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Drug maker Cipla Limited on Sunday announced the launch of experimental anti-viral drug remdesivir under its <keyword id="9441113" type="UNKNOWN" weightage="20" keywordseo="brand-name-cipremi">brand name Cipremi</keyword>. Remdesivir is the only US FDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalized with suspected or laboratory confirmed COVID-19 infection. In May, US drug maker Gilead Sciences extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla's generic version of remedisvir called Cipremi. The Drug Controller General of India (DCGI) has granted Cipla regulatory approval for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need, the company said in a statement. As part of a risk management plan, Cipla will provide training on use of the drug, inform patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword> on Indian patients. "Cipla appreciates the strong partnership with Gilead to bring remdesivir to patients in India. We have been deeply invested in exploring all possible avenues to save millions of lives impacted by Covid-19 pandemic, and this launch is a significant milestone in that direction," said Umang Vohra MD and Global CEO, Cipla. According to a preliminary report from the ACTT-1 (Adaptive COVID-19 Treatment Trial 1) study, a randomized clinical trial conducted with remdesivir on 1,063 patients over 60 centres across US, Europe and Asia demonstrated a faster time to clinical recovery in hospitalised patients as compared to placebo. Most of these patients were on oxygen therapy of which some were receiving high flow oxygen or non-invasive ventilation, and some were on a mechanical ventilator. The mortality rates in the study were 7.1 per cent in those given remdesivir and 11.9 per cent in those who were given placebo. In May, Gilead Sciences signed non-exclusive voluntary licensing agreements with six Indian pharmaceutical companies to boost the supply of remdesivir, the experimental antiviral drug that has shown promise in Covid-19 treatment. These companies were -- Dr. Reddy's Laboratories Ltd., <keyword id="9441116" type="COMPANY" weightage="20" keywordseo="zydus-cadila-healthcare-ltd-">Zydus Cadila Healthcare Ltd.</keyword>, Biocon company Syngene, Hetero Labs Ltd.; Jubilant Lifesciences; and Cipla Ltd. Media reports said that Hetero Labs Ltd has also received regulatory approval from DCGI but the drug maker was yet to make it official. Cipla said it will be commercialising remdesivir through its own facilities and partnered sites. The drug will be supplied through government and open market channels, to ensure equitable distribution. SEE ALSO: <a href="https://www.businessinsider.in/india/news/water-sold-in-aluminum-cans-to-avoid-plastic-use-is-the-latest-trend-in-india/articleshow/76490551.cms" data-type="tilCustomLink">Water sold in aluminum cans to avoid plastic use is the latest trend in India – but costs six times than that of a mineral water bottle</a> <a href="https://www.businessinsider.in/tech/news/can-non-chinese-mobile-brands-leverage-current-consumer-sentiment-in-india/articleshow/76490835.cms" data-type="tilCustomLink">Can non-Chinese mobile brands leverage current consumer sentiment in India?</a>

Cipla to sell anti-viral drug remdesivir as Cipremi in India

New Delhi, Mar 11 () Drug firm Cadila Healthcare on Wednesday said its board has approved the transfer of its animal healthcare business on a going concern basis to its wholly-owned arm Zydus Animal Health and Investments Ltd (ZAHL) as part of its internal restructuring exercise. The transfer of animal healthcare business is through execution of a definitive agreement, Cadila Healthcare said in a filing to BSE. The animal healthcare business (AHB) consists of development, manufacturing, marketing and selling of animal healthcare products in India and other countries, it added. "No cash consideration will be paid by ZAHL for transfer of AHB. ZAHL will issue and allot 227,33,50,000, 8 per cent non-convertible non-cumulative redeemable preference shares of Rs 10 each at face value, aggregating to Rs 2,273.35 crore, in exchange for transfer of AHB," Cadila Healthcare said. ZAHL is engaged in the business of pharmaceuticals and investments, it added. Cadila Healthcare Ltd and ZAHL are the parties to the definitive agreement, the filing said. Cadila Healthcare shares closed at Rs 258.15 on BSE, up 0.84 per cent from the previous close. AKT MR

