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Hyderabad, <keyword id="138856" type="DOMAIN" weightage="20" keywordseo="Aurobindo-Pharma-Ltd">Aurobindo Pharma Ltd</keyword> and Covaxx, a US-based company, have entered into an <keyword id="10489747" type="UNKNOWN" weightage="20" keywordseo="exclusive-license-agreement">exclusive license agreement</keyword> to develop, commercialise and manufacture UB-612, the first Multitope Peptide-based vaccine to fight COVID-19, for <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword> and UNICEF. According to a release issued by the city-based drug maker, Covaxx is currently conducting a Phase 1 clinical trial for the vaccine candidate. Managing Director of <keyword id="70473" type="DOMAIN" weightage="20" keywordseo="Aurobindo-Pharma">Aurobindo Pharma</keyword> Ltd, N Govindarajan, said, "We are proud to partner with Covaxx in developing the first-ever synthetic peptide-based vaccine to combat the <keyword id="8902449" type="UNKNOWN" weightage="20" keywordseo="covid-19-pandemic">COVID-19 pandemic</keyword>. This vaccine has immense potential in eliminating shedding, and hence containing, the spread of the pandemic." Under the signed agreement, Aurobindo Pharma has obtained the exclusive rights to develop, manufacture and sell Covaxxs UB-612 vaccine in India and to UNICEF, as well as non-exclusive rights in other select emerging and developing markets, it said. Aurobindo Pharma and Covaxx are partnering on clinical development, manufacturing and marketing of the vaccine candidate. Aurobindo will manufacture the finished doses at its facilities in Hyderabad. It has the capacity of manufacturing 220 million doses in multi-dose presentation and is building additional facilities to have a total capacity of nearly 480 million doses by June 2021. Mei Mei Hu, co-founder and CEO of Covaxx said his company is committed to providing an equitable distribution of UB-612 by prioritizing emerging markets where there is the unmet need. "During this global health crisis response, we must establish partners with the strongest capabilities, like Aurobindo, to prioritize the development and the delivery of our vaccine. As one of the leading industry players with a strong track record of execution and investment in vaccines, Aurobindo Pharma is the ideal partner to advance UB-612 in India and other emerging nations and to support our mission of democratizing health worldwide," Hu said. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/top-stocks-to-watch-mrs-bectors-ril-bharti-airtel-vodafone-idea-ilfs-interglobe-aviation-future-group-deepak-nitrite-jubilant-foodworks-and-others/articleshow/79933826.cms">Top stocks to watch – Mrs Bectors, RIL, Bharti Airtel, Vodafone Idea, IL&amp;FS, InterGlobe Aviation, Future Group, Deepak Nitrite, Jubilant FoodWorks, and others</a> <a href="https://www.businessinsider.in/thelife/personalities/news/from-taking-on-yahoo-to-being-tamed-by-chinas-communist-party-its-been-a-roller-coaster-decade-for-jack-ma/slidelist/79935613.cms">From taking on Yahoo to being tamed by China’s Communist Party— it’s been a roller coaster decade for Jack Ma</a> <a href="https://www.businessinsider.in/careers/news/ey-is-looking-to-hire-9000-techies-in-2021-to-boost-its-digital-services/articleshow/79936576.cms">EY is looking to hire 9,000 techies in 2021 to boost its digital services</a>

Aurobindo Pharma join hands with US-based company Covaxx to develop COVID-19 vaccine for India

New Delhi, Feb 26 () Aurobindo Pharma Ltd on Wednesday said that it has received an establishment inspection report from the US health regulator with Voluntary Action Initiated (VAl) status for its Unit VIII manufacturing facility in Hyderabad. "Further to our intimation dated November 6, 2019 with regard to the USFDA inspection of Unit VIII, API manufacturing facility at Gaddapotharam, Hyderabad, we would like to inform that the company has received the Establishment Inspection Report (EIR) with VAl status from the USFDA," the drug firm said in a filing to BSE. According to the US health regulator, a VAI classification "means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action". USFDA issues an EIR to the company when an inspection is satisfactorily closed. Shares of Aurobindo Pharma were trading at Rs 508.50 a piece on BSE, up 0.87 per cent from the previous close. SID DRR

