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Strides Pharma Science’s step-down subsidiary, Strides Pharma Global Pte., Singapore, has received approval from the US Food & Drug Administration for Prednisone tablets, Strides Pharma announced in a regulatory filing to the stock exchanges on Monday. At 2:37 pm, Strides Pharma shares were trading at ₹ 698.10, lower by 1.72 per cent, on the BSE, after touching an intra-day high of ₹ 714.40. The pharma company has received approval for Prednisone Tablets USP, 2.5 mg and 5 mg. The product is bioequivalent and therapeutically equivalent to deltasone tablets, 2.5 mg and 5 mg of Pharmacia and Upjohn, Strides Pharma added. Prednisone drugs, also known as corticosteroids, are used as anti-inflammatory and immunosuppressant medications for the treatment of allergic disorders, skin conditions, ulcerative colitis and arthritis. According to IQVIA MAT September 2020 data, the US market for Prednisone tablets is about $30 million. The product will be manufactured at the company’s flagship fac

US biotech giant Pfizer and German partner BioNTech sought approval Friday to roll out their coronavirus vaccine early, a first step towards relief as surging infections prompt a return to shutdowns that traumatized nations and the global economy earlier this year. The world is looking to scientists for salvation from the global pandemic. The US Food and Drug Administration (FDA) said its vaccines committee would meet on December 10 to discuss the request for emergency use authorization. “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines,” the organization’s head Stephen Hahn said in a statement. “I want to assure the American people that the FDA’s process and evaluation of the data for a potential Covid-19 vaccine will be as open and transparent as possible.”  He said he could not predict how long the review would take, but the federal government said earlier the final green light would probably come in December.

Vaccine maker Serum Institute of India’s CEO Adar Poonawalla on Thursday said the Oxford COVID-19 vaccine should be available for healthcare workers and elderly people by around February 2021 and by April for the general public, and will be priced at a maximum of ₹ 1,000 for two necessary doses for the public, depending on the final trial results and regulatory approvals. Probably by 2024, every Indian will get vaccinated, he said at the Hindustan Times Leadership Summit (HTLS), 2020. “It will probably take two or three years for every Indian to get inoculated, not just because of the supply constraints but because you need the budget, the vaccine, logistics, infrastructure and then, people should be willing to take the vaccine. So these are the factors that lead up to being able to vaccinate 80-90 per cent of the population. “It will be 2024 for everybody, if willing to take a two-dose vaccine, to be vaccinated,” Mr Poonawalla said. Asked at what price the public will get it, he said

The anti-viral drug remdesivir should not be used to treat Covid-19 patients no matter how severe their illness as it has “no important effect” on survival chances, the World Health Organization said Friday. Scratching one of the few treatments that had shown some initial promise in severe patients, a WHO Guideline Development Group (GDG) of international experts said there was “no evidence based on currently available data that it does improve patient-important outcomes”. The United States, the European Union and other countries have granted temporary approval for the use of remdesivir after initial research showed it may shorten recovery time in some coronavirus patients. US President Donald Trump was treated with remdesivir among other medicines after he tested positive for Covid-19 in October. Friday’s WHO recommendation was based on four international randomised trials among more than 7,000 patients hospitalised with the virus. Publishing updated treatment guidance in the BMJ medi

Britain has secured 5 million doses of an experimental COVID-19 vaccine developed by Moderna Inc after it reported positive trial results, health minister Matt Hancock said on Monday, with the earliest doses expected for delivery in spring. Interim data from a late-stage trial indicated Moderna’s vaccine was 94.5% effective in preventing COVID-19. “We have today secured an initial agreement for 5 million doses of the Moderna vaccine,” Hancock said at a news conference. Britain had previously secured supply deals for a total of 350 million vaccine doses from six different suppliers, including Pfizer Inc, whose vaccine was found to be more than 90% effective, and 100 million doses of an AstraZeneca/Oxford candidate expected to report late-stage results in coming weeks. Earlier, Prime Minister Boris Johnson’s spokesman said the government had prioritised deals with vaccine developers who could provide early supply to Britain and have advanced manufacturing supply chains in place. Asked if

Shares of Aurobindo Pharma on Thursday gained nearly 7 per cent in early trade after the company reported a 26 per cent increase in consolidated net profit in the second quarter ended September. After opening in the green, the stock further jumped 6.47 per cent to Rs 863.60 on the BSE. On the NSE, shares of the company rose by 6.56 per cent to Rs 864. Aurobindo Pharma on Wednesday reported a 26 per cent increase in consolidated net profit at Rs 805.65 crore in the second quarter ended September. The company had posted a consolidated net profit of Rs 639.53 crore in the same quarter last fiscal, Aurobindo Pharma said in a regulatory filing. Consolidated total revenue from operations during the period under review stood at Rs 6,483.44 crore as against Rs 5,600.47 crore in the corresponding quarter last fiscal, it added. Aurobindo Pharma Managing Director N Govindarajan said: “We continue to perform well across all our key geographies and segments to report a consistent set of earnings.