Cadila Healthcare board approves transfer of animal healthcare biz to subsidiary

New Delhi, Apr 30 () Drug firm Cadila Healthcare on Thursday said it has signed a definitive pact to sell its 49 per cent stake in Windlas Healthcare to Windlas Biotech for Rs 99.44 crore. The company's board has approved and signed the agreement for sale of 2,31,33,717 equity shares of Rs 10 each fully paid-up capital, representing 49 per cent of the total paid-up share capital of Windlas Healthcare Pvt Ltd (WHPL), to Windlas Biotech Pvt Ltd, Cadila Healthcare said in a filing to the BSE. "Consequent to above divestment and upon completion of the transaction in relation to the sale of the said equity shares, the company shall cease to hold any equity shares in WHPL, it added. A total of Rs 99,44,07,423 will be received as consideration for the sale, which is expected to be completed within 10 business days, Cadila Healthcare said. Shares of Cadila Healtcare were trading at Rs 325.95 per scrip on the BSE, down 0.18 per cent from its previous close. AKT HRS

Cadila Healthcare to sell 49 pc stake in WHPL to Windlas Biotech for Rs 99.44 cr

Surpassing its domestic and global peers, Cadila Healthcare has come up as the frontrunner to acquire the generic sterile injectables business of Ahmedabad-headquartered <keyword id="356962" type="COMPANY" weightage="80" keywordseo="Claris-Lifesciences-Ltd">Claris Lifesciences Ltd</keyword> (CLL). 
 
As per sources, the last minutes negotiations are underway between the both companies, including tax and other financial matters. A formal announcement is expected next month as the deal has not yet closed. 
 Cadila Healthcare, the <keyword id="270579" type="COMPANY" weightage="80" keywordseo="Zydus-Cadila-Group">Zydus Cadila Group</keyword> flagship, is likely to pay a significant premium, valuing the company between Rs 3,100 crore - Rs 3,400 crore. 
 
For 12 months ending December 31, 2014, Claris Lifesciences business reported revenues of Rs 405.6 crore and EBITDA of Rs 149.4 crore (37% EBITDA margin). 
 
Presently, the market cap of parent Claris Lifesciences including all the different businesses is Rs 1,793 crore. 
 
The Cadila Healthcare spokesperson told ET, as a matter of policy, the company does not comment on market speculation. A Claris spokesperson however denied any such development. 
 
Economic Times in February first reported about the business being put on the block. 
 
The financial daily reported the possible deal underscores amplified interest in the business in the backdrop of a global shortage of injectables -- drugs that are delivered through vials, syringes and bags, as well as pumps. The supply problems have driven many transactions both in India and overseas, including Pfizer's $17 billion takeover of Hospira, earlier this year. 
 
Pankaj Patel-led Cadila had competition from domestic rivals like Lupin who were also pursuing the opportunity to buy the asset, but valuations apart, comfort between the two Gujarat based entrepreneurs is said to have provided extra comfort to Arjun Handa, the promoter, vice-chairman &amp; managing director of CLL. 
 
ET reported both Patel and Handa are from Ahmedabad and have been old industry associates. Even global players like Pfizer, Amneal and Novartis, among others, were initially in the fray, added sources. 
 
One of the sources told ET, if talks with Cadila breaks down at the wire then the prospects of Lupin, another potential contender, to walk away with the asset could improve considerably. 
 
Cadila, among the top five pharmaceuticals companies in the country in terms of revenues --- these amounted to Rs 8,651 crore for year ended 31 March 2015 ---has been acquisitive for a while having executed 17 M&amp;A deals since 1995. 
 
(Image: Indiatimes)

Cadila Healthcare trumps peers, in talks to acquire Claris Lifesciences for whooping Rs 3,400 crore