Aurobindo Pharma gets EIR with VAI status from USFDA for Hyderabad facility

New Delhi, Jan 30 () Drug firm Aurobindo Pharma on Thursday reported that the US health regulator has cautioned that its oral solids formulation manufacturing facility may be subject to regulatory actions.
 The company stressed that it will work closely with the US Food and Drug Administration (USFDA) to comprehensively address the issues.
 "Further to our intimations... with regard to the USFDA inspection of Unit VII, an oral solids formulation manufacturing facility of the company, we inform you that the company has received a letter from the USFDA classifying the inspection conducted at the aforesaid facility as official action indicated (OAI)," Aurobindo Pharma Ltd said in a filing to BSE.
 According to USFDA's definitions, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections.
 The company said that it believes that this OAI classification will not have any material impact on the existing revenues or the supplies to its US business at this juncture.
 The shares of Aurobindo Pharma were trading at Rs 484.50 apiece on BSE, down 4.49 per cent from the previous close. SID ANS
ANS

USFDA cautions Aurobindo Pharma's oral solids formulation facility of regulatory action

Pharmaceutical major <a href="http://www.businessinsider.in/searchresult.cms?query=Novartis">Novartis India</a> reported a 600% jump in its net profit at Rs 103.82 crore for the quarter ended September 30, 2015 on the back of slump sale of its OTC division to GlaxoSmithKline Plc for Rs 109.7 crore. It had posted a net profit of Rs 14 crore a year ago. 
 
The stand-alone total income from operations of the company declined 4.4% to Rs 224.43 crore during the reported quarter, from Rs 234.79 crore in the year-ago period. 
 "Proceeds of Rs 1,09.7 crore from slump sale of the OTC division to GSK CPL has been accounted for in the quarter ended September 30, 2015 results," <keyword id="69388" type="COMPANY" weightage="20" keywordseo="Novartis">Novartis</keyword> said in a statement. 
 
In January, its board had approved a slump sale of OTC business to <a href="http://www.businessinsider.in/searchresult.cms?query=GSK+consumer">GSK Consumer</a>. 
 
According to the company, sale of company’s OTC business in India follows the divestment of Novartis AG’s global OTC business, including all of Novartis AG’s major OTC patents, trade-marks and R&amp;D assets. 
 
Its parent Novartis AG also recently agreed to create a consumer healthcare joint venture with GlaxoSmithKline in which GSK will own a 63.5% stake while Novartis will own the remaining 36.5%. 
 
Last year, another deal was signed between Novartis and GSK where GSK will acquire Swiss major's vaccine business for $7 billion, while Novartis will purchase GSK's cancer drugs portfolio. The two companies will also combine their over-the-counter drug businesses under Glaxo’s management. 
 
In April last year, Novartis had agreed to divest its global animal health business to Lilly by transferring it to Elanco India, an affiliate of Lilly. 
 
"Proceeds of Rs 86.6 crore from slump sale of the animal health division to Elanco India have not been accounted for in the quarter as the transaction is subject to legal and regulatory approvals," Novartis said in the statement. 
 
In January this year, Novartis AG completed sale of its animal-health division to Eli Lilly &amp; Co for $5.4 billion as part of the Swiss drug giant’s portfolio overhaul. 
 
The sale of the animal-health division is part of a complex overhaul of Novartis that will enable it to focus on three core businesses—pharmaceuticals, eye care and generic drugs. 
 
Of late, <a href="http://www.businessinsider.in/searchresult.cms?query=pharma">Indian pharmaceutical sector</a> has been seeing intense M&amp;A activity. In March, <a href="http://www.businessinsider.in/searchresult.cms?query=Sun+Pharmaceutical+Industries+">Sun Pharmaceutical Industries</a> completed a $3.2 billion acquisition of <keyword id="82365" type="CITY" weightage="20" keywordseo="Ranbaxy-Laboratories">Ranbaxy Laboratories</keyword> Ltd to create India’s largest drug maker, with a local market share of 10%, and the world’s fifth-biggest generic pharmaceutical firm by revenue. 
 
