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Dubai Airports and GMR Hyderabad agree deal to aid vaccine distribution

Dubai Airports and the operator of Hyderabad airport, GMR Hyderabad, have agreed a logistics deal for COVID-19 vaccine distribution to handle up to 300 tonnes of vaccines per day, the companies said on Monday.

The vaccine corridor between Dubai and Hyderabad connects leading vaccine manufacturers in India with markets around the world through the Dubai International Airport cargo hub.

“A major surge in demand for the efficient, safe and reliable global distribution of high volumes of COVID-19 vaccines is expected in the coming months,” said Paul Griffiths, CEO of Dubai Airports.

“We wanted to be ready to respond to and accommodate that demand.”

Hyderabad is the world’s emerging vaccine capital, with five major vaccine producers in the vicinity.

India, which has the second-highest number of coronavirus infections in the world, on Sunday approved two coronavirus vaccines for emergency use – one developed by AstraZeneca and Oxford University, the other by local company Bharat Biotech.

https://www.reuters.com/article/us-emirates-india-vaccine/dubai-airports-and-gmr-hyderabad-agree-deal-to-aid-vaccine-distribution-idUSKBN299165

Private Brazilian clinics to buy COVID-19 vaccine from India's Bharat

Private Brazilian clinics plan to buy 5 million doses of a COVID-19 vaccine developed by Indian company Bharat Biotech, their association said on Monday, one day after India’s health regulator gave it emergency use approval.

Bharat Biotech has not yet applied for approval by Brazil’s health regulator Anvisa for its Covaxin vaccine, and the agency said it would have to undergo Phase III trials in the country.

Geraldo Barbosa, head of the Brazilian Association of Vaccine Clinics (ABCVAC), who will lead a delegation to India departing on Monday, said a memorandum of understanding has already been signed with Bharat Biotech.

“This should be the first vaccine available on the private market in Brazil,” he said.The plan is for the 5 million doses of Covaxin to arrive in Brazil in mid-March, to be sold by private clinics after regulators there approve the vaccine.

Anvisa said in a statement on Sunday that Covaxin does not fit the continuous data submission process for vaccine registration and the vaccine would have to undergo late phase clinical trials in Brazil.

On Sunday, India’s drugs regulator DCGI approved Covaxin and AstraZeneca’s vaccine for emergency use, the first approvals of vaccines in India.

The fast-tracking of the home-grown vaccine faced questions from industry experts and opposition lawmakers because the company has not published efficacy data.

Covaxin is currently undergoing late stage trials in the largest such trial in India. A spokeswoman for Bharat Biotech said 24,000 volunteers have been recruited out of a target of 26,000 for the Phase III trial, which began in November.

The pharmaceutical company, based in Hyderabad in southern India, produces millions of doses of vaccines for hepatitis, Zika, Japanese encephalitis and others illnesses.

In November, Bharat Biotech executives visited Brazil and offered the vaccine and a possible technology transfer partnership.

https://www.reuters.com/article/us-health-coronavirus-brazil-india/private-brazilian-clinics-to-buy-covid-19-vaccine-from-indias-bharat-idUSKBN2991IJ

Dentsply Sirona acquires dental aligner maker Byte for $1.04B

Dental technology supplier Dentsply Sirona Inc has acquired Byte, a maker of custom teeth aligners, for $1.04 billion in cash, the companies said on Monday.

Los Angeles-based Byte is an online company that provides patients access to at-home clear aligner kits for teeth.

Rival SmiledirectClub began selling aligners directly to customers last year.

Dentsply Chief Financial Officer Jorge Gomez expects the transaction to add to the company's long-term financial commitments.

Byte Chief Executive Officer Neeraj Gunsagar and the company's existing management team will continue to operate the business, the companies said in a statement.

https://www.marketscreener.com/quote/stock/DENTSPLY-SIRONA-INC-40311122/news/Dentsply-Sirona-acquires-dental-aligner-maker-Byte-for-1-04-bln-32115497/

Bharat Biotech says approved COVID shot trials 'honest'

A top executive at an Indian biotechnology company defended its COVID-19 vaccine candidate, approved for emergency use by the government, and said it will produce efficacy data from late-stage trials by March.

The vaccine, COVAXIN, received emergency use approval from India's drugs regulator on Sunday, but the move faced questions after the regulator took the step without publishing information about its efficacy.

Hyderabad-based Bharat Biotech had carried out "200 percent honest clinical trials", Krishna Ella, chairman and managing director, told reporters an online address on Monday.

Ella highlighted the company's experience and expertise in producing vaccines, its numerous patents and its presence in 123 countries.

The approval for COVAXIN, jointly developed with a government institute, was hailed by Prime Minister Narendra Modi and his ministers as a success in India's self-reliance push.

Efficacy data from the company's ongoing late-stage trial should be available by March, Ella said.

Health Minister Harsh Vardhan clarified on Twitter on Sunday that the emergency use approval for COVAXIN was "in clinical trial mode", wherein all recipients of the vaccine would be tracked and monitored as if they were in trial.

The company is also investing in four manufacturing facilities and is planning to make around 200 million doses in Hyderabad and 500 million doses in other cities this year. The company has 20 million available doses so far.

India has the second-highest number of coronavirus infections in the world, though cases have been steadily falling since a peak in September.

India also approved the use of a vaccine developed by AstraZeneca and Oxford University which will be the lead vaccine in the country's immunisation programme.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Bharat-Biotech-says-approved-COVID-shot-trials-honest-32116541/

EMA Validates Two Applications for Expanded Bristol Opdivo Approval

Bristol Myers Squibb Co. on Monday said the European Medicines Agency has validated a pair of applications seeking expanded approval of its cancer drug Opdivo.

The New York biopharmaceutical company said validation confirms that the filings are complete and begins the agency's centralized review process for the applications.

Bristol Myers is seeking approval of Opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adults with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma.

The company is also seeking approval for Opdivo as an adjuvant treatment for esophageal or gastroesophageal junction cancer in adults with residual pathologic disease after neoadjuvant chemoradiotherapy and resection.

Opdivo, which harnesses the body's own immune system to fight cancer, is currently approved in more than 65 countries across multiple cancers.

https://www.marketscreener.com/quote/stock/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-EMA-Validates-Two-Applications-for-Expanded-Opdivo-Approval-32116766/