Indian regulator seeks feedback from stent makers, importers on price caps | EU approves Boehringer Ingelheim's biosimilar version of Humira | Sandoz reports clinical trial data on 2 biosimilars
November 16, 2017
DIA Global SmartBrief
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Indian regulator seeks feedback from stent makers, importers on price caps
Stent manufacturers and importers in India were asked by the National Pharmaceutical Pricing Authority to submit feedback on the issue of coronary stent pricing by Dec. 31. The regulator is expected to revisit its order fixing ceiling prices of the stents in the first two months of next year.
PharmaBiz (India) (11/13) 
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7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
EU approves Boehringer Ingelheim's biosimilar version of Humira
Boehringer Ingelheim's Cyltezo, or adalimumab, a biosimilar version of AbbVie's Humira, was granted European approval to treat inflammatory diseases including Crohn's disease, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis. A comprehensive data package comprising analytical, pharmacological, nonclinical and clinical data supported the biosimilarity of Cyltezo to Humira.
PharmaTimes (U.K.) (11/14) 
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Sandoz reports clinical trial data on 2 biosimilars
Novartis unit Sandoz reported that its biosimilar version of adalimumab had safety and efficacy profiles similar to those of AbbVie's Humira, and its rituximab matched the safety and efficacy of Roche and Biogen's Rituxan.
Reuters (11/14) 
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Asia Pacific
Lupin warned by US FDA over quality violation in 2 facilities
The US FDA issued a warning letter to Lupin for repeatedly ignoring tests demonstrating that pills produced at two of its facilities didn't meet quality standards. The agency found that in 2015 and 2016, Lupin ignored results 134 times that showed its pills or active ingredients failed initial tests, and at another plant, the company deleted failing sample results and retested to get a passing result.
LiveMint (India) (11/15) 
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Genedrive makes distribution deal with Sysmex Asia Pacific for hepatitis C kit
A distribution deal has been completed between Sysmex Asia Pacific and Genedrive for marketing rights to the latter's HCV ID kit and PCR platform for the Asia Pacific region. The partners plan to pursue regulatory approvals in a number of Asian countries for the assay.
GenomeWeb Daily News (free registration) (11/14) 
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India updates rising number of dengue, malaria, chikungunya cases
India updates rising number of dengue, malaria, chikungunya cases
(Mario Tama/Getty Images)
The number of confirmed cases of dengue in India has reached 8,063, with 4,188 of those located in Delhi. Indian health officials also reported that the number of recorded cases of malaria as of Saturday stands at 1,106, while the number of chikungunya cases has reached 855.
The Indian Express (India)/Press Trust of India (11/13) 
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Viewpoints on Innovation
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North America
FDA approves Abilify pills embedded with digital tracker
The FDA approved a formulation of Otsuka Pharmaceutical's mental health drug Abilify that contains a tracking device developed by Proteus Digital Health. The device is activated by stomach juices and sends a signal to a wearable patch, which transmits data to a smartphone application, in an effort to help with medication regimen compliance.
Reuters (11/14) 
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Group names 9 countries on track to wipe out hepatitis C by 2030
The US is one of 22 countries engaged in the elimination of the hepatitis C virus, but only nine nations are making progressive headway toward total elimination by 2030, according to the Polaris Observatory, which provides data on hepatitis B and C elimination. Australia, Egypt, France, Georgia, Germany, Iceland, Japan, the Netherlands and Qatar are slated to eliminate HCV by 2030, the target date set by the World Health Organization.
MD Magazine online (11/13) 
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Use of seasonal malaria chemoprevention in West Africa proves effective
Seasonal malaria chemoprevention, an older process that involves providing patients with a monthly combination dose of antimalarial drugs during the rainy season, was found to reduce the prevalence of malaria in West African children by up to 84%, according to data reported at a meeting of the American Society of Tropical Medicine and Hygiene. Seasonal malaria chemoprevention involves combining three drugs, sulphadoxine, pyrimethamine and amodiaquine, which will not negate the efficacy of the malaria drug artemisinin once that is taken.
Nature (free content) (11/10) 
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DIA News
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Editor's Note
A summary that ran Nov. 14 incorrectly identified the company that developed the multiple sclerosis drug Mavenclad. The company should have been listed as Merck KGaA, Darmstadt, Germany. SmartBrief regrets the error.
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