Pfizer shares soared nearly 20 per cent to an all-time high on the BSE in early trading after its parent company, the US-based multinational pharma firm Pfizer said that its COVID-19 vaccine, developed in association with the German partner BioNTech SE, was more than 90 per cent effective against SARS-CoV-2, the novel coronavirus that causes Covid-19. Riding on the research developments, the shares of Pfizer opened at the day’s and all-time high of ₹ 5,875, up as much as 19.5 per cent, on the BSE. At 12:20 pm, the shares pared most of their gains and were trading at ₹ 5,100, up 3.7 per cent. Pfizer and German partner BioNTech have been the first to release data showing that their vaccine worked in large, late-stage clinical trials and said they did not find any serious safety concerns as yet. They will be seeking US emergency use authorization this month.

A vaccine jointly developed by Pfizer and BioNTech was 90 percent effective in preventing Covid-19 infections in ongoing Phase 3 trials, the companies announced Monday. The statement was released as coronavirus cases are soaring across the world, and European stock markets and oil prices jumped on the news. According to preliminary findings, protection in patients was achieved seven days after the second of two doses, and 28 days after the first. “The first set of results from our Phase 3 Covid-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent Covid-19,” Pfizer chairman and CEO Albert Bourla said in a statement. “We are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis,” he said. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most.” Across much of the globe, Covid-19 infections rates are hitting re

India raced ahead with work on its coronavirus vaccine while Britain’s AstraZeneca said its deliveries were running “a little bit late” as countries around the world sought to conquer the pandemic and rescue their economies. A vaccine is seen as the world’s best bet for taming a virus that has infected more than 48 million people, led to more than 1.2 million deaths, roiled economies and disrupted billions of lives since it was first identified in China in December. Australia is beefing up its prospective arsenal against the pandemic to 135 million doses of various vaccine candidates. “We aren’t putting all our eggs in one basket,” Prime Minister Scott Morrison said on Thursday. Some 45 vaccine candidates are in human trials worldwide, with Pfizer Inc saying it could file in late November for U.S. authorisation, opening up the possibility of a vaccine being available in the United States by the end of the year. Moderna and AstraZeneca are close behind the largest U.S. drugmaker and are

Moderna, one of the front-runners in the race to develop a vaccine for the new coronavirus, said on Thursday it was preparing to launch the experimental vaccine and had already received $1.1 billion in deposits for supply. The Cambridge, Massachusetts-based company has signed deals with the US government and several other countries, and is in talks with a WHO-led group for supply of the vaccine, which is in large, late-stage human trials. While the company did not give a clear timeline on the release of data from these trials on Thursday, it has said that early data is expected in the coming weeks, depending on the number of infections seen in its 30,000-volunteer study. Moderna, which has no approved products on the market yet, is one of the handful of companies in final trials for the vaccine, along with large drugmakers like Johnson & Johnson and Pfizer. “I believe that if we launch our COVID-19 vaccine, 2021 could be the most important inflection year in Moderna’s history,” sai

Health officials reviewing Gilead Science Inc’s remdesivir against COVID-19 should consider all evidence, including a trial in which the medicine failed, before giving it the green light, the top WHO scientist said on Friday. US regulators appeared not to have done so when approving the drug this week, Soumya Swaminathan told a news conference. The US Food and Drug Administration on Thursday approved Gilead’s antiviral drug for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States. The FDA decision came a week after the release of the results of the World Health Organization’s Solidarity trial, which concluded remdesivir has little or no impact on a patient’s chances of surviving COVID-19. The FDA said its approval was based on three trials, including a 1,062-patient study by the National Institute of Allergy and Infectious Disease, which found that remdesivir reduced hospital stays to 10 days from 15 days, and hel

Covaxin, the coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has been cleared for the third phase of clinical trials. The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission to conduct Phase 3 trials for its COVID-19 vaccine candidate. The firm in its application said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites – including Delhi, Mumbai, Patna and Lucknow – across 10 states. Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials. The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of the candidate in India. In a report last month, Bharat Biotech had said that an animal

The Russian Direct Investment Fund (RDIF) and Dr Reddy’s Laboratories Ltd have received renewed approval to conduct late-stage clinical trials in India of the Russian COVID-19 vaccine, the sovereign wealth fund said on Saturday. Large-scale trials of the Sputnik V vaccine in India were first announced and then knocked back by Indian regulators, who said the scale of Phase I and II trials conducted in Russia earlier this year was too small, requesting that they be repeated. Following a new agreement, India will now carry out an adaptive phase II and III human clinical trial involving 1,500 participants, RDIF, which is marketing the vaccine abroad, said on Saturday. Under the deal, Dr Reddy’s will conduct the clinical trials and, subject to approval, distribute the finished vaccine in India. RDIF will supply 100 million doses to Dr Reddy’s. Russia, the first country to grant regulatory approval for a novel coronavirus vaccine, is also conducting Phase III trials of Sputnik V in Belarus,

