of October | Ahmedabad News - Times of India

    Ahmedabad: Onion price may touch Rs 100/kg by end of October

    Prices have already gone up by 15% to 20% in the wholesale market and 20% in the retail market
    AHMEDABAD: Onion prices continue to cause tears. According to APMC sources, retail price this year is likely to touch Rs 100 per kg by October end. The price in the wholesale market has already gone up by 15-20% and by 20% in the retail market.
    On Tuesday, the price at the Mahuva wholesale market was Rs 25 per kg and at the Ahmedabad APMC it was between Rs 15 and Rs 30. In retail, however, the price was around Rs 50 per kg on Tuesday.
    An office-bearer of Bhavnagar APMC Bhikhabhai Jhaghadiya said that the onion crop this suffered because of heavy rains. “The crop has been damaged not only in Gujarat but in other onion-growing states too,” he said.
    “The lockdown after Covid-19 outbreak led to several crises. Last year also onion price had touched Rs 100 per kg and indications are that the retail price will increase to Rs 100 per kg in the next 50 days,” said a leading onion trader of Ahmedabad. He, however, said that ban on exports may prevent the increase in prices.
    Ghanshyam Patel, chairman of Mahuva APMC, said that the exports ban move has come a bit early. “Ban on exports will once again crash the market which will bring the prices to below Rs 20 per kg. This will bring losses to the farmer,” said Patel.
    Patel said that he will write to the Union and the state governments on behalf of the farmer to reconsider the decision.
    Another officer-bearer of Mahuva APMC said that it’s not that only farmers will suffer loss. “Even the traders who have stocked onion will be incurring heavy loss in the business,” he said.
    Small-time farmers have already sold off the produce, he said.

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      Woman speaks up against stalker, assaulted by him | Noida News - Times of India

      Woman speaks up against stalker, assaulted by him

      Ghaziabad: A 47-year-old woman was beaten up and her head banged against a chair thrice by an alleged stalker after she objected to indecent remarks being passed by him against her and her daughter.
      The woman, Mukesh Devi, has been admitted to a hospital and her husband said she was incoherent and could not recognise anybody. The alleged assault took place on September 12, when Mukesh was going to a grocery store in their neighbourhood in Kavi Nagar along with her daughter.
      The accused, Sunil Chaudhary, lives in the same neighbourhood and works as a storekeeper at a private college. Mukesh’s husband Ashok Kumar, a private firm employee, said Sunil would often pass objectionable comments against his wife and daughter whenever they went out in the marketplace. Earlier, too, he had allegedly beaten up Mukesh with a stick when she had raised an objection. Being a local strongman, not many people dared speak against him, Kumar said.
      Around 5pm on September 12, Mukesh and her 25-year-old daughter were on their way to the marketplace when Sunil allegedly started shouting from the terrace. Mukesh objected to it, but Sunil allegedly hurled expletives at her. The 47-year-old woman then went inside Sunil’s house and told his wife how he would often harass her in public. The accused started beating up Mukesh. He allegedly banged her head against a chair until she lost consciousness.
      “I rushed home and took my wife to the hospital. She is still critical and not being able to recognise anybody,” Ashok added.
      SP (city) Abhishek Verma said Sunil had been arrested. “An FIR has been lodged against Sunil under sections 323 (voluntarily causing hurt), 504 (intentional insult with intent to provoke breach of the peace) and 506 (criminal intimidation) of the IPC. The police have also imposed the Goondas Act on the accused,” Verma added.

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        Coronavirus in Kolkata: Covid cases dip in Kolkata in first fortnight of September | Kolkata News - Times of India

        Covid cases dip in Kolkata in first fortnight of September

        Representative image
        KOLKATA: Covid positive cases and deaths in Bengal in the first two weeks of September have gone up marginally compared to the corresponding period last month. But in Kolkata, both - positive cases as well as Covid deaths - have dipped significantly. While health experts hailed this as a good sign, they cautioned that the trend must be observed for at least two more weeks to conclude that the numbers are indeed dropping.
        Between August 1 and 14, the number of positive cases and deaths across the state, including Kolkata, were 40,170 and 738, respectively. In the first two weeks this month, the numbers climbed up to 43,136 cases and 771 deaths - a marginal rise of about 7% and 4%, respectively.