<keyword id="146915" type="COMPANY" weightage="20" keywordseo="Pfizer-India">Pfizer India</keyword> has become the <keyword id="10389973" type="UNKNOWN" weightage="20" keywordseo="first-pharmaceutical-firm">first pharmaceutical firm</keyword> to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine in the country, after its parent company secured such clearance in the UK and Bahrain. The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under <keyword id="10188407" type="COMPANY" weightage="20" keywordseo="the-new-drugs-and-clinical-trials-rules">the New Drugs and Clinical Trials Rules</keyword>, 2019, <keyword id="233909" type="POSITION" weightage="20" keywordseo="official-sources">official sources</keyword> said. "Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its COVID-19 vaccine in India," a source said. "The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech's COVID-19 mRNA vaccine BNT162b2 in the country," the source said, citing the application. The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) granting a temporary authorisation for its emergency use. The British regulator said the jab, which claims to offer up to 95 per cent protection against COVID-19, is safe for roll-out. Bahrain on Friday also announced that it has granted an EUA for the two-dose vaccine made by Pfizer and its German partner BioNTech. The pharma company has already applied to the US FDA seeking EUA for the vaccine. The extreme low temperature of minus 70 degrees Celsius required for storing the vaccine poses a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, top government officials have said. When contacted, Pfizer said it remains committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country. "During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval," the global pharma major said in a statement. Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial. Drug firm <keyword id="72130" type="COMPANY" weightage="20" keywordseo="Zydus-Cadila">Zydus Cadila</keyword> has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed anti-coronavirus vaccine. Dr Reddy's Laboratories and <keyword id="9667533" type="COMPANY" weightage="20" keywordseo="the-russian-direct-investment-fund">the Russian Direct Investment Fund</keyword> (RDIF) have announced that they commenced adaptive phase 2 and 3 clinical trials for COVID-19 vaccine Sputnik V in India, Also, Biological E. Ltd has started early phase 1 and 2 human trials of its COVID-19 vaccine candidate. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/oxford-covid-19-vaccine-serum-institute-seeks-emergency-use-nod-for-covishield-vaccine-in-india/articleshow/79600349.cms" data-type="tilCustomLink">Oxford COVID-19 vaccine: Serum Institute seeks emergency use nod for Covishield vaccine in India</a> <a href="https://www.businessinsider.in/india/news/section-144-extended-across-noida-and-greater-noida-till-january-2/articleshow/79600323.cms" data-type="tilCustomLink">Section 144 extended across Noida and Greater Noida till January 2</a>

Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

NEW DELHI: The <keyword id="30287" type="CITY" weightage="40" keywordseo="SP">S&amp;P</keyword> <keyword id="53232" type="COMPANY" weightage="40" keywordseo="BSE-sensex">BSE Sensex</keyword> managed to bounce back on Monday even though the macro triggers remain muted with IIP data reflecting the underlying weakening production trend in the manufacturing sector. Today, the index is witnessing dull trade. 
 Last week, index of industrial production (IIP) contracted for the second straight month. The index fell by 2.1 per cent for November on a year-on-year basis, which was even sharper than October’s decline of 1.6 per cent. Now all eyes are on <keyword id="279236" type="UNKNOWN" weightage="40" keywordseo="Inflation-data">inflation data</keyword> due on Wednesday for the month of December. 
 The BSE <keyword id="6484188" type="CITY" weightage="40" keywordseo="Sensex">Sensex</keyword> rallied over 400 points in intraday trade on Monday, led by smart buying seen in IT, banks, capital goods and oil &amp; gas <keyword id="6354298" type="ORGANIZATION" weightage="40" keywordseo="stocks">stocks</keyword>. The index finally closed 375.72 points, or 1.8 per cent higher, at 21,134.21. 
 The large part of the optimism can be attributed to <keyword id="6354512" type="CITY" weightage="40" keywordseo="Infosys">Infosys</keyword>' stellar results on Friday for the quarter ended December 31. However, most analysts rule out any major surprises from Q3 results considering the fact that the benefit of the currency which was there in the previous quarter might not be available in December quarter. 
 “Markets would be closely watching the <keyword id="22195" type="COMPANY" weightage="40" keywordseo="Inflation">inflation</keyword> data and that would definitely give some cues as to what the RBI would do in the upcoming policy meet,” said Ankit Agarwal, <keyword id="1134824" type="POSITION" weightage="40" keywordseo="VP-Fund-Manager">VP &amp; Fund Manager</keyword>, Centrum Broking. 
 
“We feel that the markets in the near-term will continue to remain a little volatile as we do not expect any great wonders from the quarterly results. In the Q2, they had got a benefit of higher depreciated currency, but on a QoQ basis, even that benefit has sort of normalised,” he added. 
 Agarwal is of <keyword id="358683" type="ENTERTAINMENT" weightage="40" keywordseo="The-View">the view</keyword> that any dips in the market, any significant dips in the market, we would buy into some of the cyclicals with a 10 to 15-month investment horizon as there could be some disappointment in the results. 
 