The deal was closed after Sun Pharma faced mounting challenges procuring approvals from authorities including the courts, capital markets regulator and anti-trust watchdogs in India and the US. Sun Pharma and Ranbaxy also overcame allegations of insider trading that cast uncertainty over the deal. 
 
Other Indian pharma firms also have been aggressively looking at acquisitions in order to gain faster and easier access to new territories, increased balance sheet strength and new drug molecules. 
 
In July, Lupin acquired Russia-based ZAO Biocom for an undisclosed amount, entering a country that will be one of the top eight markets for drugmakers by 2018. 
 
The deal followed just two months after Lupin acquired Brazil-based Medquimica Industria Farmaceutica SA. In March 2014, it also purchased Mexican ophthalmic drug maker Laboratorios Grin SA, the fourth-largest pharma company in Mexico, for an undisclosed sum. 
 
In December 2014, Aurobindo Pharma acquired US-based Natrol Inc for $132.5 million for gaining access to the latter’s nutraceutical brands in the US. In January 2014, Aurobindo bought Actavis Plc’s (now Allergan Plc) Western European businesses to gain access to products, infrastructure and a marketing set-up in seven European countries. 
 
Domestic M&amp;A activities have also been gaining traction among drugmakers as they have been trying to leverage favourable valuations. In May this year, Torrent Pharma acquired ZYG Pharma Pvt Ltd that manufactures dermatological formulations such as creams, ointments, gels and lotions. This came after its December 2013 acquisition of Mumbai-based Elder Pharmaceuticals Ltd for around Rs 2,000 crore that gave it access to Elder’s brands in women’s healthcare, pain management and nutraceuticals. 
 
In addition, <a href="http://www.businessinsider.in/searchresult.cms?query=cadila">Cadila Healthcare</a> recently emerged the front-runner to snap the generic sterile injectables business of Ahmedabad-based Claris Lifesciences Ltd. 
 
Outbound M&amp;As in the pharma sector have specifically been driven by an increasing appetite among drugmakers for acquiring firms that have approved facilities outside the country and whose products are sold in expanding overseas markets. Indian drugmakers have also been looking for intermediaries and distributors with established, large distribution and marketing networks as snapping such players would help them market own products in international geographies. 
 
The series of acquisitions has also enlivened investors’ interest in pharma companies. 
 
Over the last year, Singapore’s Temasek Holdings has invested as much as $600 million to buy stakes in Intas Pharmaceuticals, Glenmark Pharmaceuticals and Sun Pharmaceutical Industries. 
 
According to a recent study by PricewaterhouseCoopers, India is expected to be one of the top 10 pharmaceutical markets by sales and reach a value of around $50 billion by 2020. 
 
Indian pharma firms are already among the global leaders in producing generics, accounting for more than 20% of the world’s generics. According to PwC, around $70 billion worth of drugs are expected to go off patent in the US over the next three years, and India is capable of manufacturing a substantial share of the product to support the resulting generics opportunities.

Indian pharma sector is going through an interesting phase with Novartis being the latest

