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FDA rejects Intarcia’s hotly promoted diabetes drug/device, citing manufacturing issues

Boston-based Intarcia Therapeutics became the latest casualty of the FDA’s manufacturing standards. The agency has rejected Intarcia’s implanted diabetes drug/device, which company execs have long insisted is on a straight path to blockbuster sales.
- Source: Endpts
- 426
- September 29, 2017
Company Insight diabetes implanted
Two Scientists Nab Another $20 Million for Their CRISPR Biotech Eligo Bioscience

Eligo Bioscience, the French microbiome company developing drugs to prevent and treat bacteria-associated diseases, has secured a $20 million Series A round of financing from Khosla Ventures and Seventure Partners, including a $2 million award from the Worldwide Innovation Challenge. This comes just months after Eligo was selected as one of the 30 Most Innovative Companies in 2017 by the World Economic Forum. This funding will enable Eligo to strengthen its biotherapeutic platform, begin clinical trials for its lead indication and extensively grow its international team of scientists, engineers, and executives.
- Source: Biospace
- 525
- September 29, 2017
Market Views microbiome Series
Novo Nordisk’s new-generation basal insulin Tresiba® approved in China

Novo Nordisk announced that the China Food and Drug Administration (CFDA) has approved Tresiba® (insulin degludec) for the treatment of diabetes in China. Tresiba® is a new-generation, once-daily basal insulin with an ultra-long duration of action which allows for flexibility in day-to-day dosing.
- Source: Novonordisk
- 544
- September 29, 2017
CFDA diabetes New Approvals Tresiba
Innovative Business Development Strategies for the Modern Medical Trade

International business development has been reliant on a couple of trusty old work horses for some time now. Google, development letters and site visits have lead the charge and they are very effective when used correctly. They can however, be costly and time consuming and with the ever-changing world that we live in. New ways of development are constantly making an appearance and if you want your business to prosper, adaptation is key.
- Source: Ddu
- 566
- September 28, 2017
business development Ddu College
Boehringer’s new risk-prediction model will tap patients who could be good Jardiance candidates

Boehringer Ingelheim has reason to believe its diabetes medication Jardiance can help fend off cardiovascular death, kidney failure and hospitalization for heart failure. And now, it’s developing a model to help predict which patients are best suited for treatment with the therapy.
- Source: company insights
- 559
- September 28, 2017
cardiovascular Company Insight diabetes kidney
Siemens gets CE-Mark for new diagnostic solution

Siemens Healthineers has received CE-Mark for its new Atellica Solution with immunoassay and chemistry analysers, which will allow commercial launch in Europe.
- Source: medicaldevice-network
- 545
- September 28, 2017
CE IVD New Approvals
Amgen And Simcere Announce Strategic Collaboration To Co-Develop And Commercialize Biosimilars In China

Amgen and Simcere Pharmaceutical Group today announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology.
- Source: Amgen
- 643
- September 28, 2017
biosimilar inflammation Market Views oncology
Merck’s Keytruda resumes regulatory hot streak with stomach cancer approval

Just a few months after Merck’s monster May for Keytruda, which featured three FDA approvals, the New Jersey drugmaker is back with another green light.
- Source: Fiercepharma
- 714
- September 27, 2017
cancer FDA keytruda Merck
Pfizer launches upstart with $103M, phase 3-ready drugs

In a first for the Big Pharma and as part of a new model, Pfizer is taking drugs from its shelves and licensing them to, while investing in, its SpringWorks Therapeutics startup.
- Source: Fiercebiotech
- 574
- September 27, 2017
Clinical Trials Pfizer Series
J&J lines up its 4-in-1 HIV pill for FDA behind rivals from Gilead, GSK

A couple of months after posting positive late-stage data for its quadruplet-in-one-pill for quelling HIV, J&J says it’s filed a marketing application with the FDA ahead of a planned marketing campaign.
- Source: Endpts
- 553
- September 27, 2017
FDA Gilead GSK HIV J&J Market Views

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