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Japan orders Novartis unit to suspend activities

Japanese health authorities said Friday that they have ordered the local unit of Swiss pharmaceutical giant Novartis to temporarily suspend its operations for failing to report drug side effects.

Japan orders Novartis unit to suspend activities
Photo: AFP

The health ministry's 15-day suspension — reportedly a first for a pharmaceutical firm operating in Japan — means the company will not be able to sell most of its drugs during that period, which is to start from March 5.
   
Tokyo-based Novartis Pharma K.K. in December admitted it failed to promptly report more than 3,000 cases of adverse effects from about two dozen company drugs.

Drugmakers are required to report serious side effects to the ministry within 15 to 30 days.
   
The Novartis unit declined to comment when contacted by AFP on Friday.
   
The penalty marks the latest headache for the drugmaker in Japan.
   
In July it was handed a business improvement order for failing to properly report side effects of two leukaemia drugs.
   
Also in July prosecutors laid charges against the unit over claims that falsified data were used to exaggerate the benefits of a popular blood-pressure drug.
   
They also indicted a former employee, Nobuo Shirahashi, alleging he manipulated the data in clinical studies that were later used in marketing the drug Diovan.

The drug's generic name is Valsartan.

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NOVARTIS

Switzerland’s Novartis to help make Pfizer-BioNTech Covid vaccine

Swiss pharmaceuticals giant Novartis said Friday it had signed an initial agreement to help produce the Pfizer-BioNTech vaccine against Covid-19, as countries scramble to boost supplies.

Switzerland's Novartis to help make Pfizer-BioNTech Covid vaccine
Novartis will help manufacture Pfizer vaccine. Photo by AFP.

The rare act of cooperation — in an industry usually marked by cut-throat competition — comes after French pharma group Sanofi announced earlier this week that it would also team up with rivals Pfizer and BioNTech to help produce 125 million doses of their jab.

The two-dose vaccine, which is based on mRNA technology, has been shown to be around 95 percent effective and has been approved for use by the World Health Organization and in some 50 countries.

But it is in limited supply as nations around the world race to immunise their populations against the coronavirus, which has killed nearly 2.2 million people in just over a year.

Novartis said in a statement that it would use its sterilised manufacturing facilities at its site in Stein, Switzerland to help produce the Pfizer-BioNTech jabs.

Under the agreement, the company said it would “take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for their distribution to healthcare system customers around the world”.

Once a final agreement is reached, Novartis said it expected to begin production in the second quarter of the year, with initial shipment of finished product expected in the third quarter.

Steffen Lang, Head of Novartis Technical Operations, stressed that the company was “committed to leverage our manufacturing capabilities to help support the supply of COVID-19 vaccines and therapeutics around the world”.

“We expect this to be the first of a number of such agreements,” he said in the statement.

Novartis said it was already in “advanced discussions” with a number of other companies about with other production tasks, including of mRNA, therapeutic protein and raw material production for Covid vaccines and therapeutics. 

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