First oral blood thinner for children wins FDA approval 

FDA has approved Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) oral pellets for children with venous thromboembolism who are between three months and under 12 years old.

The indication stipulates that children receiving Pradaxa have received prior treatment with an injectable blood thinner given by injection for at least five days.

FDA has also approved Pradaxa in capsule form to treat blood clots in patients eight years and older with venous thromboembolism. That approval also requires that the patients receive a prior injectable blood thinner for at least five days. FDA has also approved the use of Pradaxa to prevent recurrent clots in patients eight and older who finished treatment for their first venous thromboembolism.

Besides Pradaxa, there is no other approved oral blood thinner for children.

The drug first won FDA approval in 2010 to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation.

“The F…

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Novatek requalified as a supplier for Boehringer Ingelheim’s aseptic manufacturing facilities

Environmental monitoring software developer Novatek (Quebec, Canada) has extended its partnership with Boehringer Ingelheim. In particular, Novatek has announced that it has won reapproval from the drugmaker to use its software in its human pharma, animal health and biopharmaceutical aseptic (sterile) manufacturing sites internationally.

“We are excited to announce that Novatek is requalified as an approved supplier of Boehringer Ingelheim for Novatek’s Environmental Monitoring Software around the world,” said Mazda Famili, vice president quality at Novatek International, in a statement. 

Ingelheim, Germany–headquartered Boehringer Ingelheim is the world’s largest private pharma company.

Boehringer Ingelheim selected Novatek as an approved vendor and partner in 2017. 

Novatek’s software supports the management of multiple critical aspects within quality-controlled environments. Novatek’s environmental monitoring management software supports labeli…

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Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society. 

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)

Get the full picture from our sister site, Drug Discovery & Development. 

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Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]

The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society. 

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)

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6 notable pulmonary fibrosis research efforts 

Image courtesy of Pixabay

Idiopathic pulmonary fibrosis (IPF) is frequently a debilitating disease associated with significant morbidity and mortality. Although a rare disease, its incidence has increased in recent decades, and it leads to more deaths than some cancers. 

The treatment landscape for the condition changed in 2014 when FDA approved the first drugs indicated for IPF, nintedanib from Boehringer Ingelheim and pirfenidone from Roche (OTCMKTS:RHHBY). 

[Related: The pulmonary fibrosis treatment landscape: An expert interview]

Research on pulmonary fibrosis has increased in recent years. 

Here’s a summary of notable IPF research: 

Boehringer Ingelheim has an international study investigating a phosphodiesterase 4b (PDE4b) inhibitor in patients with idiopathic pulmonary fibrosis. Researchers have found that the drug has anti-fibrotic effects in animal models and lung fibrosis …
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