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EquityPandit

EquityPandit
MARKETS

Granules India Shares Crash 4% as USFDA Issues Six Observations 

After conducting the inspection, the USFDA issued a Form 483 with six observations.

Shares of Granules India Ltd crashed 4% on 9 September after the company announced receiving six observations from the US Food and Drug Administration (USFDA). 

The US regulator conducted an inspection at the company’s Gagillapur facility in Hyderabad, Telangana, between 26 August and 6 September. The inspection covered both Pre-Approval Inspection (PAI) and Current Good Manufacturing Practices (cGMP). 

After conducting the inspection, the USFDA issued a Form 483 with six observations. 

The company said that they will address these observations promptly and will submit their responses to the US health regulator within the stipulated timeline. 

Earlier in August, the company’s wholly-owned subsidiary, Granules Pharmaceuticals Inc. received approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL.

The Glycopyrrolate Oral Solution 1mg/5mL is a bioequivalent and therapeutically equivalent to Merz Pharmaceuticals’ Cuvposa Oral Solutions 1 mg/5 ml. 

At 3:30 pm, the shares of Granules India closed 2.22% lower at Rs 672.85 on NSE.

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EUROPE

BioNTech Covid-19 Vaccine Effective Against New Coronavirus Strain

Amrita Chakravorty

BioNTech CEO Ugur Sahin said on Monday he was confident a COVID-19 vaccine co-developed by his company would be effective against a variant of the coronavirus that has emerged in Britain.
He said on Bild TV that the German company would investigate the mutation in the coming days but that he viewed the matter with “with a degree of soberness”.
Countries across the globe shut their borders to Britain on Monday due to fears about a highly infectious new coronavirus strain, causing travel chaos and raising the prospect of food shortages in the United Kingdom.
Sahin was speaking shortly after the European Union cleared regulatory hurdles for the vaccine, co-developed with Pfizer, to be rolled out after Christmas.
The note of calm from the CEO about the UK mutation echoed the World Health Organization, which cautioned against major alarm, saying this was a normal part of a pandemic’s evolution.
Sahin said he hadn’t yet been immunized but would like to be. He said it was more important that his employees get the vaccine so they can continue to do their jobs.

EUROPE

New Coronavirus Strain ‘Out of control’ in UK, Govt Calls Meet

Amrita Chakravorty

The Union health ministry on Sunday called an urgent meeting of its Joint Monitoring Group (JMG) after a new strain of the coronavirus disease (Covid-19) surfaced in the United Kingdom.
The Director General of Health Services (DGHS), will hold a meeting on Monday morning to discuss the issue of the mutated variant of the coronavirus reported from the UK. WHO’s India representative Dr. Roderico H Ofrin, who is also a member of the JMG, is likely to participate in the meeting.
According to the health ministry website, the JMG has been formed to review regularly the global/ Indian situation and provide recommendations on technical matters to the ministry. It would also monitor the outbreak situation.
Belgium and the Netherlands suspended flights from the UK on Sunday and several other countries were weighing similar measures to stop a new, fast-spreading virus strain that UK PM Boris Johnson says is up to 70% “more transmissible” and other UK authorities describe as “out of control”.
Around 16.4 million people entered the strictest “tier four” measures from Sunday, or 31 percent of England’s population.
European countries began closing their borders to travelers from the United Kingdom as British health secretary Matt Hancock said on Sunday that the government has imposed a strict Christmas lockdown in London and southeast England because the new strain of the coronavirus was “out of control”.
Scientists first discovered the new variant in a patient in September, Susan Hopkins of Public Health England told Sky News. She confirmed the figure given by Johnson that the new virus strain could be 70 percent more transmissible while saying this was an initial figure.

EUROPE

AstraZeneca Vaccine Set to Clearance by Year-End

Amrita Chakravorty

The Oxford University vaccine against COVID-19 being produced by AstraZeneca is likely to get regulatory approval from the UK’s independent regulator by the end of this year for a rollout to begin in early 2021.
The Medicines and Healthcare Regulatory Agency (MHRA), which had been formally tasked by the UK government last month with the process of clearance after the jab emerged safe and effective against the novel coronavirus in human trials, is expected to authorize the vaccine by December 28 or 29 after the final data is provided on Monday.
Authorization by the MHRA will also give confidence to countries across the world. India has already manufactured more than 50 million of the AstraZeneca vaccines, the newspaper notes.
In India, the vaccine is being produced as part of a tie-up with the Serum Institute of India.
Health officials in the UK hope that the authorization of the Oxford jab will prove a game-changer, allowing vaccines to be transported and administered far more easily compared to the Pfizer/BioNTech vaccine which must be stored at very cold temperatures.
The Oxford vaccine can be stored in normal refrigerators but like the Pfizer vaccine, it also requires two doses with a three-week gap between the two doses for the Pfizer jabs and a four-week gap for the Oxford/AstraZeneca vaccine.
The Oxford/AstraZeneca, AZD1222, the vaccine has taken longer for regulators to assess because of differences in the efficacy rates found in different groups, ranging from 62 to 90 per cent.

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