Glenmark Pharma on Wednesday announced the launch of its generic version of Nintedanib (NINDANIB), used for the treatment of pulmonary fibrosis, in India. “Glenmark being a leader in the area of respiratory has been amongst the first to launch the branded generic version at an affordable cost for the treatment of pulmonary fibrosis in India, it said in a regulatory filing. This will provide patients a far more cost effective treatment option, and enable doctors to treat a wider patient population in the country, it added. Glenmark said Nintedanib is approved by the Indian drug regulator for the treatment of Idiopathic (unknown cause) Pulmonary Fibrosis (IPF). “Since IPF is a progressive disease that gets worse over time, starting treatment early and continuing treatment are important to slow disease progression. A lower monthly treatment cost therefore becomes crucial to ensure patients adhere to prescribed treatment in the long term. So far, Nintedanib has been studied extensively in

A vaccine against coronavirus is expected to be available in India by early next year and there could be vaccines from more than one source, Union Health Minister Dr Harsh Vardhan today. “We’re expecting that early next year, we should have vaccine in the country from maybe more than one source. Our expert groups are already formulating and devising strategies to plan on how to roll out the distribution of the vaccines in the country, who do we give the vaccine first and then of course we are strengthening  the cold chain facilities,” Dr Harsh Vardhan said during a meeting of the Group of Ministers. At present, four coronavirus vaccines are in advanced stages of pre-clinical trial in India. The minister had earlier said that a COVID-19 vaccine is likely to be available by the first quarter of 2021. On Sunday, the minister had said that considering the large population size of India, one vaccine or vaccine manufacturer will not be able to fulfil the requirements of vaccinating the whole

Johnson & Johnson said Monday it had temporarily halted its Covid-19 vaccine trial because one of its participants had become sick. “We have temporarily paused further dosing in all our Covid-19 vaccine candidate clinical trials, including the  Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” the company said in a statement. The pause means the online enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened. J&J said that serious adverse events (SAEs) are “an expected part of any clinical study, especially large studies.” Company guidelines allowed them to pause a study to determine if the SAE was related to the drug in question and whether to resume study. The J&J Phase 3 trial had started recruiting participants in late September, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the US and around the world. The other countries where the tri

India recorded 70,496 fresh cases of coronavirus and 964 deaths on Friday, taking the total number of COVID-19 cases to 69 lakh, according to the Health Ministry data. 78,365 people successfully fought off the viral disease on Friday, bringing down the overall active cases to almost 13 per cent of the total caseload. According to the government figures, total Covid cases in India now stand at 69,06,151, including 8,93,592 active cases, 59,06,069 recoveries and 1,06,490 total deaths. India’s recovery rate has increased marginally to 85.5 per cent while the death rate stands steady at 1.5 per cent.

The government plans to provide Covid vaccines to around 25 crore (250 million) people – of the country’s 130 crore (1.3 billion) – by July 2021, Union Health Minister Dr Harsh Vardhan said Sunday afternoon. Dr Vardhan said the government would receive between 400 and 500 million vaccine doses for this purpose and that it would ensure “equitable access”. The Health Minister also said that state and UT governments had been advised to send details of “priority population groups” – a reference to frontline health workers (both government and private-sector employees), who will be first in line to receive the vaccine – by the end of October. “Vaccine procurement is being done centrally and each consignment will be tracked in real time. Priority will be given to frontline health care workers,” Dr Vardhan said in the fourth edition of “ Sunday Samvad “, his weekly social media interaction with the public. “The government is offering full support to Indian vaccine manufacturers and is commit

Scientists have developed a new method of testing for COVID-19 that doesn’t make use of key reagents but still delivers an accurate result, an advance that may lead to an inexpensive diagnosis technique in developing countries where chemical supplies are in short supply. The method, described in the journal PLOS Biology, omits the step in the widely used reverse transcription polymerase chain reaction (RT-PCR) test where the scarce reagents are needed, but has an accuracy of 92 per cent, missing only the lowest viral loads. The researchers, including those from the University of Washington in the US, tested the new method using 215 COVID-19 samples that RT-PCR tests had shown were positive, with a range of viral loads, and 30 that were negative. They said it correctly identified 92 per cent of the positive samples and 100 per cent of the negatives. While the positive samples the new test failed to catch had very low levels of the virus, the scientists said ultra-sensitive tests that id

All India Institute of Medical Sciences (AIIMS) Director Dr Randeep Guleria said an effective Covid-19 vaccine can be expected in India by January 2021 if everything goes as planned. Speaking during a session of the India Today Healthgiri Awards 2020, Guleria admitted that it is hard to say when a vaccine will be available in the country and that it depends on a lot of factors – from the ongoing trials to the effectiveness of the vaccine against Covid-19 infections. If all things go as planned, the vaccine could be available in the market by early next year, said the AIIMS director. However, Guleria made it clear that the initial availability of doses will not be enough for the entire population in the country. “If everything goes as planned, it can be hoped that a vaccine will be available in the market by early next year (January 2021) to some extent,” Guleria said. Highlighting the next big challenge after the vaccine is ready, Guleria said, “The second challenge after the vaccine i