We have collated list of ten stocks from various brokerage firm which can deliver return upto 50 per cent in 2014: 
 
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Indiabulls Real Estate: Motilal Oswal maintains ‘BUY’ rating on the stock as the firm’s cash flow is likely to remain steady due to execution progress, which will lead to a decline in net debt. The stock is trading at around 40 per cent discount to its NAV estimate of 125. 
 
Prestige Estates Projects Ltd: Religare maintains ‘BUY’ rating on the stock as the company has posted steady sales in the third quarter aided by a big launch in Bangalore. Its full-year guidance is good and a pick-up in deliveries is the key performance indicator. 
 VST Tillers Tractors: Nirmal Bank maintain ‘BUY’ rating on the stock since the company is asset-rich, with a clean balance sheet, and enjoys dominance in its product range. Earnings growth is expected to be high at a <keyword id="107168" type="ORGANIZATION" weightage="40" keywordseo="CAGR">CAGR</keyword> of 36.9 per cent over 2013-15. 
 Adani Ports and SEZ: <keyword id="48085" type="CITY" weightage="40" keywordseo="Credit-Suisse">Credit Suisse</keyword> initiates coverage with ‘outperform’ rating as the release of corporate guarantees for Abbot and continuation of strong volume growth at Mundra are the key catalysts. 
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Ipca Laboratories Ltd: Edelweiss maintains ‘BUY’ rating on the stock as the domestic business is gaining traction and will continue to grow at a sustainable 16-17 per cent over the next two years. We forecast 24 per cent EPS CAGR over 2013-16. 
 Sobha Developers Ltd: <keyword id="6361649" type="CITY" weightage="40" keywordseo="Goldman-Sachs">Goldman Sachs</keyword> retains ‘BUY’ rating on the stock as the company will continue to witness a robust revenue growth and operating cash flow since the rolling 8-quarter pre-sales momentum remains strong. 
 <keyword id="201473" type="COMPANY" weightage="40" keywordseo="HDFC-Bank-Ltd">HDFC Bank Ltd</keyword>: IIFL upgrades the stock to ‘BUY’ as the mobilisation of <keyword id="91029" type="ORGANIZATION" weightage="40" keywordseo="FCNR">FCNR</keyword> (B) deposits will enhance competitiveness and lead to significant improvement in earnings and profitability over the medium term. 
 Sintex Industries Ltd: <keyword id="2013974" type="UNKNOWN" weightage="40" keywordseo="Sunidhi-Securities-Ltd">Sunidhi Securities Ltd</keyword> recommend ‘BUY’ as Sintex enjoys an early-mover advantage in businesses that are geared towards social sector spending in India, which is likely to continue. The company is poised to accelerate business growth. 
 <keyword id="192306" type="CITY" weightage="40" keywordseo="Britannia-Industries-Ltd">Britannia Industries Ltd</keyword>: <keyword id="6358584" type="CITY" weightage="40" keywordseo="HSBC">HSBC</keyword> has initiated coverage of <keyword id="6359432" type="PERSON" weightage="40" keywordseo="Britannia">Britannia</keyword> Industries Ltd with an 'overweight' rating and a price target of Rs 1,100, citing the company's strength in the fast-growing mid-to-premium segment in biscuits/bakery. 
 <keyword id="233533" type="COMPANY" weightage="40" keywordseo="Cadila-Healthcare-Ltd">Cadila Healthcare Ltd</keyword>: <keyword id="189016" type="CITY" weightage="40" keywordseo="Bank-of-America-Merrill-Lynch">Bank of America-Merrill Lynch</keyword> upgraded the stock to "buy" from "underperform" and raised its target to Rs 1,000 from Rs 705, saying the worst is behind and earnings will accelerate from fiscal 2015. 
 The investment bank also expects that Cadila is likely to get 20 or more drug approvals from the <keyword id="6356255" type="ORGANIZATION" weightage="40" keywordseo="US-Food-and-Drug-Administration">US Food and Drug Administration</keyword>, and that it expects domestic sales to recover in fiscal 2015. 
 