<ul><li>The SGX Nifty was trading nearly a percent higher, indicating a positive start for the Sensex and Nifty50.</li><li>Here's a list of stocks to watch out for in trade today.</li><li><a href="https://www.businessinsider.in/">Check out the latest news and updates on Business Insider.</a> </li></ul>Amid positive cues from the global market, Indian stock-market indices are likely to open higher on Thursday. At 8:05 am, the SGX Nifty was trading nearly a percent higher, indicating a positive start for the Sensex and Nifty50. On Wednesday, the <keyword id="70622" type="ORGANIZATION" weightage="20" keywordseo="Dow-Jones-Industrial-Average">Dow Jones Industrial Average</keyword> gained 1.05%, to 27,976.84 points. These are the stocks to watch out for during the trading session on August 13: Tata Power The board of Tata Power has approved the merger of its wholly-owned subsidiary Coastal Gujarat Power Ltd, into the parent company to provide financial relief as it continues to face losses. Gujarat Power operates the ultra mega power plant at Mundra. Besides that, the company on Wednesday posted a consolidated net profit of ₹268 crore, up 10% compared to the same quarter last year. The shares of Tata Power ended nearly 3% higher yesterday. <keyword id="146218" type="COMPANY" weightage="20" keywordseo="Britannia-Industries">Britannia Industries</keyword> According to a stock-exchange filing Britannia Industries has allotted ‘commercial papers’ for an aggregate amount of ₹300 crores on August 12, with tenure of 12 months. Commercial paper is an unsecured debt instrument issued typically for the financing of a firm’s short-term liabilities. The shares of Britannia Industries ended over 2% lower yesterday. <keyword id="6357252" type="COMPANY" weightage="20" keywordseo="Hero-MotoCorp">Hero MotoCorp</keyword> Hero MotoCorp is slated to report its first quarterly earnings, today. According analysts, the company is expected to see a 66% revenue dip, and over 88% fall in its profit. The shares of Hero MotoCorp ended over 2% higher yesterday. Ashok Leyland <keyword id="120582" type="COMPANY" weightage="20" keywordseo="Hinduja-Group">Hinduja Group</keyword> flagship firm Ashok Leyland reported a consolidated net loss of ₹388.82 crore for the first quarter ended June 30. The company’s revenue from operations in April-June 2020 significantly declined to ₹1,486.04 crore as compared with ₹6,588.23 crore in the year-ago period. The shares of Ashok Leyland ended nearly 4% higher yesterday. Aurobindo Pharma Drugmaker Aurobindo Pharma’s net profit was up 22.81% to ₹780.68 crore for the quarter ended on June 30, 2020, mainly on account of robust sales in the US market. The shares of Aurobindo Pharma ended nearly 1% lower yesterday. <keyword id="6363556" type="DOMAIN" weightage="20" keywordseo="indiabulls">Indiabulls</keyword> Housing Finance Sameer Gehlaut has stepped down as the Executive Chairman of Indiabulls Housing Finance (IBH). The company has appointed former RBI deputy governor SS Mundra as its non-executive chairman with immediate effect. The shares of Indiabulls Housing Finance ended over 2% higher yesterday. Mahindra &amp; Mahindra Financial Services Mahindra &amp; Mahindra Financial Services has raised ₹3,088.82 crore through a rights issue which was oversubscribed approximately 1.3 times. The rights issue of the deposit-taking non-banking finance company closed on Tuesday. The shares of Mahindra &amp; Mahindra Financial Services ended nearly 1% higher yesterday. Eicher Motors, GAIL India, Grasim Industries, Aditya Birla Fashion These companies are slated to report their first quarterly earnings today. SEE ALSO:<a href="https://www.businessinsider.in/india/news/interglobe-aviation-indigo-shares-gained-over-9-after-the-company-decides-to-lease-back-12-of-its-aircrafts/articleshow/77500385.cms" data-type="tilCustomLink"> IndiGo shares rally over 9% after the company decides to lease back 12 of its aircrafts</a> <a href="https://www.businessinsider.in/tech/news/it-only-takes-50-tweets-to-find-a-troll-on-twitter/articleshow/77512151.cms" data-type="tilCustomLink">It only takes 50 tweets to find a troll on Twitter</a>

Top stocks to watch today— Britannia, Hero MotoCorp, Ashok Leyland, M&M Financial, Indiabulls Housing and more

New Delhi, Mar 12 () As the market rout continued, as many as 1,180 stocks, including Reliance Industries, Tata Consultancy Services and HDFC Bank, touched their 52-week low levels on Thursday. Despite this, shares of 13 companies, including Ruchi Soya Industries and Apollo Finvest (India) Ltd, managed to make gains and hit 52-week high levels on the BSE. After nosediving over 3,204.30 points during the day, the BSE's benchmark Sensex settled 2,919.26 points or 8.18 per cent lower at 32,778.14 as the coronavirus pandemic wreaked havoc on global markets. "Recession fears increased after WHO declared coronavirus a pandemic which forced investors to sell-off risky assets. Fresh travel bans across nations is contributing to the fears that economic impact will be much larger than earlier estimates," said Vinod Nair, Head of Research at Geojit Financial Services. Apart from RIL, TCS and HDFC Bank, shares of Hero MotoCorp, GAIL, ACC, ABB, BEML, Glenmark Pharmaceuticals and Gillette, also featured among those that touched their 52-week low levels on BSE. Besides, Axis Bank, Bajaj Auto, Bank of Baroda, BHEL, HDFC, HCL Technologies and Aurobindo Pharma also hit their 52-week low levels. SP RUJRVK