        In contrast, positive cases and deaths in Kolkata during the first two weeks of September have come down to 6,984 and 199 against last month's 9,446 and 276 - a drop of around 26% and 28% - respectively.
        "There could be three reasons for this drop in numbers in Kolkata. Fewer people going for tests as most asymptomatic patients are avoiding confirmatory tests. Secondly, the number of cases is now genuinely less and third, those recovered from the infection are acting as a barrier from transmitting the infection," said Debkishore Gupta, infectious diseases control specialist attached with CMRI.
        Even as Kolkata was recording daily cases in the 700s and 600s in early-August, the number started dropping towards the month-end. This month, daily cases have not touched the 600 mark on a single day, hovering between 500s and 300s.
        "We need to see this decline keeping R0 (R naught) on the backdrop, which is currently decreasing. This is a good sign. But we need this trend to persist for a week to 10 days to conclude that we are actually going downhill," said Sumon Poddar, assistant professor at Institute of Child Health.
        R0 denotes the number of people an infected person can infect according to a mathematical model.
        There has been a constant rise, though marginal, in the number of cumulative daily cases for the state. Experts said that this was due to the ramped up tests. "Kolkata is ahead of the rest of Bengal. The city was the first to face the worst surge. It will be the same trend in case of declining numbers," added Poddar. Currently, North 24 Parganas has the highest number of active cases (4,409) while Kolkata has 4216 active cases.

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          2 barge in house, snatch owner’s gold chain | Noida News - Times of India

          2 barge in house, snatch owner’s gold chain

          Greater Noida: Two bike-borne assailants snatched a woman’s gold chain after barging inside her house in Sector 36 on Monday.
          The complainant Sonu Bhati, who works in a private company in Noida, told police that his 56-year-old mother was dusting in the porch of the single-storey house when two men on a Pulsar motorcycle came on the gate and asked for directions to reach an address.
          When she refused, one of them allegedly opened the iron gate and went inside to show a paper that had the complete address written on it, but as soon as he went near her, he pushed her to the ground and snatched the gold chain that she was wearing. “On hearing my mother’s screams, I rushed outside and saw him running outside. My neighbours also tried to catch them, but they sped away,” he said.
          Sonu added that the men did not wear a helmet and there was no number plate on their motorbike. “We also tried to check the CCTV footage of the cameras installed at the sector’s entry gate but they were found non-operational. We have somehow managed to get their picture from a camera installed at my neighbour’s house which we have handed over to the police,” he said.
          Meanwhile, the other residents of the sector have raised concern over the security. Last week too, a theft had taken place at a temple in the sector.
          Kailash Bhati, president of the residents welfare association (RWA) of the sector told TOI that the residents have stopped paying the maintenance fee after the nationwide lockdown was imposed due to which the security guards were removed. “Since then, these incidents are rampant. Even the CCTV cameras were stolen about a month ago. We are requesting the residents to pay the maintenance fee so that we can restore the security,” he said.
          Following the complaint, the two unknown robbers have been booked under IPC Section 392 (robbery). “Efforts are on to identify and arrest the accused men,” said senior sub-inspector at Sector Beta 2 police station, R P Singh Shekhawat.

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            Real value and real growth | Value Research

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            Real value and real growth

            Real value should lead to growth and real growth should lead to an accretion of value

            Real value and real growth

            For the investor, there are few words that hold so much meaning and so much promise as 'value'. For me personally, it's been a lifelong fascination with the concept, as is evident from the name that I gave my company when I started it at the age of 20. In fact, back in 1990, the point of the phrase 'Value Research' was not that it was the name of the company, but that it was literally the activity I was spending all my thinking hours on. Thirty years later, that remains just as true.

            Of course, it's not all milk and honey. The trouble with the term 'value' is that it holds the potential for as much doubt and confusion as it does promise and meaning. It's easy to define but hard to recognise, except in hindsight. And while we can mock hindsight as much as we'd like, it's actually the only tool we have. After all, hindsight can mean learning from the past. And since we cannot see into the future, the past is all we have which we can learn from.

            Remember, what you want to buy is a value stock but what you want to sell is a growth stock. That's the ideal, and it's often unattainable simply because ideal results are unattainable in real life. However, when it does happen in some companies, then it's worthwhile to analyse and study those examples closely.