(The above report is compiled from inputs from ET Wealth publication dated 13 January 2014.)

Ten Stocks That Can Return Upto 50% In 2014

New Delhi, Dec 11 () Drug firm Zydus Cadila on Wednesday said it has launched its affordable oral anti-diabetic Vinglyn brand tablets available in two formulations in India.
 As the product patent on popular diabetes drug Vildagliptin has expired in India on December 9, some domestic drug firms have launched the generic versions of the drug in the country that are much cheaper than the patented medicine.
 "Priced at just Rs 4.95 per tablet, which is almost 1/6th the price at which the patented Vildagliptin was initially launched in India, Vinglyn is now one of the most affordable brands of Vildagliptin for diabetic patients in India," Zydus Cadila said in a statement.
 Vinglyn and Vinglyn M will be marketed by Zydus Healthcare Ltd, it added.
 Zydus Cadila Managing Director Sharvil Patel said, "Fortifying our fight against diabetes, our aim is to make therapies affordable and accessible to patients from across sections of society."
 With Vinglyn, Zydus Cadila believes that it has once again been able to offer this. The access to one of the most affordable gliptin therapies will help a large number of patients suffering from type-2 diabetes, in India, he added.
 With a patient population of almost 77 million diabetics in India, access to affordable therapy is vital for the effective management of the disease, the statement said.
 The drug belongs to the class of oral anti-diabetic agents, known as DPP4 inhibitors, which have shown promise in achieving glycaemic control without deterioration in beta cell function and are one of the recent advancements in diabetes care and management, the statement said.
 Another drug firm Panacea Biotec on Tuesday had said it had launched its VilACT brand tablets available in four formulations, for treatment of type-2 diabetes in India.
 The company had also said its brand will be an affordable and high-quality medicine.
 According to the AIOCD MAT October 2019 data, the total market size of this molecule and its combination is Rs 969 crore and is growing at the rate of 4 per cent, Panacea Biotec had said.
 Shares of Cadila Healthcare, the listed entity of the Zydus group closed at Rs 262.25 per scrip on the BSE, up 0.50 per cent from its previous close. AKT HRS

Zydus Cadila launches affordable oral anti-diabetic tablets in India as drug goes off patent

(Eds: Adds details about COVID vaccine) New Delhi, Jul 3 () Zydus on Friday said it has received approval from authorities to start human trials for its COVID-19 vaccine contender - the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide. The vaccine, ZyCoV-D, showed a "strong immune response" in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus, part of Cadila Healthcare Ltd, said in a statement. This comes within days of Bharat Biotech's Covaxin vaccine getting approval of the drug regulator to start clinical trials. Over seven vaccines are being researched in India and two of them have got go-ahead to start human clinical trials just this week. Globally, over 100 candidates are being tested on humans but no vaccine has yet been approved. "Zydus has already manufactured clinical good manufacturing practice (GMP) batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1,000 subjects," the company said. ZyCoV-D, developed at the company's Vaccine Technology Centre in Ahmedabad, has now received permission from the Drug Controller General of India (DGCI) - Central Drugs Standard Control Organisation (CDSCO) to initiate phase I/II human clinical trials in India, Cadila Healthcare said. In animal studies, the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralise the wild type virus in virus neutralisation assay indicating the protective potential of the vaccine candidate, it said. It further said no safety concerns were observed for the vaccine candidate in repeat-dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well-tolerated and immunogenic. Zydus said, with its ZyCoV-D, it has successfully established the DNA vaccine platform in India using non-replicating and a non-integrating plasmid carrying the gene of interest making it very safe. The company claimed that the vaccine candidate has no vector response and with the absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements. It is also known to show much-improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest parts of the country, it said. "Furthermore, the platform can be rapidly used to modify the vaccine in a couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection," it added. The company now intends to rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand. RKL MR

