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In chasing down rare cancers, Pfizer has used real-world evidence to turn up hard-to-treat and minuscule patient populations—and win a niche FDA approval for Ibrance along the way. Now Pfizer's touting more real-world data to support the fast-growing drug's case. [...]
Wed, Dec 11, 2019
Source FiercePharma
Sanofi, which has moved purposefully into high technologies to get more from its manufacturing, will lean even more on that strategy to save costs and fatten margins. Using robotics, artificial intelligence and new generation manufacturing should save it half a billion euros in annual costs by 2022. [...]
Wed, Dec 11, 2019
Source FiercePharma
In a quiet, last-minute deal during North American trade talks, the Trump administration agreed to scrap rules protecting biologic drugs from copycat competition. Instead, the three countries could set their own rules, potentially opening big brands up to earlier-than-expected biosim rivals. [...]
Wed, Dec 11, 2019
Source FiercePharma
Sanofi's new CEO Paul Hudson predicted this week that its eczema drug Dupixent would be an $11 billion blockbuster. But competition is brewing—a risk that became all too apparent Tuesday, when rival Dermira said the FDA had fast-tracked its phase 3 eczema drug. [...]
Wed, Dec 11, 2019
Source FiercePharma
Officials have confirmed an outbreak of bird flu in Suffolk, but stress the risk to the public is low [...]
Wed, Dec 11, 2019
Source PharmaTimes
The drug has hit survival and disease progression targets in Phase III trials [...]
Wed, Dec 11, 2019
Source PharmaTimes
Children with cystic fibrosis as young as six months with certain mutations can now access the treatment [...]
Wed, Dec 11, 2019
Source PharmaTimes
AstraZeneca
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today presented positive detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody drug conjugate (ADC) and potential new medicine, in patients with HER2-positive metastatic breast cancer who received two or more prior HER2-targeted [...]
Wed, Dec 11, 2019
Source WorldPharmaNews
The main reason for not sharing DNA for drug research is the fear it could be used without knowledge for corporate gain [...]
Wed, Dec 11, 2019
Source PharmaTimes
Chronic inflammatory bowel diseases, such as Crohn's Disease and ulcerative colitis, are linked to abnormalities of the gut microbiota in humans and in animals. Patients generally present reduced bacterial diversity in their intestinal flora along with excessive levels of bacteria that express a protein called flagellin, which favors their mobility. [...]
Wed, Dec 11, 2019
Source WorldPharmaNews
Novartis
Novartis holded an investor event in London to provide a comprehensive overview of the company's progress in advancing its industry-leading R&D pipeline. Vas Narasimhan, CEO of Novartis, said “Novartis had a year of breakthrough innovation in 2019, with five potential blockbuster NME approvals. The near term brings yet another catalyst-rich [...]
Tue, Dec 10, 2019
Source WorldPharmaNews
A team of scientists from Peter the Great St.Petersburg Polytechnic University (SPbPU) together with their colleagues developed a method of targeted drug delivery to cancer cells. The discovery is based on the use of mesenchymal stem cells and microcapsules made of polymeric compounds. [...]
Tue, Dec 10, 2019
Source WorldPharmaNews
Sponsors submitting pediatric study plans should consider whether a product affects adults and children similarly when choosing an approach, the FDA says. [...]
Fri, Jan 16, 2015
Source FDANews