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By Emily Hayes 18 Sep 2017
An 'imperfect biomarker' – that's how a New England Journal of Medicine editorial describes the eosinophil count used in METREX and METREO studies.
Topic Clinical trials
Pink Sheet
By Ian Schofield 16 Sep 2017
Massimo Scaccabarozzi, president of Italy’s Farmindustria and Janssen Italy’s MD, warns that the EMA could lose almost all of its current staff.
Topic Brexit
Pink Sheet
By Cathy Kelly 16 Sep 2017
Biopharma manufacturers, payers and other stakeholders strongly support changing an Obama-era policy for reimbursing biosimilars.
Topic Biosimilars
Pink Sheet
By Brenda Sandburg 16 Sep 2017
Commissioner Gottlieb says FDA is looking to work with provider groups to set dosage based on indication.
Pink Sheet
By Brenda Sandburg 14 Sep 2017
US FDA's preclinical policies should be 'more closely matched to the complexion of modern technologies,' commissioner explains.
Topic Clinical trials
Pink Sheet
By Michael Cipriano 14 Sep 2017
US FDA Commissioner notes that combined-phase clinical trials could be expanded beyond oncology as one way of reducing drug development costs.
Pink Sheet
By Brenda Sandburg 12 Sep 2017
As state attorneys general and Department of Justice move against generic manufacturers, plaintiffs’ firms have filed more than 90 antitrust suits.
Scrip, In Vivo, Pink Sheet, Medtech Insight
07 Sep 2017
What actually keeps biopharma execs up at night? Take our quiz to find out.
Topic Deal trends Diseases Drug development landscape FDA Medtech Personalized Medicine Parkinsons disease Reimbursement
Pink Sheet
By Vibha Sharma 06 Sep 2017
The European Medicines Agency’s pharmacovigilance committee has recommended the withdrawal of all modified-release paracetamol products from the EU market.
Pink Sheet
By Ian Schofield 06 Sep 2017
Massimo Scaccabarozzi, president of Italy’s Farmindustria, warns that the EMA could lose almost all of its current staff.
Topic Brexit
Pink Sheet
By Michael Cipriano 01 Sep 2017
Merck previously disclosed the clinical hold on the three trials at the beginning of July
Topic Clinical trials
Pink Sheet
By Cathy Kelly 01 Sep 2017
The Centers for Medicare and Medicaid Services will only pay for Kymriah if patients respond after one month.
Topic Reimbursement
Pink Sheet
By Brenda Sandburg 31 Aug 2017
AbbVie seeks injunction against Boehringer Ingelheim's Cyltezo claiming infringement of 74 patents.
Topic Biosimilars
Pink Sheet
By Ian Schofield 31 Aug 2017
Recent evidence indicates that using DAAs together with warfarin, a vitamin K antagonist, may result in changes in the INR.
Topic Drug review
Pink Sheet
By Ian Schofield 23 Aug 2017
A position paper from the UK government has laid out some ideas for ensuring a smooth transition to a post-Brexit world in the area of regulation.
Topic Brexit
Pink Sheet
21 Sep 2017
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