RIL, TCS, HDFC Bank among 1,180 stocks to hit 52-week low

<ul class="summary-list"><li>As millions of anxious American look for <keyword id="6354774" type="ORGANIZATION" weightage="60" keywordseo="Mental-health">mental health</keyword> resources, supplies of America's most popular antidepressant are running low.</li><li>The FDA said that Zoloft, or the generic sertraline, is in short supply because of increased demand.</li><li>According to <a href="https://www.bloomberg.com/news/articles/2020-06-01/zoloft-falls-into-shortage-as-virus-heightens-supply-strains?sref=9f0rXTjL">Bloomberg</a>, a record-setting 4.9 million people got Zoloft prescriptions in March, the most ever in the US.</li></ul>Zoloft is one of America's most popular <keyword id="40993" type="PERSON" weightage="60" keywordseo="antidepressants">antidepressants</keyword>, and it's now in short supply because of the psychological toll of the pandemic, according to <a href="https://www.bloomberg.com/news/articles/2020-06-01/zoloft-falls-into-shortage-as-virus-heightens-supply-strains?sref=9f0rXTjL">Bloomberg.</a>The pandemic has taken a psychological toll on many people, and recent Census Bureau data showed <a href="https://www.insider.com/a-third-of-americans-experiencing-mid-pandemic-anxiety-or-depression-2020-5">a third of Americans</a> are experiencing symptoms of anxiety and depression, which is almost double the amount of Americans reporting those symptoms in 2014.Now the <a href="https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sertraline+Hydrochloride+Tablets&amp;st=c&amp;tab=tabs-4&amp;panels=0amp;panels=0">FDA</a> says that sertraline, sold under the brand name Zoloft, is becoming a rare commodity.According to <a href="https://www.bloomberg.com/news/articles/2020-06-01/zoloft-falls-into-shortage-as-virus-heightens-supply-strains?sref=9f0rXTjL">Bloomberg</a>, a record-setting 4.9 million people got Zoloft prescriptions in March, the most ever in the US. This was an increase of 12% from last year.The prescription-only medication is used to treat depression, panic disorder, post-traumatic stress disorder, and a number of other mental illnesses. It works by <a href="https://www.mayoclinic.org/drugs-supplements/sertraline-oral-route/description/drg-20065940">increasing the amount of serotonin,</a> a chemical that works as a natural mood stabilizer, that goes to the brain.<h2>Companies that produce generic sertraline aren't able to get enough ingredients needed to make the drug</h2>According to the FDA website, sertraline producer Accord Healthcare says it is dealing with a shortage because it does not have enough of the drug's active pharmaceutical ingredients to create it. Without those ingredients, sertraline cannot be manufactured. Both Lupin Ltd and Pfizer, the manufacturer of name-brand Zoloft, also said that some of its products were going to be in short supply.InvaGen Pharmaceuticals has some versions of its product on backorder, while Aurobindo Pharma says it has enough supply to handle current and future demand increases. Other alternatives to Zoloft include Prozac, Celexa, or Lexapro, which are part of the same class of medications.

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Aurobindo Pharma join hands with US-based company Covaxx to develop COVID-19 vaccine for India

PTI

Aurobindo Pharma gets EIR with VAI status from USFDA for Hyderabad facility

PTI

USFDA cautions Aurobindo Pharma's oral solids formulation facility of regulatory action

PTI

Indian pharma sector is going through an interesting phase with Novartis being the latest

Preetam Kaushik

Top stocks to watch today— Britannia, Hero MotoCorp, Ashok Leyland, M&M Financial, Indiabulls Housing and more

Navdeep Yadav

RIL, TCS, HDFC Bank among 1,180 stocks to hit 52-week low

PTI

Zoloft is in short supply as anxious Americans reach for antidepressants during the pandemic

Shira Feder

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