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19 Total results for product and free and sample content found

Pink Sheet

Pharma Industry Still Not At 'Tipping Point' In Adopting Continuous Manufacturing

By Joanne Eglovitch 26 Apr 2017

Regulators and industry officials agree that despite efforts to spur development of continuous manufacturing, uptake has been slow globally. FDA still is on learning curve and acknowledges a knowledge gap around some of the higher order principles associated with continuous manufacturing.

Topic BioPharmaceutical

Pink Sheet

Pharma Firms Spend ‘Billions’ On Failing: More Collaboration Needed On Innovation

By Ian Schofield 26 Apr 2017

Speakers at a DIA EuroMeeting session on the challenges and opportunities facing regulators in the years to come discussed several options including more proactive engagement by regulators, more sharing by drug sponsors, and being innovative across the whole of the regulatory landscape.

Medtech Insight

Starts & Stops: ICS' Emblok Medtronic's Arctic Front, Abbott's Absorb, Boston Scientific's S-ICD

By Reed Miller 24 Apr 2017

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. Over the last month, 31 new trials started, 25 trial were completed, one trial was "reinitiated," and six trials were terminated or suspended, according to meddevicetracker.

Topic Clinical trials Research

Medtech Insight

View Of The IVD Horizon: How Roche Diagnostics Sees The Sector Evolving

By Tina Tan 18 Apr 2017

While the in vitro diagnostics landscape has seen players come and go, Roche Diagnostics has remained at the top. But the Swiss giant, like all its other smaller rivals, is facing a new reality, with increasing pressures to prove medical value, and a more stringent regulatory environment. Medtech Insight spoke to Roche Diagnostics' Jean-Claude Gottraux, head of centralized and point of care solutions, and Jean-Jacques Palombo, lifecycle leader for the company's cardiac, women's health and personalized health care solutions immunoassay portfolio, to gain their perspectives on how the sector has evolved and will continue to evolve. They also spoke about the company's strategy to address these changes and challenges.

Pink Sheet

A Hiring Freeze By A Different Name: OMB Wants Agency 'Workforce Reduction' Plans

By Derrick Gingery 18 Apr 2017

Latest Office of Management and Budget directive lifts the pause on federal hiring, but requires US FDA and others to develop long-term plans to cut staff.

Topic BioPharmaceutical FDA

Pink Sheet

Just Trust Me: Most Firms Unwilling To Publicly Pledge Pricing Restraint

By Cathy Kelly 18 Apr 2017

Public Citizen reached out to the 28 largest biopharma manufacturers after Allergan announced its pricing pledge to see who else might follow suit. The answer was, not many.


Biocad’s Asian Biosimilars Play Undaunted By Roche

By Anju Ghangurde 11 Apr 2017

Biocad has made significant strides in Vietnam with its biosimilar rituximab, and an anticipated “permanent registration” there is expected to unshackle limitations on imported supplies of the product. The Russian company tells Scrip that it is also planning to build its biosimilars presence in other Asian markets.

Topic Biosimilars


ALEX Ups The Ante For Alecensa In ALK+ NSCLC

By Alex Shimmings 11 Apr 2017

Roche's Alecensa has bested Pfizer's Xalkori in the Phase III head-to-head ALEX study in first-line non-small-cell lung cancer, making a strong case for it to be the new gold standard therapy in ALK-positive patients, in favor of Novartis's Zykadia.

Topic Clinical trials Research Company analysis

Pink Sheet

A Look At Payers' Early Game Plans For Driving Biosimilar Use

By Emily Hayes 05 Apr 2017

Interviews with US payers suggest that at first they are more likely to focus on promoting biosimilars in treatment-naïve patients, as opposed to switching those on branded drugs, according to a new Datamonitor report.

Topic Biosimilars

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