            If you sit back and think about what the concept of value is, you will realise something quite interesting. Value or growth is not just a characteristic of the company itself but of what the market thinks of the company. That's where we get the dreaded concept of 'value trap'. What you want is a company that is attractively priced. But what you do not want is a company that stays attractively priced for a long time. That's usually an indication that there's something inherently wrong with the business. Of course, it's possible that you have recognised value and the rest of the market has not, but what use is that? For you to eventually make money, the rest of the market has to agree with your judgement! If it doesn't, then it doesn't.

            A few months ago, when the coronavirus had barely started off and so the context was different, I had quoted Warren Buffett on how the concept of value had evolved. "Whether appropriate or not, the term 'value investing' is widely used. Typically, it connotes the purchase of stocks having attributes such as a low ratio of price to book value, a low price earnings ratio, or a high dividend yield. Unfortunately, such characteristics, even if they appear in combination, are far from determinative as to whether an investor is indeed buying something for what it is worth and is therefore truly operating on the principle of obtaining value in his investments. Correspondingly, opposite characteristics - a high ratio of price to book value, a high price-earnings ratio, and a low dividend yield - are in no way inconsistent with a 'value' purchase. Growth benefits investors only when the business in point can invest at incremental returns that are enticing - in other words, only when each dollar used to finance the growth creates over a dollar of long-term market value."

            As usual, the old man provides a lot of food for thought. Value has to lead to growth, but growth too has to lead to an accretion of real value in business! It's a hard concept to appreciate, but most things worth understanding are hard.

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            Serum Institute gets nod to resume clinical trials of Oxford COVID-19 vaccine in India

            Heavy rain in Karnataka sends vegetable prices soaring | Mangaluru News - Times of India

            Heavy rain in Karnataka sends vegetable prices soaring

            Representative image
            BENGALURU: The Consumer Price Index-based retail inflation moderated slightly last month and brought smiles, but the relief has come to a rude end. The prices of vegetables have doubled, and even trebled, in Bengaluru and other major cities across the state. A kilogram of carrot, for instance, which cost Rs 50 just over a week ago now sells at Rs 90-120. Tomato has shot up to Rs 60 from Rs 25 a kilo, while green peas has touched Rs 250 from Rs 120 a fortnight ago.
            While soaring prices of vegetables have upset kitchen budgets — especially in these homebound times when most meals are being eaten at home — those tracking the demand-and-supply situation say these prices are unlikely to see a drastic fall for at least a month.

            The reason for the sharp rise in vegetable prices, Hopcoms and senior state government officials say, is due to the heavy rain lashing the state. “Whenever it rains continuously for 4-5 days, the crops start rotting. This results in a drop in supply and increase in prices. This happens almost every year,” a Hopcoms official said. Sources maintained that there has been a minimum 20% increase in vegetable prices across the board.
            “The consumption of vegetables in our house has increased in the backdrop of Covid, and we cannot afford a price rise now. We hope there is some intervention from the government and relief is extended to consumers, especially the middle class who are struggling with job losses and dwindling incomes,” said Sushma Dev, a resident of Shantinagar.
            Dip in demand for expensive veggies
            Restaurant owners, who are looking to bounce back in business, are worse off. The owner of a restaurant in Malleswaram said: “A hike in vegetable prices will push us to the edge in this pandemic situation when footfall is already low. We cannot cut down on the portion of vegetables served or increase the price of dishes, we have to bear the burden.”
            Traders in Bengaluru say there is a dip in demand for expensive vegetables over the past few days. M Raju, a vegetable vendor in Sanjayanagar, said, “The prices of only a few vegetables have gone up. People are buying less of costly vegetables and more of the cheaper ones.” Bengaluru’s vegetables come from Bengaluru Rural, Ramanagara, Chikkaballapur and Kolar districts and these areas have got good rains in the past week.
            Not just Bengaluru, other cities too have seen a sharp rise in vegetable prices in the past week. Prices have gone up by 10-30% in Mangaluru markets. Prices of locally grown vegetables like spinach have seen an increase of 30% compared to just a few days ago. In Mysuru, the price of beans, drumstick, carrot and radish are soaring. “Till last week, there was hardly any demand for the vegetables. Rates of all the major vegetables almost doubled in the one-and-a-half weeks,” said Suresh Siddappa, a vegetable vendor from Nanjumalige circle in Mysuru. Hubballi, though, has been spared in the price surge.

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