Zydus gets nod for human trials of COVID-19 vaccine

<ul><li>The <keyword id="6354458" type="UNKNOWN" weightage="20" keywordseo="US">US</keyword> Department of Health and Human Services (HHS) has secured more than 500,000 treatment courses of the drug for American hospitals through September.</li><li>This represents 100 per cent of Gilead's projected production for July (94,200 treatment courses), 90 per cent of production in August (174,900 treatment courses), and 90 per cent of production in September (232,800 treatment courses), in addition to an allocation for clinical trials.</li></ul> The Donald Trump administration has secured nearly the entire world stock of antiviral drug <keyword id="8775508" type="UNKNOWN" weightage="20" keywordseo="remdesivir">remdesivir</keyword> from US-based Gilead Sciences for the next three months, leaving hardly any stock of the key Covid-19 drug for the rest of the world. As a result of an agreement with the drug maker announced earlier this week, the US Department of Health and Human Services (HHS) has secured more than 500,000 treatment courses of the drug for American hospitals through September. This represents 100 per cent of Gilead's projected production for July (94,200 treatment courses), 90 per cent of production in August (174,900 treatment courses), and 90 per cent of production in September (232,800 treatment courses), in addition to an allocation for clinical trials. A treatment course of remdesivir is, on average, 6.25 vials, the US Health and Human Services said. The agreement allows hospitals in the US to purchase the drug in amounts allocated by HHS and state health departments. Hospitals in the US will receive the product shipped by AmerisourceBergen and will pay no more than Gilead's Wholesale Acquisition Price (WAC), which amounts to approximately $3,200 per treatment course. "President Trump has struck an amazing deal to ensure Americans have access to the first authorised therapeutic for Covid-19," US Health and Human Services Secretary Alex Azar said in a statement. "To the extent possible, we want to ensure that any American patient who needs remdesivir can get it. The Trump Administration is doing everything in our power to learn more about life-saving therapeutics for COVID-19 and secure access to these options for the American people." Remdesivir is considered a key drug in the fight against Covid-19 as a randomised clinical trial conducted with the drug on 1,063 patients over 60 centres across US, Europe and Asia demonstrated a faster time to clinical recovery in hospitalised patients as compared to placebo. To expand supply of remdesivir, Gilead earlier announced non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in India, Egypt and Pakistan The agreements allow the companies -- Cipla Ltd.; Dr. Reddy's Laboratories Ltd.; Eva Pharma; Ferozsons Laboratories; Hetero Labs Ltd.; Jubilant Lifesciences; Mylan; Syngene, a Biocon company; and Zydus Cadila Healthcare Ltd. -- to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access. The regulatory approval status of remdesivir varies by country, and the distribution of remdesivir within each country is subject to local laws and regulations. Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly. The licensees also set their own prices for the generic product they produce. The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding Covid-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent Covid-19, whichever is earlier.

US secures almost entire world stock of Covid-19 drug remdesivir from Gilead Sciences for the next three months

Three COVID-19 vaccines, developed by Bharat Biotech, Serum Institute of India and Pfizer, are under active consideration of India's drug regulator and there is hope that early licensure is possible for all or any of them, the Union health ministry said on Tuesday. Over the last four days, the Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have applied to the <keyword id="281019" type="POSITION" weightage="20" keywordseo="Drugs-Controller-General">Drugs Controller General</keyword> of India (DCGI) seeking emergency use authorisation for their COVID-19 vaccines. At a press briefing, NITI Aayog member (Health) V K Paul said the COVID-19 situation in India has stabilised. With active cases reducing, a "clear-cut declining trend" in the pandemic is being seen even though the situation in many other countries is becoming quite serious, he said. The concern and anxiety following an increase in daily cases of infection in Delhi also looks like to have settled, Paul added. Asked what steps would be followed by the DCGI in the absence of a water-tight emergency use authorisation law for granting licence to <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> makers, Union Health Secretary Rajesh Bhushan said not all countries' regulatory framework or rules and acts mention emergency use authorisation. "So, the fact that this phrase is not used in the national regulatory framework of any country does not mean that a specific country would not have an enabling provision to accord an approval which is early and distinct from a regular market approval. "India's regulatory framework has a specific provision for grant of emergency use authorisation, although this phrase is not used," he said. The New Drugs and Clinical Trials Rules, 2019, clearly specifies that under specific special situations, relaxation, abbreviation, omission, or deferment of data including local clinical trial data may be considered for approval. "This is our law. Similarly, other countries too have their laws," Bhushan said. Giving a bird's-eye view of the Indian landscape of COVID-19 vaccines, Bhushan mentioned that eight vaccines are at different stages of development. One is Covishield, manufactured by Serum Institute of India in collaboration with <keyword id="6409874" type="COMPANY" weightage="20" keywordseo="astrazeneca">AstraZeneca</keyword>. Phase two and three clinical trials of this vaccine is underway and the firm has applied for emergency use authorisation. Another is Covaxin, which is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and is in phase three of clinical trials. It has also applied for emergency use authorisation. The third one is ZyCOV-D, being developed by Cadila Healthcare Ltd in Ahmedabad in collaboration with the Centre's Department of Biotechnology and is in phase two of the trials. The fourth vaccine candidate is Sputnik V which is being manufactured by Dr Reddy's Lab, Hyderabad, in collaboration with Russia's Gamaleya National Centre. The phase two trial in India is over and phase three will begin next week. The fifth one is NVX-CoV2373, which is being developed by Serum Institute of India in collaboration with Novavax and its phase three clinical trial is under consideration with the drug regulator. The sixth vaccine candidate is Recombinant Protein Antigen-based vaccine, to be manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA. Its pre-clinical animal studies have concluded and phase one and two human clinical trials have started. Another one is HGCO 19, being manufactured by Genova in Pune in collaboration with HDT, USA. Its pre-clinical animal studies are over and phase one and two clinical trials is set to start. The eighth vaccine is being developed by <keyword id="1028672" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech-International">Bharat Biotech International</keyword> Ltd in collaboration with Thomas Jefferson University, USA and it is at the pre-clinical stages. "Another vaccine, which is in the initial stage, is being developed by <keyword id="171312" type="COMPANY" weightage="20" keywordseo="Aurbindo-Pharma">Aurbindo Pharma</keyword>. So, there are nine vaccines out of which six are in clinical trials and three are in pre-clinical stage," Bhushan said. "There are multiple vaccine candidates in different stages of development and some may get licensed in the next few weeks. But we cannot foretell at this moment because licensure or market authorization is the domain of the national regulator." Most of the vaccines are of two or three doses to be administered three to four weeks apart. However, even after vaccination, COVID precautions must be taken and this has been advised by WHO also, Bhushan said, adding, "Vaccination does not mean people become carefree." About cold chain infrastructure augmentation, the health secretary said presently the system consists of 85,634 equipment for storage of vaccine at about 28,947 cold chain points across the country. "Current cold chain is capable of storing additional quantity of COVID-19 vaccine required for first the three crore -- healthcare and frontline workers," he said, adding states have collected data of frontline healthcare workers who would get the shots. The data is being uploaded on Co-WIN software, Bhushan said. The ministry, in consultation with states, has assessed the additional requirement for cold chain storage and the first supply of such additional equipment would begin from December 10, the health secretary said. Bhushan said that while 2.38 lakh auxiliary nurse midwives help in vaccination under universal immunisation programme, only 1.54 lakh such health workers will be used for COVID-19 inoculation. Additional vaccinators are being arranged in collaboration with states and UTs, he added. SEE ALSO: <a href="https://www.businessinsider.in/india/news/farmers-protest-talks-between-amit-shah-and-farmer-leaders-fail-sixth-round-of-talks-uncertain/articleshow/79635770.cms" data-type="tilCustomLink">Farmers' protest: Talks between Amit Shah and farmer leaders fail — sixth round of talks uncertain</a> <a href="https://www.businessinsider.in/finance/banks/news/supreme-court-told-that-blanket-waiver-of-moratorium-loans-would-take-6-lakh-crore-and-wipe-out-the-net-worth-of-banks/articleshow/79636002.cms" data-type="tilCustomLink">Supreme Court told that blanket waiver of moratorium loans would take ₹6 lakh crore and wipe out the net worth of banks</a>

You Searched For "Cadila Healthcare Ltd" and got 10 results

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Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

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Zydus Cadila launches affordable oral anti-diabetic tablets in India as drug goes off patent

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Zydus gets nod for human trials of COVID-19 vaccine

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US secures almost entire world stock of Covid-19 drug remdesivir from Gilead Sciences for the next three months

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Three COVID-19 vaccines under active consideration of drug regulator: Health Ministry

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